The U.S. Food and Drug Administration (FDA) has approved daratumumab + hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy.

Using the newly approved combination in this setting is a time-saver for patients and clinics, observed an investigator.

“The approval of subcutaneous daratumumab in combination with Kd will help clinicians address unmet patient needs by reducing the administration time from hours to just minutes and reducing the frequency of infusion-related reactions, as compared to the intravenous daratumumab formulation in combination with Kd,” said Ajai Chari, MD, of Mount Sinai Cancer Clinical Trials Office in New York City in a Janssen press statement.

Efficacy data for the new approval come from a single-arm cohort of PLEIADES, a multicohort, open-label trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had received one or more prior lines of therapy. Patients received daratumumab + hyaluronidase-fihj subcutaneously in combination with carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached.

The response rate with the new combination, which features a subcutaneous injection, was akin to those with the older combination, which features the more time-consuming IV administration and was FDA approved, according to the company press release.

The most common adverse reactions (≥20%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

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

The U.S. Food and Drug Administration (FDA) has approved daratumumab + hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy.

Using the newly approved combination in this setting is a time-saver for patients and clinics, observed an investigator.

“The approval of subcutaneous daratumumab in combination with Kd will help clinicians address unmet patient needs by reducing the administration time from hours to just minutes and reducing the frequency of infusion-related reactions, as compared to the intravenous daratumumab formulation in combination with Kd,” said Ajai Chari, MD, of Mount Sinai Cancer Clinical Trials Office in New York City in a Janssen press statement.

Efficacy data for the new approval come from a single-arm cohort of PLEIADES, a multicohort, open-label trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had received one or more prior lines of therapy. Patients received daratumumab + hyaluronidase-fihj subcutaneously in combination with carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached.

The response rate with the new combination, which features a subcutaneous injection, was akin to those with the older combination, which features the more time-consuming IV administration and was FDA approved, according to the company press release.

The most common adverse reactions (≥20%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

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

The U.S. Food and Drug Administration (FDA) has approved daratumumab + hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy.

Using the newly approved combination in this setting is a time-saver for patients and clinics, observed an investigator.

“The approval of subcutaneous daratumumab in combination with Kd will help clinicians address unmet patient needs by reducing the administration time from hours to just minutes and reducing the frequency of infusion-related reactions, as compared to the intravenous daratumumab formulation in combination with Kd,” said Ajai Chari, MD, of Mount Sinai Cancer Clinical Trials Office in New York City in a Janssen press statement.

Efficacy data for the new approval come from a single-arm cohort of PLEIADES, a multicohort, open-label trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had received one or more prior lines of therapy. Patients received daratumumab + hyaluronidase-fihj subcutaneously in combination with carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached.

The response rate with the new combination, which features a subcutaneous injection, was akin to those with the older combination, which features the more time-consuming IV administration and was FDA approved, according to the company press release.

The most common adverse reactions (≥20%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

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

Not that long ago, a man in his mid-20s whom Morgan Farrington calls Kiddo showed up at her house with a fever, chills, and nausea. He was increasingly out of it. These were all signs of an abscess from missing a vein and using someone else’s syringe, said Farrington, founder of Goodworks, in Huntsville, Alabama.

But it wasn’t just an abscess. It was four blood clots and sepsis. He’d been craving his next fix of heroin so hard, and the relief that comes from the act of shooting up itself, that he’d dug a 3-day-old blood shot – a used syringe with someone else’s blood in it – out of the garbage and had used it.

“He was almost dead,” said Farrington. “Another day, maybe two, he would have been dead, for sure, for sure.”

Farrington gets it. She has her own history of injection drug use. She knows the compulsion to, in her words, “shoot up sugar water just to get a hit.” And that’s fine, she said. “I just wish that he would do so with his own safety in mind.”

So when he got out of the hospital a few weeks later, Farrington talked to him about not just clean syringes but also HIV pre-exposure prophylaxis (PrEP), the daily HIV prevention pills that have been found to be up to 84% protective against HIV in people who inject drugs. Both approaches – syringe services and PrEP – play a key role in the president’s new National HIV/AIDS Strategy. The strategy calls for expanding access to both services in traditional and nontraditional settings but doesn’t include mechanisms for that to happen.

Of the 1.2 million people in the U.S. who could benefit from PrEP, according to the Centers for Disease Control and Prevention, 23% are using it. But according to data published in 2020, just 0% and 5% of people who inject drugs who could benefit are using it. And most, like the guy Farrington continues to talk to, don’t even know it exists.
 

People who inject drugs are willing, clinicians may not be

Clinicians have a role to play, but right now, many clinicians act as gatekeepers, picking and choosing whom they’ll offer PrEP to. In 2014, just 1% of PrEP prescribers said they had prescribed the prevention pill to people who inject drugs. And recent data published in AIDS and Behavior showed that clinicians who expressed negative attitudes about people who injected drugs were less likely to offer to prescribe PrEP to a theoretical man who injected drugs asking for PrEP. There was a paradox in there, however: Clinicians were also more likely to think men who inject drugs were at high risk for acquiring HIV. But they also believed those men would be less likely to adhere, less safety conscious, and less responsible than gay and bisexual men. So, the investigators found that despite need, clinicians were more likely to prescribe to men at risk via sex than men at risk via injection drug use.

According to the CDC, to qualify for PrEP, the only requirements for people who inject drugs are testing negative for HIV and not sharing injection equipment – whether their injecting partners have confirmed HIV or whether their HIV status is unknown.

“As long as PrEP is a prescription, medication providers are really going to determine who accesses PrEP and who does not,” said study lead author Sarah Calabrese, PhD, assistant professor of psychiatry at George Washington University. “Even if you do anticipate that a patient might have adherence struggles. The solution is not withholding something that could be beneficial to them. The solution is supporting them to take that beneficial medication.”

And it appears that providers and regular people like Farrington have stepped into the access vacuum, with a decidedly harm-reduction approach: syringe services programs. While there’s no national data on how many people receive PrEP through needle exchange programs, those programs are the natural place to offer other health care services, said Hansel Tookes, MD, assistant professor of medicine at the University of Miami and founder of the Infectious Disease Elimination Act (IDEA) Syringe Exchange program and clinic. At the clinic, 80% of the people living with HIV have undetectable viral loads – a sign of good adherence to medication and general health. Previous research suggests that when people who inject drugs find out about PrEP, 57% are game for trying it. But early work suggests that people who inject drugs might need to access PrEP in a different way from other people who use PrEP.

Dr. Tookes is currently conducting a study looking at whether referring people who inject drugs out from needle exchanges to PrEP prescribers is as effective as offering it on site at the exchanges.

“My experience in the past 5 years of being faculty at the university and being a cofounder of a program like IDEA is that we really, if we’re going to be successful with engaging people who inject drugs in things like PrEP, we have to, like all things harm reduction, meet them where they’re at, both physically and mentally, and on their own terms,” said Dr. Tookes. “What better place than a syringe services program?”
 

Where people are: the exchanges

That’s where community health worker Farrington and others come in. More than 400 syringe access programs that exist in North America have PrEP programs, according to the North American Syringe Exchange Network (NASEN), and 86 of them report offering access to PrEP, either directly or through referrals. It’s an HIV prevention one-two punch: PrEP protects a person once they are exposed to HIV, and needle exchanges themselves reduce HIV transmission rates by reducing the odds that people will engage in behavior that exposes them to the virus in the first place.

So far, PrEP access for people who inject drugs looks different everywhere. At Las Vegas’ Huntridge Family Clinic, people can come to the lobby and pick up clean supplies from a syringe exchange vending machine, and while they’re there, talk to nurse practitioner Rob Phoenix, MSN, APRN, about HIV prevention.

In Cincinnati, where Adam Reilly, CDCA, runs a Ryan White–funded PrEP program out of the nonprofit Caracole, PrEP navigators go out with the syringe services vans run by the county health department and can connect them with providers willing to prescribe it. In Alabama, where needle exchanges are illegal, Farrington works as a community health worker through the North Alabama Area Health Education Center to go in to Huntsville’s legal tent cities to offer HIV and hepatitis C testing and tell them about PrEP. In Philadelphia, Drexel University, the city Department of Health, and Prevention Point Philadelphia co-offer PrEP through Prevention Point, which increased the number of people who inject drugs taking PrEP from just two to three a year to 584 times in 2021, according to Andres Freire, director of harm reduction health services at Prevention Point Philadelphia.

“Co-locating a PrEP clinic with our syringe-services program is the most effective means of delivering care to people who use drugs,” he said. “It is a friendly, nonstigmatizing place, as well as a place where individuals are already coming for services.”

At Dr. Tookes’ IDEA clinic and its PrEP study, people who inject drugs can not only get clean supplies, they can get a PrEP prescription on site and store their medications at the exchange so they don’t get stolen or used by others. And that idea didn’t come from him.

“It was one of my patients,” he said. “That person gave me an idea that impacted the health of hundreds of people in Miami.”

Indeed, Boston Health Care for the Homeless Program does the same. New data showed that what really worked for people who injected drugs in the group was not just medication storage on site but also PrEP prescriptions that lasted just a week at a time, or even same-day prescribing, as well as the program’s PrEP nurses showing up in person to their communities. That program managed to get PrEP referrals to 239 people, 152 of whom started taking PrEP. Six months later, 22 people were still using it.

But Dr. Tookes’s is a rare study on PrEP among people who inject drugs. The only data so far on the efficacy of PrEP for this group come from a 2013 study out of Thailand. Angela Bazzi, PhD, an associate professor of family medicine and public health at the University of California, San Diego, who studied the Boston program, said the dearth of research into effective ways of getting PrEP to people who inject drugs is fueling a negative feedback loop, where people who inject drugs and their providers largely don’t know about the HIV prevention pills, don’t see research on it, and therefore think it won’t work in people who inject drugs.

“There’s been a systematic exclusion of people who inject drugs from HIV prevention drug trials,” Dr. Bazzi told this news organization. Together with colleagues she wrote a viewpoint on the issue that was published in the International Journal of Drug Policy. “It really extends into effectiveness research, public health research, and clinical practice. We argued that the stigma surrounding addiction is the key driver of this.”

This is especially important, she said, because the U.S. Food and Drug Administration had been expected to make an approval decision on an injectable form of PrEP by Jan. 2021. That drug, cabotegravir, has been found to work for a month at a time. Injection drug users were excluded from the primary clinical trial of that drug, though a ViiV Healthcare spokesperson said the company is planning an after-market study in people who inject drugs some time in the future.
 

An incomplete solution

But syringe services aren’t enough, said Mr. Reilly. For one thing, public funding of PrEP programs can limit things like where navigators can send people. For instance, in Ohio, Mr. Reilly’s team can cover the costs of PrEP for people who inject drugs – but only with certain providers. State law prohibits them from contracting with Planned Parenthood.

Also, syringe services aren’t available everywhere. In Pennsylvania, where syringe services are legal only in the counties containing Philadelphia and Pittsburgh, the state’s two large cities, funding for basic syringe services precludes expanding services to offer PrEP.

“A lot of our focus has to stay with making sure our folks have access to the harm-reduction supplies they need, because the number of people we are seeing has grown exponentially during the pandemic,” said Katie Houston, a coordinator for Prevention Point Pittsburgh, which tries to address its clients’s PrEP needs by holding syringe-services distribution at a local clinic that provides PrEP. “Getting funding for our core supplies like syringes, crack pipes, and the works is extremely difficult because many grants/foundations don’t want to fund these supplies. And with the growing number of SSPs, the funding that has been available is being spread thin.”

And that means that traditional clinicians still have an important role to play, said Mr. Reilly.

“Syringe services programs are supposed to now provide treatment for hepatitis C and make sure people get on PrEP?” he said. “That seems like medical providers’s job.”

As for Farrington, operating as a solo health worker without the benefit of exchanges to help people like the young man who came to her house that night, she’ll keep going in to tent city and inviting sick people who inject drugs into her home to offer them what she can. She can’t legally offer syringe services. But she can keep checking in on people and offering them the help that’s available.

Recently, she saw that young man again. He was in a better place. He had found a place to live for the winter, so he wouldn’t have to stay in the hammock in someone’s yard when the temperatures dipped. And that was going a long way to stabilize everything else in his life. He’s still shooting up, she said, but having housing is making it easier for him to moderate his use. As for PrEP, he hasn’t started on that, either. But Farrington hasn’t given up hope.

“Not yet,” she said.

Dr. Tookes reports receiving research funding from Gilead Sciences. Dr. Calabrese reports receiving conference travel funding from Gilead Sciences. Farrington, Dr. Bazzi, Ms. Houston, Mr. Freire, and Mr. Reilly reported no relevant financial relationships.

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

Not that long ago, a man in his mid-20s whom Morgan Farrington calls Kiddo showed up at her house with a fever, chills, and nausea. He was increasingly out of it. These were all signs of an abscess from missing a vein and using someone else’s syringe, said Farrington, founder of Goodworks, in Huntsville, Alabama.

But it wasn’t just an abscess. It was four blood clots and sepsis. He’d been craving his next fix of heroin so hard, and the relief that comes from the act of shooting up itself, that he’d dug a 3-day-old blood shot – a used syringe with someone else’s blood in it – out of the garbage and had used it.

“He was almost dead,” said Farrington. “Another day, maybe two, he would have been dead, for sure, for sure.”

Farrington gets it. She has her own history of injection drug use. She knows the compulsion to, in her words, “shoot up sugar water just to get a hit.” And that’s fine, she said. “I just wish that he would do so with his own safety in mind.”

So when he got out of the hospital a few weeks later, Farrington talked to him about not just clean syringes but also HIV pre-exposure prophylaxis (PrEP), the daily HIV prevention pills that have been found to be up to 84% protective against HIV in people who inject drugs. Both approaches – syringe services and PrEP – play a key role in the president’s new National HIV/AIDS Strategy. The strategy calls for expanding access to both services in traditional and nontraditional settings but doesn’t include mechanisms for that to happen.

Of the 1.2 million people in the U.S. who could benefit from PrEP, according to the Centers for Disease Control and Prevention, 23% are using it. But according to data published in 2020, just 0% and 5% of people who inject drugs who could benefit are using it. And most, like the guy Farrington continues to talk to, don’t even know it exists.
 

People who inject drugs are willing, clinicians may not be

Clinicians have a role to play, but right now, many clinicians act as gatekeepers, picking and choosing whom they’ll offer PrEP to. In 2014, just 1% of PrEP prescribers said they had prescribed the prevention pill to people who inject drugs. And recent data published in AIDS and Behavior showed that clinicians who expressed negative attitudes about people who injected drugs were less likely to offer to prescribe PrEP to a theoretical man who injected drugs asking for PrEP. There was a paradox in there, however: Clinicians were also more likely to think men who inject drugs were at high risk for acquiring HIV. But they also believed those men would be less likely to adhere, less safety conscious, and less responsible than gay and bisexual men. So, the investigators found that despite need, clinicians were more likely to prescribe to men at risk via sex than men at risk via injection drug use.

According to the CDC, to qualify for PrEP, the only requirements for people who inject drugs are testing negative for HIV and not sharing injection equipment – whether their injecting partners have confirmed HIV or whether their HIV status is unknown.

“As long as PrEP is a prescription, medication providers are really going to determine who accesses PrEP and who does not,” said study lead author Sarah Calabrese, PhD, assistant professor of psychiatry at George Washington University. “Even if you do anticipate that a patient might have adherence struggles. The solution is not withholding something that could be beneficial to them. The solution is supporting them to take that beneficial medication.”

And it appears that providers and regular people like Farrington have stepped into the access vacuum, with a decidedly harm-reduction approach: syringe services programs. While there’s no national data on how many people receive PrEP through needle exchange programs, those programs are the natural place to offer other health care services, said Hansel Tookes, MD, assistant professor of medicine at the University of Miami and founder of the Infectious Disease Elimination Act (IDEA) Syringe Exchange program and clinic. At the clinic, 80% of the people living with HIV have undetectable viral loads – a sign of good adherence to medication and general health. Previous research suggests that when people who inject drugs find out about PrEP, 57% are game for trying it. But early work suggests that people who inject drugs might need to access PrEP in a different way from other people who use PrEP.

Dr. Tookes is currently conducting a study looking at whether referring people who inject drugs out from needle exchanges to PrEP prescribers is as effective as offering it on site at the exchanges.

“My experience in the past 5 years of being faculty at the university and being a cofounder of a program like IDEA is that we really, if we’re going to be successful with engaging people who inject drugs in things like PrEP, we have to, like all things harm reduction, meet them where they’re at, both physically and mentally, and on their own terms,” said Dr. Tookes. “What better place than a syringe services program?”
 

Where people are: the exchanges

That’s where community health worker Farrington and others come in. More than 400 syringe access programs that exist in North America have PrEP programs, according to the North American Syringe Exchange Network (NASEN), and 86 of them report offering access to PrEP, either directly or through referrals. It’s an HIV prevention one-two punch: PrEP protects a person once they are exposed to HIV, and needle exchanges themselves reduce HIV transmission rates by reducing the odds that people will engage in behavior that exposes them to the virus in the first place.

So far, PrEP access for people who inject drugs looks different everywhere. At Las Vegas’ Huntridge Family Clinic, people can come to the lobby and pick up clean supplies from a syringe exchange vending machine, and while they’re there, talk to nurse practitioner Rob Phoenix, MSN, APRN, about HIV prevention.

In Cincinnati, where Adam Reilly, CDCA, runs a Ryan White–funded PrEP program out of the nonprofit Caracole, PrEP navigators go out with the syringe services vans run by the county health department and can connect them with providers willing to prescribe it. In Alabama, where needle exchanges are illegal, Farrington works as a community health worker through the North Alabama Area Health Education Center to go in to Huntsville’s legal tent cities to offer HIV and hepatitis C testing and tell them about PrEP. In Philadelphia, Drexel University, the city Department of Health, and Prevention Point Philadelphia co-offer PrEP through Prevention Point, which increased the number of people who inject drugs taking PrEP from just two to three a year to 584 times in 2021, according to Andres Freire, director of harm reduction health services at Prevention Point Philadelphia.

“Co-locating a PrEP clinic with our syringe-services program is the most effective means of delivering care to people who use drugs,” he said. “It is a friendly, nonstigmatizing place, as well as a place where individuals are already coming for services.”

At Dr. Tookes’ IDEA clinic and its PrEP study, people who inject drugs can not only get clean supplies, they can get a PrEP prescription on site and store their medications at the exchange so they don’t get stolen or used by others. And that idea didn’t come from him.

“It was one of my patients,” he said. “That person gave me an idea that impacted the health of hundreds of people in Miami.”

Indeed, Boston Health Care for the Homeless Program does the same. New data showed that what really worked for people who injected drugs in the group was not just medication storage on site but also PrEP prescriptions that lasted just a week at a time, or even same-day prescribing, as well as the program’s PrEP nurses showing up in person to their communities. That program managed to get PrEP referrals to 239 people, 152 of whom started taking PrEP. Six months later, 22 people were still using it.

But Dr. Tookes’s is a rare study on PrEP among people who inject drugs. The only data so far on the efficacy of PrEP for this group come from a 2013 study out of Thailand. Angela Bazzi, PhD, an associate professor of family medicine and public health at the University of California, San Diego, who studied the Boston program, said the dearth of research into effective ways of getting PrEP to people who inject drugs is fueling a negative feedback loop, where people who inject drugs and their providers largely don’t know about the HIV prevention pills, don’t see research on it, and therefore think it won’t work in people who inject drugs.

“There’s been a systematic exclusion of people who inject drugs from HIV prevention drug trials,” Dr. Bazzi told this news organization. Together with colleagues she wrote a viewpoint on the issue that was published in the International Journal of Drug Policy. “It really extends into effectiveness research, public health research, and clinical practice. We argued that the stigma surrounding addiction is the key driver of this.”

This is especially important, she said, because the U.S. Food and Drug Administration had been expected to make an approval decision on an injectable form of PrEP by Jan. 2021. That drug, cabotegravir, has been found to work for a month at a time. Injection drug users were excluded from the primary clinical trial of that drug, though a ViiV Healthcare spokesperson said the company is planning an after-market study in people who inject drugs some time in the future.
 

An incomplete solution

But syringe services aren’t enough, said Mr. Reilly. For one thing, public funding of PrEP programs can limit things like where navigators can send people. For instance, in Ohio, Mr. Reilly’s team can cover the costs of PrEP for people who inject drugs – but only with certain providers. State law prohibits them from contracting with Planned Parenthood.

Also, syringe services aren’t available everywhere. In Pennsylvania, where syringe services are legal only in the counties containing Philadelphia and Pittsburgh, the state’s two large cities, funding for basic syringe services precludes expanding services to offer PrEP.

“A lot of our focus has to stay with making sure our folks have access to the harm-reduction supplies they need, because the number of people we are seeing has grown exponentially during the pandemic,” said Katie Houston, a coordinator for Prevention Point Pittsburgh, which tries to address its clients’s PrEP needs by holding syringe-services distribution at a local clinic that provides PrEP. “Getting funding for our core supplies like syringes, crack pipes, and the works is extremely difficult because many grants/foundations don’t want to fund these supplies. And with the growing number of SSPs, the funding that has been available is being spread thin.”

And that means that traditional clinicians still have an important role to play, said Mr. Reilly.

“Syringe services programs are supposed to now provide treatment for hepatitis C and make sure people get on PrEP?” he said. “That seems like medical providers’s job.”

As for Farrington, operating as a solo health worker without the benefit of exchanges to help people like the young man who came to her house that night, she’ll keep going in to tent city and inviting sick people who inject drugs into her home to offer them what she can. She can’t legally offer syringe services. But she can keep checking in on people and offering them the help that’s available.

Recently, she saw that young man again. He was in a better place. He had found a place to live for the winter, so he wouldn’t have to stay in the hammock in someone’s yard when the temperatures dipped. And that was going a long way to stabilize everything else in his life. He’s still shooting up, she said, but having housing is making it easier for him to moderate his use. As for PrEP, he hasn’t started on that, either. But Farrington hasn’t given up hope.

“Not yet,” she said.

Dr. Tookes reports receiving research funding from Gilead Sciences. Dr. Calabrese reports receiving conference travel funding from Gilead Sciences. Farrington, Dr. Bazzi, Ms. Houston, Mr. Freire, and Mr. Reilly reported no relevant financial relationships.

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

Not that long ago, a man in his mid-20s whom Morgan Farrington calls Kiddo showed up at her house with a fever, chills, and nausea. He was increasingly out of it. These were all signs of an abscess from missing a vein and using someone else’s syringe, said Farrington, founder of Goodworks, in Huntsville, Alabama.

But it wasn’t just an abscess. It was four blood clots and sepsis. He’d been craving his next fix of heroin so hard, and the relief that comes from the act of shooting up itself, that he’d dug a 3-day-old blood shot – a used syringe with someone else’s blood in it – out of the garbage and had used it.

“He was almost dead,” said Farrington. “Another day, maybe two, he would have been dead, for sure, for sure.”

Farrington gets it. She has her own history of injection drug use. She knows the compulsion to, in her words, “shoot up sugar water just to get a hit.” And that’s fine, she said. “I just wish that he would do so with his own safety in mind.”

So when he got out of the hospital a few weeks later, Farrington talked to him about not just clean syringes but also HIV pre-exposure prophylaxis (PrEP), the daily HIV prevention pills that have been found to be up to 84% protective against HIV in people who inject drugs. Both approaches – syringe services and PrEP – play a key role in the president’s new National HIV/AIDS Strategy. The strategy calls for expanding access to both services in traditional and nontraditional settings but doesn’t include mechanisms for that to happen.

Of the 1.2 million people in the U.S. who could benefit from PrEP, according to the Centers for Disease Control and Prevention, 23% are using it. But according to data published in 2020, just 0% and 5% of people who inject drugs who could benefit are using it. And most, like the guy Farrington continues to talk to, don’t even know it exists.
 

People who inject drugs are willing, clinicians may not be

Clinicians have a role to play, but right now, many clinicians act as gatekeepers, picking and choosing whom they’ll offer PrEP to. In 2014, just 1% of PrEP prescribers said they had prescribed the prevention pill to people who inject drugs. And recent data published in AIDS and Behavior showed that clinicians who expressed negative attitudes about people who injected drugs were less likely to offer to prescribe PrEP to a theoretical man who injected drugs asking for PrEP. There was a paradox in there, however: Clinicians were also more likely to think men who inject drugs were at high risk for acquiring HIV. But they also believed those men would be less likely to adhere, less safety conscious, and less responsible than gay and bisexual men. So, the investigators found that despite need, clinicians were more likely to prescribe to men at risk via sex than men at risk via injection drug use.

According to the CDC, to qualify for PrEP, the only requirements for people who inject drugs are testing negative for HIV and not sharing injection equipment – whether their injecting partners have confirmed HIV or whether their HIV status is unknown.

“As long as PrEP is a prescription, medication providers are really going to determine who accesses PrEP and who does not,” said study lead author Sarah Calabrese, PhD, assistant professor of psychiatry at George Washington University. “Even if you do anticipate that a patient might have adherence struggles. The solution is not withholding something that could be beneficial to them. The solution is supporting them to take that beneficial medication.”

And it appears that providers and regular people like Farrington have stepped into the access vacuum, with a decidedly harm-reduction approach: syringe services programs. While there’s no national data on how many people receive PrEP through needle exchange programs, those programs are the natural place to offer other health care services, said Hansel Tookes, MD, assistant professor of medicine at the University of Miami and founder of the Infectious Disease Elimination Act (IDEA) Syringe Exchange program and clinic. At the clinic, 80% of the people living with HIV have undetectable viral loads – a sign of good adherence to medication and general health. Previous research suggests that when people who inject drugs find out about PrEP, 57% are game for trying it. But early work suggests that people who inject drugs might need to access PrEP in a different way from other people who use PrEP.

Dr. Tookes is currently conducting a study looking at whether referring people who inject drugs out from needle exchanges to PrEP prescribers is as effective as offering it on site at the exchanges.

“My experience in the past 5 years of being faculty at the university and being a cofounder of a program like IDEA is that we really, if we’re going to be successful with engaging people who inject drugs in things like PrEP, we have to, like all things harm reduction, meet them where they’re at, both physically and mentally, and on their own terms,” said Dr. Tookes. “What better place than a syringe services program?”
 

Where people are: the exchanges

That’s where community health worker Farrington and others come in. More than 400 syringe access programs that exist in North America have PrEP programs, according to the North American Syringe Exchange Network (NASEN), and 86 of them report offering access to PrEP, either directly or through referrals. It’s an HIV prevention one-two punch: PrEP protects a person once they are exposed to HIV, and needle exchanges themselves reduce HIV transmission rates by reducing the odds that people will engage in behavior that exposes them to the virus in the first place.

So far, PrEP access for people who inject drugs looks different everywhere. At Las Vegas’ Huntridge Family Clinic, people can come to the lobby and pick up clean supplies from a syringe exchange vending machine, and while they’re there, talk to nurse practitioner Rob Phoenix, MSN, APRN, about HIV prevention.

In Cincinnati, where Adam Reilly, CDCA, runs a Ryan White–funded PrEP program out of the nonprofit Caracole, PrEP navigators go out with the syringe services vans run by the county health department and can connect them with providers willing to prescribe it. In Alabama, where needle exchanges are illegal, Farrington works as a community health worker through the North Alabama Area Health Education Center to go in to Huntsville’s legal tent cities to offer HIV and hepatitis C testing and tell them about PrEP. In Philadelphia, Drexel University, the city Department of Health, and Prevention Point Philadelphia co-offer PrEP through Prevention Point, which increased the number of people who inject drugs taking PrEP from just two to three a year to 584 times in 2021, according to Andres Freire, director of harm reduction health services at Prevention Point Philadelphia.

“Co-locating a PrEP clinic with our syringe-services program is the most effective means of delivering care to people who use drugs,” he said. “It is a friendly, nonstigmatizing place, as well as a place where individuals are already coming for services.”

At Dr. Tookes’ IDEA clinic and its PrEP study, people who inject drugs can not only get clean supplies, they can get a PrEP prescription on site and store their medications at the exchange so they don’t get stolen or used by others. And that idea didn’t come from him.

“It was one of my patients,” he said. “That person gave me an idea that impacted the health of hundreds of people in Miami.”

Indeed, Boston Health Care for the Homeless Program does the same. New data showed that what really worked for people who injected drugs in the group was not just medication storage on site but also PrEP prescriptions that lasted just a week at a time, or even same-day prescribing, as well as the program’s PrEP nurses showing up in person to their communities. That program managed to get PrEP referrals to 239 people, 152 of whom started taking PrEP. Six months later, 22 people were still using it.

But Dr. Tookes’s is a rare study on PrEP among people who inject drugs. The only data so far on the efficacy of PrEP for this group come from a 2013 study out of Thailand. Angela Bazzi, PhD, an associate professor of family medicine and public health at the University of California, San Diego, who studied the Boston program, said the dearth of research into effective ways of getting PrEP to people who inject drugs is fueling a negative feedback loop, where people who inject drugs and their providers largely don’t know about the HIV prevention pills, don’t see research on it, and therefore think it won’t work in people who inject drugs.

“There’s been a systematic exclusion of people who inject drugs from HIV prevention drug trials,” Dr. Bazzi told this news organization. Together with colleagues she wrote a viewpoint on the issue that was published in the International Journal of Drug Policy. “It really extends into effectiveness research, public health research, and clinical practice. We argued that the stigma surrounding addiction is the key driver of this.”

This is especially important, she said, because the U.S. Food and Drug Administration had been expected to make an approval decision on an injectable form of PrEP by Jan. 2021. That drug, cabotegravir, has been found to work for a month at a time. Injection drug users were excluded from the primary clinical trial of that drug, though a ViiV Healthcare spokesperson said the company is planning an after-market study in people who inject drugs some time in the future.
 

An incomplete solution

But syringe services aren’t enough, said Mr. Reilly. For one thing, public funding of PrEP programs can limit things like where navigators can send people. For instance, in Ohio, Mr. Reilly’s team can cover the costs of PrEP for people who inject drugs – but only with certain providers. State law prohibits them from contracting with Planned Parenthood.

Also, syringe services aren’t available everywhere. In Pennsylvania, where syringe services are legal only in the counties containing Philadelphia and Pittsburgh, the state’s two large cities, funding for basic syringe services precludes expanding services to offer PrEP.

“A lot of our focus has to stay with making sure our folks have access to the harm-reduction supplies they need, because the number of people we are seeing has grown exponentially during the pandemic,” said Katie Houston, a coordinator for Prevention Point Pittsburgh, which tries to address its clients’s PrEP needs by holding syringe-services distribution at a local clinic that provides PrEP. “Getting funding for our core supplies like syringes, crack pipes, and the works is extremely difficult because many grants/foundations don’t want to fund these supplies. And with the growing number of SSPs, the funding that has been available is being spread thin.”

And that means that traditional clinicians still have an important role to play, said Mr. Reilly.

“Syringe services programs are supposed to now provide treatment for hepatitis C and make sure people get on PrEP?” he said. “That seems like medical providers’s job.”

As for Farrington, operating as a solo health worker without the benefit of exchanges to help people like the young man who came to her house that night, she’ll keep going in to tent city and inviting sick people who inject drugs into her home to offer them what she can. She can’t legally offer syringe services. But she can keep checking in on people and offering them the help that’s available.

Recently, she saw that young man again. He was in a better place. He had found a place to live for the winter, so he wouldn’t have to stay in the hammock in someone’s yard when the temperatures dipped. And that was going a long way to stabilize everything else in his life. He’s still shooting up, she said, but having housing is making it easier for him to moderate his use. As for PrEP, he hasn’t started on that, either. But Farrington hasn’t given up hope.

“Not yet,” she said.

Dr. Tookes reports receiving research funding from Gilead Sciences. Dr. Calabrese reports receiving conference travel funding from Gilead Sciences. Farrington, Dr. Bazzi, Ms. Houston, Mr. Freire, and Mr. Reilly reported no relevant financial relationships.

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

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

The risk of bullying and teasing is higher in children and young people with poorer asthma control, an international study reported. Published online in the Archives of Disease in Childhood, the Room to Breathe survey of 943 children in six countries found 9.9% had experienced asthma-related bullying or teasing (n = 93).

Children with well-controlled disease, however, were less likely to report being victimized by asthma-related bullying/teasing: odds ratio, 0.51; 95% confidence interval, 0.23-0.84; P = .006).

“It’s important for pediatricians to recognize that children and young people with asthma commonly report bullying or teasing as a result of their condition,” Will Carroll, MD, of the Paediatric Respiratory Service at Staffordshire Children’s Hospital at Royal Stoke, Stoke-on-Trent, England, told this news organization. “Pediatricians should talk to children themselves with asthma about this and not just their parents, and efforts should be made to improve asthma control whenever possible.”

Though common and potentially long-lasting in its effects, bullying is rarely addressed by health care professionals, the U.K. authors said.

But things may differ in the United States. According to Mark Welles, MD, a pediatrician at Cohen Children’s Medical Center at Northwell Health in Queen’s, N.Y., and regional cochair of the American Academy of Pediatrics antibullying committee, young doctors here are trained to ask about bullying when seeing a child, no matter what the reason for the visit. “It’s important to build a rapport with the child, and you need to ask about the disease they may have but also generally ask, ‘How are things at school? Is everyone nice to you?’ It is becoming more common practice to ask this,” said Dr. Welles, who was not involved with the U.K. research.

The U.K. study drew on unpublished data from the Room to Breathe survey conducted by Dr. Carroll’s group during 2008-2009 in Canada, the United Kingdom, Greece, Hungary, South Africa, and the Netherlands. Only 358 of 930 (38.5%) children were found to be well controlled according to current Global Initiative for Asthma symptom-control criteria.

The analysis also found a highly significant association (P < .0001) between Childhood Asthma Control Test (C-ACT) score and reported bullying/teasing, with bullied children having lower scores. C-ACT–defined controlled asthma scores of 20 or higher were significantly associated with a lower risk of bullying (OR, 0.46; 95% CI, 0.28-0.76; P = .001).

In other study findings, harassment was more common in children whose asthma was serious enough to entail activity restriction (OR, 1.74; 95% CI, 1.11-2.75; P = .010) and who described their asthma as “bad” (OR, 3.02; 95% CI, 1.86-4.85; P < .001), as well as those whose parents reported ongoing asthma-related health worries (OR, 1.64; 95% CI, 1.04-2.58; P = .024).

“When a child is clearly different from others, such as having bad asthma or being limited in activities due to asthma, they stand out more and are more frequently bullied,” said Tracy Evian Waasdorp, PhD, MSEd, director of research for school-based bullying and social-emotional learning at Children’s Hospital of Philadelphia, and also not a participant in the U.K. study.

In contrast to the 10% bullying rate in Dr. Carroll’s study, Dr. Waasdorp referred to a CHOP analysis of more than 64,000 youth from a Northeastern state in which those with asthma were 40% more likely to be victims of in-person bullying and 70% were more likely to be cyberbullied than youth without asthma. “Having a medical condition can therefore put you at risk of being bullied regardless of what country you live in,” she said.

CHOP policy encourages practitioners to routinely ask about bullying and to provide handouts and resources for parents, she added.

Interestingly, the U.K. investigators found that open public use of spacers was not associated with asthma-related bullying, nor was parental worry at diagnosis or parental concern about steroid use.

But according to Dr. Welles, “Kids may be using the inhaler in front of other kids, and they may be embarrassed and not want to be seen as different. So they may not use the inhaler when needed for gym class or sports, forcing them to sit out and then potentially be bullied again. It’s a vicious cycle.”

Previous research has identified the bullying and teasing of children with food allergies.

Behaviors have included allergy-specific harassment such as smearing peanut butter on a youngster’s forehead or putting peanut butter cookie crumbs in a child’s lunch box.

“In our survey we asked the question ‘Have you been teased or bullied because of your asthma?’ but we didn’t ask what form this took,” Dr. Carroll said. “But we were surprised at just how many children said yes. It’s time for more research, I think.”

“There are never enough studies around this,” added Dr. Welles. “Bullying, whether because of asthma or otherwise, has the potential for long-term effects well into adulthood.”

In the meantime, asthma consultations should incorporate specific questions about bullying. They should also be child focused in order to gain a representative appreciation of asthma control and its effect on the child’s life.

“As pediatricians, we need to be continuously supporting parents and find the help they need to address any mental health issues,” Dr. Welles said. “Every pediatrician and parent needs to be aware and recognize when something is different in their child’s life. Please don’t ignore it.”

Dr. Waasdorp stressed that school and other communities should be aware that children with asthma may be at increased risk for aggression and harmful interactions related to their asthma. “Programming to reduce bullying should focus broadly on shifting the climate so that bullying is not perceived to be normative and on improving ‘upstander,’ or positive bystander, responses.” she said.

The original survey was funded by Nycomed (Zurich). No additional funding was requested for the current analysis. Dr. Carroll reported personal fees from GlaxoSmithKline, Novartis, and Trudell Medical International outside the submitted work. Dr. Welles and Dr. Waasdorp disclosed no competing interests relevant to their comments.

The risk of bullying and teasing is higher in children and young people with poorer asthma control, an international study reported. Published online in the Archives of Disease in Childhood, the Room to Breathe survey of 943 children in six countries found 9.9% had experienced asthma-related bullying or teasing (n = 93).

Children with well-controlled disease, however, were less likely to report being victimized by asthma-related bullying/teasing: odds ratio, 0.51; 95% confidence interval, 0.23-0.84; P = .006).

“It’s important for pediatricians to recognize that children and young people with asthma commonly report bullying or teasing as a result of their condition,” Will Carroll, MD, of the Paediatric Respiratory Service at Staffordshire Children’s Hospital at Royal Stoke, Stoke-on-Trent, England, told this news organization. “Pediatricians should talk to children themselves with asthma about this and not just their parents, and efforts should be made to improve asthma control whenever possible.”

Though common and potentially long-lasting in its effects, bullying is rarely addressed by health care professionals, the U.K. authors said.

But things may differ in the United States. According to Mark Welles, MD, a pediatrician at Cohen Children’s Medical Center at Northwell Health in Queen’s, N.Y., and regional cochair of the American Academy of Pediatrics antibullying committee, young doctors here are trained to ask about bullying when seeing a child, no matter what the reason for the visit. “It’s important to build a rapport with the child, and you need to ask about the disease they may have but also generally ask, ‘How are things at school? Is everyone nice to you?’ It is becoming more common practice to ask this,” said Dr. Welles, who was not involved with the U.K. research.

The U.K. study drew on unpublished data from the Room to Breathe survey conducted by Dr. Carroll’s group during 2008-2009 in Canada, the United Kingdom, Greece, Hungary, South Africa, and the Netherlands. Only 358 of 930 (38.5%) children were found to be well controlled according to current Global Initiative for Asthma symptom-control criteria.

The analysis also found a highly significant association (P < .0001) between Childhood Asthma Control Test (C-ACT) score and reported bullying/teasing, with bullied children having lower scores. C-ACT–defined controlled asthma scores of 20 or higher were significantly associated with a lower risk of bullying (OR, 0.46; 95% CI, 0.28-0.76; P = .001).

In other study findings, harassment was more common in children whose asthma was serious enough to entail activity restriction (OR, 1.74; 95% CI, 1.11-2.75; P = .010) and who described their asthma as “bad” (OR, 3.02; 95% CI, 1.86-4.85; P < .001), as well as those whose parents reported ongoing asthma-related health worries (OR, 1.64; 95% CI, 1.04-2.58; P = .024).

“When a child is clearly different from others, such as having bad asthma or being limited in activities due to asthma, they stand out more and are more frequently bullied,” said Tracy Evian Waasdorp, PhD, MSEd, director of research for school-based bullying and social-emotional learning at Children’s Hospital of Philadelphia, and also not a participant in the U.K. study.

In contrast to the 10% bullying rate in Dr. Carroll’s study, Dr. Waasdorp referred to a CHOP analysis of more than 64,000 youth from a Northeastern state in which those with asthma were 40% more likely to be victims of in-person bullying and 70% were more likely to be cyberbullied than youth without asthma. “Having a medical condition can therefore put you at risk of being bullied regardless of what country you live in,” she said.

CHOP policy encourages practitioners to routinely ask about bullying and to provide handouts and resources for parents, she added.

Interestingly, the U.K. investigators found that open public use of spacers was not associated with asthma-related bullying, nor was parental worry at diagnosis or parental concern about steroid use.

But according to Dr. Welles, “Kids may be using the inhaler in front of other kids, and they may be embarrassed and not want to be seen as different. So they may not use the inhaler when needed for gym class or sports, forcing them to sit out and then potentially be bullied again. It’s a vicious cycle.”

Previous research has identified the bullying and teasing of children with food allergies.

Behaviors have included allergy-specific harassment such as smearing peanut butter on a youngster’s forehead or putting peanut butter cookie crumbs in a child’s lunch box.

“In our survey we asked the question ‘Have you been teased or bullied because of your asthma?’ but we didn’t ask what form this took,” Dr. Carroll said. “But we were surprised at just how many children said yes. It’s time for more research, I think.”

“There are never enough studies around this,” added Dr. Welles. “Bullying, whether because of asthma or otherwise, has the potential for long-term effects well into adulthood.”

In the meantime, asthma consultations should incorporate specific questions about bullying. They should also be child focused in order to gain a representative appreciation of asthma control and its effect on the child’s life.

“As pediatricians, we need to be continuously supporting parents and find the help they need to address any mental health issues,” Dr. Welles said. “Every pediatrician and parent needs to be aware and recognize when something is different in their child’s life. Please don’t ignore it.”

Dr. Waasdorp stressed that school and other communities should be aware that children with asthma may be at increased risk for aggression and harmful interactions related to their asthma. “Programming to reduce bullying should focus broadly on shifting the climate so that bullying is not perceived to be normative and on improving ‘upstander,’ or positive bystander, responses.” she said.

The original survey was funded by Nycomed (Zurich). No additional funding was requested for the current analysis. Dr. Carroll reported personal fees from GlaxoSmithKline, Novartis, and Trudell Medical International outside the submitted work. Dr. Welles and Dr. Waasdorp disclosed no competing interests relevant to their comments.

The risk of bullying and teasing is higher in children and young people with poorer asthma control, an international study reported. Published online in the Archives of Disease in Childhood, the Room to Breathe survey of 943 children in six countries found 9.9% had experienced asthma-related bullying or teasing (n = 93).

Children with well-controlled disease, however, were less likely to report being victimized by asthma-related bullying/teasing: odds ratio, 0.51; 95% confidence interval, 0.23-0.84; P = .006).

“It’s important for pediatricians to recognize that children and young people with asthma commonly report bullying or teasing as a result of their condition,” Will Carroll, MD, of the Paediatric Respiratory Service at Staffordshire Children’s Hospital at Royal Stoke, Stoke-on-Trent, England, told this news organization. “Pediatricians should talk to children themselves with asthma about this and not just their parents, and efforts should be made to improve asthma control whenever possible.”

Though common and potentially long-lasting in its effects, bullying is rarely addressed by health care professionals, the U.K. authors said.

But things may differ in the United States. According to Mark Welles, MD, a pediatrician at Cohen Children’s Medical Center at Northwell Health in Queen’s, N.Y., and regional cochair of the American Academy of Pediatrics antibullying committee, young doctors here are trained to ask about bullying when seeing a child, no matter what the reason for the visit. “It’s important to build a rapport with the child, and you need to ask about the disease they may have but also generally ask, ‘How are things at school? Is everyone nice to you?’ It is becoming more common practice to ask this,” said Dr. Welles, who was not involved with the U.K. research.

The U.K. study drew on unpublished data from the Room to Breathe survey conducted by Dr. Carroll’s group during 2008-2009 in Canada, the United Kingdom, Greece, Hungary, South Africa, and the Netherlands. Only 358 of 930 (38.5%) children were found to be well controlled according to current Global Initiative for Asthma symptom-control criteria.

The analysis also found a highly significant association (P < .0001) between Childhood Asthma Control Test (C-ACT) score and reported bullying/teasing, with bullied children having lower scores. C-ACT–defined controlled asthma scores of 20 or higher were significantly associated with a lower risk of bullying (OR, 0.46; 95% CI, 0.28-0.76; P = .001).

In other study findings, harassment was more common in children whose asthma was serious enough to entail activity restriction (OR, 1.74; 95% CI, 1.11-2.75; P = .010) and who described their asthma as “bad” (OR, 3.02; 95% CI, 1.86-4.85; P < .001), as well as those whose parents reported ongoing asthma-related health worries (OR, 1.64; 95% CI, 1.04-2.58; P = .024).

“When a child is clearly different from others, such as having bad asthma or being limited in activities due to asthma, they stand out more and are more frequently bullied,” said Tracy Evian Waasdorp, PhD, MSEd, director of research for school-based bullying and social-emotional learning at Children’s Hospital of Philadelphia, and also not a participant in the U.K. study.

In contrast to the 10% bullying rate in Dr. Carroll’s study, Dr. Waasdorp referred to a CHOP analysis of more than 64,000 youth from a Northeastern state in which those with asthma were 40% more likely to be victims of in-person bullying and 70% were more likely to be cyberbullied than youth without asthma. “Having a medical condition can therefore put you at risk of being bullied regardless of what country you live in,” she said.

CHOP policy encourages practitioners to routinely ask about bullying and to provide handouts and resources for parents, she added.

Interestingly, the U.K. investigators found that open public use of spacers was not associated with asthma-related bullying, nor was parental worry at diagnosis or parental concern about steroid use.

But according to Dr. Welles, “Kids may be using the inhaler in front of other kids, and they may be embarrassed and not want to be seen as different. So they may not use the inhaler when needed for gym class or sports, forcing them to sit out and then potentially be bullied again. It’s a vicious cycle.”

Previous research has identified the bullying and teasing of children with food allergies.

Behaviors have included allergy-specific harassment such as smearing peanut butter on a youngster’s forehead or putting peanut butter cookie crumbs in a child’s lunch box.

“In our survey we asked the question ‘Have you been teased or bullied because of your asthma?’ but we didn’t ask what form this took,” Dr. Carroll said. “But we were surprised at just how many children said yes. It’s time for more research, I think.”

“There are never enough studies around this,” added Dr. Welles. “Bullying, whether because of asthma or otherwise, has the potential for long-term effects well into adulthood.”

In the meantime, asthma consultations should incorporate specific questions about bullying. They should also be child focused in order to gain a representative appreciation of asthma control and its effect on the child’s life.

“As pediatricians, we need to be continuously supporting parents and find the help they need to address any mental health issues,” Dr. Welles said. “Every pediatrician and parent needs to be aware and recognize when something is different in their child’s life. Please don’t ignore it.”

Dr. Waasdorp stressed that school and other communities should be aware that children with asthma may be at increased risk for aggression and harmful interactions related to their asthma. “Programming to reduce bullying should focus broadly on shifting the climate so that bullying is not perceived to be normative and on improving ‘upstander,’ or positive bystander, responses.” she said.

The original survey was funded by Nycomed (Zurich). No additional funding was requested for the current analysis. Dr. Carroll reported personal fees from GlaxoSmithKline, Novartis, and Trudell Medical International outside the submitted work. Dr. Welles and Dr. Waasdorp disclosed no competing interests relevant to their comments.

A single dose of human papillomavirus (HPV) vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens, according to results from the KEN SHE trial, based in Kenya.

The findings, published on the preprint server Research Square and presented Nov. 17 at the 34th International Papillomavirus Conference in Toronto, bring “renewed energy to the push to make cervical cancer the first cancer to be wiped out globally,” according to co–principal investigator Ruanne V. Barnabas, PhD, a professor of global health at the University of Washington, Seattle.

Decision-makers will consider these findings, which have not yet been peer-reviewed, along with other evidence to determine if dosing-schedule changes are warranted, she told this news organization.

In a press release, Samuel Kariuki, PhD, acting director general, Kenya Medical Research Institute, who was not involved in the research, called the findings a “game changer” that could “substantially reduce the incidence of HPV-attributable cervical cancer.”

Between 2018 and 2019, Dr. Barnabas and her colleagues enrolled 2,275 sexually active, HPV-vaccine–naive women in Kenya in their study. The women, 15-20 years of age, were randomly assigned to receive a bivalent vaccine (HPV 16/18), a nonavalent vaccine (HPV 16/18/31/33/45/52/58/6/11), or a vaccine against meningococcal meningitis.

Most participants (57%) were between 15 and 17 years of age, and 61% reported one lifetime sexual partner. The women underwent genital and cervical swabs at enrollment to test for HPV DNA and had blood drawn to test for antibodies. During 18 months of follow-up, they had cervical swabs every 6 months and a vaginal swab at 3 months to test for HPV DNA.

The researchers detected 38 persistent HPV 16/18 infections in women who had tested negative for HPV 16/18 antibodies at enrollment and for HPV 16/18 DNA at enrollment and month 3 – one in each of the HPV-vaccine groups and 36 in the meningococcal group. This infection rate corresponded to a vaccine efficacy of 97.5% (P < .001) against HPV 16/18 for both the bivalent and nonavalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers write.

Among women negative for HPV 16/18/31/33/45/52/58 at the beginning of the trial, 33 had persistent infections: four in the nonavalent vaccine group and 29 in the meningococcal group, demonstrating an efficacy of 89% (P < .001) against all seven oncogenic strains contained in the vaccine.

Even if women tested positive for one strain of HPV, the vaccine protected them from other strains of the virus, the investigators noted.

Serious adverse events occurred in 4.5%-5.2% of participants across the study arms.

The KEN SHE trial comes 15 years after the U.S. Food and Drug Administration approved the first HPV vaccine – Merck’s Gardasil. Two others, Cervarix and Gardasil-9, have since been approved, but cost and supply issues have inhibited coverage, particularly in areas where the cervical cancer burden is high, the researchers noted.

Recent data indicate that just 15% of girls globally are vaccinated against HPV, but a single-dose vaccine would “simplify logistics and decrease costs,” thereby improving the chances of reaching the World Health Organization goal of vaccinating 90% of 15-year-old girls against HPV by 2030, Dr. Barnabas said in a press release about the trial.

Co–principal investigator Nelly Mugo, MBChB, MPH, senior principal clinical research scientist with the Center for Clinical Research at the Kenya Medical Research Institute in Nairobi, further emphasized the importance of the findings, noting in the press release that the “trial brings new energy to the elimination of cervical cancer. It brings great hope to the women living in countries like Kenya, who have a high burden of the disease.”

Dr. Mugo is also an associate research professor of global health at the University of Washington, Seattle.

Dr. Barnabas said women have been given multiple doses of the HPV vaccine because of “gaps in evidence for the effectiveness of a single-dose vaccine and concerns about clinically meaningful differences in efficacy.

“Observational data suggested that the single-dose HPV vaccine could have good efficacy, but because the data were not from randomized trials, that could have been from chance,” she explained, noting, however, that “sufficient evidence supported the decrease in doses from three to two doses for girls 15 years of age and younger.”

Going forward, the researchers will conduct immunobridging studies to other populations and will continue follow-up to assess the durability of single-dose efficacy, Dr. Barnabas said.

“The results from the KEN SHE trial support the use of single-dose HPV vaccination to increase access and coverage,” she concluded.

The KEN SHE trial was funded by the Bill & Melinda Gates Foundation (BMGF). Dr. Barnabas reports grants from BMGF and grants from King K. Holmes Professorship in STDs and AIDS during the conduct of the study, and grants from BMGF, National Institutes of Health, and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work.

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

A single dose of human papillomavirus (HPV) vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens, according to results from the KEN SHE trial, based in Kenya.

The findings, published on the preprint server Research Square and presented Nov. 17 at the 34th International Papillomavirus Conference in Toronto, bring “renewed energy to the push to make cervical cancer the first cancer to be wiped out globally,” according to co–principal investigator Ruanne V. Barnabas, PhD, a professor of global health at the University of Washington, Seattle.

Decision-makers will consider these findings, which have not yet been peer-reviewed, along with other evidence to determine if dosing-schedule changes are warranted, she told this news organization.

In a press release, Samuel Kariuki, PhD, acting director general, Kenya Medical Research Institute, who was not involved in the research, called the findings a “game changer” that could “substantially reduce the incidence of HPV-attributable cervical cancer.”

Between 2018 and 2019, Dr. Barnabas and her colleagues enrolled 2,275 sexually active, HPV-vaccine–naive women in Kenya in their study. The women, 15-20 years of age, were randomly assigned to receive a bivalent vaccine (HPV 16/18), a nonavalent vaccine (HPV 16/18/31/33/45/52/58/6/11), or a vaccine against meningococcal meningitis.

Most participants (57%) were between 15 and 17 years of age, and 61% reported one lifetime sexual partner. The women underwent genital and cervical swabs at enrollment to test for HPV DNA and had blood drawn to test for antibodies. During 18 months of follow-up, they had cervical swabs every 6 months and a vaginal swab at 3 months to test for HPV DNA.

The researchers detected 38 persistent HPV 16/18 infections in women who had tested negative for HPV 16/18 antibodies at enrollment and for HPV 16/18 DNA at enrollment and month 3 – one in each of the HPV-vaccine groups and 36 in the meningococcal group. This infection rate corresponded to a vaccine efficacy of 97.5% (P < .001) against HPV 16/18 for both the bivalent and nonavalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers write.

Among women negative for HPV 16/18/31/33/45/52/58 at the beginning of the trial, 33 had persistent infections: four in the nonavalent vaccine group and 29 in the meningococcal group, demonstrating an efficacy of 89% (P < .001) against all seven oncogenic strains contained in the vaccine.

Even if women tested positive for one strain of HPV, the vaccine protected them from other strains of the virus, the investigators noted.

Serious adverse events occurred in 4.5%-5.2% of participants across the study arms.

The KEN SHE trial comes 15 years after the U.S. Food and Drug Administration approved the first HPV vaccine – Merck’s Gardasil. Two others, Cervarix and Gardasil-9, have since been approved, but cost and supply issues have inhibited coverage, particularly in areas where the cervical cancer burden is high, the researchers noted.

Recent data indicate that just 15% of girls globally are vaccinated against HPV, but a single-dose vaccine would “simplify logistics and decrease costs,” thereby improving the chances of reaching the World Health Organization goal of vaccinating 90% of 15-year-old girls against HPV by 2030, Dr. Barnabas said in a press release about the trial.

Co–principal investigator Nelly Mugo, MBChB, MPH, senior principal clinical research scientist with the Center for Clinical Research at the Kenya Medical Research Institute in Nairobi, further emphasized the importance of the findings, noting in the press release that the “trial brings new energy to the elimination of cervical cancer. It brings great hope to the women living in countries like Kenya, who have a high burden of the disease.”

Dr. Mugo is also an associate research professor of global health at the University of Washington, Seattle.

Dr. Barnabas said women have been given multiple doses of the HPV vaccine because of “gaps in evidence for the effectiveness of a single-dose vaccine and concerns about clinically meaningful differences in efficacy.

“Observational data suggested that the single-dose HPV vaccine could have good efficacy, but because the data were not from randomized trials, that could have been from chance,” she explained, noting, however, that “sufficient evidence supported the decrease in doses from three to two doses for girls 15 years of age and younger.”

Going forward, the researchers will conduct immunobridging studies to other populations and will continue follow-up to assess the durability of single-dose efficacy, Dr. Barnabas said.

“The results from the KEN SHE trial support the use of single-dose HPV vaccination to increase access and coverage,” she concluded.

The KEN SHE trial was funded by the Bill & Melinda Gates Foundation (BMGF). Dr. Barnabas reports grants from BMGF and grants from King K. Holmes Professorship in STDs and AIDS during the conduct of the study, and grants from BMGF, National Institutes of Health, and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work.

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

A single dose of human papillomavirus (HPV) vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens, according to results from the KEN SHE trial, based in Kenya.

The findings, published on the preprint server Research Square and presented Nov. 17 at the 34th International Papillomavirus Conference in Toronto, bring “renewed energy to the push to make cervical cancer the first cancer to be wiped out globally,” according to co–principal investigator Ruanne V. Barnabas, PhD, a professor of global health at the University of Washington, Seattle.

Decision-makers will consider these findings, which have not yet been peer-reviewed, along with other evidence to determine if dosing-schedule changes are warranted, she told this news organization.

In a press release, Samuel Kariuki, PhD, acting director general, Kenya Medical Research Institute, who was not involved in the research, called the findings a “game changer” that could “substantially reduce the incidence of HPV-attributable cervical cancer.”

Between 2018 and 2019, Dr. Barnabas and her colleagues enrolled 2,275 sexually active, HPV-vaccine–naive women in Kenya in their study. The women, 15-20 years of age, were randomly assigned to receive a bivalent vaccine (HPV 16/18), a nonavalent vaccine (HPV 16/18/31/33/45/52/58/6/11), or a vaccine against meningococcal meningitis.

Most participants (57%) were between 15 and 17 years of age, and 61% reported one lifetime sexual partner. The women underwent genital and cervical swabs at enrollment to test for HPV DNA and had blood drawn to test for antibodies. During 18 months of follow-up, they had cervical swabs every 6 months and a vaginal swab at 3 months to test for HPV DNA.

The researchers detected 38 persistent HPV 16/18 infections in women who had tested negative for HPV 16/18 antibodies at enrollment and for HPV 16/18 DNA at enrollment and month 3 – one in each of the HPV-vaccine groups and 36 in the meningococcal group. This infection rate corresponded to a vaccine efficacy of 97.5% (P < .001) against HPV 16/18 for both the bivalent and nonavalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers write.

Among women negative for HPV 16/18/31/33/45/52/58 at the beginning of the trial, 33 had persistent infections: four in the nonavalent vaccine group and 29 in the meningococcal group, demonstrating an efficacy of 89% (P < .001) against all seven oncogenic strains contained in the vaccine.

Even if women tested positive for one strain of HPV, the vaccine protected them from other strains of the virus, the investigators noted.

Serious adverse events occurred in 4.5%-5.2% of participants across the study arms.

The KEN SHE trial comes 15 years after the U.S. Food and Drug Administration approved the first HPV vaccine – Merck’s Gardasil. Two others, Cervarix and Gardasil-9, have since been approved, but cost and supply issues have inhibited coverage, particularly in areas where the cervical cancer burden is high, the researchers noted.

Recent data indicate that just 15% of girls globally are vaccinated against HPV, but a single-dose vaccine would “simplify logistics and decrease costs,” thereby improving the chances of reaching the World Health Organization goal of vaccinating 90% of 15-year-old girls against HPV by 2030, Dr. Barnabas said in a press release about the trial.

Co–principal investigator Nelly Mugo, MBChB, MPH, senior principal clinical research scientist with the Center for Clinical Research at the Kenya Medical Research Institute in Nairobi, further emphasized the importance of the findings, noting in the press release that the “trial brings new energy to the elimination of cervical cancer. It brings great hope to the women living in countries like Kenya, who have a high burden of the disease.”

Dr. Mugo is also an associate research professor of global health at the University of Washington, Seattle.

Dr. Barnabas said women have been given multiple doses of the HPV vaccine because of “gaps in evidence for the effectiveness of a single-dose vaccine and concerns about clinically meaningful differences in efficacy.

“Observational data suggested that the single-dose HPV vaccine could have good efficacy, but because the data were not from randomized trials, that could have been from chance,” she explained, noting, however, that “sufficient evidence supported the decrease in doses from three to two doses for girls 15 years of age and younger.”

Going forward, the researchers will conduct immunobridging studies to other populations and will continue follow-up to assess the durability of single-dose efficacy, Dr. Barnabas said.

“The results from the KEN SHE trial support the use of single-dose HPV vaccination to increase access and coverage,” she concluded.

The KEN SHE trial was funded by the Bill & Melinda Gates Foundation (BMGF). Dr. Barnabas reports grants from BMGF and grants from King K. Holmes Professorship in STDs and AIDS during the conduct of the study, and grants from BMGF, National Institutes of Health, and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work.

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

To the Editor:

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or drug-induced hypersensitivity syndrome, is a serious and potentially fatal multiorgan drug hypersensitivity reaction. Drug reaction with eosinophilia and systemic symptoms syndrome shares many clinical features with viral exanthems and may be difficult to diagnose in the setting of atopic dermatitis (AD) in which children may have baseline eosinophilia from an atopic diathesis. The cutaneous exanthema also may be variable in presentation, further complicating diagnosis.^1,2

A 3-year-old boy with AD since infancy and a history of anaphylaxis to peanuts presented to the emergency department with reported fever, rash, sore throat, and decreased oral intake. Ten days prior, the patient was treated for cellulitis of the left foot with a 7-day course of cefdinir with complete resolution of symptoms. Four days prior to admission, the patient started developing “bumps” on the face and fevers. He was seen at an outside facility, where a rapid test for Streptococcus was negative, and the patient was treated with ibuprofen and fluids for a presumed viral exanthem. The rash subsequently spread to involve the trunk and extremities. On the day of admission, the patient had a positive rapid test for Streptococcus and was referred to the emergency department with concern for superinfected eczema and eczema herpeticum. The patient recently traveled to Puerto Rico, where he had contact with an aunt with active herpes zoster but no other sick contacts. The patient’s immunizations were reported to be up-to-date.

Physical examination revealed the patient was afebrile but irritable and had erythematous crusted papules and patches on the face, arms, and legs, as well as erythematous dry patches on the chest, abdomen, and back (Figure). There were no conjunctival erythematous or oral erosions. The patient was admitted to the hospital for presumed superinfected AD and possible eczema herpeticum. He was started on intravenous clindamycin and acyclovir.

The following day, the patient had new facial edema and fever (temperature, 102.8 °F [39.36 °C]) in addition to palpable mobile cervical, axillary, and inguinal lymphadenopathy. He also was noted to have notably worsening eosinophilia from 1288 (14%) to 2570 (29.2%) cells/µL (reference range, 0%–5%) and new-onset transaminitis. Herpes and varicella-zoster direct fluorescent antibody tests, culture, and serum polymerase chain reaction were all negative, and acyclovir was discontinued. Repeat laboratory tests 12 hours later showed a continued uptrend in transaminitis. Serologies for acute and chronic cytomegalovirus; Epstein-Barr virus; and hepatitis A, B, and C were all nonreactive. The patient was started on intravenous methylprednisolone 1 mg/kg daily for suspected DRESS syndrome likely due to cefdinir.

The patient’s eosinophilia completely resolved (from approximately 2600 to 100 cells/µL) after 1 dose of steroids, and his transaminitis trended down over the next few days. He remained afebrile for the remainder of his admission, and his facial swelling and rash continued to improve. Bacterial culture from the skin grew oxacillin-susceptible Staphylococcus aureus and group A Streptococcus pyogenes. A blood culture was negative. The patient was discharged home to complete a 10-day course of clindamycin and was given topical steroids for the eczema. He continued on oral prednisolone 1 mg/kg daily for 10 days, after which the dose was tapered down for a total 1-month course of systemic corticosteroids. At 1-month follow-up after completing the course of steroids, he was doing well with normal hepatic enzyme levels and no recurrence of fever, facial edema, or rash. He continues to be followed for management of the AD.

Drug reaction with eosinophilia and systemic symptoms syndrome is a serious systemic adverse drug reaction, with high morbidity and even mortality, estimated at 10% in the adult population, though more specific pediatric mortality data are not available.^1,2 The exact pathogenesis of DRESS syndrome has not been elucidated. Certain human leukocyte antigen class I alleles are predisposed to the development of DRESS syndrome, but there has not been a human leukocyte antigen subtype identified with beta-lactam–associated DRESS syndrome. Some studies have demonstrated a reactivation of human herpesvirus 6, human herpesvirus 7, and Epstein-Barr virus.³ One study involving 40 patients with DRESS syndrome identified viremia in 76% (29/38) of patients and identified CD8⁺ T-cell populations directed toward viral epitopes.³ Finally, DRESS syndrome may be related to the slow detoxification and elimination of intermediary products of offending medications that serve as an immunogenic stimulus for the inflammatory cascade.²

In adults, DRESS syndrome was first identified in association with phenytoin, but more recently other drugs have been identified, including other aromatic anticonvulsants (ie, lamotrigine, phenobarbital, carbamazepine), allopurinol, sulfonamides, antiretrovirals (particularly abacavir), and minocycline.² In a 3-year pediatric prospective study, 11 cases of DRESS syndrome were identified: 4 cases due to lamotrigine, and 3 caused by penicillins.⁴ The trigger in our patient’s case was the beta-lactam, third-generation cephalosporin cefdinir, and his symptoms developed within 6 days of starting the medication. Many articles report that beta-lactams are a rare cause of DRESS syndrome, with only a handful of cases reported.^1,5,6

The diagnosis of DRESS syndrome often can be delayed, as children present acutely febrile and toxic appearing. Unlike many adverse drug reactions, DRESS syndrome does not show rapid resolution with withdrawal of the causative agent, further complicating the diagnosis. The typical onset of DRESS syndrome generally ranges from 2 to 6 weeks after the initiation of the offending drug; however, faster onset of symptoms, similar to our case, has been noted in antibiotic-triggered cases. In the prospective pediatric series by Sasidharanpillai et al,⁴ the average time to onset among 3 antibiotic-triggered DRESS cases was 5.8 days vs 23.9 days among the 4 cases of lamotrigine-associated DRESS syndrome.

Our patient demonstrated the classic features of DRESS syndrome, including fever, rash, lymphadenopathy, facial edema, peripheral eosinophilia, atypical lymphocytosis, and hepatitis. Based on the proposed RegiSCAR scoring system, our patient was classified as a “definite” case of DRESS syndrome.^1,7 Other hematologic findings in DRESS syndrome may include thrombocytopenia and anemia. The liver is the most commonly affected internal organ in DRESS syndrome, with pneumonitis, carditis, and nephritis reported less frequently.¹ The pattern of liver injury in our patient was mixed (hepatocellular and cholestatic), the second most common pattern in patients with DRESS syndrome (the cholestatic pattern is most common).⁸

The exanthem of DRESS syndrome can vary in morphology, with up to 7% of patients reported to have eczemalike lesions in the multinational prospective RegiSCAR study.¹ Other entities in the differential diagnosis for our patient included Kawasaki disease, where conjunctivitis and strawberry tongue are classically present, as well as erythrodermic AD, where internal organ involvement is not common.² Our patient’s exanthem initially was considered to be a flare of AD with superimposed bacterial infection and possible eczema herpeticum. Although bacterial cultures did grow Staphylococcus and Streptococcus, viral studies were all negative, and this alone would not have explained the facial edema, rapidly rising eosinophil count, and transaminitis. The dramatic drop in his eosinophil count and decrease in hepatic enzymes after 1 dose of intravenous methylprednisolone also supported the diagnosis of DRESS syndrome.

Treatment recommendations remain largely anecdotal. Early systemic steroids generally are accepted as the first line of therapy, with a slow taper. Although the average required duration of systemic steroids in 1 series of adults was reported at 50.1 days,⁹ the duration was shorter (21–35 days) in a series of pediatric patients.⁴ Our patient’s clinical symptoms and laboratory values normalized after completing a 1-month steroid taper. Other therapies have been tried for recalcitrant cases, including intravenous immunoglobulin, plasmapheresis, rituximab, and valganciclovir.²

Early clinical recognition of the signs and symptoms of DRESS syndrome in the setting of a new medication can decrease morbidity and mortality. Although DRESS syndrome in pediatric patients presents with many similar clinical features as in adults, it may be a greater diagnostic challenge. As in adult cases, timely administration of systemic corticosteroids and tapering based on clinical signs and symptoms can lead to resolution of the hypersensitivity syndrome.

To the Editor:

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or drug-induced hypersensitivity syndrome, is a serious and potentially fatal multiorgan drug hypersensitivity reaction. Drug reaction with eosinophilia and systemic symptoms syndrome shares many clinical features with viral exanthems and may be difficult to diagnose in the setting of atopic dermatitis (AD) in which children may have baseline eosinophilia from an atopic diathesis. The cutaneous exanthema also may be variable in presentation, further complicating diagnosis.^1,2

A 3-year-old boy with AD since infancy and a history of anaphylaxis to peanuts presented to the emergency department with reported fever, rash, sore throat, and decreased oral intake. Ten days prior, the patient was treated for cellulitis of the left foot with a 7-day course of cefdinir with complete resolution of symptoms. Four days prior to admission, the patient started developing “bumps” on the face and fevers. He was seen at an outside facility, where a rapid test for Streptococcus was negative, and the patient was treated with ibuprofen and fluids for a presumed viral exanthem. The rash subsequently spread to involve the trunk and extremities. On the day of admission, the patient had a positive rapid test for Streptococcus and was referred to the emergency department with concern for superinfected eczema and eczema herpeticum. The patient recently traveled to Puerto Rico, where he had contact with an aunt with active herpes zoster but no other sick contacts. The patient’s immunizations were reported to be up-to-date.

Physical examination revealed the patient was afebrile but irritable and had erythematous crusted papules and patches on the face, arms, and legs, as well as erythematous dry patches on the chest, abdomen, and back (Figure). There were no conjunctival erythematous or oral erosions. The patient was admitted to the hospital for presumed superinfected AD and possible eczema herpeticum. He was started on intravenous clindamycin and acyclovir.

The following day, the patient had new facial edema and fever (temperature, 102.8 °F [39.36 °C]) in addition to palpable mobile cervical, axillary, and inguinal lymphadenopathy. He also was noted to have notably worsening eosinophilia from 1288 (14%) to 2570 (29.2%) cells/µL (reference range, 0%–5%) and new-onset transaminitis. Herpes and varicella-zoster direct fluorescent antibody tests, culture, and serum polymerase chain reaction were all negative, and acyclovir was discontinued. Repeat laboratory tests 12 hours later showed a continued uptrend in transaminitis. Serologies for acute and chronic cytomegalovirus; Epstein-Barr virus; and hepatitis A, B, and C were all nonreactive. The patient was started on intravenous methylprednisolone 1 mg/kg daily for suspected DRESS syndrome likely due to cefdinir.

The patient’s eosinophilia completely resolved (from approximately 2600 to 100 cells/µL) after 1 dose of steroids, and his transaminitis trended down over the next few days. He remained afebrile for the remainder of his admission, and his facial swelling and rash continued to improve. Bacterial culture from the skin grew oxacillin-susceptible Staphylococcus aureus and group A Streptococcus pyogenes. A blood culture was negative. The patient was discharged home to complete a 10-day course of clindamycin and was given topical steroids for the eczema. He continued on oral prednisolone 1 mg/kg daily for 10 days, after which the dose was tapered down for a total 1-month course of systemic corticosteroids. At 1-month follow-up after completing the course of steroids, he was doing well with normal hepatic enzyme levels and no recurrence of fever, facial edema, or rash. He continues to be followed for management of the AD.

Drug reaction with eosinophilia and systemic symptoms syndrome is a serious systemic adverse drug reaction, with high morbidity and even mortality, estimated at 10% in the adult population, though more specific pediatric mortality data are not available.^1,2 The exact pathogenesis of DRESS syndrome has not been elucidated. Certain human leukocyte antigen class I alleles are predisposed to the development of DRESS syndrome, but there has not been a human leukocyte antigen subtype identified with beta-lactam–associated DRESS syndrome. Some studies have demonstrated a reactivation of human herpesvirus 6, human herpesvirus 7, and Epstein-Barr virus.³ One study involving 40 patients with DRESS syndrome identified viremia in 76% (29/38) of patients and identified CD8⁺ T-cell populations directed toward viral epitopes.³ Finally, DRESS syndrome may be related to the slow detoxification and elimination of intermediary products of offending medications that serve as an immunogenic stimulus for the inflammatory cascade.²

In adults, DRESS syndrome was first identified in association with phenytoin, but more recently other drugs have been identified, including other aromatic anticonvulsants (ie, lamotrigine, phenobarbital, carbamazepine), allopurinol, sulfonamides, antiretrovirals (particularly abacavir), and minocycline.² In a 3-year pediatric prospective study, 11 cases of DRESS syndrome were identified: 4 cases due to lamotrigine, and 3 caused by penicillins.⁴ The trigger in our patient’s case was the beta-lactam, third-generation cephalosporin cefdinir, and his symptoms developed within 6 days of starting the medication. Many articles report that beta-lactams are a rare cause of DRESS syndrome, with only a handful of cases reported.^1,5,6

The diagnosis of DRESS syndrome often can be delayed, as children present acutely febrile and toxic appearing. Unlike many adverse drug reactions, DRESS syndrome does not show rapid resolution with withdrawal of the causative agent, further complicating the diagnosis. The typical onset of DRESS syndrome generally ranges from 2 to 6 weeks after the initiation of the offending drug; however, faster onset of symptoms, similar to our case, has been noted in antibiotic-triggered cases. In the prospective pediatric series by Sasidharanpillai et al,⁴ the average time to onset among 3 antibiotic-triggered DRESS cases was 5.8 days vs 23.9 days among the 4 cases of lamotrigine-associated DRESS syndrome.

Our patient demonstrated the classic features of DRESS syndrome, including fever, rash, lymphadenopathy, facial edema, peripheral eosinophilia, atypical lymphocytosis, and hepatitis. Based on the proposed RegiSCAR scoring system, our patient was classified as a “definite” case of DRESS syndrome.^1,7 Other hematologic findings in DRESS syndrome may include thrombocytopenia and anemia. The liver is the most commonly affected internal organ in DRESS syndrome, with pneumonitis, carditis, and nephritis reported less frequently.¹ The pattern of liver injury in our patient was mixed (hepatocellular and cholestatic), the second most common pattern in patients with DRESS syndrome (the cholestatic pattern is most common).⁸

The exanthem of DRESS syndrome can vary in morphology, with up to 7% of patients reported to have eczemalike lesions in the multinational prospective RegiSCAR study.¹ Other entities in the differential diagnosis for our patient included Kawasaki disease, where conjunctivitis and strawberry tongue are classically present, as well as erythrodermic AD, where internal organ involvement is not common.² Our patient’s exanthem initially was considered to be a flare of AD with superimposed bacterial infection and possible eczema herpeticum. Although bacterial cultures did grow Staphylococcus and Streptococcus, viral studies were all negative, and this alone would not have explained the facial edema, rapidly rising eosinophil count, and transaminitis. The dramatic drop in his eosinophil count and decrease in hepatic enzymes after 1 dose of intravenous methylprednisolone also supported the diagnosis of DRESS syndrome.

Treatment recommendations remain largely anecdotal. Early systemic steroids generally are accepted as the first line of therapy, with a slow taper. Although the average required duration of systemic steroids in 1 series of adults was reported at 50.1 days,⁹ the duration was shorter (21–35 days) in a series of pediatric patients.⁴ Our patient’s clinical symptoms and laboratory values normalized after completing a 1-month steroid taper. Other therapies have been tried for recalcitrant cases, including intravenous immunoglobulin, plasmapheresis, rituximab, and valganciclovir.²

Early clinical recognition of the signs and symptoms of DRESS syndrome in the setting of a new medication can decrease morbidity and mortality. Although DRESS syndrome in pediatric patients presents with many similar clinical features as in adults, it may be a greater diagnostic challenge. As in adult cases, timely administration of systemic corticosteroids and tapering based on clinical signs and symptoms can lead to resolution of the hypersensitivity syndrome.

To the Editor:

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or drug-induced hypersensitivity syndrome, is a serious and potentially fatal multiorgan drug hypersensitivity reaction. Drug reaction with eosinophilia and systemic symptoms syndrome shares many clinical features with viral exanthems and may be difficult to diagnose in the setting of atopic dermatitis (AD) in which children may have baseline eosinophilia from an atopic diathesis. The cutaneous exanthema also may be variable in presentation, further complicating diagnosis.^1,2

A 3-year-old boy with AD since infancy and a history of anaphylaxis to peanuts presented to the emergency department with reported fever, rash, sore throat, and decreased oral intake. Ten days prior, the patient was treated for cellulitis of the left foot with a 7-day course of cefdinir with complete resolution of symptoms. Four days prior to admission, the patient started developing “bumps” on the face and fevers. He was seen at an outside facility, where a rapid test for Streptococcus was negative, and the patient was treated with ibuprofen and fluids for a presumed viral exanthem. The rash subsequently spread to involve the trunk and extremities. On the day of admission, the patient had a positive rapid test for Streptococcus and was referred to the emergency department with concern for superinfected eczema and eczema herpeticum. The patient recently traveled to Puerto Rico, where he had contact with an aunt with active herpes zoster but no other sick contacts. The patient’s immunizations were reported to be up-to-date.

Physical examination revealed the patient was afebrile but irritable and had erythematous crusted papules and patches on the face, arms, and legs, as well as erythematous dry patches on the chest, abdomen, and back (Figure). There were no conjunctival erythematous or oral erosions. The patient was admitted to the hospital for presumed superinfected AD and possible eczema herpeticum. He was started on intravenous clindamycin and acyclovir.

The following day, the patient had new facial edema and fever (temperature, 102.8 °F [39.36 °C]) in addition to palpable mobile cervical, axillary, and inguinal lymphadenopathy. He also was noted to have notably worsening eosinophilia from 1288 (14%) to 2570 (29.2%) cells/µL (reference range, 0%–5%) and new-onset transaminitis. Herpes and varicella-zoster direct fluorescent antibody tests, culture, and serum polymerase chain reaction were all negative, and acyclovir was discontinued. Repeat laboratory tests 12 hours later showed a continued uptrend in transaminitis. Serologies for acute and chronic cytomegalovirus; Epstein-Barr virus; and hepatitis A, B, and C were all nonreactive. The patient was started on intravenous methylprednisolone 1 mg/kg daily for suspected DRESS syndrome likely due to cefdinir.

The patient’s eosinophilia completely resolved (from approximately 2600 to 100 cells/µL) after 1 dose of steroids, and his transaminitis trended down over the next few days. He remained afebrile for the remainder of his admission, and his facial swelling and rash continued to improve. Bacterial culture from the skin grew oxacillin-susceptible Staphylococcus aureus and group A Streptococcus pyogenes. A blood culture was negative. The patient was discharged home to complete a 10-day course of clindamycin and was given topical steroids for the eczema. He continued on oral prednisolone 1 mg/kg daily for 10 days, after which the dose was tapered down for a total 1-month course of systemic corticosteroids. At 1-month follow-up after completing the course of steroids, he was doing well with normal hepatic enzyme levels and no recurrence of fever, facial edema, or rash. He continues to be followed for management of the AD.

Drug reaction with eosinophilia and systemic symptoms syndrome is a serious systemic adverse drug reaction, with high morbidity and even mortality, estimated at 10% in the adult population, though more specific pediatric mortality data are not available.^1,2 The exact pathogenesis of DRESS syndrome has not been elucidated. Certain human leukocyte antigen class I alleles are predisposed to the development of DRESS syndrome, but there has not been a human leukocyte antigen subtype identified with beta-lactam–associated DRESS syndrome. Some studies have demonstrated a reactivation of human herpesvirus 6, human herpesvirus 7, and Epstein-Barr virus.³ One study involving 40 patients with DRESS syndrome identified viremia in 76% (29/38) of patients and identified CD8⁺ T-cell populations directed toward viral epitopes.³ Finally, DRESS syndrome may be related to the slow detoxification and elimination of intermediary products of offending medications that serve as an immunogenic stimulus for the inflammatory cascade.²

In adults, DRESS syndrome was first identified in association with phenytoin, but more recently other drugs have been identified, including other aromatic anticonvulsants (ie, lamotrigine, phenobarbital, carbamazepine), allopurinol, sulfonamides, antiretrovirals (particularly abacavir), and minocycline.² In a 3-year pediatric prospective study, 11 cases of DRESS syndrome were identified: 4 cases due to lamotrigine, and 3 caused by penicillins.⁴ The trigger in our patient’s case was the beta-lactam, third-generation cephalosporin cefdinir, and his symptoms developed within 6 days of starting the medication. Many articles report that beta-lactams are a rare cause of DRESS syndrome, with only a handful of cases reported.^1,5,6

The diagnosis of DRESS syndrome often can be delayed, as children present acutely febrile and toxic appearing. Unlike many adverse drug reactions, DRESS syndrome does not show rapid resolution with withdrawal of the causative agent, further complicating the diagnosis. The typical onset of DRESS syndrome generally ranges from 2 to 6 weeks after the initiation of the offending drug; however, faster onset of symptoms, similar to our case, has been noted in antibiotic-triggered cases. In the prospective pediatric series by Sasidharanpillai et al,⁴ the average time to onset among 3 antibiotic-triggered DRESS cases was 5.8 days vs 23.9 days among the 4 cases of lamotrigine-associated DRESS syndrome.

Our patient demonstrated the classic features of DRESS syndrome, including fever, rash, lymphadenopathy, facial edema, peripheral eosinophilia, atypical lymphocytosis, and hepatitis. Based on the proposed RegiSCAR scoring system, our patient was classified as a “definite” case of DRESS syndrome.^1,7 Other hematologic findings in DRESS syndrome may include thrombocytopenia and anemia. The liver is the most commonly affected internal organ in DRESS syndrome, with pneumonitis, carditis, and nephritis reported less frequently.¹ The pattern of liver injury in our patient was mixed (hepatocellular and cholestatic), the second most common pattern in patients with DRESS syndrome (the cholestatic pattern is most common).⁸

The exanthem of DRESS syndrome can vary in morphology, with up to 7% of patients reported to have eczemalike lesions in the multinational prospective RegiSCAR study.¹ Other entities in the differential diagnosis for our patient included Kawasaki disease, where conjunctivitis and strawberry tongue are classically present, as well as erythrodermic AD, where internal organ involvement is not common.² Our patient’s exanthem initially was considered to be a flare of AD with superimposed bacterial infection and possible eczema herpeticum. Although bacterial cultures did grow Staphylococcus and Streptococcus, viral studies were all negative, and this alone would not have explained the facial edema, rapidly rising eosinophil count, and transaminitis. The dramatic drop in his eosinophil count and decrease in hepatic enzymes after 1 dose of intravenous methylprednisolone also supported the diagnosis of DRESS syndrome.

Treatment recommendations remain largely anecdotal. Early systemic steroids generally are accepted as the first line of therapy, with a slow taper. Although the average required duration of systemic steroids in 1 series of adults was reported at 50.1 days,⁹ the duration was shorter (21–35 days) in a series of pediatric patients.⁴ Our patient’s clinical symptoms and laboratory values normalized after completing a 1-month steroid taper. Other therapies have been tried for recalcitrant cases, including intravenous immunoglobulin, plasmapheresis, rituximab, and valganciclovir.²

Early clinical recognition of the signs and symptoms of DRESS syndrome in the setting of a new medication can decrease morbidity and mortality. Although DRESS syndrome in pediatric patients presents with many similar clinical features as in adults, it may be a greater diagnostic challenge. As in adult cases, timely administration of systemic corticosteroids and tapering based on clinical signs and symptoms can lead to resolution of the hypersensitivity syndrome.

COVID-19’s relentless toll on the clinical workforce inspired four doctors to draft an action plan to stem the exits and help colleagues preserve their physical and mental health.

Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.

“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.

The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.

“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”

Among the other action items are:

• Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
• Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
• Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
• Encourage clinicians to use vacation time; leaders should model this.
• Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.

The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine

Action items intended to be easily achievable, low cost

Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.

She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.

“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.

Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.

“It’s not just about a hug or a piece of pizza,” she said.

Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.

“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”

Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.

“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.

Favorable reactions to list

Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”

Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.

Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.

“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
 

Outside expert: Not all items may be easy to implement

Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.

The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.

According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.

“Most of these things are hard and we need to be in it for the long run,” she said.

The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
 

Related research

A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.

The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.

Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.

The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”

Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.

COVID-19’s relentless toll on the clinical workforce inspired four doctors to draft an action plan to stem the exits and help colleagues preserve their physical and mental health.

Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.

“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.

The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.

“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”

Among the other action items are:

• Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
• Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
• Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
• Encourage clinicians to use vacation time; leaders should model this.
• Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.

The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine

Action items intended to be easily achievable, low cost

Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.

She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.

“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.

Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.

“It’s not just about a hug or a piece of pizza,” she said.

Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.

“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”

Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.

“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.

Favorable reactions to list

Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”

Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.

Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.

“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
 

Outside expert: Not all items may be easy to implement

Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.

The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.

According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.

“Most of these things are hard and we need to be in it for the long run,” she said.

The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
 

Related research

A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.

The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.

Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.

The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”

Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.

COVID-19’s relentless toll on the clinical workforce inspired four doctors to draft an action plan to stem the exits and help colleagues preserve their physical and mental health.

Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.

“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.

The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.

“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”

Among the other action items are:

• Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
• Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
• Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
• Encourage clinicians to use vacation time; leaders should model this.
• Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.

The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine

Action items intended to be easily achievable, low cost

Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.

She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.

“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.

Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.

“It’s not just about a hug or a piece of pizza,” she said.

Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.

“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”

Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.

“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.

Favorable reactions to list

Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”

Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.

Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.

“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
 

Outside expert: Not all items may be easy to implement

Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.

The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.

According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.

“Most of these things are hard and we need to be in it for the long run,” she said.

The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
 

Related research

A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.

The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.

Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.

The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”

Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.

Even before their baby is born, parents face some tough questions: Home birth or hospital? Cloth or disposable diapers? Breast, bottle, or both? But advances in genetic sequencing technology mean that parents will soon face yet another choice: whether to sequence their newborn’s DNA for an overview of the baby’s entire genome.

Genetic testing has been used for decades to diagnose conditions even before birth. But DNA sequencing technologies, once expensive and tough to access, are now rapid and cheap enough that doctors could order genomic screening for any infant, regardless of health status.

The possibility has raised many questions about the ethical, legal, and social repercussions of doing so. One of the biggest sticking points of sequencing newborns is the potential psychosocial fallout for families of such wide-scale use of genetic screening.

“There’s a narrative of catastrophic distress,” says Robert Green, MD, a geneticist at Harvard Medical School and lead investigator on the BabySeq study, which is evaluating the medical, social, and economic consequences of newborn genetic screening. The concern is that parents learning that their child carries a gene variant related to cancer or heart disease will become “incredibly anxious and distressed,” he says. “And it’s not an unreasonable speculation.”

But Dr. Green’s team found no evidence of such anxiety in the results from a randomized trial it conducted, published in JAMA Pediatrics. In the meantime, Genomics England announced it would begin a pilot study involving whole-genome sequencing of up to 200,000 babies. The first goal is to identify severe disease that starts in childhood, but the information would also be stored and used to detect drug sensitivities and conditions that come up later in life.

The large U.K. project is a bold move, according to David Amor, PhD, a pediatric geneticist at Murdoch Children’s Research Institute in Australia, who says its time has come. Geneticists have been accused of thinking their field involves unique pitfalls, compared with the rest of medicine, he points out, and that doctors need to protect patients and families from the potential harm genetic testing poses.

“But it is becoming apparent that that’s not really the case,” he says, and “maybe there’s not a whole lot special about genetics – it’s just medicine.”

When a first-draft copy of the human genome was published in 2001, scientists and doctors hailed the start of a new era of precision medicine. Knowing our genome sequence was expected to lead to a better grasp on our individual disease risks. Yet even as technologies advanced, clinical genetics remained focused on diagnosis rather than screening, according to Lilian Downie, a clinical genetics PhD candidate at the University of Melbourne. She calls the difference subtle but important.

Diagnostic genetic testing confirms whether a person has a specific condition, whereas genetic screening tests evaluate someone’s risk of getting an illness. Both approaches use sequencing, but they answer different questions, explains Ms. Downie.
 

Diagnosing disease versus predicting future illness

Genetic testing is on the upswing for both purposes, whether clinically for diagnosis or through direct-to-consumer screening-oriented services like 23andMe. Scientists began to note that many people carried disease-related genetic variants without having signs of disease. In some cases, a variant that is mathematically linked to a disease simply doesn’t cause it. In other cases, though, even if the gene variant contributes to a disease, not everyone who carries the genetic change will get the condition.

This potential disconnect between having a variant and developing the condition is a big problem, says Katie Stoll, a genetic counselor and executive director of the Genetic Support Foundation in Olympia, WA.

“It’s more complicated than just looking at one gene variant and one outcome,” she says. Without a sure link between the two, this information could unnecessarily entail “some pretty big emotional and financial costs.”

Ms. Stoll and others in the genetics field who share similar concerns are one reason the BabySeq project was first funded back in 2015. Although the overall aim of the initiative is to answer questions about the value of genomic sequencing in newborn screening, the media and scientific attention has focused on the psychosocial impact of healthy newborn sequencing, says Dr. Green. In the study published in JAMA Pediatrics, his group focused on these issues, too.

For that randomized trial, they enrolled 325 families, 257 with healthy babies and 68 whose babies had spent time in neonatal intensive care. Enrolled infants were randomly given standard care alone or standard care with genomic sequencing added on. The genomic sequencing report contained information about the presence of genetic variants associated with disease that start in childhood. Parents also could choose whether to learn about genetic risks for conditions that start in adulthood, such as cancer.

Boston-based Tina Moniz was one of those parents. When her first daughter was born in Jan. 2016, someone from the BabySeq study asked her and her husband if they would like to take part. The decision was simple for the couple.

“I didn’t hesitate,” she says. “To me, knowledge is power.”

Using screening tools for parental and marital distress and parent-child bonding, the research evaluated BabySeq families at 3 and 10 months after parents received the sequencing results. The investigators found no significant differences in any of these measures between screened and unscreened families. Ms. Moniz learned that her daughter’s only concerning result was being a carrier for cystic fibrosis. Rather than finding this information anxiety-provoking, Ms. Moniz considered it to be reassuring.

“My mom brain worries about so many things, but at least I know I don’t have to add genetic disease to the list,” she says.

But Ms. Stoll, who wasn’t involved in the BabySeq study, isn’t as convinced. She says that less than 10% of the families approached about the trial ultimately agreed to take part, suggesting potential bias in the selection process. Most participants were white, well-educated, and well-off, making it hard to generalize the study’s results.

What’s more, the standard care involved meeting with a genetic counselor and giving a detailed family history, neither of which is routinely offered to new parents, Ms. Stoll says. These study features leave her unconvinced that healthy newborn genetic screening is beneficial.

“We can’t assume these psychosocial consequences will be true for everyone,” she says.
 

Follow-up and treatment needed

Traditional newborn screening relies on blood biochemical tests to detect and diagnose metabolic diseases. This approach still outperforms DNA sequencing in trials, says Cynthia Powell, MD, a pediatric geneticist at the University of North Carolina at Chapel Hill, who wasn’t involved with the BabySeq study. Despite the enthusiasm for genomics, this kind of screening won’t replace newborn biochemical screening anytime soon, she says.

“There are some states that have only one geneticist available, so should we really be doing this if we can’t provide the necessary follow-up and treatment for these babies?” she asks.

Still, Dr. Powell says, the BabySeq study helps advance understanding of what the infrastructure needs are for widespread use of DNA sequencing in newborns. She says those needs include appropriate consent processes, access to genetic counselors to discuss testing, and referrals for further testing and treatment in those babies with concerning results.

The BabySeq program will also guide new initiatives, like the pilot program that Genomics England launched in Sept. 2021. As part of that project, the U.K. group intends to look into how practical whole-genome sequencing for newborn screening would be and look at the risks, benefits, and limits of its widespread use.

“For the first time, we’re putting real data into these questions that people have basically just speculated and hypothesized and created narratives about,” Dr. Green says.

But for now, the findings on the psychosocial effects of general newborn genomic screening show that “we should consider genetics to be just one more arrow in our medical quiver.”

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

Even before their baby is born, parents face some tough questions: Home birth or hospital? Cloth or disposable diapers? Breast, bottle, or both? But advances in genetic sequencing technology mean that parents will soon face yet another choice: whether to sequence their newborn’s DNA for an overview of the baby’s entire genome.

Genetic testing has been used for decades to diagnose conditions even before birth. But DNA sequencing technologies, once expensive and tough to access, are now rapid and cheap enough that doctors could order genomic screening for any infant, regardless of health status.

The possibility has raised many questions about the ethical, legal, and social repercussions of doing so. One of the biggest sticking points of sequencing newborns is the potential psychosocial fallout for families of such wide-scale use of genetic screening.

“There’s a narrative of catastrophic distress,” says Robert Green, MD, a geneticist at Harvard Medical School and lead investigator on the BabySeq study, which is evaluating the medical, social, and economic consequences of newborn genetic screening. The concern is that parents learning that their child carries a gene variant related to cancer or heart disease will become “incredibly anxious and distressed,” he says. “And it’s not an unreasonable speculation.”

But Dr. Green’s team found no evidence of such anxiety in the results from a randomized trial it conducted, published in JAMA Pediatrics. In the meantime, Genomics England announced it would begin a pilot study involving whole-genome sequencing of up to 200,000 babies. The first goal is to identify severe disease that starts in childhood, but the information would also be stored and used to detect drug sensitivities and conditions that come up later in life.

The large U.K. project is a bold move, according to David Amor, PhD, a pediatric geneticist at Murdoch Children’s Research Institute in Australia, who says its time has come. Geneticists have been accused of thinking their field involves unique pitfalls, compared with the rest of medicine, he points out, and that doctors need to protect patients and families from the potential harm genetic testing poses.

“But it is becoming apparent that that’s not really the case,” he says, and “maybe there’s not a whole lot special about genetics – it’s just medicine.”

When a first-draft copy of the human genome was published in 2001, scientists and doctors hailed the start of a new era of precision medicine. Knowing our genome sequence was expected to lead to a better grasp on our individual disease risks. Yet even as technologies advanced, clinical genetics remained focused on diagnosis rather than screening, according to Lilian Downie, a clinical genetics PhD candidate at the University of Melbourne. She calls the difference subtle but important.

Diagnostic genetic testing confirms whether a person has a specific condition, whereas genetic screening tests evaluate someone’s risk of getting an illness. Both approaches use sequencing, but they answer different questions, explains Ms. Downie.
 

Diagnosing disease versus predicting future illness

Genetic testing is on the upswing for both purposes, whether clinically for diagnosis or through direct-to-consumer screening-oriented services like 23andMe. Scientists began to note that many people carried disease-related genetic variants without having signs of disease. In some cases, a variant that is mathematically linked to a disease simply doesn’t cause it. In other cases, though, even if the gene variant contributes to a disease, not everyone who carries the genetic change will get the condition.

This potential disconnect between having a variant and developing the condition is a big problem, says Katie Stoll, a genetic counselor and executive director of the Genetic Support Foundation in Olympia, WA.

“It’s more complicated than just looking at one gene variant and one outcome,” she says. Without a sure link between the two, this information could unnecessarily entail “some pretty big emotional and financial costs.”

Ms. Stoll and others in the genetics field who share similar concerns are one reason the BabySeq project was first funded back in 2015. Although the overall aim of the initiative is to answer questions about the value of genomic sequencing in newborn screening, the media and scientific attention has focused on the psychosocial impact of healthy newborn sequencing, says Dr. Green. In the study published in JAMA Pediatrics, his group focused on these issues, too.

For that randomized trial, they enrolled 325 families, 257 with healthy babies and 68 whose babies had spent time in neonatal intensive care. Enrolled infants were randomly given standard care alone or standard care with genomic sequencing added on. The genomic sequencing report contained information about the presence of genetic variants associated with disease that start in childhood. Parents also could choose whether to learn about genetic risks for conditions that start in adulthood, such as cancer.

Boston-based Tina Moniz was one of those parents. When her first daughter was born in Jan. 2016, someone from the BabySeq study asked her and her husband if they would like to take part. The decision was simple for the couple.

“I didn’t hesitate,” she says. “To me, knowledge is power.”

Using screening tools for parental and marital distress and parent-child bonding, the research evaluated BabySeq families at 3 and 10 months after parents received the sequencing results. The investigators found no significant differences in any of these measures between screened and unscreened families. Ms. Moniz learned that her daughter’s only concerning result was being a carrier for cystic fibrosis. Rather than finding this information anxiety-provoking, Ms. Moniz considered it to be reassuring.

“My mom brain worries about so many things, but at least I know I don’t have to add genetic disease to the list,” she says.

But Ms. Stoll, who wasn’t involved in the BabySeq study, isn’t as convinced. She says that less than 10% of the families approached about the trial ultimately agreed to take part, suggesting potential bias in the selection process. Most participants were white, well-educated, and well-off, making it hard to generalize the study’s results.

What’s more, the standard care involved meeting with a genetic counselor and giving a detailed family history, neither of which is routinely offered to new parents, Ms. Stoll says. These study features leave her unconvinced that healthy newborn genetic screening is beneficial.

“We can’t assume these psychosocial consequences will be true for everyone,” she says.
 

Follow-up and treatment needed

Traditional newborn screening relies on blood biochemical tests to detect and diagnose metabolic diseases. This approach still outperforms DNA sequencing in trials, says Cynthia Powell, MD, a pediatric geneticist at the University of North Carolina at Chapel Hill, who wasn’t involved with the BabySeq study. Despite the enthusiasm for genomics, this kind of screening won’t replace newborn biochemical screening anytime soon, she says.

“There are some states that have only one geneticist available, so should we really be doing this if we can’t provide the necessary follow-up and treatment for these babies?” she asks.

Still, Dr. Powell says, the BabySeq study helps advance understanding of what the infrastructure needs are for widespread use of DNA sequencing in newborns. She says those needs include appropriate consent processes, access to genetic counselors to discuss testing, and referrals for further testing and treatment in those babies with concerning results.

The BabySeq program will also guide new initiatives, like the pilot program that Genomics England launched in Sept. 2021. As part of that project, the U.K. group intends to look into how practical whole-genome sequencing for newborn screening would be and look at the risks, benefits, and limits of its widespread use.

“For the first time, we’re putting real data into these questions that people have basically just speculated and hypothesized and created narratives about,” Dr. Green says.

But for now, the findings on the psychosocial effects of general newborn genomic screening show that “we should consider genetics to be just one more arrow in our medical quiver.”

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

Even before their baby is born, parents face some tough questions: Home birth or hospital? Cloth or disposable diapers? Breast, bottle, or both? But advances in genetic sequencing technology mean that parents will soon face yet another choice: whether to sequence their newborn’s DNA for an overview of the baby’s entire genome.

Genetic testing has been used for decades to diagnose conditions even before birth. But DNA sequencing technologies, once expensive and tough to access, are now rapid and cheap enough that doctors could order genomic screening for any infant, regardless of health status.

The possibility has raised many questions about the ethical, legal, and social repercussions of doing so. One of the biggest sticking points of sequencing newborns is the potential psychosocial fallout for families of such wide-scale use of genetic screening.

“There’s a narrative of catastrophic distress,” says Robert Green, MD, a geneticist at Harvard Medical School and lead investigator on the BabySeq study, which is evaluating the medical, social, and economic consequences of newborn genetic screening. The concern is that parents learning that their child carries a gene variant related to cancer or heart disease will become “incredibly anxious and distressed,” he says. “And it’s not an unreasonable speculation.”

But Dr. Green’s team found no evidence of such anxiety in the results from a randomized trial it conducted, published in JAMA Pediatrics. In the meantime, Genomics England announced it would begin a pilot study involving whole-genome sequencing of up to 200,000 babies. The first goal is to identify severe disease that starts in childhood, but the information would also be stored and used to detect drug sensitivities and conditions that come up later in life.

The large U.K. project is a bold move, according to David Amor, PhD, a pediatric geneticist at Murdoch Children’s Research Institute in Australia, who says its time has come. Geneticists have been accused of thinking their field involves unique pitfalls, compared with the rest of medicine, he points out, and that doctors need to protect patients and families from the potential harm genetic testing poses.

“But it is becoming apparent that that’s not really the case,” he says, and “maybe there’s not a whole lot special about genetics – it’s just medicine.”

When a first-draft copy of the human genome was published in 2001, scientists and doctors hailed the start of a new era of precision medicine. Knowing our genome sequence was expected to lead to a better grasp on our individual disease risks. Yet even as technologies advanced, clinical genetics remained focused on diagnosis rather than screening, according to Lilian Downie, a clinical genetics PhD candidate at the University of Melbourne. She calls the difference subtle but important.

Diagnostic genetic testing confirms whether a person has a specific condition, whereas genetic screening tests evaluate someone’s risk of getting an illness. Both approaches use sequencing, but they answer different questions, explains Ms. Downie.
 

Diagnosing disease versus predicting future illness

Genetic testing is on the upswing for both purposes, whether clinically for diagnosis or through direct-to-consumer screening-oriented services like 23andMe. Scientists began to note that many people carried disease-related genetic variants without having signs of disease. In some cases, a variant that is mathematically linked to a disease simply doesn’t cause it. In other cases, though, even if the gene variant contributes to a disease, not everyone who carries the genetic change will get the condition.

This potential disconnect between having a variant and developing the condition is a big problem, says Katie Stoll, a genetic counselor and executive director of the Genetic Support Foundation in Olympia, WA.

“It’s more complicated than just looking at one gene variant and one outcome,” she says. Without a sure link between the two, this information could unnecessarily entail “some pretty big emotional and financial costs.”

Ms. Stoll and others in the genetics field who share similar concerns are one reason the BabySeq project was first funded back in 2015. Although the overall aim of the initiative is to answer questions about the value of genomic sequencing in newborn screening, the media and scientific attention has focused on the psychosocial impact of healthy newborn sequencing, says Dr. Green. In the study published in JAMA Pediatrics, his group focused on these issues, too.

For that randomized trial, they enrolled 325 families, 257 with healthy babies and 68 whose babies had spent time in neonatal intensive care. Enrolled infants were randomly given standard care alone or standard care with genomic sequencing added on. The genomic sequencing report contained information about the presence of genetic variants associated with disease that start in childhood. Parents also could choose whether to learn about genetic risks for conditions that start in adulthood, such as cancer.

Boston-based Tina Moniz was one of those parents. When her first daughter was born in Jan. 2016, someone from the BabySeq study asked her and her husband if they would like to take part. The decision was simple for the couple.

“I didn’t hesitate,” she says. “To me, knowledge is power.”

Using screening tools for parental and marital distress and parent-child bonding, the research evaluated BabySeq families at 3 and 10 months after parents received the sequencing results. The investigators found no significant differences in any of these measures between screened and unscreened families. Ms. Moniz learned that her daughter’s only concerning result was being a carrier for cystic fibrosis. Rather than finding this information anxiety-provoking, Ms. Moniz considered it to be reassuring.

“My mom brain worries about so many things, but at least I know I don’t have to add genetic disease to the list,” she says.

But Ms. Stoll, who wasn’t involved in the BabySeq study, isn’t as convinced. She says that less than 10% of the families approached about the trial ultimately agreed to take part, suggesting potential bias in the selection process. Most participants were white, well-educated, and well-off, making it hard to generalize the study’s results.

What’s more, the standard care involved meeting with a genetic counselor and giving a detailed family history, neither of which is routinely offered to new parents, Ms. Stoll says. These study features leave her unconvinced that healthy newborn genetic screening is beneficial.

“We can’t assume these psychosocial consequences will be true for everyone,” she says.
 

Follow-up and treatment needed

Traditional newborn screening relies on blood biochemical tests to detect and diagnose metabolic diseases. This approach still outperforms DNA sequencing in trials, says Cynthia Powell, MD, a pediatric geneticist at the University of North Carolina at Chapel Hill, who wasn’t involved with the BabySeq study. Despite the enthusiasm for genomics, this kind of screening won’t replace newborn biochemical screening anytime soon, she says.

“There are some states that have only one geneticist available, so should we really be doing this if we can’t provide the necessary follow-up and treatment for these babies?” she asks.

Still, Dr. Powell says, the BabySeq study helps advance understanding of what the infrastructure needs are for widespread use of DNA sequencing in newborns. She says those needs include appropriate consent processes, access to genetic counselors to discuss testing, and referrals for further testing and treatment in those babies with concerning results.

The BabySeq program will also guide new initiatives, like the pilot program that Genomics England launched in Sept. 2021. As part of that project, the U.K. group intends to look into how practical whole-genome sequencing for newborn screening would be and look at the risks, benefits, and limits of its widespread use.

“For the first time, we’re putting real data into these questions that people have basically just speculated and hypothesized and created narratives about,” Dr. Green says.

But for now, the findings on the psychosocial effects of general newborn genomic screening show that “we should consider genetics to be just one more arrow in our medical quiver.”

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

A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.

The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before.  He sought testing on Nov. 24.  His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health.  The man was fully vaccinated, the department said.

He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.

“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”

The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.

This breaking news story will be updated.

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

A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.

The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before.  He sought testing on Nov. 24.  His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health.  The man was fully vaccinated, the department said.

He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.

“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”

The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.

This breaking news story will be updated.

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

A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.

The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before.  He sought testing on Nov. 24.  His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health.  The man was fully vaccinated, the department said.

He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.

“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”

The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.

This breaking news story will be updated.

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

Will my child outgrow the eczema?

That is perhaps the No. 1 atopic dermatitis–related question that Lawrence F. Eichenfield, MD, fields from parents in his role as chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego.

The answer “is pretty tricky,” he said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We used to say, ‘yeah, your kid will probably outgrow the disease,’ but we now have good data that show there are variable courses.”

Using data from the birth study cohort known as the Avon Longitudinal Study of Parents and Children, researchers in the United Kingdom investigated the existence of different longitudinal phenotypes of AD among 9,894 children. They found that 58% of the children in the cohort were unaffected or had transient AD, while 12.9% had early-onset/early-resolving AD. The remaining AD phenotypes consisted of 7%-8% patients each (early-onset persistent, early-onset late-resolving, mid-onset resolving, and late-onset resolving).

“There have been several studies that looked at the natural course of AD,” said Dr. Eichenfield, distinguished professor of dermatology and pediatrics at the University of California, San Diego. “A cohort study from Thailand showed that 50% of patients with childhood AD lost their AD diagnosis about 5 years into it, while there was an increase in allergic rhino-conjunctivitis and asthma, similar to what’s been seen in atopic march studies,” he noted.

A separate group of investigators analyzed records from The Health Improvement Network in the UK to determine the prevalence of AD among more than 8 million patients seen in primary care between 1994 and 2013. They found that the cumulative lifetime prevalence of atopic eczema was 9.9% and the highest rates of active disease were among children and older adults. “The takeaway was markedly inconsistent in terms of whether AD went away over time or increased over time, so it’s really not especially helpful prevalence data,” Dr. Eichenfield said. “Overall, you have a high prevalence in the first years of life, it decreases, and it may increase again when people are 60 years and older. Whether that’s truly AD or xerotic eczema isn’t known in this data set.”

A separate meta-analysis of 17 studies reported that 26% of adults with AD said they had adult-onset disease, which is characterized by more atopy, more foot dermatitis, and less flexural involvement.

Dr. Eichenfield tells parents, “there’s a really good chance (depending on disease severity) that 60% to 70% of children will outgrow their eczema or most of it,” he said. “If you ask me when, I won’t tell you. The important thing is to treat it to minimize its impact. We want minimal rash, minimal itch, and minimal sleep disturbance. Sometimes I say, ‘that might improve the chance of the eczema getting better over time.’ ”

Following are four other common questions parents and patients ask him:

Can we figure out the allergies causing the eczema? “This is probably one of the most unnerving questions I get asked,” he said. “It’s a loaded question. My answer is that allergies are intertwined with AD. Searching for the secret allergy causing the atopic dermatitis is rarely successful.” Sensitization is much more common with AD, he added, meaning specific IgE testing, whether it be blood testing or skin prick testing. “The more severe your eczema is, the more chance you’ll have of real food allergy,” he said. “About 15% of milder eczema patients will have at least one food allergy, but when you get to the more moderate to severe cases, about 40% will have a true food allergy.”

Food reactions may not cause eczema, though. Food reactions can cause urticaria, angioedema, eczematous dermatitis, allergic contact dermatitis, contact urticaria, and respiratory findings. According to National Institutes of Health guidelines for food allergy, skin prick tests and serum IgE tests are recommended to assist in identification of foods that may be provoking IgE-mediated food reactions, but are not diagnostic of food allergy.

“There’s a huge literature showing that there’s a lot of food allergy testing that’s just not helpful,” he said. In one study, 89% of food challenges administered in patients who were listed as being allergic based on skin prick tests or serum IgE tests did not have a true food allergy.

“Empiric elimination diets aren’t especially useful. However, we occasionally see children who do have AD exacerbated by food allergies in the first year of life,” he said. NIH guidelines suggest that children younger than 5 years of age with moderate to severe AD be considered for food allergy evaluation for milk, egg, peanut, wheat, and soy, if at least one of the following conditions is met: the child has persistent AD in spite of optimized management and topical therapy, and/or the child has a reliable history of an immediate reaction after ingestion of a specific food.

“We do know that there are high rates of comorbid allergic processes, besides food allergy, associated with atopic dermatitis, including allergic rhinitis and asthma both in children and adults,” Dr. Eichenfield said. “I do discuss allergy triggers and their importance in the life of the individual, though not necessarily as factors in AD. There are a variety of environmental allergens and/or environmental triggers that can significantly impact AD. Recently, we have seen studies discussing air pollution and wildfires as exacerbators of AD.”

How should I bathe and moisturize? There are no standard guidelines for the frequency, type, or duration of bathing in patients with AD, he said, though in more severe disease, frequent bathing can be helpful along with standard anti-inflammatory topical medicines. “I keep my general recommendations vague,” Dr. Eichenfield said. “I do explain that we don’t want to use harsh soaps; we want to be gentle in our washing. I usually recommend daily to every other day bathing. It’s important to pat the skin dry and then apply a moisturizer. Applying a moisturizer 2-3 minutes after bathing is important and limited significant cleanser use can be helpful.”

Moisturizers and emollients are a standard of care in U.S. guidelines published in 2013 and 2014, and international guidelines, and are steroid-sparing and useful for both prevention and maintenance. “I tell parents and patients that there is no reason to avoid bathing because of AD as long as you moisturize after,” he said.

Do I have to use topical [name of drug]? “I try to explain that there is skin barrier dysfunction that stimulates the inflammatory milieu, and that inflammation in the skin or blood in AD negatively impacts skin barrier function,” Dr. Eichenfield said. “I explain that if inflammation doesn’t get better with good skin care, moisturizers, and avoidance of triggers, we need anti-inflammatory medication. Then we discuss what the options are, the significant variation in strengths of topical corticosteroids, and topical nonsteroid options.”

When he counsels parents and patients on the use of topical corticosteroids, he tells them that cortisone is a naturally-occurring metabolite, and that “we can work together to let you know how much medicine to use, and how a safe amount is a powerful tool to fix the eczema.” He often says that topical steroids “are like hammers. We have tiny hammers, like over-the-counter hydrocortisone, and sledgehammers like clobetasol. We also have ‘screwdrivers’ and ‘pliers’ with nonsteroidal topical calcineurin and PDE-4 inhibitors, which are especially useful for maintenance therapy. Topical ruxolitinib is a new medicine that we may use for patients as well. The label includes discussion of side effects from oral JAK inhibitors as well as from the drug development program, so it takes some time to talk through.”

Is it time for a stronger systemic medicine? Any conversation about this topic should support the concept that the AD is multifactorial. “We have the rash of eczema,” he said. “We have the itch. We have impact on sleep disturbance. We have the comorbidities. We have other physical changes, which can happen with bacterial infections and other immune system or cardiovascular changes. We have the impact on quality of life and impact on school and work. When we recognize that if patients have significant enough disease that it is not getting better with topicals and is having a negative impact on their lives, we can move our discussion to systemic therapy.”

When counseling patients about systemic therapy, Dr. Eichenfield will conduct a body surface area assessment and document how bad the itch is. “But I’m not just recording the information; I’m bringing it out in the room,” he said. “I’ll do a BSA assessment and say, for example, ‘oh, you have 32% of your body involved with eczema.’ I ask about sleep disturbance, to get the answer ‘out in the room.’ ” He also asks questions such as: “When was the last time your skin was last totally clear? Are there activities that you or your family don’t do because of your eczema, or that you’re living your life around it? Is there anxiety or depression?” Documenting both the impact on quality of life and the severity of disease “makes it easier to discuss systemic therapy,” Dr. Eichenfield said. “Meanwhile, as the provider, I am trying to figure out if the patient should ‘go into the topical therapy bucket’ or into the ‘systemic therapy bucket.’ ”

Counseling about systemic therapy includes shared decision-making regarding the choice of biologics versus oral JAK inhibitors versus traditional systemic agent or phototherapy. Factors to consider in the decision making include patient age, sex, severity, comorbidities, prior therapy, risk aversion, duration, medication access, and desired efficacy. “Evolving therapies can change the conversation, the questions, and the outcomes, but the overarching desired outcome is long-term disease control, minimal eczematous rash, minimal pruritus, and minimal sleep disturbance,” he said.

Dr. Eichenfield disclosed that he has served as a consultant to or investigator for AbbVie; Almirall; Arcutis; Arena; Asana; Termagant; Dermira; Forte Biosciences; Galderma Laboratories; Glenmark/Chinos; Incyte; Kyowa Kirin; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Otsuka; Pfizer; Freestone; Regeneron, and Sanofi Genzyme.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

Will my child outgrow the eczema?

That is perhaps the No. 1 atopic dermatitis–related question that Lawrence F. Eichenfield, MD, fields from parents in his role as chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego.

The answer “is pretty tricky,” he said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We used to say, ‘yeah, your kid will probably outgrow the disease,’ but we now have good data that show there are variable courses.”

Using data from the birth study cohort known as the Avon Longitudinal Study of Parents and Children, researchers in the United Kingdom investigated the existence of different longitudinal phenotypes of AD among 9,894 children. They found that 58% of the children in the cohort were unaffected or had transient AD, while 12.9% had early-onset/early-resolving AD. The remaining AD phenotypes consisted of 7%-8% patients each (early-onset persistent, early-onset late-resolving, mid-onset resolving, and late-onset resolving).

“There have been several studies that looked at the natural course of AD,” said Dr. Eichenfield, distinguished professor of dermatology and pediatrics at the University of California, San Diego. “A cohort study from Thailand showed that 50% of patients with childhood AD lost their AD diagnosis about 5 years into it, while there was an increase in allergic rhino-conjunctivitis and asthma, similar to what’s been seen in atopic march studies,” he noted.

A separate group of investigators analyzed records from The Health Improvement Network in the UK to determine the prevalence of AD among more than 8 million patients seen in primary care between 1994 and 2013. They found that the cumulative lifetime prevalence of atopic eczema was 9.9% and the highest rates of active disease were among children and older adults. “The takeaway was markedly inconsistent in terms of whether AD went away over time or increased over time, so it’s really not especially helpful prevalence data,” Dr. Eichenfield said. “Overall, you have a high prevalence in the first years of life, it decreases, and it may increase again when people are 60 years and older. Whether that’s truly AD or xerotic eczema isn’t known in this data set.”

A separate meta-analysis of 17 studies reported that 26% of adults with AD said they had adult-onset disease, which is characterized by more atopy, more foot dermatitis, and less flexural involvement.

Dr. Eichenfield tells parents, “there’s a really good chance (depending on disease severity) that 60% to 70% of children will outgrow their eczema or most of it,” he said. “If you ask me when, I won’t tell you. The important thing is to treat it to minimize its impact. We want minimal rash, minimal itch, and minimal sleep disturbance. Sometimes I say, ‘that might improve the chance of the eczema getting better over time.’ ”

Following are four other common questions parents and patients ask him:

Can we figure out the allergies causing the eczema? “This is probably one of the most unnerving questions I get asked,” he said. “It’s a loaded question. My answer is that allergies are intertwined with AD. Searching for the secret allergy causing the atopic dermatitis is rarely successful.” Sensitization is much more common with AD, he added, meaning specific IgE testing, whether it be blood testing or skin prick testing. “The more severe your eczema is, the more chance you’ll have of real food allergy,” he said. “About 15% of milder eczema patients will have at least one food allergy, but when you get to the more moderate to severe cases, about 40% will have a true food allergy.”

Food reactions may not cause eczema, though. Food reactions can cause urticaria, angioedema, eczematous dermatitis, allergic contact dermatitis, contact urticaria, and respiratory findings. According to National Institutes of Health guidelines for food allergy, skin prick tests and serum IgE tests are recommended to assist in identification of foods that may be provoking IgE-mediated food reactions, but are not diagnostic of food allergy.

“There’s a huge literature showing that there’s a lot of food allergy testing that’s just not helpful,” he said. In one study, 89% of food challenges administered in patients who were listed as being allergic based on skin prick tests or serum IgE tests did not have a true food allergy.

“Empiric elimination diets aren’t especially useful. However, we occasionally see children who do have AD exacerbated by food allergies in the first year of life,” he said. NIH guidelines suggest that children younger than 5 years of age with moderate to severe AD be considered for food allergy evaluation for milk, egg, peanut, wheat, and soy, if at least one of the following conditions is met: the child has persistent AD in spite of optimized management and topical therapy, and/or the child has a reliable history of an immediate reaction after ingestion of a specific food.

“We do know that there are high rates of comorbid allergic processes, besides food allergy, associated with atopic dermatitis, including allergic rhinitis and asthma both in children and adults,” Dr. Eichenfield said. “I do discuss allergy triggers and their importance in the life of the individual, though not necessarily as factors in AD. There are a variety of environmental allergens and/or environmental triggers that can significantly impact AD. Recently, we have seen studies discussing air pollution and wildfires as exacerbators of AD.”

How should I bathe and moisturize? There are no standard guidelines for the frequency, type, or duration of bathing in patients with AD, he said, though in more severe disease, frequent bathing can be helpful along with standard anti-inflammatory topical medicines. “I keep my general recommendations vague,” Dr. Eichenfield said. “I do explain that we don’t want to use harsh soaps; we want to be gentle in our washing. I usually recommend daily to every other day bathing. It’s important to pat the skin dry and then apply a moisturizer. Applying a moisturizer 2-3 minutes after bathing is important and limited significant cleanser use can be helpful.”

Moisturizers and emollients are a standard of care in U.S. guidelines published in 2013 and 2014, and international guidelines, and are steroid-sparing and useful for both prevention and maintenance. “I tell parents and patients that there is no reason to avoid bathing because of AD as long as you moisturize after,” he said.

Do I have to use topical [name of drug]? “I try to explain that there is skin barrier dysfunction that stimulates the inflammatory milieu, and that inflammation in the skin or blood in AD negatively impacts skin barrier function,” Dr. Eichenfield said. “I explain that if inflammation doesn’t get better with good skin care, moisturizers, and avoidance of triggers, we need anti-inflammatory medication. Then we discuss what the options are, the significant variation in strengths of topical corticosteroids, and topical nonsteroid options.”

When he counsels parents and patients on the use of topical corticosteroids, he tells them that cortisone is a naturally-occurring metabolite, and that “we can work together to let you know how much medicine to use, and how a safe amount is a powerful tool to fix the eczema.” He often says that topical steroids “are like hammers. We have tiny hammers, like over-the-counter hydrocortisone, and sledgehammers like clobetasol. We also have ‘screwdrivers’ and ‘pliers’ with nonsteroidal topical calcineurin and PDE-4 inhibitors, which are especially useful for maintenance therapy. Topical ruxolitinib is a new medicine that we may use for patients as well. The label includes discussion of side effects from oral JAK inhibitors as well as from the drug development program, so it takes some time to talk through.”

Is it time for a stronger systemic medicine? Any conversation about this topic should support the concept that the AD is multifactorial. “We have the rash of eczema,” he said. “We have the itch. We have impact on sleep disturbance. We have the comorbidities. We have other physical changes, which can happen with bacterial infections and other immune system or cardiovascular changes. We have the impact on quality of life and impact on school and work. When we recognize that if patients have significant enough disease that it is not getting better with topicals and is having a negative impact on their lives, we can move our discussion to systemic therapy.”

When counseling patients about systemic therapy, Dr. Eichenfield will conduct a body surface area assessment and document how bad the itch is. “But I’m not just recording the information; I’m bringing it out in the room,” he said. “I’ll do a BSA assessment and say, for example, ‘oh, you have 32% of your body involved with eczema.’ I ask about sleep disturbance, to get the answer ‘out in the room.’ ” He also asks questions such as: “When was the last time your skin was last totally clear? Are there activities that you or your family don’t do because of your eczema, or that you’re living your life around it? Is there anxiety or depression?” Documenting both the impact on quality of life and the severity of disease “makes it easier to discuss systemic therapy,” Dr. Eichenfield said. “Meanwhile, as the provider, I am trying to figure out if the patient should ‘go into the topical therapy bucket’ or into the ‘systemic therapy bucket.’ ”

Counseling about systemic therapy includes shared decision-making regarding the choice of biologics versus oral JAK inhibitors versus traditional systemic agent or phototherapy. Factors to consider in the decision making include patient age, sex, severity, comorbidities, prior therapy, risk aversion, duration, medication access, and desired efficacy. “Evolving therapies can change the conversation, the questions, and the outcomes, but the overarching desired outcome is long-term disease control, minimal eczematous rash, minimal pruritus, and minimal sleep disturbance,” he said.

Dr. Eichenfield disclosed that he has served as a consultant to or investigator for AbbVie; Almirall; Arcutis; Arena; Asana; Termagant; Dermira; Forte Biosciences; Galderma Laboratories; Glenmark/Chinos; Incyte; Kyowa Kirin; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Otsuka; Pfizer; Freestone; Regeneron, and Sanofi Genzyme.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

Will my child outgrow the eczema?

That is perhaps the No. 1 atopic dermatitis–related question that Lawrence F. Eichenfield, MD, fields from parents in his role as chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego.

The answer “is pretty tricky,” he said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We used to say, ‘yeah, your kid will probably outgrow the disease,’ but we now have good data that show there are variable courses.”

Using data from the birth study cohort known as the Avon Longitudinal Study of Parents and Children, researchers in the United Kingdom investigated the existence of different longitudinal phenotypes of AD among 9,894 children. They found that 58% of the children in the cohort were unaffected or had transient AD, while 12.9% had early-onset/early-resolving AD. The remaining AD phenotypes consisted of 7%-8% patients each (early-onset persistent, early-onset late-resolving, mid-onset resolving, and late-onset resolving).

“There have been several studies that looked at the natural course of AD,” said Dr. Eichenfield, distinguished professor of dermatology and pediatrics at the University of California, San Diego. “A cohort study from Thailand showed that 50% of patients with childhood AD lost their AD diagnosis about 5 years into it, while there was an increase in allergic rhino-conjunctivitis and asthma, similar to what’s been seen in atopic march studies,” he noted.

A separate group of investigators analyzed records from The Health Improvement Network in the UK to determine the prevalence of AD among more than 8 million patients seen in primary care between 1994 and 2013. They found that the cumulative lifetime prevalence of atopic eczema was 9.9% and the highest rates of active disease were among children and older adults. “The takeaway was markedly inconsistent in terms of whether AD went away over time or increased over time, so it’s really not especially helpful prevalence data,” Dr. Eichenfield said. “Overall, you have a high prevalence in the first years of life, it decreases, and it may increase again when people are 60 years and older. Whether that’s truly AD or xerotic eczema isn’t known in this data set.”

A separate meta-analysis of 17 studies reported that 26% of adults with AD said they had adult-onset disease, which is characterized by more atopy, more foot dermatitis, and less flexural involvement.

Dr. Eichenfield tells parents, “there’s a really good chance (depending on disease severity) that 60% to 70% of children will outgrow their eczema or most of it,” he said. “If you ask me when, I won’t tell you. The important thing is to treat it to minimize its impact. We want minimal rash, minimal itch, and minimal sleep disturbance. Sometimes I say, ‘that might improve the chance of the eczema getting better over time.’ ”

Following are four other common questions parents and patients ask him:

Can we figure out the allergies causing the eczema? “This is probably one of the most unnerving questions I get asked,” he said. “It’s a loaded question. My answer is that allergies are intertwined with AD. Searching for the secret allergy causing the atopic dermatitis is rarely successful.” Sensitization is much more common with AD, he added, meaning specific IgE testing, whether it be blood testing or skin prick testing. “The more severe your eczema is, the more chance you’ll have of real food allergy,” he said. “About 15% of milder eczema patients will have at least one food allergy, but when you get to the more moderate to severe cases, about 40% will have a true food allergy.”

Food reactions may not cause eczema, though. Food reactions can cause urticaria, angioedema, eczematous dermatitis, allergic contact dermatitis, contact urticaria, and respiratory findings. According to National Institutes of Health guidelines for food allergy, skin prick tests and serum IgE tests are recommended to assist in identification of foods that may be provoking IgE-mediated food reactions, but are not diagnostic of food allergy.

“There’s a huge literature showing that there’s a lot of food allergy testing that’s just not helpful,” he said. In one study, 89% of food challenges administered in patients who were listed as being allergic based on skin prick tests or serum IgE tests did not have a true food allergy.

“Empiric elimination diets aren’t especially useful. However, we occasionally see children who do have AD exacerbated by food allergies in the first year of life,” he said. NIH guidelines suggest that children younger than 5 years of age with moderate to severe AD be considered for food allergy evaluation for milk, egg, peanut, wheat, and soy, if at least one of the following conditions is met: the child has persistent AD in spite of optimized management and topical therapy, and/or the child has a reliable history of an immediate reaction after ingestion of a specific food.

“We do know that there are high rates of comorbid allergic processes, besides food allergy, associated with atopic dermatitis, including allergic rhinitis and asthma both in children and adults,” Dr. Eichenfield said. “I do discuss allergy triggers and their importance in the life of the individual, though not necessarily as factors in AD. There are a variety of environmental allergens and/or environmental triggers that can significantly impact AD. Recently, we have seen studies discussing air pollution and wildfires as exacerbators of AD.”

How should I bathe and moisturize? There are no standard guidelines for the frequency, type, or duration of bathing in patients with AD, he said, though in more severe disease, frequent bathing can be helpful along with standard anti-inflammatory topical medicines. “I keep my general recommendations vague,” Dr. Eichenfield said. “I do explain that we don’t want to use harsh soaps; we want to be gentle in our washing. I usually recommend daily to every other day bathing. It’s important to pat the skin dry and then apply a moisturizer. Applying a moisturizer 2-3 minutes after bathing is important and limited significant cleanser use can be helpful.”

Moisturizers and emollients are a standard of care in U.S. guidelines published in 2013 and 2014, and international guidelines, and are steroid-sparing and useful for both prevention and maintenance. “I tell parents and patients that there is no reason to avoid bathing because of AD as long as you moisturize after,” he said.

Do I have to use topical [name of drug]? “I try to explain that there is skin barrier dysfunction that stimulates the inflammatory milieu, and that inflammation in the skin or blood in AD negatively impacts skin barrier function,” Dr. Eichenfield said. “I explain that if inflammation doesn’t get better with good skin care, moisturizers, and avoidance of triggers, we need anti-inflammatory medication. Then we discuss what the options are, the significant variation in strengths of topical corticosteroids, and topical nonsteroid options.”

When he counsels parents and patients on the use of topical corticosteroids, he tells them that cortisone is a naturally-occurring metabolite, and that “we can work together to let you know how much medicine to use, and how a safe amount is a powerful tool to fix the eczema.” He often says that topical steroids “are like hammers. We have tiny hammers, like over-the-counter hydrocortisone, and sledgehammers like clobetasol. We also have ‘screwdrivers’ and ‘pliers’ with nonsteroidal topical calcineurin and PDE-4 inhibitors, which are especially useful for maintenance therapy. Topical ruxolitinib is a new medicine that we may use for patients as well. The label includes discussion of side effects from oral JAK inhibitors as well as from the drug development program, so it takes some time to talk through.”

Is it time for a stronger systemic medicine? Any conversation about this topic should support the concept that the AD is multifactorial. “We have the rash of eczema,” he said. “We have the itch. We have impact on sleep disturbance. We have the comorbidities. We have other physical changes, which can happen with bacterial infections and other immune system or cardiovascular changes. We have the impact on quality of life and impact on school and work. When we recognize that if patients have significant enough disease that it is not getting better with topicals and is having a negative impact on their lives, we can move our discussion to systemic therapy.”

When counseling patients about systemic therapy, Dr. Eichenfield will conduct a body surface area assessment and document how bad the itch is. “But I’m not just recording the information; I’m bringing it out in the room,” he said. “I’ll do a BSA assessment and say, for example, ‘oh, you have 32% of your body involved with eczema.’ I ask about sleep disturbance, to get the answer ‘out in the room.’ ” He also asks questions such as: “When was the last time your skin was last totally clear? Are there activities that you or your family don’t do because of your eczema, or that you’re living your life around it? Is there anxiety or depression?” Documenting both the impact on quality of life and the severity of disease “makes it easier to discuss systemic therapy,” Dr. Eichenfield said. “Meanwhile, as the provider, I am trying to figure out if the patient should ‘go into the topical therapy bucket’ or into the ‘systemic therapy bucket.’ ”

Counseling about systemic therapy includes shared decision-making regarding the choice of biologics versus oral JAK inhibitors versus traditional systemic agent or phototherapy. Factors to consider in the decision making include patient age, sex, severity, comorbidities, prior therapy, risk aversion, duration, medication access, and desired efficacy. “Evolving therapies can change the conversation, the questions, and the outcomes, but the overarching desired outcome is long-term disease control, minimal eczematous rash, minimal pruritus, and minimal sleep disturbance,” he said.

Dr. Eichenfield disclosed that he has served as a consultant to or investigator for AbbVie; Almirall; Arcutis; Arena; Asana; Termagant; Dermira; Forte Biosciences; Galderma Laboratories; Glenmark/Chinos; Incyte; Kyowa Kirin; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Otsuka; Pfizer; Freestone; Regeneron, and Sanofi Genzyme.

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