MDedge Dermatology

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

A version of this article first appeared on Medscape.com.

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

A version of this article first appeared on Medscape.com.

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

A version of this article first appeared on Medscape.com.

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

• Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
• Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
• Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
• Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
• Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
• Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
• Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

A version of this article first appeared on WebMD.com.

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

• Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
• Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
• Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
• Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
• Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
• Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
• Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

A version of this article first appeared on WebMD.com.

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

• Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
• Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
• Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
• Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
• Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
• Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
• Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

A version of this article first appeared on WebMD.com.

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

A version of this article first appeared on Medscape.com.

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

A version of this article first appeared on Medscape.com.

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

A version of this article first appeared on Medscape.com.

Inflation is the senility of democracies.

–Sylvia Townsend Warner

What is the greatest threat to your practice? COVID? Government rules and regulations? Stagnant reimbursements? Electronic medical records? No, all of these are minor annoyances in the face of the practice killer, inflation.

Physicians live in a closed box where medical reimbursements are fixed, directly or by contract proxy to the government (Medicare) pay rate. Inflation is projected to be between 5% and 10% this year. We cannot increase our rates to increase the salaries of our employees, cover our increased medical disposable costs, and pay more for our state licensures and DEA registrations. No, we must try to find savings in our budget, which we have been squeezing for years.

Currently, medicine is facing a 9.75% cut in Medicare reimbursements, which will reset most private insurance rates, based on a percentage of Medicare. The temporary 3.75% conversion factor (CF) increase for all services is expiring. Also expiring is the 2% sequester from the Budget Control Act of 2011 (BCA), signed into law in August 2011. This was originally scheduled to sunset in 2021, but is going to continue to 2030.

A 4% statutory pay-as-you-go (PAYGO) sequester resulting from passage of the American Rescue Plan Act is being imposed. Statutory PAYGO is a policy written into law (it can be changed only through new legislation) that requires deficit neutrality overall in the laws (other than annual appropriations) enacted by Congress and imposes automatic spending reductions at the end of the year if such laws increase the deficit when they are added together.

There is a statutory freeze on Medicare Physician Fee Schedule (PFS) updates until 2026, at which time an annual increase of 0.25%, which is lower than inflation, will be enacted. This adds up to a 9.75% cut in Medicare pay until at least 2026. Recall that almost all of your private insurance contracts are tied to Medicare (some more, some less) and that this cut to the physician is doubled if your overhead is fixed at the typical 50% for most practices. This means an almost 20% cut in take-home pay for most physicians.

Now, when considering the most recent inflation number, which projects 5%-10% inflation for this year and at least 2% annually in the future, which compounds yearly (the Fed target), you are looking at catastrophic numbers.

The conversion factor – the pool of money doled out to physicians – has failed to keep pace with inflation – even at 2%-3% a year – and reimbursement is only 50% of what it was when created in 1998, despite small increases by Congress along the way. A recent Wall Street Journal guest editorial claimed that Medicare payments benefited from cost of living adjustments, same as Social Security. I do not agree, hence the 50% pay gap since 1998.

In addition, the costs of running a practice have increased by 37% between 2001 and 2020, 1.7% per year, according to the Medicare Economic Index.

Some of this may include general inflation, but certainly new OSHA rules, electronic medical records, Medicare quality improvement measures, and assorted other costs do not. So based on my own conservative estimate, on top of the 50% decline in the payment pool, physicians’ noninflationary operating costs increased by at least another 10% over the last 20 odd years. This is a 60% decline in reimbursements!

Medicare payments have been under pressure from the Centers for Medicare & Medicaid Services (CMS) anti-inflationary payment policies for more than 20 years. While physician services represent a very modest portion of the overall growth in health care costs, they are an easy target for cuts when policymakers seek to limit spending. Although we avoided direct cuts to reimbursements caused by the Medicare sustainable growth rate formula (SGR) – which was enacted in 1997 and repealed in 2015 – Medicare provider payments have remained constrained by a budget-neutral financing system.

There used to be ways out of the box. Physicians could go to work for hospitals or have their practices acquired by them, resulting in much better hospital-based reimbursement. This has been eliminated by site-neutral payments, which while instituted by President Trump, are unopposed by President Biden. You could also join larger groups with some loss of autonomy, which could presumably negotiate better rates with private insurers as another way out, but these rates are almost always based on a percentage of Medicare as noted above.

There may be a bit of good news, with price transparency being instituted, which again is unopposed by the Biden administration. At least private practice physicians may be able to show their services are a bargain compared to hospitals.

One could also take the low road, and sell out to private equity, but I suspect these deals will become much less attractive since some of these entities are going broke and all will feel the bite of lower reimbursements.

Physicians and patients should rise up and demand better reimbursements for physicians, or there will be no physicians to see. This is not greed, a bigger house, or a newer car, this is becoming a matter of practice survival. And seniors are not greedy, they have paid hundreds of thousands of dollars into Medicare in taxes for health insurance in retirement.

Physicians and retirees should contact their federal legislators and let them know a 9.75% cut is untenable and ask for Medicare rates to be fixed to the cost of living, just as Social Security is. Before we fund trillions of dollars in new government programs, perhaps we should look to the solvency of the existing ones we have.
 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Inflation is the senility of democracies.

–Sylvia Townsend Warner

What is the greatest threat to your practice? COVID? Government rules and regulations? Stagnant reimbursements? Electronic medical records? No, all of these are minor annoyances in the face of the practice killer, inflation.

Physicians live in a closed box where medical reimbursements are fixed, directly or by contract proxy to the government (Medicare) pay rate. Inflation is projected to be between 5% and 10% this year. We cannot increase our rates to increase the salaries of our employees, cover our increased medical disposable costs, and pay more for our state licensures and DEA registrations. No, we must try to find savings in our budget, which we have been squeezing for years.

Currently, medicine is facing a 9.75% cut in Medicare reimbursements, which will reset most private insurance rates, based on a percentage of Medicare. The temporary 3.75% conversion factor (CF) increase for all services is expiring. Also expiring is the 2% sequester from the Budget Control Act of 2011 (BCA), signed into law in August 2011. This was originally scheduled to sunset in 2021, but is going to continue to 2030.

A 4% statutory pay-as-you-go (PAYGO) sequester resulting from passage of the American Rescue Plan Act is being imposed. Statutory PAYGO is a policy written into law (it can be changed only through new legislation) that requires deficit neutrality overall in the laws (other than annual appropriations) enacted by Congress and imposes automatic spending reductions at the end of the year if such laws increase the deficit when they are added together.

There is a statutory freeze on Medicare Physician Fee Schedule (PFS) updates until 2026, at which time an annual increase of 0.25%, which is lower than inflation, will be enacted. This adds up to a 9.75% cut in Medicare pay until at least 2026. Recall that almost all of your private insurance contracts are tied to Medicare (some more, some less) and that this cut to the physician is doubled if your overhead is fixed at the typical 50% for most practices. This means an almost 20% cut in take-home pay for most physicians.

Now, when considering the most recent inflation number, which projects 5%-10% inflation for this year and at least 2% annually in the future, which compounds yearly (the Fed target), you are looking at catastrophic numbers.

The conversion factor – the pool of money doled out to physicians – has failed to keep pace with inflation – even at 2%-3% a year – and reimbursement is only 50% of what it was when created in 1998, despite small increases by Congress along the way. A recent Wall Street Journal guest editorial claimed that Medicare payments benefited from cost of living adjustments, same as Social Security. I do not agree, hence the 50% pay gap since 1998.

In addition, the costs of running a practice have increased by 37% between 2001 and 2020, 1.7% per year, according to the Medicare Economic Index.

Some of this may include general inflation, but certainly new OSHA rules, electronic medical records, Medicare quality improvement measures, and assorted other costs do not. So based on my own conservative estimate, on top of the 50% decline in the payment pool, physicians’ noninflationary operating costs increased by at least another 10% over the last 20 odd years. This is a 60% decline in reimbursements!

Medicare payments have been under pressure from the Centers for Medicare & Medicaid Services (CMS) anti-inflationary payment policies for more than 20 years. While physician services represent a very modest portion of the overall growth in health care costs, they are an easy target for cuts when policymakers seek to limit spending. Although we avoided direct cuts to reimbursements caused by the Medicare sustainable growth rate formula (SGR) – which was enacted in 1997 and repealed in 2015 – Medicare provider payments have remained constrained by a budget-neutral financing system.

There used to be ways out of the box. Physicians could go to work for hospitals or have their practices acquired by them, resulting in much better hospital-based reimbursement. This has been eliminated by site-neutral payments, which while instituted by President Trump, are unopposed by President Biden. You could also join larger groups with some loss of autonomy, which could presumably negotiate better rates with private insurers as another way out, but these rates are almost always based on a percentage of Medicare as noted above.

There may be a bit of good news, with price transparency being instituted, which again is unopposed by the Biden administration. At least private practice physicians may be able to show their services are a bargain compared to hospitals.

One could also take the low road, and sell out to private equity, but I suspect these deals will become much less attractive since some of these entities are going broke and all will feel the bite of lower reimbursements.

Physicians and patients should rise up and demand better reimbursements for physicians, or there will be no physicians to see. This is not greed, a bigger house, or a newer car, this is becoming a matter of practice survival. And seniors are not greedy, they have paid hundreds of thousands of dollars into Medicare in taxes for health insurance in retirement.

Physicians and retirees should contact their federal legislators and let them know a 9.75% cut is untenable and ask for Medicare rates to be fixed to the cost of living, just as Social Security is. Before we fund trillions of dollars in new government programs, perhaps we should look to the solvency of the existing ones we have.
 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Inflation is the senility of democracies.

–Sylvia Townsend Warner

What is the greatest threat to your practice? COVID? Government rules and regulations? Stagnant reimbursements? Electronic medical records? No, all of these are minor annoyances in the face of the practice killer, inflation.

Physicians live in a closed box where medical reimbursements are fixed, directly or by contract proxy to the government (Medicare) pay rate. Inflation is projected to be between 5% and 10% this year. We cannot increase our rates to increase the salaries of our employees, cover our increased medical disposable costs, and pay more for our state licensures and DEA registrations. No, we must try to find savings in our budget, which we have been squeezing for years.

Currently, medicine is facing a 9.75% cut in Medicare reimbursements, which will reset most private insurance rates, based on a percentage of Medicare. The temporary 3.75% conversion factor (CF) increase for all services is expiring. Also expiring is the 2% sequester from the Budget Control Act of 2011 (BCA), signed into law in August 2011. This was originally scheduled to sunset in 2021, but is going to continue to 2030.

A 4% statutory pay-as-you-go (PAYGO) sequester resulting from passage of the American Rescue Plan Act is being imposed. Statutory PAYGO is a policy written into law (it can be changed only through new legislation) that requires deficit neutrality overall in the laws (other than annual appropriations) enacted by Congress and imposes automatic spending reductions at the end of the year if such laws increase the deficit when they are added together.

There is a statutory freeze on Medicare Physician Fee Schedule (PFS) updates until 2026, at which time an annual increase of 0.25%, which is lower than inflation, will be enacted. This adds up to a 9.75% cut in Medicare pay until at least 2026. Recall that almost all of your private insurance contracts are tied to Medicare (some more, some less) and that this cut to the physician is doubled if your overhead is fixed at the typical 50% for most practices. This means an almost 20% cut in take-home pay for most physicians.

Now, when considering the most recent inflation number, which projects 5%-10% inflation for this year and at least 2% annually in the future, which compounds yearly (the Fed target), you are looking at catastrophic numbers.

The conversion factor – the pool of money doled out to physicians – has failed to keep pace with inflation – even at 2%-3% a year – and reimbursement is only 50% of what it was when created in 1998, despite small increases by Congress along the way. A recent Wall Street Journal guest editorial claimed that Medicare payments benefited from cost of living adjustments, same as Social Security. I do not agree, hence the 50% pay gap since 1998.

In addition, the costs of running a practice have increased by 37% between 2001 and 2020, 1.7% per year, according to the Medicare Economic Index.

Some of this may include general inflation, but certainly new OSHA rules, electronic medical records, Medicare quality improvement measures, and assorted other costs do not. So based on my own conservative estimate, on top of the 50% decline in the payment pool, physicians’ noninflationary operating costs increased by at least another 10% over the last 20 odd years. This is a 60% decline in reimbursements!

Medicare payments have been under pressure from the Centers for Medicare & Medicaid Services (CMS) anti-inflationary payment policies for more than 20 years. While physician services represent a very modest portion of the overall growth in health care costs, they are an easy target for cuts when policymakers seek to limit spending. Although we avoided direct cuts to reimbursements caused by the Medicare sustainable growth rate formula (SGR) – which was enacted in 1997 and repealed in 2015 – Medicare provider payments have remained constrained by a budget-neutral financing system.

There used to be ways out of the box. Physicians could go to work for hospitals or have their practices acquired by them, resulting in much better hospital-based reimbursement. This has been eliminated by site-neutral payments, which while instituted by President Trump, are unopposed by President Biden. You could also join larger groups with some loss of autonomy, which could presumably negotiate better rates with private insurers as another way out, but these rates are almost always based on a percentage of Medicare as noted above.

There may be a bit of good news, with price transparency being instituted, which again is unopposed by the Biden administration. At least private practice physicians may be able to show their services are a bargain compared to hospitals.

One could also take the low road, and sell out to private equity, but I suspect these deals will become much less attractive since some of these entities are going broke and all will feel the bite of lower reimbursements.

Physicians and patients should rise up and demand better reimbursements for physicians, or there will be no physicians to see. This is not greed, a bigger house, or a newer car, this is becoming a matter of practice survival. And seniors are not greedy, they have paid hundreds of thousands of dollars into Medicare in taxes for health insurance in retirement.

Physicians and retirees should contact their federal legislators and let them know a 9.75% cut is untenable and ask for Medicare rates to be fixed to the cost of living, just as Social Security is. Before we fund trillions of dollars in new government programs, perhaps we should look to the solvency of the existing ones we have.
 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

To the Editor:

Broader availability and utilization of novel biologic treatments has heralded the emergence of unusual infections, including skin and soft tissue infections. These unusual infections may not be seen in clinical trials due to their overall rare incidence. In modern society, exposure to unusual pathogens can occur in locations far from their natural habitat.¹ Tissue culture remains the gold standard, as histopathology and smears may not identify the organisms. Tissue culture of these less-common pathogens is challenging and may require multiple samples and specialized laboratory evaluations.² In some cases, a skin biopsy with histopathologic examination is an efficient means to confirm or exclude a dermatologic manifestation of an inflammatory disease. This information can quickly change the course of treatment, especially for those on immunosuppressive medications.³ We report a case of unusual cutaneous infection with Chaetomium globosum in a patient concomitantly treated with vedolizumab, a gut-specific integrin inhibitor, alongside traditional immunosuppressive therapy.

A 33-year-old woman with Crohn disease on vedolizumab and mercaptopurine was referred to the dermatology clinic with firm, tender, erythematous lesions on the legs of 1 month’s duration (Figure, A). She had a history of inflammatory bowel disease with perianal fistula, sacroiliitis, uveitis, guttate psoriasis, and erythema nodosum. She denied recent medication changes, foreign travel, swimming in freshwater or a hot tub, chills, fever, malaise, night sweats, and weight loss. Physical examination revealed several tender, indurated, erythematous plaques across the legs, ranging in size from 4 to 12 cm. The plaques had central hyperpigmentation, atrophy, and scant scale without ulceration, drainage, or pustules. The largest plaque demonstrated a well-defined area of central fluctuance. Prednisone (60 mg) with taper was initiated for presumed recurrence of erythema nodosum with close follow-up.

This case illustrates the importance of a high index of suspicion for unusual infections in the setting of biologic therapy. An infectious etiology of a cutaneous eruption in an immunosuppressed patient should always be included in the differential diagnosis and actively pursued early on; tissue culture may shorten the treatment course and decrease severity of the disease. Although a direct link between the mechanism of action of vedolizumab and cutaneous infection is not clear, given the rare incidence of this infection, a report of such a case is important to the practicing clinician.

To the Editor:

Broader availability and utilization of novel biologic treatments has heralded the emergence of unusual infections, including skin and soft tissue infections. These unusual infections may not be seen in clinical trials due to their overall rare incidence. In modern society, exposure to unusual pathogens can occur in locations far from their natural habitat.¹ Tissue culture remains the gold standard, as histopathology and smears may not identify the organisms. Tissue culture of these less-common pathogens is challenging and may require multiple samples and specialized laboratory evaluations.² In some cases, a skin biopsy with histopathologic examination is an efficient means to confirm or exclude a dermatologic manifestation of an inflammatory disease. This information can quickly change the course of treatment, especially for those on immunosuppressive medications.³ We report a case of unusual cutaneous infection with Chaetomium globosum in a patient concomitantly treated with vedolizumab, a gut-specific integrin inhibitor, alongside traditional immunosuppressive therapy.

A 33-year-old woman with Crohn disease on vedolizumab and mercaptopurine was referred to the dermatology clinic with firm, tender, erythematous lesions on the legs of 1 month’s duration (Figure, A). She had a history of inflammatory bowel disease with perianal fistula, sacroiliitis, uveitis, guttate psoriasis, and erythema nodosum. She denied recent medication changes, foreign travel, swimming in freshwater or a hot tub, chills, fever, malaise, night sweats, and weight loss. Physical examination revealed several tender, indurated, erythematous plaques across the legs, ranging in size from 4 to 12 cm. The plaques had central hyperpigmentation, atrophy, and scant scale without ulceration, drainage, or pustules. The largest plaque demonstrated a well-defined area of central fluctuance. Prednisone (60 mg) with taper was initiated for presumed recurrence of erythema nodosum with close follow-up.

This case illustrates the importance of a high index of suspicion for unusual infections in the setting of biologic therapy. An infectious etiology of a cutaneous eruption in an immunosuppressed patient should always be included in the differential diagnosis and actively pursued early on; tissue culture may shorten the treatment course and decrease severity of the disease. Although a direct link between the mechanism of action of vedolizumab and cutaneous infection is not clear, given the rare incidence of this infection, a report of such a case is important to the practicing clinician.

To the Editor:

Broader availability and utilization of novel biologic treatments has heralded the emergence of unusual infections, including skin and soft tissue infections. These unusual infections may not be seen in clinical trials due to their overall rare incidence. In modern society, exposure to unusual pathogens can occur in locations far from their natural habitat.¹ Tissue culture remains the gold standard, as histopathology and smears may not identify the organisms. Tissue culture of these less-common pathogens is challenging and may require multiple samples and specialized laboratory evaluations.² In some cases, a skin biopsy with histopathologic examination is an efficient means to confirm or exclude a dermatologic manifestation of an inflammatory disease. This information can quickly change the course of treatment, especially for those on immunosuppressive medications.³ We report a case of unusual cutaneous infection with Chaetomium globosum in a patient concomitantly treated with vedolizumab, a gut-specific integrin inhibitor, alongside traditional immunosuppressive therapy.

A 33-year-old woman with Crohn disease on vedolizumab and mercaptopurine was referred to the dermatology clinic with firm, tender, erythematous lesions on the legs of 1 month’s duration (Figure, A). She had a history of inflammatory bowel disease with perianal fistula, sacroiliitis, uveitis, guttate psoriasis, and erythema nodosum. She denied recent medication changes, foreign travel, swimming in freshwater or a hot tub, chills, fever, malaise, night sweats, and weight loss. Physical examination revealed several tender, indurated, erythematous plaques across the legs, ranging in size from 4 to 12 cm. The plaques had central hyperpigmentation, atrophy, and scant scale without ulceration, drainage, or pustules. The largest plaque demonstrated a well-defined area of central fluctuance. Prednisone (60 mg) with taper was initiated for presumed recurrence of erythema nodosum with close follow-up.

This case illustrates the importance of a high index of suspicion for unusual infections in the setting of biologic therapy. An infectious etiology of a cutaneous eruption in an immunosuppressed patient should always be included in the differential diagnosis and actively pursued early on; tissue culture may shorten the treatment course and decrease severity of the disease. Although a direct link between the mechanism of action of vedolizumab and cutaneous infection is not clear, given the rare incidence of this infection, a report of such a case is important to the practicing clinician.

To the Editor:

Verrucous carcinoma is a rare, well-differentiated, locally aggressive squamous cell carcinoma first described by Ackerman in 1948.¹ There are 4 main clinicopathologic types: oral florid papillomatosis or Ackerman tumor, giant condyloma acuminatum or Buschke-Lowenstein tumor, plantar verrucous carcinoma, and cutaneous verrucous carcinoma.^2,3 Historically, most patients are older white men. The lesion commonly occurs in sites of inflammation⁴ or chronic irritation/trauma. Clinically, patients present with a slowly enlarging, exophytic, verrucous plaque violating the skin, fascia, and occasionally bone. Although these lesions have little tendency to metastasize, substantial morbidity can be seen due to local invasion. Despite surgical excision, recurrence is not uncommon and is associated with a poor prognosis and higher infiltrative potential.⁵

A 45-year-old male veteran initially presented to our dermatology clinic with a 4-cm, macerated, verrucous plaque on the left lateral ankle in the area of a skin graft placed during a prior limb salvage surgery (Figure 1). The patient experienced a traumatic blast injury while deployed 7 years prior with a subsequent right-sided below-the-knee amputation and left lower limb salvage. The lesion was clinically diagnosed as verruca vulgaris and treated with daily salicylic acid. Six weeks after the initial presentation, the lesion remained largely unchanged. A biopsy subsequently was obtained to confirm the diagnosis. At that time, the histopathology was consistent with verruca vulgaris without evidence of carcinoma. Due to the persistence of the lesion, lack of improvement with topical treatment, and overall size, the patient opted for surgical excision.

Verrucous carcinoma can represent a diagnostic dilemma, as histologic sections may mimic benign entities. The features of a well-differentiated squamous epithelium with hyperkeratosis, papillomatosis, and acanthosis can be mistaken for verruca vulgaris, keratoacanthoma, and pseudoepitheliomatous hyperplasia,⁶ which are characteristic of verrucous hyperplasia. Accurate diagnosis can be difficult with a superficial biopsy because of the mature appearance of the epithelium,⁷ prompting the need for multiple and deeper biopsies⁸ to include sampling of the base of the hyperplastic epithelium in which the characteristic bulbous pushing growth pattern of the rete ridges is visualized. Precise histologic diagnosis can be further confounded by external mechanical factors, such as pressure, which can distort the classic histopathology.⁷ The histopathologic features leading to the diagnosis of verrucous carcinoma in our specimen were minimal squamous atypia present in a predominantly exophytic squamous proliferation with human papillomavirus cytopathic effect and focal endophytic pushing borders by rounded bulbous rete ridges into the mid and deep dermis (Figure 2).

To the Editor:

Verrucous carcinoma is a rare, well-differentiated, locally aggressive squamous cell carcinoma first described by Ackerman in 1948.¹ There are 4 main clinicopathologic types: oral florid papillomatosis or Ackerman tumor, giant condyloma acuminatum or Buschke-Lowenstein tumor, plantar verrucous carcinoma, and cutaneous verrucous carcinoma.^2,3 Historically, most patients are older white men. The lesion commonly occurs in sites of inflammation⁴ or chronic irritation/trauma. Clinically, patients present with a slowly enlarging, exophytic, verrucous plaque violating the skin, fascia, and occasionally bone. Although these lesions have little tendency to metastasize, substantial morbidity can be seen due to local invasion. Despite surgical excision, recurrence is not uncommon and is associated with a poor prognosis and higher infiltrative potential.⁵

A 45-year-old male veteran initially presented to our dermatology clinic with a 4-cm, macerated, verrucous plaque on the left lateral ankle in the area of a skin graft placed during a prior limb salvage surgery (Figure 1). The patient experienced a traumatic blast injury while deployed 7 years prior with a subsequent right-sided below-the-knee amputation and left lower limb salvage. The lesion was clinically diagnosed as verruca vulgaris and treated with daily salicylic acid. Six weeks after the initial presentation, the lesion remained largely unchanged. A biopsy subsequently was obtained to confirm the diagnosis. At that time, the histopathology was consistent with verruca vulgaris without evidence of carcinoma. Due to the persistence of the lesion, lack of improvement with topical treatment, and overall size, the patient opted for surgical excision.

Verrucous carcinoma can represent a diagnostic dilemma, as histologic sections may mimic benign entities. The features of a well-differentiated squamous epithelium with hyperkeratosis, papillomatosis, and acanthosis can be mistaken for verruca vulgaris, keratoacanthoma, and pseudoepitheliomatous hyperplasia,⁶ which are characteristic of verrucous hyperplasia. Accurate diagnosis can be difficult with a superficial biopsy because of the mature appearance of the epithelium,⁷ prompting the need for multiple and deeper biopsies⁸ to include sampling of the base of the hyperplastic epithelium in which the characteristic bulbous pushing growth pattern of the rete ridges is visualized. Precise histologic diagnosis can be further confounded by external mechanical factors, such as pressure, which can distort the classic histopathology.⁷ The histopathologic features leading to the diagnosis of verrucous carcinoma in our specimen were minimal squamous atypia present in a predominantly exophytic squamous proliferation with human papillomavirus cytopathic effect and focal endophytic pushing borders by rounded bulbous rete ridges into the mid and deep dermis (Figure 2).

To the Editor:

Verrucous carcinoma is a rare, well-differentiated, locally aggressive squamous cell carcinoma first described by Ackerman in 1948.¹ There are 4 main clinicopathologic types: oral florid papillomatosis or Ackerman tumor, giant condyloma acuminatum or Buschke-Lowenstein tumor, plantar verrucous carcinoma, and cutaneous verrucous carcinoma.^2,3 Historically, most patients are older white men. The lesion commonly occurs in sites of inflammation⁴ or chronic irritation/trauma. Clinically, patients present with a slowly enlarging, exophytic, verrucous plaque violating the skin, fascia, and occasionally bone. Although these lesions have little tendency to metastasize, substantial morbidity can be seen due to local invasion. Despite surgical excision, recurrence is not uncommon and is associated with a poor prognosis and higher infiltrative potential.⁵

A 45-year-old male veteran initially presented to our dermatology clinic with a 4-cm, macerated, verrucous plaque on the left lateral ankle in the area of a skin graft placed during a prior limb salvage surgery (Figure 1). The patient experienced a traumatic blast injury while deployed 7 years prior with a subsequent right-sided below-the-knee amputation and left lower limb salvage. The lesion was clinically diagnosed as verruca vulgaris and treated with daily salicylic acid. Six weeks after the initial presentation, the lesion remained largely unchanged. A biopsy subsequently was obtained to confirm the diagnosis. At that time, the histopathology was consistent with verruca vulgaris without evidence of carcinoma. Due to the persistence of the lesion, lack of improvement with topical treatment, and overall size, the patient opted for surgical excision.

Verrucous carcinoma can represent a diagnostic dilemma, as histologic sections may mimic benign entities. The features of a well-differentiated squamous epithelium with hyperkeratosis, papillomatosis, and acanthosis can be mistaken for verruca vulgaris, keratoacanthoma, and pseudoepitheliomatous hyperplasia,⁶ which are characteristic of verrucous hyperplasia. Accurate diagnosis can be difficult with a superficial biopsy because of the mature appearance of the epithelium,⁷ prompting the need for multiple and deeper biopsies⁸ to include sampling of the base of the hyperplastic epithelium in which the characteristic bulbous pushing growth pattern of the rete ridges is visualized. Precise histologic diagnosis can be further confounded by external mechanical factors, such as pressure, which can distort the classic histopathology.⁷ The histopathologic features leading to the diagnosis of verrucous carcinoma in our specimen were minimal squamous atypia present in a predominantly exophytic squamous proliferation with human papillomavirus cytopathic effect and focal endophytic pushing borders by rounded bulbous rete ridges into the mid and deep dermis (Figure 2).

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Psoriasis is a chronic and relapsing systemic inflammatory disease that predisposes patients to a host of other conditions. It is believed that these widespread effects are due to chronic inflammation and cytokine activation, which affect multiple body processes and lead to the development of various comorbidities that need to be proactively managed.

In April 2019, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) released recommendation guidelines for managing psoriasis in adults with an emphasis on common disease comorbidities, including psoriatic arthritis (PsA), cardiovascular disease (CVD), inflammatory bowel disease (IBD), metabolic syndrome, and mood disorders. Psychosocial wellness, mental health, and quality of life (QOL) measures in relation to psoriatic disease also were discussed.¹

The AAD-NPF guidelines address current screening, monitoring, education, and treatment recommendations for the management of psoriatic comorbidities. The Table and eTable summarize the screening recommendations. These guidelines aim to assist dermatologists with comprehensive disease management by addressing potential extracutaneous manifestations of psoriasis in adults.

Screening and Risk Assessment

Patients with psoriasis should receive a thorough history and physical examination to assess disease severity and risk for potential comorbidities. Patients with greater disease severity—as measured by body surface area (BSA) involvement and type of therapy required—have a greater risk for other disease-related comorbidities, specifically metabolic syndrome, renal disease, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, uveitis, IBD, malignancy, and increased mortality.² Because the likelihood of comorbidities is greatest with severe disease, more frequent monitoring is recommended for these patients.

Psoriatic Arthritis

Patients with psoriasis need to be evaluated for PsA at every visit. Patients presenting with signs and symptoms suspicious for PsA—joint swelling, peripheral joint involvement, and joint inflammation—warrant further evaluation and consultation. Early detection and treatment of PsA is essential for preventing unnecessary suffering and progressive joint destruction.³

There are several PsA screening questionnaires currently available, including the Psoriatic Arthritis Screening Evaluation, Psoriasis Epidemiology Screening Tool, and Toronto Psoriatic Arthritis Screen. No significant differences in sensitivity and specificity were found among these questionnaires when using the Classification Criteria for Psoriatic Arthritis as the gold standard. All 3 questionnaires—the Psoriatic Arthritis Screening Evaluation and the Psoriasis Epidemiology Screening Tool were developed for use in dermatology and rheumatology clinics, and the Toronto Psoriatic Arthritis Screen was developed for use in the primary care setting—were found to be effective in dermatology/rheumatology clinics and primary care clinics, respectively.³ False-positive results predominantly were seen in patients with degenerative joint disease or osteoarthritis. Dermatologists should conduct a thorough physical examination to distinguish PsA from degenerative joint disease. Imaging and laboratory tests to evaluate for signs of systemic inflammation (erythrocyte sedimentation rate, C-reactive protein) also can be helpful in distinguishing the 2 conditions; however, these metrics have not been shown to contribute to PsA diagnosis.¹ Full rheumatologic consultation is warranted in challenging cases.

Cardiovascular Disease

The American Heart Association and the American College of Cardiology have identified chronic inflammatory states, such as psoriasis, as inducing factors that predispose patients to CVD. Many studies have found an association among psoriasis, coronary artery disease, myocardial infarction (MI), and stroke.^4-7 It is strongly recommended that dermatologists educate patients of their increased risk for CVD, given the association between psoriasis and major adverse cardiovascular events (eg, stroke, heart failure, MI) and cardiovascular health. However, patients with congestive heart failure were found to have an increased risk of mortality associated with use of tumor necrosis factor (TNF) α inhibitors (P=.016).⁸ Thus, TNF inhibitors are contraindicated in patients with New York Heart Association Class III or Class IV congestive heart failure.⁹

Primary care physicians (PCPs) are recommended to screen patients for CVD risk factors using height, weight, blood pressure, blood glucose, hemoglobin A_1C, lipid levels, abdominal circumference, and body mass index (BMI). Lifestyle modifications such as smoking cessation, exercise, and dietary changes are encouraged to achieve and maintain a normal BMI.

Dermatologists also need to give special consideration to comorbidities when selecting medications and/or therapies for disease management. Patients on TNF inhibitors have a lower risk for MI compared with patients using topical medications, phototherapy, and other oral agents.¹⁰ Additionally, patients on TNF inhibitors have a lower risk for occurrence of major adverse cardiovascular events compared with patients treated with methotrexate or phototherapy.^11,12

Metabolic Syndrome

Numerous studies have demonstrated an association between psoriasis and metabolic syndrome. Patients with increased BSA involvement and psoriasis area and severity index scores have a higher prevalence of metabolic syndrome.¹³ Patients with psoriasis have an increased risk for the following conditions compared to controls: obesity (38% vs 31%; odds ratio [OR], 1.38; 95% CI, 1.29-1.48), elevated triglycerides (36% vs 28%; OR, 1.49; 95% CI, 1.39-1.60), hypertension (31% vs 28%; OR, 1.20; 95% CI, 1.11-12.9), and elevated glucose levels (22% vs 16%; OR, 1.44; 95% CI, 1.33-1.56).¹⁴ Dermatologists are strongly recommended to inform patients about the risk for metabolic syndrome and to encourage the measurement of blood pressure, waist circumference, fasting blood glucose, hemoglobin A_1C, and fasting lipid levels with their PCP when indicated. Body mass index and waist circumference also should be measured annually in patients with moderate to severe psoriasis because of the association with disease severity.

The association between psoriasis and weight loss has been analyzed in several studies. Weight loss, particularly in obese patients, has been shown to improve psoriasis severity, as measured by psoriasis area and severity index score and QOL measures.¹⁵ Another study found that gastric bypass was associated with a significant risk reduction in the development of psoriasis (P=.004) and the disease prognosis (P=.02 for severe psoriasis; P=.01 for PsA).¹⁶ Therefore, patients with moderate to severe psoriasis are recommended to have their obesity status determined according to national guidelines. For patients with a BMI above 40 kg/m² and standard weight-loss measures fail, bariatric surgery is recommended. Additionally, the impact of psoriasis medications on weight has been studied. Apremilast has been associated with weight loss, whereas etanercept and infliximab have been linked to weight gain.^17,18

An association between psoriasis and hypertension also has been demonstrated by studies, especially among patients with severe disease. Therefore, patients with moderate to severe psoriasis are recommended to have their blood pressure evaluated according to national guidelines, and those with a blood pressure of 140/90 mm Hg or higher should be referred to their PCP for assessment and treatment. Current evidence does not support restrictions on antihypertensive medications in patients with psoriasis. Physicians should be aware of the potential for cyclosporine to induce hypertension, which should be treated, specifically with amlodipine.¹⁹

Many studies have demonstrated an association between psoriasis and dyslipidemia, though the results are somewhat conflicting. In 2018, the American Heart Association and the American College of Cardiology deemed psoriasis as an atherosclerotic CVD risk-enhancing condition, favoring early initiation of statin therapy. Because dyslipidemia plays a prominent role in atherosclerosis and CVD, patients with moderate to severe psoriasis are recommended to undergo periodic screening with lipid tests (eg, fasting total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides).²⁰ Patients with elevated fasting triglycerides or low-density lipoprotein cholesterol should be referred to their PCP for further management. Certain psoriasis medications also have been linked to dyslipidemia. Acitretin and cyclosporine are known to adversely affect lipid levels, so patients treated with either agent should undergo routine monitoring of serum lipid levels.

Psoriasis is strongly associated with diabetes mellitus. Because of the increased risk for diabetes in patients with severe disease, regular monitoring of fasting blood glucose and/or hemoglobin A_1C levels in patients with moderate to severe psoriasis is recommended. Patients who meet criteria for prediabetes or diabetes should be referred to their PCP for further assessment and management.^21,22

Mood Disorders

Psoriasis affects QOL and can have a major impact on patients’ interpersonal relationships. Studies have shown an association between psoriasis and mood disorders, specifically depression and anxiety. Unfortunately, patients with mood disorders are less likely to seek intervention for their skin disease, which poses a tremendous treatment barrier. Dermatologists should regularly monitor patients for psychiatric symptoms so that resources and treatments can be offered.

Certain psoriasis therapies have been shown to help alleviate associated depression and anxiety. Improvements in Beck Depression Inventory and Hamilton Depression Rating Scale scores were seen with etanercept.²³ Adalimumab and ustekinumab showed improvement in Dermatology Life Quality Index compared with placebo.^24,25 Patients receiving Goeckerman treatment also had improvement in anxiety and depression scores compared with conventional therapy.²⁶ Biologic medications had the largest impact on improving depression symptoms compared with conventional systemic therapy and phototherapy.²⁷ The recommendations support use of biologics and the Goeckerman regimen for the concomitant treatment of mood disorders and psoriasis.

Renal Disease

Studies have supported an association between psoriasis and chronic kidney disease (CKD), independent of risk factors including vascular disease, hypertension, and diabetes. The prevalence of moderate to advanced CKD also has been found to be directly related to increasing BSA affected by psoriasis.²⁸ Patients should receive testing of blood urea nitrogen, creatinine, and urine microalbumin levels to assess for occult renal disease. In addition, physicians should be cautious when prescribing nephrotoxic drugs (nonsteroidal anti-inflammatory drugs and cyclosporine) and renally excreted agents (methotrexate and apremilast) because of the risk for underlying renal disease in patients with psoriasis. If newly acquired renal disease is suspected, physicians should withhold the offending agents. Patients with psoriasis with CKD are recommended to follow up with their PCP or nephrologist for evaluation and management.

Pulmonary Disease

Psoriasis also has an independent association with COPD. Patients with psoriasis have a higher likelihood of developing COPD (hazard ratio, 2.35; 95% CI, 1.42-3.89; P<.01) than controls.²⁹ The prevalence of COPD also was found to correlate with psoriasis severity. Dermatologists should educate patients about the association between smoking and psoriasis as well as advise patients to discontinue smoking to reduce their risk for developing COPD and cancer.

Patients with psoriasis also are at an increased risk for obstructive sleep apnea. Obstructive sleep apnea should be considered in patients with risk factors including snoring, obesity, hypertension, or diabetes.

Inflammatory Bowel Disease

Patients with psoriasis have an increased risk for developing IBD. The prevalence ratios of both Crohn disease (2.49) and ulcerative colitis (1.64) are increased in patients with psoriasis relative to patients without psoriasis.³⁰ Physicians need to be aware of the association between psoriasis and IBD and the effect that their coexistence may have on treatment choice for patients.

Adalimumab and infliximab are approved for the treatment of IBD, and certolizumab and ustekinumab are approved for Crohn disease. Use of TNF inhibitors in patients with IBD may cause psoriasiform lesions to develop.³¹ Nonetheless, treatment should be individualized and psoriasiform lesions treated with standard psoriasis measures. Psoriasis patients with IBD are recommended to avoid IL-17–inhibitor therapy, given its potential to worsen IBD flares.

Malignancy

Psoriasis patients aged 0 to 79 years have a greater overall risk for malignancy compared with patients without psoriasis.³² Patients with psoriasis have an increased risk for respiratory tract cancer, upper aerodigestive tract cancer, urinary tract cancer, and non-Hodgkin lymphoma.³³ A mild association exists between PsA and lymphoma, nonmelanoma skin cancer (NMSC), and lung cancer.³⁴ More severe psoriasis is associated with greater risk for lymphoma and NMSC. Dermatologists are recommended to educate patients on their risk for certain malignancies and to refer patients to specialists upon suspicion of malignancy.

Risk for malignancy has been shown to be affected by psoriasis treatments. Patients treated with UVB have reduced overall cancer rates for all age groups (hazard ratio, 0.52; P=.3), while those treated with psoralen plus UVA have an increased incidence of squamous cell carcinoma.^32,33 Adalimumab was correlated with increased risk for NMSC in patients with psoriasis but did not have an increased risk for all cancers collectively when used for various immune-mediated inflammatory diseases.³⁵ In contrast, a meta-analysis of randomized clinical trials found no association with TNF inhibitor use and NMSC.³⁶ Ustekinumab had no association with malignancy.³⁷ Treatment history should be elucidated because of higher rates of squamous cell carcinoma in patients with prior psoralen plus UVA, cyclosporine, or methotrexate use.³³ To address malignancy risk, patients with psoriasis should undergo regular screenings for skin cancer and follow national guidelines for age-appropriate cancer screenings.

Lifestyle Choices and QOL

A crucial aspect of successful psoriasis management is patient education. The strongest recommendations support lifestyle changes, such as smoking cessation and limitation of alcohol use. A tactful discussion regarding substance use, work productivity, interpersonal relationships, and sexual function can address substantial effects of psoriasis on QOL so that support and resources can be provided.

Final Thoughts

Management of psoriasis is multifaceted and involves screening, education, monitoring, and collaboration with PCPs and specialists. Regular follow-up with a dermatologist and PCP is strongly recommended for patients with psoriasis given the systemic nature of the disease. The 2019 AAD-NPF recommendations provide important information for dermatologists to coordinate care for complicated psoriasis cases, but clinical judgment is paramount when making medical decisions. The consideration of comorbidities is critical for developing a comprehensive treatment approach, and this approach will lead to better health outcomes and improved QOL for patients with psoriasis.

Psoriasis is a chronic and relapsing systemic inflammatory disease that predisposes patients to a host of other conditions. It is believed that these widespread effects are due to chronic inflammation and cytokine activation, which affect multiple body processes and lead to the development of various comorbidities that need to be proactively managed.

In April 2019, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) released recommendation guidelines for managing psoriasis in adults with an emphasis on common disease comorbidities, including psoriatic arthritis (PsA), cardiovascular disease (CVD), inflammatory bowel disease (IBD), metabolic syndrome, and mood disorders. Psychosocial wellness, mental health, and quality of life (QOL) measures in relation to psoriatic disease also were discussed.¹

The AAD-NPF guidelines address current screening, monitoring, education, and treatment recommendations for the management of psoriatic comorbidities. The Table and eTable summarize the screening recommendations. These guidelines aim to assist dermatologists with comprehensive disease management by addressing potential extracutaneous manifestations of psoriasis in adults.

Screening and Risk Assessment

Patients with psoriasis should receive a thorough history and physical examination to assess disease severity and risk for potential comorbidities. Patients with greater disease severity—as measured by body surface area (BSA) involvement and type of therapy required—have a greater risk for other disease-related comorbidities, specifically metabolic syndrome, renal disease, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, uveitis, IBD, malignancy, and increased mortality.² Because the likelihood of comorbidities is greatest with severe disease, more frequent monitoring is recommended for these patients.

Psoriatic Arthritis

Patients with psoriasis need to be evaluated for PsA at every visit. Patients presenting with signs and symptoms suspicious for PsA—joint swelling, peripheral joint involvement, and joint inflammation—warrant further evaluation and consultation. Early detection and treatment of PsA is essential for preventing unnecessary suffering and progressive joint destruction.³

There are several PsA screening questionnaires currently available, including the Psoriatic Arthritis Screening Evaluation, Psoriasis Epidemiology Screening Tool, and Toronto Psoriatic Arthritis Screen. No significant differences in sensitivity and specificity were found among these questionnaires when using the Classification Criteria for Psoriatic Arthritis as the gold standard. All 3 questionnaires—the Psoriatic Arthritis Screening Evaluation and the Psoriasis Epidemiology Screening Tool were developed for use in dermatology and rheumatology clinics, and the Toronto Psoriatic Arthritis Screen was developed for use in the primary care setting—were found to be effective in dermatology/rheumatology clinics and primary care clinics, respectively.³ False-positive results predominantly were seen in patients with degenerative joint disease or osteoarthritis. Dermatologists should conduct a thorough physical examination to distinguish PsA from degenerative joint disease. Imaging and laboratory tests to evaluate for signs of systemic inflammation (erythrocyte sedimentation rate, C-reactive protein) also can be helpful in distinguishing the 2 conditions; however, these metrics have not been shown to contribute to PsA diagnosis.¹ Full rheumatologic consultation is warranted in challenging cases.

Cardiovascular Disease

The American Heart Association and the American College of Cardiology have identified chronic inflammatory states, such as psoriasis, as inducing factors that predispose patients to CVD. Many studies have found an association among psoriasis, coronary artery disease, myocardial infarction (MI), and stroke.^4-7 It is strongly recommended that dermatologists educate patients of their increased risk for CVD, given the association between psoriasis and major adverse cardiovascular events (eg, stroke, heart failure, MI) and cardiovascular health. However, patients with congestive heart failure were found to have an increased risk of mortality associated with use of tumor necrosis factor (TNF) α inhibitors (P=.016).⁸ Thus, TNF inhibitors are contraindicated in patients with New York Heart Association Class III or Class IV congestive heart failure.⁹

Primary care physicians (PCPs) are recommended to screen patients for CVD risk factors using height, weight, blood pressure, blood glucose, hemoglobin A_1C, lipid levels, abdominal circumference, and body mass index (BMI). Lifestyle modifications such as smoking cessation, exercise, and dietary changes are encouraged to achieve and maintain a normal BMI.

Dermatologists also need to give special consideration to comorbidities when selecting medications and/or therapies for disease management. Patients on TNF inhibitors have a lower risk for MI compared with patients using topical medications, phototherapy, and other oral agents.¹⁰ Additionally, patients on TNF inhibitors have a lower risk for occurrence of major adverse cardiovascular events compared with patients treated with methotrexate or phototherapy.^11,12

Metabolic Syndrome

Numerous studies have demonstrated an association between psoriasis and metabolic syndrome. Patients with increased BSA involvement and psoriasis area and severity index scores have a higher prevalence of metabolic syndrome.¹³ Patients with psoriasis have an increased risk for the following conditions compared to controls: obesity (38% vs 31%; odds ratio [OR], 1.38; 95% CI, 1.29-1.48), elevated triglycerides (36% vs 28%; OR, 1.49; 95% CI, 1.39-1.60), hypertension (31% vs 28%; OR, 1.20; 95% CI, 1.11-12.9), and elevated glucose levels (22% vs 16%; OR, 1.44; 95% CI, 1.33-1.56).¹⁴ Dermatologists are strongly recommended to inform patients about the risk for metabolic syndrome and to encourage the measurement of blood pressure, waist circumference, fasting blood glucose, hemoglobin A_1C, and fasting lipid levels with their PCP when indicated. Body mass index and waist circumference also should be measured annually in patients with moderate to severe psoriasis because of the association with disease severity.

The association between psoriasis and weight loss has been analyzed in several studies. Weight loss, particularly in obese patients, has been shown to improve psoriasis severity, as measured by psoriasis area and severity index score and QOL measures.¹⁵ Another study found that gastric bypass was associated with a significant risk reduction in the development of psoriasis (P=.004) and the disease prognosis (P=.02 for severe psoriasis; P=.01 for PsA).¹⁶ Therefore, patients with moderate to severe psoriasis are recommended to have their obesity status determined according to national guidelines. For patients with a BMI above 40 kg/m² and standard weight-loss measures fail, bariatric surgery is recommended. Additionally, the impact of psoriasis medications on weight has been studied. Apremilast has been associated with weight loss, whereas etanercept and infliximab have been linked to weight gain.^17,18

An association between psoriasis and hypertension also has been demonstrated by studies, especially among patients with severe disease. Therefore, patients with moderate to severe psoriasis are recommended to have their blood pressure evaluated according to national guidelines, and those with a blood pressure of 140/90 mm Hg or higher should be referred to their PCP for assessment and treatment. Current evidence does not support restrictions on antihypertensive medications in patients with psoriasis. Physicians should be aware of the potential for cyclosporine to induce hypertension, which should be treated, specifically with amlodipine.¹⁹

Many studies have demonstrated an association between psoriasis and dyslipidemia, though the results are somewhat conflicting. In 2018, the American Heart Association and the American College of Cardiology deemed psoriasis as an atherosclerotic CVD risk-enhancing condition, favoring early initiation of statin therapy. Because dyslipidemia plays a prominent role in atherosclerosis and CVD, patients with moderate to severe psoriasis are recommended to undergo periodic screening with lipid tests (eg, fasting total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides).²⁰ Patients with elevated fasting triglycerides or low-density lipoprotein cholesterol should be referred to their PCP for further management. Certain psoriasis medications also have been linked to dyslipidemia. Acitretin and cyclosporine are known to adversely affect lipid levels, so patients treated with either agent should undergo routine monitoring of serum lipid levels.

Psoriasis is strongly associated with diabetes mellitus. Because of the increased risk for diabetes in patients with severe disease, regular monitoring of fasting blood glucose and/or hemoglobin A_1C levels in patients with moderate to severe psoriasis is recommended. Patients who meet criteria for prediabetes or diabetes should be referred to their PCP for further assessment and management.^21,22

Mood Disorders

Psoriasis affects QOL and can have a major impact on patients’ interpersonal relationships. Studies have shown an association between psoriasis and mood disorders, specifically depression and anxiety. Unfortunately, patients with mood disorders are less likely to seek intervention for their skin disease, which poses a tremendous treatment barrier. Dermatologists should regularly monitor patients for psychiatric symptoms so that resources and treatments can be offered.

Certain psoriasis therapies have been shown to help alleviate associated depression and anxiety. Improvements in Beck Depression Inventory and Hamilton Depression Rating Scale scores were seen with etanercept.²³ Adalimumab and ustekinumab showed improvement in Dermatology Life Quality Index compared with placebo.^24,25 Patients receiving Goeckerman treatment also had improvement in anxiety and depression scores compared with conventional therapy.²⁶ Biologic medications had the largest impact on improving depression symptoms compared with conventional systemic therapy and phototherapy.²⁷ The recommendations support use of biologics and the Goeckerman regimen for the concomitant treatment of mood disorders and psoriasis.

Renal Disease

Studies have supported an association between psoriasis and chronic kidney disease (CKD), independent of risk factors including vascular disease, hypertension, and diabetes. The prevalence of moderate to advanced CKD also has been found to be directly related to increasing BSA affected by psoriasis.²⁸ Patients should receive testing of blood urea nitrogen, creatinine, and urine microalbumin levels to assess for occult renal disease. In addition, physicians should be cautious when prescribing nephrotoxic drugs (nonsteroidal anti-inflammatory drugs and cyclosporine) and renally excreted agents (methotrexate and apremilast) because of the risk for underlying renal disease in patients with psoriasis. If newly acquired renal disease is suspected, physicians should withhold the offending agents. Patients with psoriasis with CKD are recommended to follow up with their PCP or nephrologist for evaluation and management.

Pulmonary Disease

Psoriasis also has an independent association with COPD. Patients with psoriasis have a higher likelihood of developing COPD (hazard ratio, 2.35; 95% CI, 1.42-3.89; P<.01) than controls.²⁹ The prevalence of COPD also was found to correlate with psoriasis severity. Dermatologists should educate patients about the association between smoking and psoriasis as well as advise patients to discontinue smoking to reduce their risk for developing COPD and cancer.

Patients with psoriasis also are at an increased risk for obstructive sleep apnea. Obstructive sleep apnea should be considered in patients with risk factors including snoring, obesity, hypertension, or diabetes.

Inflammatory Bowel Disease

Patients with psoriasis have an increased risk for developing IBD. The prevalence ratios of both Crohn disease (2.49) and ulcerative colitis (1.64) are increased in patients with psoriasis relative to patients without psoriasis.³⁰ Physicians need to be aware of the association between psoriasis and IBD and the effect that their coexistence may have on treatment choice for patients.

Adalimumab and infliximab are approved for the treatment of IBD, and certolizumab and ustekinumab are approved for Crohn disease. Use of TNF inhibitors in patients with IBD may cause psoriasiform lesions to develop.³¹ Nonetheless, treatment should be individualized and psoriasiform lesions treated with standard psoriasis measures. Psoriasis patients with IBD are recommended to avoid IL-17–inhibitor therapy, given its potential to worsen IBD flares.

Malignancy

Psoriasis patients aged 0 to 79 years have a greater overall risk for malignancy compared with patients without psoriasis.³² Patients with psoriasis have an increased risk for respiratory tract cancer, upper aerodigestive tract cancer, urinary tract cancer, and non-Hodgkin lymphoma.³³ A mild association exists between PsA and lymphoma, nonmelanoma skin cancer (NMSC), and lung cancer.³⁴ More severe psoriasis is associated with greater risk for lymphoma and NMSC. Dermatologists are recommended to educate patients on their risk for certain malignancies and to refer patients to specialists upon suspicion of malignancy.

Risk for malignancy has been shown to be affected by psoriasis treatments. Patients treated with UVB have reduced overall cancer rates for all age groups (hazard ratio, 0.52; P=.3), while those treated with psoralen plus UVA have an increased incidence of squamous cell carcinoma.^32,33 Adalimumab was correlated with increased risk for NMSC in patients with psoriasis but did not have an increased risk for all cancers collectively when used for various immune-mediated inflammatory diseases.³⁵ In contrast, a meta-analysis of randomized clinical trials found no association with TNF inhibitor use and NMSC.³⁶ Ustekinumab had no association with malignancy.³⁷ Treatment history should be elucidated because of higher rates of squamous cell carcinoma in patients with prior psoralen plus UVA, cyclosporine, or methotrexate use.³³ To address malignancy risk, patients with psoriasis should undergo regular screenings for skin cancer and follow national guidelines for age-appropriate cancer screenings.

Lifestyle Choices and QOL

A crucial aspect of successful psoriasis management is patient education. The strongest recommendations support lifestyle changes, such as smoking cessation and limitation of alcohol use. A tactful discussion regarding substance use, work productivity, interpersonal relationships, and sexual function can address substantial effects of psoriasis on QOL so that support and resources can be provided.

Final Thoughts

Management of psoriasis is multifaceted and involves screening, education, monitoring, and collaboration with PCPs and specialists. Regular follow-up with a dermatologist and PCP is strongly recommended for patients with psoriasis given the systemic nature of the disease. The 2019 AAD-NPF recommendations provide important information for dermatologists to coordinate care for complicated psoriasis cases, but clinical judgment is paramount when making medical decisions. The consideration of comorbidities is critical for developing a comprehensive treatment approach, and this approach will lead to better health outcomes and improved QOL for patients with psoriasis.

Psoriasis is a chronic and relapsing systemic inflammatory disease that predisposes patients to a host of other conditions. It is believed that these widespread effects are due to chronic inflammation and cytokine activation, which affect multiple body processes and lead to the development of various comorbidities that need to be proactively managed.

In April 2019, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) released recommendation guidelines for managing psoriasis in adults with an emphasis on common disease comorbidities, including psoriatic arthritis (PsA), cardiovascular disease (CVD), inflammatory bowel disease (IBD), metabolic syndrome, and mood disorders. Psychosocial wellness, mental health, and quality of life (QOL) measures in relation to psoriatic disease also were discussed.¹

The AAD-NPF guidelines address current screening, monitoring, education, and treatment recommendations for the management of psoriatic comorbidities. The Table and eTable summarize the screening recommendations. These guidelines aim to assist dermatologists with comprehensive disease management by addressing potential extracutaneous manifestations of psoriasis in adults.

Screening and Risk Assessment

Patients with psoriasis should receive a thorough history and physical examination to assess disease severity and risk for potential comorbidities. Patients with greater disease severity—as measured by body surface area (BSA) involvement and type of therapy required—have a greater risk for other disease-related comorbidities, specifically metabolic syndrome, renal disease, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, uveitis, IBD, malignancy, and increased mortality.² Because the likelihood of comorbidities is greatest with severe disease, more frequent monitoring is recommended for these patients.

Psoriatic Arthritis

Patients with psoriasis need to be evaluated for PsA at every visit. Patients presenting with signs and symptoms suspicious for PsA—joint swelling, peripheral joint involvement, and joint inflammation—warrant further evaluation and consultation. Early detection and treatment of PsA is essential for preventing unnecessary suffering and progressive joint destruction.³

There are several PsA screening questionnaires currently available, including the Psoriatic Arthritis Screening Evaluation, Psoriasis Epidemiology Screening Tool, and Toronto Psoriatic Arthritis Screen. No significant differences in sensitivity and specificity were found among these questionnaires when using the Classification Criteria for Psoriatic Arthritis as the gold standard. All 3 questionnaires—the Psoriatic Arthritis Screening Evaluation and the Psoriasis Epidemiology Screening Tool were developed for use in dermatology and rheumatology clinics, and the Toronto Psoriatic Arthritis Screen was developed for use in the primary care setting—were found to be effective in dermatology/rheumatology clinics and primary care clinics, respectively.³ False-positive results predominantly were seen in patients with degenerative joint disease or osteoarthritis. Dermatologists should conduct a thorough physical examination to distinguish PsA from degenerative joint disease. Imaging and laboratory tests to evaluate for signs of systemic inflammation (erythrocyte sedimentation rate, C-reactive protein) also can be helpful in distinguishing the 2 conditions; however, these metrics have not been shown to contribute to PsA diagnosis.¹ Full rheumatologic consultation is warranted in challenging cases.

Cardiovascular Disease

The American Heart Association and the American College of Cardiology have identified chronic inflammatory states, such as psoriasis, as inducing factors that predispose patients to CVD. Many studies have found an association among psoriasis, coronary artery disease, myocardial infarction (MI), and stroke.^4-7 It is strongly recommended that dermatologists educate patients of their increased risk for CVD, given the association between psoriasis and major adverse cardiovascular events (eg, stroke, heart failure, MI) and cardiovascular health. However, patients with congestive heart failure were found to have an increased risk of mortality associated with use of tumor necrosis factor (TNF) α inhibitors (P=.016).⁸ Thus, TNF inhibitors are contraindicated in patients with New York Heart Association Class III or Class IV congestive heart failure.⁹

Primary care physicians (PCPs) are recommended to screen patients for CVD risk factors using height, weight, blood pressure, blood glucose, hemoglobin A_1C, lipid levels, abdominal circumference, and body mass index (BMI). Lifestyle modifications such as smoking cessation, exercise, and dietary changes are encouraged to achieve and maintain a normal BMI.

Dermatologists also need to give special consideration to comorbidities when selecting medications and/or therapies for disease management. Patients on TNF inhibitors have a lower risk for MI compared with patients using topical medications, phototherapy, and other oral agents.¹⁰ Additionally, patients on TNF inhibitors have a lower risk for occurrence of major adverse cardiovascular events compared with patients treated with methotrexate or phototherapy.^11,12

Metabolic Syndrome

Numerous studies have demonstrated an association between psoriasis and metabolic syndrome. Patients with increased BSA involvement and psoriasis area and severity index scores have a higher prevalence of metabolic syndrome.¹³ Patients with psoriasis have an increased risk for the following conditions compared to controls: obesity (38% vs 31%; odds ratio [OR], 1.38; 95% CI, 1.29-1.48), elevated triglycerides (36% vs 28%; OR, 1.49; 95% CI, 1.39-1.60), hypertension (31% vs 28%; OR, 1.20; 95% CI, 1.11-12.9), and elevated glucose levels (22% vs 16%; OR, 1.44; 95% CI, 1.33-1.56).¹⁴ Dermatologists are strongly recommended to inform patients about the risk for metabolic syndrome and to encourage the measurement of blood pressure, waist circumference, fasting blood glucose, hemoglobin A_1C, and fasting lipid levels with their PCP when indicated. Body mass index and waist circumference also should be measured annually in patients with moderate to severe psoriasis because of the association with disease severity.

The association between psoriasis and weight loss has been analyzed in several studies. Weight loss, particularly in obese patients, has been shown to improve psoriasis severity, as measured by psoriasis area and severity index score and QOL measures.¹⁵ Another study found that gastric bypass was associated with a significant risk reduction in the development of psoriasis (P=.004) and the disease prognosis (P=.02 for severe psoriasis; P=.01 for PsA).¹⁶ Therefore, patients with moderate to severe psoriasis are recommended to have their obesity status determined according to national guidelines. For patients with a BMI above 40 kg/m² and standard weight-loss measures fail, bariatric surgery is recommended. Additionally, the impact of psoriasis medications on weight has been studied. Apremilast has been associated with weight loss, whereas etanercept and infliximab have been linked to weight gain.^17,18

An association between psoriasis and hypertension also has been demonstrated by studies, especially among patients with severe disease. Therefore, patients with moderate to severe psoriasis are recommended to have their blood pressure evaluated according to national guidelines, and those with a blood pressure of 140/90 mm Hg or higher should be referred to their PCP for assessment and treatment. Current evidence does not support restrictions on antihypertensive medications in patients with psoriasis. Physicians should be aware of the potential for cyclosporine to induce hypertension, which should be treated, specifically with amlodipine.¹⁹

Many studies have demonstrated an association between psoriasis and dyslipidemia, though the results are somewhat conflicting. In 2018, the American Heart Association and the American College of Cardiology deemed psoriasis as an atherosclerotic CVD risk-enhancing condition, favoring early initiation of statin therapy. Because dyslipidemia plays a prominent role in atherosclerosis and CVD, patients with moderate to severe psoriasis are recommended to undergo periodic screening with lipid tests (eg, fasting total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides).²⁰ Patients with elevated fasting triglycerides or low-density lipoprotein cholesterol should be referred to their PCP for further management. Certain psoriasis medications also have been linked to dyslipidemia. Acitretin and cyclosporine are known to adversely affect lipid levels, so patients treated with either agent should undergo routine monitoring of serum lipid levels.

Psoriasis is strongly associated with diabetes mellitus. Because of the increased risk for diabetes in patients with severe disease, regular monitoring of fasting blood glucose and/or hemoglobin A_1C levels in patients with moderate to severe psoriasis is recommended. Patients who meet criteria for prediabetes or diabetes should be referred to their PCP for further assessment and management.^21,22

Mood Disorders

Psoriasis affects QOL and can have a major impact on patients’ interpersonal relationships. Studies have shown an association between psoriasis and mood disorders, specifically depression and anxiety. Unfortunately, patients with mood disorders are less likely to seek intervention for their skin disease, which poses a tremendous treatment barrier. Dermatologists should regularly monitor patients for psychiatric symptoms so that resources and treatments can be offered.

Certain psoriasis therapies have been shown to help alleviate associated depression and anxiety. Improvements in Beck Depression Inventory and Hamilton Depression Rating Scale scores were seen with etanercept.²³ Adalimumab and ustekinumab showed improvement in Dermatology Life Quality Index compared with placebo.^24,25 Patients receiving Goeckerman treatment also had improvement in anxiety and depression scores compared with conventional therapy.²⁶ Biologic medications had the largest impact on improving depression symptoms compared with conventional systemic therapy and phototherapy.²⁷ The recommendations support use of biologics and the Goeckerman regimen for the concomitant treatment of mood disorders and psoriasis.

Renal Disease

Studies have supported an association between psoriasis and chronic kidney disease (CKD), independent of risk factors including vascular disease, hypertension, and diabetes. The prevalence of moderate to advanced CKD also has been found to be directly related to increasing BSA affected by psoriasis.²⁸ Patients should receive testing of blood urea nitrogen, creatinine, and urine microalbumin levels to assess for occult renal disease. In addition, physicians should be cautious when prescribing nephrotoxic drugs (nonsteroidal anti-inflammatory drugs and cyclosporine) and renally excreted agents (methotrexate and apremilast) because of the risk for underlying renal disease in patients with psoriasis. If newly acquired renal disease is suspected, physicians should withhold the offending agents. Patients with psoriasis with CKD are recommended to follow up with their PCP or nephrologist for evaluation and management.

Pulmonary Disease

Psoriasis also has an independent association with COPD. Patients with psoriasis have a higher likelihood of developing COPD (hazard ratio, 2.35; 95% CI, 1.42-3.89; P<.01) than controls.²⁹ The prevalence of COPD also was found to correlate with psoriasis severity. Dermatologists should educate patients about the association between smoking and psoriasis as well as advise patients to discontinue smoking to reduce their risk for developing COPD and cancer.

Patients with psoriasis also are at an increased risk for obstructive sleep apnea. Obstructive sleep apnea should be considered in patients with risk factors including snoring, obesity, hypertension, or diabetes.

Inflammatory Bowel Disease

Patients with psoriasis have an increased risk for developing IBD. The prevalence ratios of both Crohn disease (2.49) and ulcerative colitis (1.64) are increased in patients with psoriasis relative to patients without psoriasis.³⁰ Physicians need to be aware of the association between psoriasis and IBD and the effect that their coexistence may have on treatment choice for patients.

Adalimumab and infliximab are approved for the treatment of IBD, and certolizumab and ustekinumab are approved for Crohn disease. Use of TNF inhibitors in patients with IBD may cause psoriasiform lesions to develop.³¹ Nonetheless, treatment should be individualized and psoriasiform lesions treated with standard psoriasis measures. Psoriasis patients with IBD are recommended to avoid IL-17–inhibitor therapy, given its potential to worsen IBD flares.

Malignancy

Psoriasis patients aged 0 to 79 years have a greater overall risk for malignancy compared with patients without psoriasis.³² Patients with psoriasis have an increased risk for respiratory tract cancer, upper aerodigestive tract cancer, urinary tract cancer, and non-Hodgkin lymphoma.³³ A mild association exists between PsA and lymphoma, nonmelanoma skin cancer (NMSC), and lung cancer.³⁴ More severe psoriasis is associated with greater risk for lymphoma and NMSC. Dermatologists are recommended to educate patients on their risk for certain malignancies and to refer patients to specialists upon suspicion of malignancy.

Risk for malignancy has been shown to be affected by psoriasis treatments. Patients treated with UVB have reduced overall cancer rates for all age groups (hazard ratio, 0.52; P=.3), while those treated with psoralen plus UVA have an increased incidence of squamous cell carcinoma.^32,33 Adalimumab was correlated with increased risk for NMSC in patients with psoriasis but did not have an increased risk for all cancers collectively when used for various immune-mediated inflammatory diseases.³⁵ In contrast, a meta-analysis of randomized clinical trials found no association with TNF inhibitor use and NMSC.³⁶ Ustekinumab had no association with malignancy.³⁷ Treatment history should be elucidated because of higher rates of squamous cell carcinoma in patients with prior psoralen plus UVA, cyclosporine, or methotrexate use.³³ To address malignancy risk, patients with psoriasis should undergo regular screenings for skin cancer and follow national guidelines for age-appropriate cancer screenings.

Lifestyle Choices and QOL

A crucial aspect of successful psoriasis management is patient education. The strongest recommendations support lifestyle changes, such as smoking cessation and limitation of alcohol use. A tactful discussion regarding substance use, work productivity, interpersonal relationships, and sexual function can address substantial effects of psoriasis on QOL so that support and resources can be provided.

Final Thoughts

Management of psoriasis is multifaceted and involves screening, education, monitoring, and collaboration with PCPs and specialists. Regular follow-up with a dermatologist and PCP is strongly recommended for patients with psoriasis given the systemic nature of the disease. The 2019 AAD-NPF recommendations provide important information for dermatologists to coordinate care for complicated psoriasis cases, but clinical judgment is paramount when making medical decisions. The consideration of comorbidities is critical for developing a comprehensive treatment approach, and this approach will lead to better health outcomes and improved QOL for patients with psoriasis.

With the rise of telehealth utilization during the COVID-19 pandemic, clinical care delivery has undergone a substantial shift. This is especially true in dermatology, as utilization of telehealth has jumped from under 15% to more than 95% of dermatologists after the COVID-19 pandemic.¹ However, with this new form of care delivery, it is important to ensure that patients don’t get left behind, either due to socioeconomic/language barriers² or hesitancy about the conditions being treated.

It may not be surprising to know that the idea of using telemedicine for rheumatology is not new. Indeed, a report from 20 years ago outlined the high level of both satisfaction with live interactive telehealth visits for rheumatologic conditions and diagnostic accuracy as compared to in-person visits.³ Through guided palpation and careful history taking, it is possible to conduct a thorough visit and even manage biologics, diagnose active arthritis/enthesitis via photographs, and evaluate pain through a visual analog scale.⁴ As far as dermatology is concerned, it is clear that certain situations seem to be better suited for teledermatology, such as follow-up visits for acne/rosacea.¹ But what of psoriatic arthritis (PsA)? Does telehealth have the potential to mitigate our undertreatment of this important condition, which finds about half of patients being treated with only topical therapy or no treatment at all?⁵ Or can we modulate our visits to accommodate these patients, taking care of not only their visible psoriasis but also the underlying PsA?

Psoriasis is well suited for teledermatology management in general, especially once the diagnosis is made. Multiple studies have shown diagnostic equivalence with in-person care and even similar outcomes after treatment.^6,7 However, most studies have looked at telemedicine primarily for cutaneous psoriasis, and translating this to screening for and management of PsA is paramount. After all, a delay of only 6 months in diagnosing and treating PsA has been associated with poor outcomes.⁸ Thankfully, we do have some tools that can help. There are 3 validated screening tools for PsA: the Psoriasis Epidemiology Screening Tool (PEST), the Psoriatic Arthritis Screening and Evaluation (PASE), and the Toronto Psoriatic Arthritis Screen (ToPAS) questionnaire.⁹ Of these, the PEST seems to be a reasonable option that is quick and easily deployed; it has shown strong performance in terms of sensitivity, specificity, and negative predictive value/positive predictive value when compared to similar screening tools.¹⁰ It also should be facile to direct patients to complete the screening tool, as an online version is available on the National Psoriasis Foundation’s website (https://www.psoriasis.org/psoriatic-arthritis-screening-test/) where patients can be directed to answer 5 simple questions and report back the outcome. For treatment decisions, this tool also can be used to help identify patients who are good candidates for systemic or biologic therapy or those who should see a rheumatologist. Of course, an in-depth discussion of joint pain, morning stiffness, and tender/swollen joints may be more fruitful but also more challenging to conduct. I would propose that this can be pared down to a more direct conversation about finger pain/tenderness, tenderness at the elbow/knee (lateral epicondyle/medial femoral condyle), or heel (Achilles) as more common sites of enthesitis, and questioning about back pain or stiffness that improves with movement.⁹ By combining the screening tool with these pointed questions, even via telehealth, we can greatly improve our yield in diagnosing PsA while only adding a minute or two to our visits. I’d argue that this is much more fruitful than asking the patient to contort their bodies and camera to show an obscure lesion!

It is interesting to consider areas in dermatology where we might make a notable impact on mortality and morbidity by expanding access to care. Earlier diagnosis of melanoma, for instance, certainly would be in consideration, especially in areas of the country where access to dermatologic care is challenging. Better management of PsA has to be up there on the list of conditions where we immediately can make a tangible difference; we have the tools to do so and excellent therapeutics that are safe and effective. Our colleagues in rheumatology have embraced telemedicine with a “how, not if” approach to embracing new technology,¹¹ and it is about time that dermatology takes a similar attitude. The gap between access to dermatologic care in urban areas vs either nonmetropolitan or rural areas is increasing, and dermatology tends to be much more available in well-resourced, urban areas.¹² There are patients who need our expertise, and if it takes the compromise of adopting a technology that sometimes gives us headaches (we’ve all been on video visits with a choppy signal and inadequate lighting), we still should try to figure out the best way to do it because it’s the right thing to do for these patients. If we don’t, the determination of how to conduct teledermatology care will be taken away from us and either insurance companies or corporations not guided by dermatologists may try to enter this health care void and decide how to provide these services.

With the rise of telehealth utilization during the COVID-19 pandemic, clinical care delivery has undergone a substantial shift. This is especially true in dermatology, as utilization of telehealth has jumped from under 15% to more than 95% of dermatologists after the COVID-19 pandemic.¹ However, with this new form of care delivery, it is important to ensure that patients don’t get left behind, either due to socioeconomic/language barriers² or hesitancy about the conditions being treated.

It may not be surprising to know that the idea of using telemedicine for rheumatology is not new. Indeed, a report from 20 years ago outlined the high level of both satisfaction with live interactive telehealth visits for rheumatologic conditions and diagnostic accuracy as compared to in-person visits.³ Through guided palpation and careful history taking, it is possible to conduct a thorough visit and even manage biologics, diagnose active arthritis/enthesitis via photographs, and evaluate pain through a visual analog scale.⁴ As far as dermatology is concerned, it is clear that certain situations seem to be better suited for teledermatology, such as follow-up visits for acne/rosacea.¹ But what of psoriatic arthritis (PsA)? Does telehealth have the potential to mitigate our undertreatment of this important condition, which finds about half of patients being treated with only topical therapy or no treatment at all?⁵ Or can we modulate our visits to accommodate these patients, taking care of not only their visible psoriasis but also the underlying PsA?

Psoriasis is well suited for teledermatology management in general, especially once the diagnosis is made. Multiple studies have shown diagnostic equivalence with in-person care and even similar outcomes after treatment.^6,7 However, most studies have looked at telemedicine primarily for cutaneous psoriasis, and translating this to screening for and management of PsA is paramount. After all, a delay of only 6 months in diagnosing and treating PsA has been associated with poor outcomes.⁸ Thankfully, we do have some tools that can help. There are 3 validated screening tools for PsA: the Psoriasis Epidemiology Screening Tool (PEST), the Psoriatic Arthritis Screening and Evaluation (PASE), and the Toronto Psoriatic Arthritis Screen (ToPAS) questionnaire.⁹ Of these, the PEST seems to be a reasonable option that is quick and easily deployed; it has shown strong performance in terms of sensitivity, specificity, and negative predictive value/positive predictive value when compared to similar screening tools.¹⁰ It also should be facile to direct patients to complete the screening tool, as an online version is available on the National Psoriasis Foundation’s website (https://www.psoriasis.org/psoriatic-arthritis-screening-test/) where patients can be directed to answer 5 simple questions and report back the outcome. For treatment decisions, this tool also can be used to help identify patients who are good candidates for systemic or biologic therapy or those who should see a rheumatologist. Of course, an in-depth discussion of joint pain, morning stiffness, and tender/swollen joints may be more fruitful but also more challenging to conduct. I would propose that this can be pared down to a more direct conversation about finger pain/tenderness, tenderness at the elbow/knee (lateral epicondyle/medial femoral condyle), or heel (Achilles) as more common sites of enthesitis, and questioning about back pain or stiffness that improves with movement.⁹ By combining the screening tool with these pointed questions, even via telehealth, we can greatly improve our yield in diagnosing PsA while only adding a minute or two to our visits. I’d argue that this is much more fruitful than asking the patient to contort their bodies and camera to show an obscure lesion!

It is interesting to consider areas in dermatology where we might make a notable impact on mortality and morbidity by expanding access to care. Earlier diagnosis of melanoma, for instance, certainly would be in consideration, especially in areas of the country where access to dermatologic care is challenging. Better management of PsA has to be up there on the list of conditions where we immediately can make a tangible difference; we have the tools to do so and excellent therapeutics that are safe and effective. Our colleagues in rheumatology have embraced telemedicine with a “how, not if” approach to embracing new technology,¹¹ and it is about time that dermatology takes a similar attitude. The gap between access to dermatologic care in urban areas vs either nonmetropolitan or rural areas is increasing, and dermatology tends to be much more available in well-resourced, urban areas.¹² There are patients who need our expertise, and if it takes the compromise of adopting a technology that sometimes gives us headaches (we’ve all been on video visits with a choppy signal and inadequate lighting), we still should try to figure out the best way to do it because it’s the right thing to do for these patients. If we don’t, the determination of how to conduct teledermatology care will be taken away from us and either insurance companies or corporations not guided by dermatologists may try to enter this health care void and decide how to provide these services.

With the rise of telehealth utilization during the COVID-19 pandemic, clinical care delivery has undergone a substantial shift. This is especially true in dermatology, as utilization of telehealth has jumped from under 15% to more than 95% of dermatologists after the COVID-19 pandemic.¹ However, with this new form of care delivery, it is important to ensure that patients don’t get left behind, either due to socioeconomic/language barriers² or hesitancy about the conditions being treated.

It may not be surprising to know that the idea of using telemedicine for rheumatology is not new. Indeed, a report from 20 years ago outlined the high level of both satisfaction with live interactive telehealth visits for rheumatologic conditions and diagnostic accuracy as compared to in-person visits.³ Through guided palpation and careful history taking, it is possible to conduct a thorough visit and even manage biologics, diagnose active arthritis/enthesitis via photographs, and evaluate pain through a visual analog scale.⁴ As far as dermatology is concerned, it is clear that certain situations seem to be better suited for teledermatology, such as follow-up visits for acne/rosacea.¹ But what of psoriatic arthritis (PsA)? Does telehealth have the potential to mitigate our undertreatment of this important condition, which finds about half of patients being treated with only topical therapy or no treatment at all?⁵ Or can we modulate our visits to accommodate these patients, taking care of not only their visible psoriasis but also the underlying PsA?

Psoriasis is well suited for teledermatology management in general, especially once the diagnosis is made. Multiple studies have shown diagnostic equivalence with in-person care and even similar outcomes after treatment.^6,7 However, most studies have looked at telemedicine primarily for cutaneous psoriasis, and translating this to screening for and management of PsA is paramount. After all, a delay of only 6 months in diagnosing and treating PsA has been associated with poor outcomes.⁸ Thankfully, we do have some tools that can help. There are 3 validated screening tools for PsA: the Psoriasis Epidemiology Screening Tool (PEST), the Psoriatic Arthritis Screening and Evaluation (PASE), and the Toronto Psoriatic Arthritis Screen (ToPAS) questionnaire.⁹ Of these, the PEST seems to be a reasonable option that is quick and easily deployed; it has shown strong performance in terms of sensitivity, specificity, and negative predictive value/positive predictive value when compared to similar screening tools.¹⁰ It also should be facile to direct patients to complete the screening tool, as an online version is available on the National Psoriasis Foundation’s website (https://www.psoriasis.org/psoriatic-arthritis-screening-test/) where patients can be directed to answer 5 simple questions and report back the outcome. For treatment decisions, this tool also can be used to help identify patients who are good candidates for systemic or biologic therapy or those who should see a rheumatologist. Of course, an in-depth discussion of joint pain, morning stiffness, and tender/swollen joints may be more fruitful but also more challenging to conduct. I would propose that this can be pared down to a more direct conversation about finger pain/tenderness, tenderness at the elbow/knee (lateral epicondyle/medial femoral condyle), or heel (Achilles) as more common sites of enthesitis, and questioning about back pain or stiffness that improves with movement.⁹ By combining the screening tool with these pointed questions, even via telehealth, we can greatly improve our yield in diagnosing PsA while only adding a minute or two to our visits. I’d argue that this is much more fruitful than asking the patient to contort their bodies and camera to show an obscure lesion!

It is interesting to consider areas in dermatology where we might make a notable impact on mortality and morbidity by expanding access to care. Earlier diagnosis of melanoma, for instance, certainly would be in consideration, especially in areas of the country where access to dermatologic care is challenging. Better management of PsA has to be up there on the list of conditions where we immediately can make a tangible difference; we have the tools to do so and excellent therapeutics that are safe and effective. Our colleagues in rheumatology have embraced telemedicine with a “how, not if” approach to embracing new technology,¹¹ and it is about time that dermatology takes a similar attitude. The gap between access to dermatologic care in urban areas vs either nonmetropolitan or rural areas is increasing, and dermatology tends to be much more available in well-resourced, urban areas.¹² There are patients who need our expertise, and if it takes the compromise of adopting a technology that sometimes gives us headaches (we’ve all been on video visits with a choppy signal and inadequate lighting), we still should try to figure out the best way to do it because it’s the right thing to do for these patients. If we don’t, the determination of how to conduct teledermatology care will be taken away from us and either insurance companies or corporations not guided by dermatologists may try to enter this health care void and decide how to provide these services.

Biologics have transformed the management of moderate to severe psoriasis. There currently are 11 biologics approved by the US Food and Drug Administration (Table) for psoriasis treatment that have been affirmed by various clinical studies. This article provides dosing initiation, maintenance information, and updated clinical data using phase 3 studies (N=8) published between May 2020 and February 2021. Generic names of the 11 biologics were searched separately in the PubMed database within the specified date range. Subsequent results were reviewed by title and selected for phase 3 and 4 trials. Clinical data in this review focus on reducing patient disease burden by allocating a biologic best fit for each patient’s individual health profile.

IL-17A Inhibitors Update

Secukinumab is safe and efficacious for skin clearance in the presence of comorbidities and can be used for improving plaque psoriasis and palmoplantar pustular psoriasis. An extension of a phase 3 randomized controlled trial (RCT)—2PRECISE—evaluated the efficacy and safety of secukinumab dosing at 300 mg (n=79) and 150 mg (n=80) in adults with moderate to severe palmoplantar pustular psoriasis (palmoplantar psoriasis area and severity index [PPPASI] score ≥12 and dermatology life quality index [DLQI] ≥10) over 148 weeks.¹ Extension patients were included from the 52-week 2PRECISE study per the investigator’s judgement of a meaningful clinical response (exact criteria not described). All treatment groups demonstrated a mean (SD) PPPASI of 22.7 (9.5) by the extension trial’s start. Results affirmed that clinical response waned after week 148 in all groups excluding placebo/secukinumab 150 mg, which maintained a mean (SD) PPPASI of 22.7 (9.5). The most frequent adverse events were nasopharyngitis, pustular psoriasis, headache, and pruritus.¹

Comorbidities do not have a major impact on secukinumab’s efficacy. A post hoc analysis of 4 phase 3 RCTs—ERASURE, FIXTURE, FEATURE, and JUNCTURE—gathered data from adult patients (N=2401) to assess baseline comorbidities with efficacy and safety of secukinumab vs etanercept after 12 weeks of treatment.² Sixty-one percent (n=1469) had at least 1 comorbidity, most frequently obesity, hypertension, psoriatic arthritis, hyperlipidemia, or diabetes mellitus. All patient groups had a greater likelihood of a psoriasis area and severity index (PASI) response with any dose of secukinumab vs patients with comorbidities who were taking etanercept or placebo (P<.05) at week 12. All groups had a greater likelihood of achieving investigator global assessment scores of 0/1 (clear/almost clear) vs patients with comorbidities taking etanercept or placebo (P<.05). Baseline comorbidities did not significantly affect treatment response, except obesity, which was associated with decreased probability of achieving all PASI and investigator global assessment (P<.01) responses. Secukinumab-treated patients with and without comorbidities had equivalent likelihood of treatment-emergent adverse events (TEAEs).²

Brodalumab is an effective biologic that has shown long-term safety with continuous administration. Continuous brodalumab and brodalumab after placebo demonstrated impactful skin clearance after 120 weeks in AMAGINE-1, a phase 3 RCT involving adults (N=442) with moderate to severe plaque psoriasis.³ Patients randomized to brodalumab 210 mg (n=222) or placebo (n=220) were rerandomized according to initial treatment response. In patients switching from brodalumab to placebo at week 12, 55% and 94% achieved PASI 75 at week 20 and week 120, respectively, and 75% reached PASI 100 at week 120. Of patients with static physician global assessment (sPGA) scores of 0/1 (clear/almost clear) at week 12 who were rerandomized to brodalumab, 96% and 80% (using observed data) achieved PASI 75 and PASI 100, respectively. Mean (SD) time to return of skin disease following withdrawal of brodalumab was 74.7 (50.5) days. Treatment-emergent adverse events included headaches, arthralgia, diarrhea, and nausea. Suicidal ideation was rare (this study had 1 completed suicide), and authors cited that no causal association has been made between brodalumab and suicidality. Brodalumab also demonstrated favorable treatment response in patients who underwent a lapse in treatment, offering real-world value, as intermittent treatment administration can occur because of personal or financial reasons.³

Ixekizumab is associated with more rapid skin clearance, better resolution of nail psoriasis, and superior improvement in quality-of-life measures when compared with guselkumab. The phase 3 study IXORA-R compared skin and nail clearance as well as patient-reported outcomes over 24 weeks with ixekizumab 80 mg (n=520) vs guselkumab 100 mg (n=507) in adults with moderate to severe plaque psoriasis.⁴ Ixekizumab (50%) was shown to be no worse than guselkumab (52%; difference, –2.3%) using a noninferiority test (noninferiority margin of –11.4%). The treatments exhibited similar efficacy, with no significant difference in proportion of patients reaching PASI 100 (P=.41). Ixekizumab patients tended to have skin clearance sooner than guselkumab patients, reaching PASI 50/75/90 and PASI 100 in a median time that was 2 weeks and 7.5 weeks earlier, respectively. More ixekizumab patients (52%) achieved clear nails vs guselkumab patients (31%; P=.007). Ixekizumab patients reported greater satisfaction with their skin disease affecting quality of life (DLQI), with more DLQI 0/1 (no effect at all on patient’s life) scores and being itch free (P<.05). Ixekizumab was associated with significantly more days of complete skin clearance (PASI 100) vs guselkumab (55.6 days vs 42.2 days; P<.001). Although an upper respiratory tract infection was the most common TEAE, the proportion of TEAEs was similar between treatments.⁴

IL-23 Inhibitors Update

Tildrakizumab has similar long-term skin clearance efficacy and safety in patients with psoriasis with and without comorbid metabolic syndrome (MetS). A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS.⁵ Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).⁵

Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose. The 200-mg dose can be utilized in patients with a high burden of disease and disability. reSURFACE 1 and reSURFACE 2 involved adults with chronic moderate to severe plaque psoriasis randomized to tildrakizumab 100 mg, 200 mg, or placebo with the option of long-term extension to week 244 if patients reached 50% or greater improvement from baseline PASI score.⁶ Patients in reSURFACE 2 also were randomized to etanercept 50 mg with partial responders and nonresponders at week 28 switching to tildrakizumab 200 mg until week 244. Extension results showed PASI 75 achievement in 88.7% (95% CI, 84.6%-92.1%) of patients taking tildrakizumab 100 mg (n=235), 92.5% (95% CI, 88.1%-95.7%) of patients taking tildrakizumab 200 mg (n=176), and 81.3% (95% CI, 72.6%-88.2%) of patients taking etanercept/partial nonresponders (n=85). The most common TEAE was nasopharyngitis (10.5/100 patient-years for tildrakizumab 100 mg and 10.7/100 patient-years for tildrakizumab 200 mg). The frequency of severe infections (eg, diverticulitis, pneumonia, cellulitis, appendicitis) was 1.2 per 100 patient-years for tildrakizumab 100 mg and 1.3 per 100 patient-years for tildrakizumab 200 mg.⁶

Risankizumab and tildrakizumab require the lowest number of injections, thereby providing sustainable skin clearance with a convenient injection dosing schedule for patients. Risankizumab efficacy (8.2% with inferiority margin of 12%) was noninferior to secukinumab when assessing the proportion of PASI 90 responders at week 16 (after 2 doses of risankizumab vs 7 doses of secukinumab).⁷ IMMerge, an international phase 3 RCT, involved adults (N=327) with moderate to severe plaque psoriasis to compare the safety and efficacy of risankizumab 150 mg (n=164) vs secukinumab 300 mg (n=163) up to 52 weeks. A greater proportion of the risankizumab arm (86.6%) achieved PASI 90 in 52 weeks compared to the secukinumab arm (57.1%). Superior skin clearance (PASI 90) at week 52 was achieved after 5 doses with risankizumab vs 16 doses of secukinumab. Risankizumab TEAEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis.⁷

Continuous risankizumab treatment shows substantially stronger skin clearing performance compared with intermittent treatment following drug withdrawal, demonstrating that treatment gaps minimize therapeutic response. IMMhance, an international phase 3 RCT involving adults (N=507) with moderate to severe plaque psoriasis, evaluated the safety and efficacy with risankizumab 150 mg after 52 weeks and 104 weeks.⁸ Part A randomized patients to risankizumab 150 mg (n=407) or placebo (n=100). Part B rerandomized patients at week 28 to continue risankizumab 150 mg or placebo (designated as withdrawal of treatment; later re-treated with risankizumab 150 mg if patients had sPGA ≥3). At week 52, significantly more patients reached sPGA score of 0/1 with risankizumab/risankizumab (n=97 [87.4%]) vs risankizumab/placebo (n=138 [61.3%]; P<.001). At week 104, significantly more patients reached an sPGA score of 0/1 with risankizumab/risankizumab (n=90 [81.1%]) vs risankizumab/placebo (n=16 [7.1%]; P<.001). Risankizumab exhibited longevity following withdrawal, as median time to loss of response and relapse was 42 weeks (sPGA ≥3). The extent of TEAEs was similar between risankizumab and placebo and included nasopharyngitis, upper respiratory tract infection, headache, and back pain.⁸

Final Thoughts

Biologics for psoriasis help produce intended results for skin disease clearance and are tools for precision medicine. Recent data demonstrate safe, durable, and continuous efficacy with biologics, which offer patients a better chance of treatment success. This guide may serve as a quick reference for biologic selection with special consideration of individual disease characteristics and comorbidities.

Biologics have transformed the management of moderate to severe psoriasis. There currently are 11 biologics approved by the US Food and Drug Administration (Table) for psoriasis treatment that have been affirmed by various clinical studies. This article provides dosing initiation, maintenance information, and updated clinical data using phase 3 studies (N=8) published between May 2020 and February 2021. Generic names of the 11 biologics were searched separately in the PubMed database within the specified date range. Subsequent results were reviewed by title and selected for phase 3 and 4 trials. Clinical data in this review focus on reducing patient disease burden by allocating a biologic best fit for each patient’s individual health profile.

IL-17A Inhibitors Update

Secukinumab is safe and efficacious for skin clearance in the presence of comorbidities and can be used for improving plaque psoriasis and palmoplantar pustular psoriasis. An extension of a phase 3 randomized controlled trial (RCT)—2PRECISE—evaluated the efficacy and safety of secukinumab dosing at 300 mg (n=79) and 150 mg (n=80) in adults with moderate to severe palmoplantar pustular psoriasis (palmoplantar psoriasis area and severity index [PPPASI] score ≥12 and dermatology life quality index [DLQI] ≥10) over 148 weeks.¹ Extension patients were included from the 52-week 2PRECISE study per the investigator’s judgement of a meaningful clinical response (exact criteria not described). All treatment groups demonstrated a mean (SD) PPPASI of 22.7 (9.5) by the extension trial’s start. Results affirmed that clinical response waned after week 148 in all groups excluding placebo/secukinumab 150 mg, which maintained a mean (SD) PPPASI of 22.7 (9.5). The most frequent adverse events were nasopharyngitis, pustular psoriasis, headache, and pruritus.¹

Comorbidities do not have a major impact on secukinumab’s efficacy. A post hoc analysis of 4 phase 3 RCTs—ERASURE, FIXTURE, FEATURE, and JUNCTURE—gathered data from adult patients (N=2401) to assess baseline comorbidities with efficacy and safety of secukinumab vs etanercept after 12 weeks of treatment.² Sixty-one percent (n=1469) had at least 1 comorbidity, most frequently obesity, hypertension, psoriatic arthritis, hyperlipidemia, or diabetes mellitus. All patient groups had a greater likelihood of a psoriasis area and severity index (PASI) response with any dose of secukinumab vs patients with comorbidities who were taking etanercept or placebo (P<.05) at week 12. All groups had a greater likelihood of achieving investigator global assessment scores of 0/1 (clear/almost clear) vs patients with comorbidities taking etanercept or placebo (P<.05). Baseline comorbidities did not significantly affect treatment response, except obesity, which was associated with decreased probability of achieving all PASI and investigator global assessment (P<.01) responses. Secukinumab-treated patients with and without comorbidities had equivalent likelihood of treatment-emergent adverse events (TEAEs).²

Brodalumab is an effective biologic that has shown long-term safety with continuous administration. Continuous brodalumab and brodalumab after placebo demonstrated impactful skin clearance after 120 weeks in AMAGINE-1, a phase 3 RCT involving adults (N=442) with moderate to severe plaque psoriasis.³ Patients randomized to brodalumab 210 mg (n=222) or placebo (n=220) were rerandomized according to initial treatment response. In patients switching from brodalumab to placebo at week 12, 55% and 94% achieved PASI 75 at week 20 and week 120, respectively, and 75% reached PASI 100 at week 120. Of patients with static physician global assessment (sPGA) scores of 0/1 (clear/almost clear) at week 12 who were rerandomized to brodalumab, 96% and 80% (using observed data) achieved PASI 75 and PASI 100, respectively. Mean (SD) time to return of skin disease following withdrawal of brodalumab was 74.7 (50.5) days. Treatment-emergent adverse events included headaches, arthralgia, diarrhea, and nausea. Suicidal ideation was rare (this study had 1 completed suicide), and authors cited that no causal association has been made between brodalumab and suicidality. Brodalumab also demonstrated favorable treatment response in patients who underwent a lapse in treatment, offering real-world value, as intermittent treatment administration can occur because of personal or financial reasons.³

Ixekizumab is associated with more rapid skin clearance, better resolution of nail psoriasis, and superior improvement in quality-of-life measures when compared with guselkumab. The phase 3 study IXORA-R compared skin and nail clearance as well as patient-reported outcomes over 24 weeks with ixekizumab 80 mg (n=520) vs guselkumab 100 mg (n=507) in adults with moderate to severe plaque psoriasis.⁴ Ixekizumab (50%) was shown to be no worse than guselkumab (52%; difference, –2.3%) using a noninferiority test (noninferiority margin of –11.4%). The treatments exhibited similar efficacy, with no significant difference in proportion of patients reaching PASI 100 (P=.41). Ixekizumab patients tended to have skin clearance sooner than guselkumab patients, reaching PASI 50/75/90 and PASI 100 in a median time that was 2 weeks and 7.5 weeks earlier, respectively. More ixekizumab patients (52%) achieved clear nails vs guselkumab patients (31%; P=.007). Ixekizumab patients reported greater satisfaction with their skin disease affecting quality of life (DLQI), with more DLQI 0/1 (no effect at all on patient’s life) scores and being itch free (P<.05). Ixekizumab was associated with significantly more days of complete skin clearance (PASI 100) vs guselkumab (55.6 days vs 42.2 days; P<.001). Although an upper respiratory tract infection was the most common TEAE, the proportion of TEAEs was similar between treatments.⁴

IL-23 Inhibitors Update

Tildrakizumab has similar long-term skin clearance efficacy and safety in patients with psoriasis with and without comorbid metabolic syndrome (MetS). A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS.⁵ Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).⁵

Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose. The 200-mg dose can be utilized in patients with a high burden of disease and disability. reSURFACE 1 and reSURFACE 2 involved adults with chronic moderate to severe plaque psoriasis randomized to tildrakizumab 100 mg, 200 mg, or placebo with the option of long-term extension to week 244 if patients reached 50% or greater improvement from baseline PASI score.⁶ Patients in reSURFACE 2 also were randomized to etanercept 50 mg with partial responders and nonresponders at week 28 switching to tildrakizumab 200 mg until week 244. Extension results showed PASI 75 achievement in 88.7% (95% CI, 84.6%-92.1%) of patients taking tildrakizumab 100 mg (n=235), 92.5% (95% CI, 88.1%-95.7%) of patients taking tildrakizumab 200 mg (n=176), and 81.3% (95% CI, 72.6%-88.2%) of patients taking etanercept/partial nonresponders (n=85). The most common TEAE was nasopharyngitis (10.5/100 patient-years for tildrakizumab 100 mg and 10.7/100 patient-years for tildrakizumab 200 mg). The frequency of severe infections (eg, diverticulitis, pneumonia, cellulitis, appendicitis) was 1.2 per 100 patient-years for tildrakizumab 100 mg and 1.3 per 100 patient-years for tildrakizumab 200 mg.⁶

Risankizumab and tildrakizumab require the lowest number of injections, thereby providing sustainable skin clearance with a convenient injection dosing schedule for patients. Risankizumab efficacy (8.2% with inferiority margin of 12%) was noninferior to secukinumab when assessing the proportion of PASI 90 responders at week 16 (after 2 doses of risankizumab vs 7 doses of secukinumab).⁷ IMMerge, an international phase 3 RCT, involved adults (N=327) with moderate to severe plaque psoriasis to compare the safety and efficacy of risankizumab 150 mg (n=164) vs secukinumab 300 mg (n=163) up to 52 weeks. A greater proportion of the risankizumab arm (86.6%) achieved PASI 90 in 52 weeks compared to the secukinumab arm (57.1%). Superior skin clearance (PASI 90) at week 52 was achieved after 5 doses with risankizumab vs 16 doses of secukinumab. Risankizumab TEAEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis.⁷

Continuous risankizumab treatment shows substantially stronger skin clearing performance compared with intermittent treatment following drug withdrawal, demonstrating that treatment gaps minimize therapeutic response. IMMhance, an international phase 3 RCT involving adults (N=507) with moderate to severe plaque psoriasis, evaluated the safety and efficacy with risankizumab 150 mg after 52 weeks and 104 weeks.⁸ Part A randomized patients to risankizumab 150 mg (n=407) or placebo (n=100). Part B rerandomized patients at week 28 to continue risankizumab 150 mg or placebo (designated as withdrawal of treatment; later re-treated with risankizumab 150 mg if patients had sPGA ≥3). At week 52, significantly more patients reached sPGA score of 0/1 with risankizumab/risankizumab (n=97 [87.4%]) vs risankizumab/placebo (n=138 [61.3%]; P<.001). At week 104, significantly more patients reached an sPGA score of 0/1 with risankizumab/risankizumab (n=90 [81.1%]) vs risankizumab/placebo (n=16 [7.1%]; P<.001). Risankizumab exhibited longevity following withdrawal, as median time to loss of response and relapse was 42 weeks (sPGA ≥3). The extent of TEAEs was similar between risankizumab and placebo and included nasopharyngitis, upper respiratory tract infection, headache, and back pain.⁸

Final Thoughts

Biologics for psoriasis help produce intended results for skin disease clearance and are tools for precision medicine. Recent data demonstrate safe, durable, and continuous efficacy with biologics, which offer patients a better chance of treatment success. This guide may serve as a quick reference for biologic selection with special consideration of individual disease characteristics and comorbidities.

Biologics have transformed the management of moderate to severe psoriasis. There currently are 11 biologics approved by the US Food and Drug Administration (Table) for psoriasis treatment that have been affirmed by various clinical studies. This article provides dosing initiation, maintenance information, and updated clinical data using phase 3 studies (N=8) published between May 2020 and February 2021. Generic names of the 11 biologics were searched separately in the PubMed database within the specified date range. Subsequent results were reviewed by title and selected for phase 3 and 4 trials. Clinical data in this review focus on reducing patient disease burden by allocating a biologic best fit for each patient’s individual health profile.

IL-17A Inhibitors Update

Secukinumab is safe and efficacious for skin clearance in the presence of comorbidities and can be used for improving plaque psoriasis and palmoplantar pustular psoriasis. An extension of a phase 3 randomized controlled trial (RCT)—2PRECISE—evaluated the efficacy and safety of secukinumab dosing at 300 mg (n=79) and 150 mg (n=80) in adults with moderate to severe palmoplantar pustular psoriasis (palmoplantar psoriasis area and severity index [PPPASI] score ≥12 and dermatology life quality index [DLQI] ≥10) over 148 weeks.¹ Extension patients were included from the 52-week 2PRECISE study per the investigator’s judgement of a meaningful clinical response (exact criteria not described). All treatment groups demonstrated a mean (SD) PPPASI of 22.7 (9.5) by the extension trial’s start. Results affirmed that clinical response waned after week 148 in all groups excluding placebo/secukinumab 150 mg, which maintained a mean (SD) PPPASI of 22.7 (9.5). The most frequent adverse events were nasopharyngitis, pustular psoriasis, headache, and pruritus.¹

Comorbidities do not have a major impact on secukinumab’s efficacy. A post hoc analysis of 4 phase 3 RCTs—ERASURE, FIXTURE, FEATURE, and JUNCTURE—gathered data from adult patients (N=2401) to assess baseline comorbidities with efficacy and safety of secukinumab vs etanercept after 12 weeks of treatment.² Sixty-one percent (n=1469) had at least 1 comorbidity, most frequently obesity, hypertension, psoriatic arthritis, hyperlipidemia, or diabetes mellitus. All patient groups had a greater likelihood of a psoriasis area and severity index (PASI) response with any dose of secukinumab vs patients with comorbidities who were taking etanercept or placebo (P<.05) at week 12. All groups had a greater likelihood of achieving investigator global assessment scores of 0/1 (clear/almost clear) vs patients with comorbidities taking etanercept or placebo (P<.05). Baseline comorbidities did not significantly affect treatment response, except obesity, which was associated with decreased probability of achieving all PASI and investigator global assessment (P<.01) responses. Secukinumab-treated patients with and without comorbidities had equivalent likelihood of treatment-emergent adverse events (TEAEs).²

Brodalumab is an effective biologic that has shown long-term safety with continuous administration. Continuous brodalumab and brodalumab after placebo demonstrated impactful skin clearance after 120 weeks in AMAGINE-1, a phase 3 RCT involving adults (N=442) with moderate to severe plaque psoriasis.³ Patients randomized to brodalumab 210 mg (n=222) or placebo (n=220) were rerandomized according to initial treatment response. In patients switching from brodalumab to placebo at week 12, 55% and 94% achieved PASI 75 at week 20 and week 120, respectively, and 75% reached PASI 100 at week 120. Of patients with static physician global assessment (sPGA) scores of 0/1 (clear/almost clear) at week 12 who were rerandomized to brodalumab, 96% and 80% (using observed data) achieved PASI 75 and PASI 100, respectively. Mean (SD) time to return of skin disease following withdrawal of brodalumab was 74.7 (50.5) days. Treatment-emergent adverse events included headaches, arthralgia, diarrhea, and nausea. Suicidal ideation was rare (this study had 1 completed suicide), and authors cited that no causal association has been made between brodalumab and suicidality. Brodalumab also demonstrated favorable treatment response in patients who underwent a lapse in treatment, offering real-world value, as intermittent treatment administration can occur because of personal or financial reasons.³

Ixekizumab is associated with more rapid skin clearance, better resolution of nail psoriasis, and superior improvement in quality-of-life measures when compared with guselkumab. The phase 3 study IXORA-R compared skin and nail clearance as well as patient-reported outcomes over 24 weeks with ixekizumab 80 mg (n=520) vs guselkumab 100 mg (n=507) in adults with moderate to severe plaque psoriasis.⁴ Ixekizumab (50%) was shown to be no worse than guselkumab (52%; difference, –2.3%) using a noninferiority test (noninferiority margin of –11.4%). The treatments exhibited similar efficacy, with no significant difference in proportion of patients reaching PASI 100 (P=.41). Ixekizumab patients tended to have skin clearance sooner than guselkumab patients, reaching PASI 50/75/90 and PASI 100 in a median time that was 2 weeks and 7.5 weeks earlier, respectively. More ixekizumab patients (52%) achieved clear nails vs guselkumab patients (31%; P=.007). Ixekizumab patients reported greater satisfaction with their skin disease affecting quality of life (DLQI), with more DLQI 0/1 (no effect at all on patient’s life) scores and being itch free (P<.05). Ixekizumab was associated with significantly more days of complete skin clearance (PASI 100) vs guselkumab (55.6 days vs 42.2 days; P<.001). Although an upper respiratory tract infection was the most common TEAE, the proportion of TEAEs was similar between treatments.⁴

IL-23 Inhibitors Update

Tildrakizumab has similar long-term skin clearance efficacy and safety in patients with psoriasis with and without comorbid metabolic syndrome (MetS). A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS.⁵ Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).⁵

Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose. The 200-mg dose can be utilized in patients with a high burden of disease and disability. reSURFACE 1 and reSURFACE 2 involved adults with chronic moderate to severe plaque psoriasis randomized to tildrakizumab 100 mg, 200 mg, or placebo with the option of long-term extension to week 244 if patients reached 50% or greater improvement from baseline PASI score.⁶ Patients in reSURFACE 2 also were randomized to etanercept 50 mg with partial responders and nonresponders at week 28 switching to tildrakizumab 200 mg until week 244. Extension results showed PASI 75 achievement in 88.7% (95% CI, 84.6%-92.1%) of patients taking tildrakizumab 100 mg (n=235), 92.5% (95% CI, 88.1%-95.7%) of patients taking tildrakizumab 200 mg (n=176), and 81.3% (95% CI, 72.6%-88.2%) of patients taking etanercept/partial nonresponders (n=85). The most common TEAE was nasopharyngitis (10.5/100 patient-years for tildrakizumab 100 mg and 10.7/100 patient-years for tildrakizumab 200 mg). The frequency of severe infections (eg, diverticulitis, pneumonia, cellulitis, appendicitis) was 1.2 per 100 patient-years for tildrakizumab 100 mg and 1.3 per 100 patient-years for tildrakizumab 200 mg.⁶

Risankizumab and tildrakizumab require the lowest number of injections, thereby providing sustainable skin clearance with a convenient injection dosing schedule for patients. Risankizumab efficacy (8.2% with inferiority margin of 12%) was noninferior to secukinumab when assessing the proportion of PASI 90 responders at week 16 (after 2 doses of risankizumab vs 7 doses of secukinumab).⁷ IMMerge, an international phase 3 RCT, involved adults (N=327) with moderate to severe plaque psoriasis to compare the safety and efficacy of risankizumab 150 mg (n=164) vs secukinumab 300 mg (n=163) up to 52 weeks. A greater proportion of the risankizumab arm (86.6%) achieved PASI 90 in 52 weeks compared to the secukinumab arm (57.1%). Superior skin clearance (PASI 90) at week 52 was achieved after 5 doses with risankizumab vs 16 doses of secukinumab. Risankizumab TEAEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis.⁷

Continuous risankizumab treatment shows substantially stronger skin clearing performance compared with intermittent treatment following drug withdrawal, demonstrating that treatment gaps minimize therapeutic response. IMMhance, an international phase 3 RCT involving adults (N=507) with moderate to severe plaque psoriasis, evaluated the safety and efficacy with risankizumab 150 mg after 52 weeks and 104 weeks.⁸ Part A randomized patients to risankizumab 150 mg (n=407) or placebo (n=100). Part B rerandomized patients at week 28 to continue risankizumab 150 mg or placebo (designated as withdrawal of treatment; later re-treated with risankizumab 150 mg if patients had sPGA ≥3). At week 52, significantly more patients reached sPGA score of 0/1 with risankizumab/risankizumab (n=97 [87.4%]) vs risankizumab/placebo (n=138 [61.3%]; P<.001). At week 104, significantly more patients reached an sPGA score of 0/1 with risankizumab/risankizumab (n=90 [81.1%]) vs risankizumab/placebo (n=16 [7.1%]; P<.001). Risankizumab exhibited longevity following withdrawal, as median time to loss of response and relapse was 42 weeks (sPGA ≥3). The extent of TEAEs was similar between risankizumab and placebo and included nasopharyngitis, upper respiratory tract infection, headache, and back pain.⁸

Final Thoughts

Biologics for psoriasis help produce intended results for skin disease clearance and are tools for precision medicine. Recent data demonstrate safe, durable, and continuous efficacy with biologics, which offer patients a better chance of treatment success. This guide may serve as a quick reference for biologic selection with special consideration of individual disease characteristics and comorbidities.