Rheumatology News

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen) and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists and American College of Endocrinology.

“This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis,” the authors wrote.

The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.

They also include a treatment algorithm to help guide choice of therapy.
 

Reiterating role of FRAX in the diagnosis of patients with osteopenia

Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.

While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.

“The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it,” Pauline M. Camacho, MD, cochair of the guidelines task force, said in an interview.

“We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria,” said Dr. Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center at Loyola University Chicago, Maywood, Ill. “It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?”

An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T score or a fragility fracture, the guidelines stated.
 

High risk vs. very high risk guides choice of first therapy

Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.

Specifically, patients should be considered at a very high fracture risk if they have the following criteria: a recent fracture (e.g., within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids), very low T score (e.g., less than −3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm.

Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.
 

Romosozumab brought into the mix

Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.

The drug’s approval by the Food and Drug Administration in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.

Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab, compared with placebo and alendronate.

Dr. Camacho noted that romosozumab “will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide.”

Romosozumab can safely be used in patients with prior radiation exposure, the guidelines noted.

Importantly, because of reports of a higher risk of serious cardiovascular events with romosozumab, compared with alendronate, romosozumab comes with a black-box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.

“Unfortunately, the very high risk group is often the older patients,” Dr. Camacho noted.

“The drug should not be given if there is a history of myocardial infarction or stroke in the past year,” she emphasized. “Clinical judgment is needed to decide who is at risk for cardiovascular complications.”

Notably, teriparatide and abaloparatide have black box warnings of their own regarding risk for osteosarcoma.

Switching therapies

Reflecting the evolving data on osteoporosis drug holidays, the guidelines also addressed the issue and the clinical challenges of switching therapies.

“In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug,” Dr. Camacho said.

For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.

The updated guidelines recommend that upon discontinuation of an anabolic agent (e.g., abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.

Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.

Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.
 

Communicate the risks with and without treatment to patients

The authors underscored that, in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.

“It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns,” they wrote.

And in estimating patients’ fracture risk, T score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.

“Treatment recommendations may be quite different; an early postmenopausal woman with a T score of −2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T score,” the authors explained.

Dr. Camacho reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.

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

Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen) and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists and American College of Endocrinology.

“This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis,” the authors wrote.

The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.

They also include a treatment algorithm to help guide choice of therapy.
 

Reiterating role of FRAX in the diagnosis of patients with osteopenia

Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.

While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.

“The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it,” Pauline M. Camacho, MD, cochair of the guidelines task force, said in an interview.

“We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria,” said Dr. Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center at Loyola University Chicago, Maywood, Ill. “It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?”

An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T score or a fragility fracture, the guidelines stated.
 

High risk vs. very high risk guides choice of first therapy

Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.

Specifically, patients should be considered at a very high fracture risk if they have the following criteria: a recent fracture (e.g., within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids), very low T score (e.g., less than −3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm.

Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.
 

Romosozumab brought into the mix

Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.

The drug’s approval by the Food and Drug Administration in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.

Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab, compared with placebo and alendronate.

Dr. Camacho noted that romosozumab “will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide.”

Romosozumab can safely be used in patients with prior radiation exposure, the guidelines noted.

Importantly, because of reports of a higher risk of serious cardiovascular events with romosozumab, compared with alendronate, romosozumab comes with a black-box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.

“Unfortunately, the very high risk group is often the older patients,” Dr. Camacho noted.

“The drug should not be given if there is a history of myocardial infarction or stroke in the past year,” she emphasized. “Clinical judgment is needed to decide who is at risk for cardiovascular complications.”

Notably, teriparatide and abaloparatide have black box warnings of their own regarding risk for osteosarcoma.

Switching therapies

Reflecting the evolving data on osteoporosis drug holidays, the guidelines also addressed the issue and the clinical challenges of switching therapies.

“In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug,” Dr. Camacho said.

For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.

The updated guidelines recommend that upon discontinuation of an anabolic agent (e.g., abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.

Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.

Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.
 

Communicate the risks with and without treatment to patients

The authors underscored that, in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.

“It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns,” they wrote.

And in estimating patients’ fracture risk, T score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.

“Treatment recommendations may be quite different; an early postmenopausal woman with a T score of −2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T score,” the authors explained.

Dr. Camacho reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.

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

Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen) and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists and American College of Endocrinology.

“This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis,” the authors wrote.

The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.

They also include a treatment algorithm to help guide choice of therapy.
 

Reiterating role of FRAX in the diagnosis of patients with osteopenia

Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.

While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.

“The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it,” Pauline M. Camacho, MD, cochair of the guidelines task force, said in an interview.

“We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria,” said Dr. Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center at Loyola University Chicago, Maywood, Ill. “It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?”

An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T score or a fragility fracture, the guidelines stated.
 

High risk vs. very high risk guides choice of first therapy

Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.

Specifically, patients should be considered at a very high fracture risk if they have the following criteria: a recent fracture (e.g., within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids), very low T score (e.g., less than −3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm.

Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.
 

Romosozumab brought into the mix

Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.

The drug’s approval by the Food and Drug Administration in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.

Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab, compared with placebo and alendronate.

Dr. Camacho noted that romosozumab “will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide.”

Romosozumab can safely be used in patients with prior radiation exposure, the guidelines noted.

Importantly, because of reports of a higher risk of serious cardiovascular events with romosozumab, compared with alendronate, romosozumab comes with a black-box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.

“Unfortunately, the very high risk group is often the older patients,” Dr. Camacho noted.

“The drug should not be given if there is a history of myocardial infarction or stroke in the past year,” she emphasized. “Clinical judgment is needed to decide who is at risk for cardiovascular complications.”

Notably, teriparatide and abaloparatide have black box warnings of their own regarding risk for osteosarcoma.

Switching therapies

Reflecting the evolving data on osteoporosis drug holidays, the guidelines also addressed the issue and the clinical challenges of switching therapies.

“In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug,” Dr. Camacho said.

For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.

The updated guidelines recommend that upon discontinuation of an anabolic agent (e.g., abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.

Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.

Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.
 

Communicate the risks with and without treatment to patients

The authors underscored that, in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.

“It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns,” they wrote.

And in estimating patients’ fracture risk, T score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.

“Treatment recommendations may be quite different; an early postmenopausal woman with a T score of −2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T score,” the authors explained.

Dr. Camacho reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.

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

Cutaneous lupus erythematosus (CLE) is present in 25% of patients with systemic lupus at the time of diagnosis, but it can also occur in up to 85% of cases at some point in their disease course, Eveline Y. Wu, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology.

“CLE can also occur without any systemic disease,” said Dr. Wu, associate professor of pediatrics at the University of North Carolina at Chapel Hill. “It’s been shown that the risk of developing systemic lupus differs according to the type of skin involvement, meaning that cutaneous lupus can be classified into acute, subacute, chronic, and intermittent forms.”

Malar rash is the prototypical acute cutaneous lesion and is associated with active systemic lupus erythematosus (SLE) and anti–double stranded DNA antibody positivity, while discoid lupus erythematosus is the most common chronic lesion. “A small percentage of patients with discoid lupus can develop systemic lupus, particularly when the lesions are more disseminated,” said Dr. Wu, who specializes in pediatric rheumatology as well as allergy and immunology.

In the American College of Rheumatology’s 1997 classification system, mucocutaneous manifestations constitute 4 out of the 11 criteria that clinicians use to make a diagnosis of SLE: malar rash, discoid-lupus rash, photosensitivity, and oral or nasal mucocutaneous ulcerations. Dr. Wu recommends performing an oral exam on suspect cases, “because the oral ulcers that we see in systemic lupus tend to be painless, so oftentimes patients don’t realize they have them.”

Five other organ-specific manifestations of SLE include nonerosive arthritis, nephritis, encephalopathy, pleuritis or pericarditis, and cytopenia. The two other criteria are positive immunoserology and a positive antinuclear antibody test. “If you have any individuals present with one of these [mucocutaneous manifestations criteria], you want to think about getting a CBC to look for cytopenia or a urinalysis to look for evidence of nephritis, and potentially some additional blood studies, depending on your level of suspicion for systemic lupus,” Dr. Wu said.

Other rarer CLE manifestations include lupus pernio or chilblains, lupus panniculitis, livedo reticularis, bullous LE, urticarial vasculitis, neutrophilic dermatoses, and alopecia.

Common treatments for cutaneous manifestations associated pediatric SLE include hydroxychloroquine, low dose corticosteroids, topical steroids, methotrexate, and leflunomide. Other options for increasing severity of systemic disease include lenalidomide/thalidomide, azathioprine, calcineurin inhibitors, belimumab (Benlysta), high-dose corticosteroids, mycophenolate mofetil (CellCept), rituximab (Rituxan), and cyclophosphamide. Cutaneous manifestations of pediatric SLE can often be refractory to treatments.

In 2017, Dr. Wu and associates published a retrospective chart review of 10 adolescents who received lenalidomide for refractory CLE. One of the subjects was a 21-year-old male with a significant malar rash despite being on hydroxychloroquine, azathioprine, and prednisone 40 mg daily. “One month after being on lenalidomide he had a pretty impressive response,” Dr. Wu said. “It’s not quite clear how lenalidomide works in cutaneous lupus. Currently it’s only approved for use in myelodysplastic syndromes, multiple myeloma, as well as certain lymphomas. It’s thought to modulate different parts of the immune system, which collectively result in the cytotoxicity against tumor cells.”

Lenalidomide is supplied in capsule sizes ranging from 2.5 mg to 25 mg and is given once daily. “For a smaller child, I would think about starting 5 mg once a day,” Dr. Wu said. “For an adult-sized adolescent, you could start at 10 mg once a day and then titrate up based on response. Side effects that you need to worry about are cytopenia and GI symptoms. The venous and arterial thromboembolism risk has been seen in patients with multiple myeloma, and it is unclear if this risk is applicable to all indications.” Use of the medication requires enrollment into a safety monitoring program.

She reported having no financial disclosures.

[email protected]

Cutaneous lupus erythematosus (CLE) is present in 25% of patients with systemic lupus at the time of diagnosis, but it can also occur in up to 85% of cases at some point in their disease course, Eveline Y. Wu, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology.

“CLE can also occur without any systemic disease,” said Dr. Wu, associate professor of pediatrics at the University of North Carolina at Chapel Hill. “It’s been shown that the risk of developing systemic lupus differs according to the type of skin involvement, meaning that cutaneous lupus can be classified into acute, subacute, chronic, and intermittent forms.”

Malar rash is the prototypical acute cutaneous lesion and is associated with active systemic lupus erythematosus (SLE) and anti–double stranded DNA antibody positivity, while discoid lupus erythematosus is the most common chronic lesion. “A small percentage of patients with discoid lupus can develop systemic lupus, particularly when the lesions are more disseminated,” said Dr. Wu, who specializes in pediatric rheumatology as well as allergy and immunology.

In the American College of Rheumatology’s 1997 classification system, mucocutaneous manifestations constitute 4 out of the 11 criteria that clinicians use to make a diagnosis of SLE: malar rash, discoid-lupus rash, photosensitivity, and oral or nasal mucocutaneous ulcerations. Dr. Wu recommends performing an oral exam on suspect cases, “because the oral ulcers that we see in systemic lupus tend to be painless, so oftentimes patients don’t realize they have them.”

Five other organ-specific manifestations of SLE include nonerosive arthritis, nephritis, encephalopathy, pleuritis or pericarditis, and cytopenia. The two other criteria are positive immunoserology and a positive antinuclear antibody test. “If you have any individuals present with one of these [mucocutaneous manifestations criteria], you want to think about getting a CBC to look for cytopenia or a urinalysis to look for evidence of nephritis, and potentially some additional blood studies, depending on your level of suspicion for systemic lupus,” Dr. Wu said.

Other rarer CLE manifestations include lupus pernio or chilblains, lupus panniculitis, livedo reticularis, bullous LE, urticarial vasculitis, neutrophilic dermatoses, and alopecia.

Common treatments for cutaneous manifestations associated pediatric SLE include hydroxychloroquine, low dose corticosteroids, topical steroids, methotrexate, and leflunomide. Other options for increasing severity of systemic disease include lenalidomide/thalidomide, azathioprine, calcineurin inhibitors, belimumab (Benlysta), high-dose corticosteroids, mycophenolate mofetil (CellCept), rituximab (Rituxan), and cyclophosphamide. Cutaneous manifestations of pediatric SLE can often be refractory to treatments.

In 2017, Dr. Wu and associates published a retrospective chart review of 10 adolescents who received lenalidomide for refractory CLE. One of the subjects was a 21-year-old male with a significant malar rash despite being on hydroxychloroquine, azathioprine, and prednisone 40 mg daily. “One month after being on lenalidomide he had a pretty impressive response,” Dr. Wu said. “It’s not quite clear how lenalidomide works in cutaneous lupus. Currently it’s only approved for use in myelodysplastic syndromes, multiple myeloma, as well as certain lymphomas. It’s thought to modulate different parts of the immune system, which collectively result in the cytotoxicity against tumor cells.”

Lenalidomide is supplied in capsule sizes ranging from 2.5 mg to 25 mg and is given once daily. “For a smaller child, I would think about starting 5 mg once a day,” Dr. Wu said. “For an adult-sized adolescent, you could start at 10 mg once a day and then titrate up based on response. Side effects that you need to worry about are cytopenia and GI symptoms. The venous and arterial thromboembolism risk has been seen in patients with multiple myeloma, and it is unclear if this risk is applicable to all indications.” Use of the medication requires enrollment into a safety monitoring program.

She reported having no financial disclosures.

[email protected]

Cutaneous lupus erythematosus (CLE) is present in 25% of patients with systemic lupus at the time of diagnosis, but it can also occur in up to 85% of cases at some point in their disease course, Eveline Y. Wu, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology.

“CLE can also occur without any systemic disease,” said Dr. Wu, associate professor of pediatrics at the University of North Carolina at Chapel Hill. “It’s been shown that the risk of developing systemic lupus differs according to the type of skin involvement, meaning that cutaneous lupus can be classified into acute, subacute, chronic, and intermittent forms.”

Malar rash is the prototypical acute cutaneous lesion and is associated with active systemic lupus erythematosus (SLE) and anti–double stranded DNA antibody positivity, while discoid lupus erythematosus is the most common chronic lesion. “A small percentage of patients with discoid lupus can develop systemic lupus, particularly when the lesions are more disseminated,” said Dr. Wu, who specializes in pediatric rheumatology as well as allergy and immunology.

In the American College of Rheumatology’s 1997 classification system, mucocutaneous manifestations constitute 4 out of the 11 criteria that clinicians use to make a diagnosis of SLE: malar rash, discoid-lupus rash, photosensitivity, and oral or nasal mucocutaneous ulcerations. Dr. Wu recommends performing an oral exam on suspect cases, “because the oral ulcers that we see in systemic lupus tend to be painless, so oftentimes patients don’t realize they have them.”

Five other organ-specific manifestations of SLE include nonerosive arthritis, nephritis, encephalopathy, pleuritis or pericarditis, and cytopenia. The two other criteria are positive immunoserology and a positive antinuclear antibody test. “If you have any individuals present with one of these [mucocutaneous manifestations criteria], you want to think about getting a CBC to look for cytopenia or a urinalysis to look for evidence of nephritis, and potentially some additional blood studies, depending on your level of suspicion for systemic lupus,” Dr. Wu said.

Other rarer CLE manifestations include lupus pernio or chilblains, lupus panniculitis, livedo reticularis, bullous LE, urticarial vasculitis, neutrophilic dermatoses, and alopecia.

Common treatments for cutaneous manifestations associated pediatric SLE include hydroxychloroquine, low dose corticosteroids, topical steroids, methotrexate, and leflunomide. Other options for increasing severity of systemic disease include lenalidomide/thalidomide, azathioprine, calcineurin inhibitors, belimumab (Benlysta), high-dose corticosteroids, mycophenolate mofetil (CellCept), rituximab (Rituxan), and cyclophosphamide. Cutaneous manifestations of pediatric SLE can often be refractory to treatments.

In 2017, Dr. Wu and associates published a retrospective chart review of 10 adolescents who received lenalidomide for refractory CLE. One of the subjects was a 21-year-old male with a significant malar rash despite being on hydroxychloroquine, azathioprine, and prednisone 40 mg daily. “One month after being on lenalidomide he had a pretty impressive response,” Dr. Wu said. “It’s not quite clear how lenalidomide works in cutaneous lupus. Currently it’s only approved for use in myelodysplastic syndromes, multiple myeloma, as well as certain lymphomas. It’s thought to modulate different parts of the immune system, which collectively result in the cytotoxicity against tumor cells.”

Lenalidomide is supplied in capsule sizes ranging from 2.5 mg to 25 mg and is given once daily. “For a smaller child, I would think about starting 5 mg once a day,” Dr. Wu said. “For an adult-sized adolescent, you could start at 10 mg once a day and then titrate up based on response. Side effects that you need to worry about are cytopenia and GI symptoms. The venous and arterial thromboembolism risk has been seen in patients with multiple myeloma, and it is unclear if this risk is applicable to all indications.” Use of the medication requires enrollment into a safety monitoring program.

She reported having no financial disclosures.

[email protected]

Antibody levels in patients with mild COVID-19, the level of disease most people have, appear to drop by half within 36 days, new research suggests. The research was conducted by F. Javier Ibarrondo, PhD, and colleagues and was published online on July 21 in a letter to the editor of the New England Journal of Medicine. Ibarrondo is associate researcher at the University of California, Los Angeles. (The original letter incorrectly calculated the half-life at 73 days.)

Coauthor Otto Yang, MD, professor of medicine in the division of infectious diseases at UCLA, told Medscape Medical News that the rapidity in the antibody drop at 5 weeks “is striking compared to other infections.”

The phenomenon has been suspected and has been observed before but had not been quantified.

“Our paper is the first to put firm numbers on the dropping of antibodies after early infection,” he said.

The researchers evaluated 34 people (average age, 43 years) who had recovered from mild COVID-19 and had referred themselves to UCLA for observational research.
 

Previous report also found a quick fade

As Medscape Medical News reported, a previous study from China that was published in Nature Medicine also found that the antibodies fade quickly.

Interpreting the meaning of the current research comes with a few caveats, Dr. Yang said.

“One is that we don’t know for sure that antibodies are what protect people from getting infected,” he said. Although it’s a reasonable assumption, he said, that’s not always the case.

Another caveat is that even if antibodies do protect, the tests being used to measure them – including the test that was used in this study – may not measure them the right way, and it is not yet known how many antibodies are needed for protection, he explained.

The UCLA researchers used an enzyme-linked immunosorbent assay to detect anti–SARS-CoV-2 spike receptor–binding domain immunoglobulin G concentrations.
 

“No reason for anybody to be getting an antibody test medically”

The study provides further proof that “[t]here’s no reason for anybody to be getting an antibody test medically right now,” Dr. Yang said.

Additionally, “FDA-approved tests are not approved for quantitative measures, only qualitative,” he continued. He noted that the findings may have implications with respect to herd immunity.

“Herd immunity depends on a lot of people having immunity to the infection all at the same time. If infection is followed by only brief protection from infection, the natural infection is not going to reach herd immunity,” he explained.

Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program in Nashville, Tenn., pointed out that antibodies “are just part of the story.”

“When we make an immune response to any germ,” he said, “we not only make an immune response for the time being but for the future. The next time we’re exposed, we can call into action B cells and T cells who have been there and done that.”

So even though the antibodies fade over time, other arms of the immune system are being trained for future action, he said.

Herd immunity does not require that populations have a huge level of antibodies that remains forever, he explained.

“It requires that in general, we’re not going to get infected as easily, and we’re not going to have disease as easily, and we’re not going to transmit the virus for as long,” he said.

Dr. Creech said he and others researching COVID-19 find that studies that show that antibodies fade quickly provide more proof “that this coronavirus is going to be here to stay unless we can take care of it through very effective treatments to take it from potentially fatal disease to one that is nothing more than a cold” or until a vaccine is developed.

He noted there are four other coronaviruses in widespread circulation every year that “amount to about 25% of the common cold.”

This study may help narrow the window as to when convalescent plasma – plasma that is taken from people who have recovered from COVID-19 and that is used to help people who are acutely ill with the disease – will be most effective, Dr. Creech explained. He said the results suggest that it is important that plasma be collected within the first couple of months after recovery so as to capture the most antibodies.

This study is important as another snapshot “so we understand the differences between severe and mild disease, so we can study it over time, so we have all the tools we need as we start these pivotal vaccine studies to make sure we’re making the right immune response for the right duration of time so we can put an end to this pandemic,” Dr. Creech concluded.

The study was supported by grants from the AIDS Healthcare Foundation, the Doris Duke Charitable Foundation, the National Institutes of Health, the James B. Pendleton Charitable Trust, and the McCarthy Family Foundation. A coauthor reports receiving grants from Gilead outside the submitted work. Dr. Creech has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Antibody levels in patients with mild COVID-19, the level of disease most people have, appear to drop by half within 36 days, new research suggests. The research was conducted by F. Javier Ibarrondo, PhD, and colleagues and was published online on July 21 in a letter to the editor of the New England Journal of Medicine. Ibarrondo is associate researcher at the University of California, Los Angeles. (The original letter incorrectly calculated the half-life at 73 days.)

Coauthor Otto Yang, MD, professor of medicine in the division of infectious diseases at UCLA, told Medscape Medical News that the rapidity in the antibody drop at 5 weeks “is striking compared to other infections.”

The phenomenon has been suspected and has been observed before but had not been quantified.

“Our paper is the first to put firm numbers on the dropping of antibodies after early infection,” he said.

The researchers evaluated 34 people (average age, 43 years) who had recovered from mild COVID-19 and had referred themselves to UCLA for observational research.
 

Previous report also found a quick fade

As Medscape Medical News reported, a previous study from China that was published in Nature Medicine also found that the antibodies fade quickly.

Interpreting the meaning of the current research comes with a few caveats, Dr. Yang said.

“One is that we don’t know for sure that antibodies are what protect people from getting infected,” he said. Although it’s a reasonable assumption, he said, that’s not always the case.

Another caveat is that even if antibodies do protect, the tests being used to measure them – including the test that was used in this study – may not measure them the right way, and it is not yet known how many antibodies are needed for protection, he explained.

The UCLA researchers used an enzyme-linked immunosorbent assay to detect anti–SARS-CoV-2 spike receptor–binding domain immunoglobulin G concentrations.
 

“No reason for anybody to be getting an antibody test medically”

The study provides further proof that “[t]here’s no reason for anybody to be getting an antibody test medically right now,” Dr. Yang said.

Additionally, “FDA-approved tests are not approved for quantitative measures, only qualitative,” he continued. He noted that the findings may have implications with respect to herd immunity.

“Herd immunity depends on a lot of people having immunity to the infection all at the same time. If infection is followed by only brief protection from infection, the natural infection is not going to reach herd immunity,” he explained.

Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program in Nashville, Tenn., pointed out that antibodies “are just part of the story.”

“When we make an immune response to any germ,” he said, “we not only make an immune response for the time being but for the future. The next time we’re exposed, we can call into action B cells and T cells who have been there and done that.”

So even though the antibodies fade over time, other arms of the immune system are being trained for future action, he said.

Herd immunity does not require that populations have a huge level of antibodies that remains forever, he explained.

“It requires that in general, we’re not going to get infected as easily, and we’re not going to have disease as easily, and we’re not going to transmit the virus for as long,” he said.

Dr. Creech said he and others researching COVID-19 find that studies that show that antibodies fade quickly provide more proof “that this coronavirus is going to be here to stay unless we can take care of it through very effective treatments to take it from potentially fatal disease to one that is nothing more than a cold” or until a vaccine is developed.

He noted there are four other coronaviruses in widespread circulation every year that “amount to about 25% of the common cold.”

This study may help narrow the window as to when convalescent plasma – plasma that is taken from people who have recovered from COVID-19 and that is used to help people who are acutely ill with the disease – will be most effective, Dr. Creech explained. He said the results suggest that it is important that plasma be collected within the first couple of months after recovery so as to capture the most antibodies.

This study is important as another snapshot “so we understand the differences between severe and mild disease, so we can study it over time, so we have all the tools we need as we start these pivotal vaccine studies to make sure we’re making the right immune response for the right duration of time so we can put an end to this pandemic,” Dr. Creech concluded.

The study was supported by grants from the AIDS Healthcare Foundation, the Doris Duke Charitable Foundation, the National Institutes of Health, the James B. Pendleton Charitable Trust, and the McCarthy Family Foundation. A coauthor reports receiving grants from Gilead outside the submitted work. Dr. Creech has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Antibody levels in patients with mild COVID-19, the level of disease most people have, appear to drop by half within 36 days, new research suggests. The research was conducted by F. Javier Ibarrondo, PhD, and colleagues and was published online on July 21 in a letter to the editor of the New England Journal of Medicine. Ibarrondo is associate researcher at the University of California, Los Angeles. (The original letter incorrectly calculated the half-life at 73 days.)

Coauthor Otto Yang, MD, professor of medicine in the division of infectious diseases at UCLA, told Medscape Medical News that the rapidity in the antibody drop at 5 weeks “is striking compared to other infections.”

The phenomenon has been suspected and has been observed before but had not been quantified.

“Our paper is the first to put firm numbers on the dropping of antibodies after early infection,” he said.

The researchers evaluated 34 people (average age, 43 years) who had recovered from mild COVID-19 and had referred themselves to UCLA for observational research.
 

Previous report also found a quick fade

As Medscape Medical News reported, a previous study from China that was published in Nature Medicine also found that the antibodies fade quickly.

Interpreting the meaning of the current research comes with a few caveats, Dr. Yang said.

“One is that we don’t know for sure that antibodies are what protect people from getting infected,” he said. Although it’s a reasonable assumption, he said, that’s not always the case.

Another caveat is that even if antibodies do protect, the tests being used to measure them – including the test that was used in this study – may not measure them the right way, and it is not yet known how many antibodies are needed for protection, he explained.

The UCLA researchers used an enzyme-linked immunosorbent assay to detect anti–SARS-CoV-2 spike receptor–binding domain immunoglobulin G concentrations.
 

“No reason for anybody to be getting an antibody test medically”

The study provides further proof that “[t]here’s no reason for anybody to be getting an antibody test medically right now,” Dr. Yang said.

Additionally, “FDA-approved tests are not approved for quantitative measures, only qualitative,” he continued. He noted that the findings may have implications with respect to herd immunity.

“Herd immunity depends on a lot of people having immunity to the infection all at the same time. If infection is followed by only brief protection from infection, the natural infection is not going to reach herd immunity,” he explained.

Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program in Nashville, Tenn., pointed out that antibodies “are just part of the story.”

“When we make an immune response to any germ,” he said, “we not only make an immune response for the time being but for the future. The next time we’re exposed, we can call into action B cells and T cells who have been there and done that.”

So even though the antibodies fade over time, other arms of the immune system are being trained for future action, he said.

Herd immunity does not require that populations have a huge level of antibodies that remains forever, he explained.

“It requires that in general, we’re not going to get infected as easily, and we’re not going to have disease as easily, and we’re not going to transmit the virus for as long,” he said.

Dr. Creech said he and others researching COVID-19 find that studies that show that antibodies fade quickly provide more proof “that this coronavirus is going to be here to stay unless we can take care of it through very effective treatments to take it from potentially fatal disease to one that is nothing more than a cold” or until a vaccine is developed.

He noted there are four other coronaviruses in widespread circulation every year that “amount to about 25% of the common cold.”

This study may help narrow the window as to when convalescent plasma – plasma that is taken from people who have recovered from COVID-19 and that is used to help people who are acutely ill with the disease – will be most effective, Dr. Creech explained. He said the results suggest that it is important that plasma be collected within the first couple of months after recovery so as to capture the most antibodies.

This study is important as another snapshot “so we understand the differences between severe and mild disease, so we can study it over time, so we have all the tools we need as we start these pivotal vaccine studies to make sure we’re making the right immune response for the right duration of time so we can put an end to this pandemic,” Dr. Creech concluded.

The study was supported by grants from the AIDS Healthcare Foundation, the Doris Duke Charitable Foundation, the National Institutes of Health, the James B. Pendleton Charitable Trust, and the McCarthy Family Foundation. A coauthor reports receiving grants from Gilead outside the submitted work. Dr. Creech has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A study that observed oral petechial lesions in a small number of COVID-19 patients with skin rash fortifies growing evidence that the virus has dermatologic manifestations. Larger studies should explore and confirm this association, the study’s authors and other experts suggested.

Dermatologists are already aware of the connection between enanthem and viral etiology. “As seen with other viral infections, we wondered if COVID-19 could produce enanthem in addition to skin rash exanthem,” one of the study author’s, Juan Jiménez-Cauhe, MD, a dermatologist with Hospital Universitario Ramon y Cajal, Madrid, said in an interview. He and his colleagues summarized their findings in a research letter in JAMA Dermatology.

They examined the oral cavity of 21 COVID-19 patients at a tertiary care hospital who also had a skin rash from March 30 to April 8. They classified enanthems into four categories: petechial, macular, macular with petechiae, or erythematovesicular. Six of the patients presented with oral lesions, all of them located in the palate; in one patient, the enanthem was macular, it was petechial in two patients and was macular with petechiae in three patients. The six patients ranged between the ages of 40 and 69 years; four were women.

Petechial or vesicular patterns are often associated with viral infections. In this particular study, the investigators did not observe vesicular lesions.

On average, mucocutaneous lesions appeared about 12 days after the onset of COVID-19 symptoms. “Interestingly, this latency was shorter in patients with petechial enanthem, compared with those with a macular lesion with petechiae appearance,” the authors wrote.

This shorter time might suggest an association for SARS-CoV-2, said Dr. Jiménez-Cauhe. Strong cough may have also caused petechial lesions on the palate, but it’s unlikely, as they appeared close in time to COVID-19 symptoms. It’s also unlikely that any drugs caused the lesions, as drug rashes can take 2-3 weeks to appear.

This fits in line with other evidence of broader skin manifestations appearing at the same time or after COVID-19, Esther Freeman, MD, said in an interview. Dr. Freeman, director of global health dermatology at Massachusetts General Hospital, Boston, is the principal investigator of the COVID-19 Dermatology Registry, a collaboration of the American Academy of Dermatology and International League of Dermatological Societies.

The study’s small cohort made it difficult to establish a solid association between the oral lesions and SARS-CoV-2. “However, the presence of enanthem in a patient with a skin rash is a useful finding that suggests a viral etiology rather than a drug reaction. This is particularly useful in COVID-19 patients, who were receiving many drugs as part of the treatment,” Dr. Jimenez-Cauhe said. Future studies should assess whether the presence of enanthem and exanthem lead physicians to consider SARS-CoV-2 as possible agents, ruling out infection with a blood or nasopharyngeal test.

This study adds to the growing body of knowledge on cutaneous and mucocutaneous findings associated with SARS-CoV-2 infection, Jules Lipoff, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, said in an interview. “One challenge in evaluating these findings is that these findings are nonspecific, and medication reactions can often cause similar rashes, such as morbilliform eruptions that can be associated with both viruses and medications.”

Enanthems, as the study authors noted, are more specific to viral infections and are less commonly associated with medication reactions. “So, even though this is a small case series with significant limitations, it does add more evidence that COVID-19 is directly responsible for findings in the skin and mucous membranes,” said Dr. Lipoff.

Dr. Freeman noted that the study may also encourage clinicians to look in a patient’s mouth when assessing for SARS-CoV-2. Additional research should examine these data in a larger population.

Several studies by Dr. Freeman, Dr. Lipoff, and others strongly suggest that SARS-CoV-2 has a spectrum of associated dermatologic manifestations. One evaluated perniolike skin lesions (J Am Acad Dermatol. 2020 Aug; 83[2]:486-92). The other was a case series from the COVID-19 registry that examined 716 cases of new-onset dermatologic symptoms in patients from 31 countries with confirmed/suspected SARS-CoV-2 (J Am Acad Dermatol. 2020 Jul 2;S0190-9622[20]32126-5.).

The authors of the report had no disclosures.

SOURCE: Jimenez-Cauhe J et al. JAMA Dermatol. 2020 Jul 15. doi: 10.1001/jamadermatol.2020.2550.

A study that observed oral petechial lesions in a small number of COVID-19 patients with skin rash fortifies growing evidence that the virus has dermatologic manifestations. Larger studies should explore and confirm this association, the study’s authors and other experts suggested.

Dermatologists are already aware of the connection between enanthem and viral etiology. “As seen with other viral infections, we wondered if COVID-19 could produce enanthem in addition to skin rash exanthem,” one of the study author’s, Juan Jiménez-Cauhe, MD, a dermatologist with Hospital Universitario Ramon y Cajal, Madrid, said in an interview. He and his colleagues summarized their findings in a research letter in JAMA Dermatology.

They examined the oral cavity of 21 COVID-19 patients at a tertiary care hospital who also had a skin rash from March 30 to April 8. They classified enanthems into four categories: petechial, macular, macular with petechiae, or erythematovesicular. Six of the patients presented with oral lesions, all of them located in the palate; in one patient, the enanthem was macular, it was petechial in two patients and was macular with petechiae in three patients. The six patients ranged between the ages of 40 and 69 years; four were women.

Petechial or vesicular patterns are often associated with viral infections. In this particular study, the investigators did not observe vesicular lesions.

On average, mucocutaneous lesions appeared about 12 days after the onset of COVID-19 symptoms. “Interestingly, this latency was shorter in patients with petechial enanthem, compared with those with a macular lesion with petechiae appearance,” the authors wrote.

This shorter time might suggest an association for SARS-CoV-2, said Dr. Jiménez-Cauhe. Strong cough may have also caused petechial lesions on the palate, but it’s unlikely, as they appeared close in time to COVID-19 symptoms. It’s also unlikely that any drugs caused the lesions, as drug rashes can take 2-3 weeks to appear.

This fits in line with other evidence of broader skin manifestations appearing at the same time or after COVID-19, Esther Freeman, MD, said in an interview. Dr. Freeman, director of global health dermatology at Massachusetts General Hospital, Boston, is the principal investigator of the COVID-19 Dermatology Registry, a collaboration of the American Academy of Dermatology and International League of Dermatological Societies.

The study’s small cohort made it difficult to establish a solid association between the oral lesions and SARS-CoV-2. “However, the presence of enanthem in a patient with a skin rash is a useful finding that suggests a viral etiology rather than a drug reaction. This is particularly useful in COVID-19 patients, who were receiving many drugs as part of the treatment,” Dr. Jimenez-Cauhe said. Future studies should assess whether the presence of enanthem and exanthem lead physicians to consider SARS-CoV-2 as possible agents, ruling out infection with a blood or nasopharyngeal test.

This study adds to the growing body of knowledge on cutaneous and mucocutaneous findings associated with SARS-CoV-2 infection, Jules Lipoff, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, said in an interview. “One challenge in evaluating these findings is that these findings are nonspecific, and medication reactions can often cause similar rashes, such as morbilliform eruptions that can be associated with both viruses and medications.”

Enanthems, as the study authors noted, are more specific to viral infections and are less commonly associated with medication reactions. “So, even though this is a small case series with significant limitations, it does add more evidence that COVID-19 is directly responsible for findings in the skin and mucous membranes,” said Dr. Lipoff.

Dr. Freeman noted that the study may also encourage clinicians to look in a patient’s mouth when assessing for SARS-CoV-2. Additional research should examine these data in a larger population.

Several studies by Dr. Freeman, Dr. Lipoff, and others strongly suggest that SARS-CoV-2 has a spectrum of associated dermatologic manifestations. One evaluated perniolike skin lesions (J Am Acad Dermatol. 2020 Aug; 83[2]:486-92). The other was a case series from the COVID-19 registry that examined 716 cases of new-onset dermatologic symptoms in patients from 31 countries with confirmed/suspected SARS-CoV-2 (J Am Acad Dermatol. 2020 Jul 2;S0190-9622[20]32126-5.).

The authors of the report had no disclosures.

SOURCE: Jimenez-Cauhe J et al. JAMA Dermatol. 2020 Jul 15. doi: 10.1001/jamadermatol.2020.2550.

A study that observed oral petechial lesions in a small number of COVID-19 patients with skin rash fortifies growing evidence that the virus has dermatologic manifestations. Larger studies should explore and confirm this association, the study’s authors and other experts suggested.

Dermatologists are already aware of the connection between enanthem and viral etiology. “As seen with other viral infections, we wondered if COVID-19 could produce enanthem in addition to skin rash exanthem,” one of the study author’s, Juan Jiménez-Cauhe, MD, a dermatologist with Hospital Universitario Ramon y Cajal, Madrid, said in an interview. He and his colleagues summarized their findings in a research letter in JAMA Dermatology.

They examined the oral cavity of 21 COVID-19 patients at a tertiary care hospital who also had a skin rash from March 30 to April 8. They classified enanthems into four categories: petechial, macular, macular with petechiae, or erythematovesicular. Six of the patients presented with oral lesions, all of them located in the palate; in one patient, the enanthem was macular, it was petechial in two patients and was macular with petechiae in three patients. The six patients ranged between the ages of 40 and 69 years; four were women.

Petechial or vesicular patterns are often associated with viral infections. In this particular study, the investigators did not observe vesicular lesions.

On average, mucocutaneous lesions appeared about 12 days after the onset of COVID-19 symptoms. “Interestingly, this latency was shorter in patients with petechial enanthem, compared with those with a macular lesion with petechiae appearance,” the authors wrote.

This shorter time might suggest an association for SARS-CoV-2, said Dr. Jiménez-Cauhe. Strong cough may have also caused petechial lesions on the palate, but it’s unlikely, as they appeared close in time to COVID-19 symptoms. It’s also unlikely that any drugs caused the lesions, as drug rashes can take 2-3 weeks to appear.

This fits in line with other evidence of broader skin manifestations appearing at the same time or after COVID-19, Esther Freeman, MD, said in an interview. Dr. Freeman, director of global health dermatology at Massachusetts General Hospital, Boston, is the principal investigator of the COVID-19 Dermatology Registry, a collaboration of the American Academy of Dermatology and International League of Dermatological Societies.

The study’s small cohort made it difficult to establish a solid association between the oral lesions and SARS-CoV-2. “However, the presence of enanthem in a patient with a skin rash is a useful finding that suggests a viral etiology rather than a drug reaction. This is particularly useful in COVID-19 patients, who were receiving many drugs as part of the treatment,” Dr. Jimenez-Cauhe said. Future studies should assess whether the presence of enanthem and exanthem lead physicians to consider SARS-CoV-2 as possible agents, ruling out infection with a blood or nasopharyngeal test.

This study adds to the growing body of knowledge on cutaneous and mucocutaneous findings associated with SARS-CoV-2 infection, Jules Lipoff, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, said in an interview. “One challenge in evaluating these findings is that these findings are nonspecific, and medication reactions can often cause similar rashes, such as morbilliform eruptions that can be associated with both viruses and medications.”

Enanthems, as the study authors noted, are more specific to viral infections and are less commonly associated with medication reactions. “So, even though this is a small case series with significant limitations, it does add more evidence that COVID-19 is directly responsible for findings in the skin and mucous membranes,” said Dr. Lipoff.

Dr. Freeman noted that the study may also encourage clinicians to look in a patient’s mouth when assessing for SARS-CoV-2. Additional research should examine these data in a larger population.

Several studies by Dr. Freeman, Dr. Lipoff, and others strongly suggest that SARS-CoV-2 has a spectrum of associated dermatologic manifestations. One evaluated perniolike skin lesions (J Am Acad Dermatol. 2020 Aug; 83[2]:486-92). The other was a case series from the COVID-19 registry that examined 716 cases of new-onset dermatologic symptoms in patients from 31 countries with confirmed/suspected SARS-CoV-2 (J Am Acad Dermatol. 2020 Jul 2;S0190-9622[20]32126-5.).

The authors of the report had no disclosures.

SOURCE: Jimenez-Cauhe J et al. JAMA Dermatol. 2020 Jul 15. doi: 10.1001/jamadermatol.2020.2550.

Pustular psoriasis is a rare condition that presents significant challenges to clinicians, not least because it comes in varied forms that are not well understood.

It has various dermatologic and rheumatologic manifestations and sometimes overlaps with plaque psoriasis. Pustular palmoplantar psoriasis (PPP) affects the palmar and plantar areas of the skin, while generalized pustular psoriasis (GPP) can affect large areas of skin and tends to be more severe, even life threatening. PPP can accompany psoriatic arthritis or can be a side effect of tumor necrosis factor (TNF) inhibitor therapy, or a non–drug-induced component of rheumatologic syndromes, according to Kristina Callis Duffin, MD, an associate professor and chair of dermatology at the University of Utah, Salt Lake City.

“Each phenotype could be considered an orphan disease, and the response to therapy is often unpredictable,” Dr. Duffin said during a session on pustular psoriasis at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

But there is some positive news. A study in 2011 of several people with GPP opened the door to better understanding the pathophysiology of pustular psoriasis. Researchers identified a causal autosomal mutation in the IL36RN gene, which encodes an antagonist to the interleukin-36 receptor (Am J Hum Genet. 2011 Sep 9;89[3]:432-7). “As a result of this paper and others, drug development in this space has recently accelerated,” Dr. Duffin said.

In fact, she added,“it’s my opinion that pustular psoriasis is now where plaque psoriasis was 20 years ago, when accelerated drug development was driving a better understanding of the pathogenesis of psoriatic disease and its comorbidities, and also driving outcome measure development.”

In another presentation at the meeting, Hervé Bachelez, MD, PhD, professor of dermatology and immunologist at the University of Paris and Saint-Louis Hospital, Paris, discussed recent advances in drug development for pustular psoriasis. He noted other recent findings of genetic variants related to the disease, including AP1S3, CARD14, and SERPINA3.

For GPP, he said, the current algorithm for management is based on weak evidence for treatments like acitretin, cyclosporine, methotrexate, and infliximab. The story is similar for other biologics, with evidence in the form of case series; open-label studies; controlled, prospective studies; or retrospective analyses. Most of the evidence has been amassed for TNF inhibitors. A retrospective study of all TNF inhibitors suggested they may be effective as induction and maintenance therapy, he noted.

Among IL-17A inhibitors, a prospective study of 12 patients in Japan found secukinumab showed efficacy against GPP, as did studies of ixekizumab and brodalumab. A small phase 3 study in Japan demonstrated efficacy for the IL-23 inhibitor guselkumab in patients with erythrodermic psoriasis and GPP (J Dermatol. 2018 May;45[5]:529-39).

The limited data are a reflection in part of the difficulty in studying GPP, since its flares tend to be more self-remitting than with psoriasis vulgaris or PPP.

There are two monoclonal antibodies against the IL-36 receptor currently being developed. A proof-of-concept study of one of them, spesolimab, showed promise against GPP, with five of seven patients reaching “clear” or “almost clear” scores on the Generalized Pustular Psoriasis Physician Global Assessment within a week after infusion and in all seven by the fourth week (N Engl J Med. 2019 Mar 7;380[10]:981-3).

With respect to PPP, the strongest evidence for conventional therapies comes from two randomized, controlled trials of cyclosporine, with response rates of 48% and 89%, compared with 19% and 21%, respectively, in the placebo groups, although the primary endpoint was poorly designed, according to Dr. Bachelez. Retinoids like etretinate and acitretin, combined with psoralen and UVA, also have some supporting evidence regarding efficacy.

Among biologics, secukinumab did not fare well in a phase 3 study of patients with PPP. A subset of patients may benefit from it, but there are no biomarkers available to identify them, Dr. Bachelez said. A phase 2 study of guselkumab in Japan told a similar story, with only weak signs of efficacy. While there are many more ongoing clinical trials evaluating treatments for PPP, which is encouraging, PPP seems to be more challenging at this stage to tackle than GPP, Dr. Bachelez added. “The genetically inherited IL-36 antagonist abnormalities are clearly driving the advances regarding the pathogenesis of the disease, mainly for GPP rather than PPP.”

Part of the efforts to develop therapies for pustular psoriasis relies on the development of new outcome measures, or adaptation of existing ones. “We have a need to adapt or develop new investigator-reported measures, we need to adapt or develop new patient-reported outcomes,” Dr. Duffin said.

Many existing measures use inconsistent language and anchoring definitions, and some may be proprietary, she added. “The language varies by sponsor and is sometimes tweaked or modified by the agencies. Often synonyms are being used … it raises questions, does it change the validity of the instrument?”

Dr. Duffin called for the research community to use the pause in clinical research during the COVID-19 pandemic to reassess the research agenda, develop consensus on performing and training for GPP and PPP assessments, develop patient-reported outcomes, and strengthen connections to industry.

Dr. Duffin and Dr. Bachelez have consulted, served on the advisory board, been a speaker for, and/or received research support from a wide range of pharmaceutical companies, including those that manufacture and develop psoriasis treatments.
 

Pustular psoriasis is a rare condition that presents significant challenges to clinicians, not least because it comes in varied forms that are not well understood.

It has various dermatologic and rheumatologic manifestations and sometimes overlaps with plaque psoriasis. Pustular palmoplantar psoriasis (PPP) affects the palmar and plantar areas of the skin, while generalized pustular psoriasis (GPP) can affect large areas of skin and tends to be more severe, even life threatening. PPP can accompany psoriatic arthritis or can be a side effect of tumor necrosis factor (TNF) inhibitor therapy, or a non–drug-induced component of rheumatologic syndromes, according to Kristina Callis Duffin, MD, an associate professor and chair of dermatology at the University of Utah, Salt Lake City.

“Each phenotype could be considered an orphan disease, and the response to therapy is often unpredictable,” Dr. Duffin said during a session on pustular psoriasis at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

But there is some positive news. A study in 2011 of several people with GPP opened the door to better understanding the pathophysiology of pustular psoriasis. Researchers identified a causal autosomal mutation in the IL36RN gene, which encodes an antagonist to the interleukin-36 receptor (Am J Hum Genet. 2011 Sep 9;89[3]:432-7). “As a result of this paper and others, drug development in this space has recently accelerated,” Dr. Duffin said.

In fact, she added,“it’s my opinion that pustular psoriasis is now where plaque psoriasis was 20 years ago, when accelerated drug development was driving a better understanding of the pathogenesis of psoriatic disease and its comorbidities, and also driving outcome measure development.”

In another presentation at the meeting, Hervé Bachelez, MD, PhD, professor of dermatology and immunologist at the University of Paris and Saint-Louis Hospital, Paris, discussed recent advances in drug development for pustular psoriasis. He noted other recent findings of genetic variants related to the disease, including AP1S3, CARD14, and SERPINA3.

For GPP, he said, the current algorithm for management is based on weak evidence for treatments like acitretin, cyclosporine, methotrexate, and infliximab. The story is similar for other biologics, with evidence in the form of case series; open-label studies; controlled, prospective studies; or retrospective analyses. Most of the evidence has been amassed for TNF inhibitors. A retrospective study of all TNF inhibitors suggested they may be effective as induction and maintenance therapy, he noted.

Among IL-17A inhibitors, a prospective study of 12 patients in Japan found secukinumab showed efficacy against GPP, as did studies of ixekizumab and brodalumab. A small phase 3 study in Japan demonstrated efficacy for the IL-23 inhibitor guselkumab in patients with erythrodermic psoriasis and GPP (J Dermatol. 2018 May;45[5]:529-39).

The limited data are a reflection in part of the difficulty in studying GPP, since its flares tend to be more self-remitting than with psoriasis vulgaris or PPP.

There are two monoclonal antibodies against the IL-36 receptor currently being developed. A proof-of-concept study of one of them, spesolimab, showed promise against GPP, with five of seven patients reaching “clear” or “almost clear” scores on the Generalized Pustular Psoriasis Physician Global Assessment within a week after infusion and in all seven by the fourth week (N Engl J Med. 2019 Mar 7;380[10]:981-3).

With respect to PPP, the strongest evidence for conventional therapies comes from two randomized, controlled trials of cyclosporine, with response rates of 48% and 89%, compared with 19% and 21%, respectively, in the placebo groups, although the primary endpoint was poorly designed, according to Dr. Bachelez. Retinoids like etretinate and acitretin, combined with psoralen and UVA, also have some supporting evidence regarding efficacy.

Among biologics, secukinumab did not fare well in a phase 3 study of patients with PPP. A subset of patients may benefit from it, but there are no biomarkers available to identify them, Dr. Bachelez said. A phase 2 study of guselkumab in Japan told a similar story, with only weak signs of efficacy. While there are many more ongoing clinical trials evaluating treatments for PPP, which is encouraging, PPP seems to be more challenging at this stage to tackle than GPP, Dr. Bachelez added. “The genetically inherited IL-36 antagonist abnormalities are clearly driving the advances regarding the pathogenesis of the disease, mainly for GPP rather than PPP.”

Part of the efforts to develop therapies for pustular psoriasis relies on the development of new outcome measures, or adaptation of existing ones. “We have a need to adapt or develop new investigator-reported measures, we need to adapt or develop new patient-reported outcomes,” Dr. Duffin said.

Many existing measures use inconsistent language and anchoring definitions, and some may be proprietary, she added. “The language varies by sponsor and is sometimes tweaked or modified by the agencies. Often synonyms are being used … it raises questions, does it change the validity of the instrument?”

Dr. Duffin called for the research community to use the pause in clinical research during the COVID-19 pandemic to reassess the research agenda, develop consensus on performing and training for GPP and PPP assessments, develop patient-reported outcomes, and strengthen connections to industry.

Dr. Duffin and Dr. Bachelez have consulted, served on the advisory board, been a speaker for, and/or received research support from a wide range of pharmaceutical companies, including those that manufacture and develop psoriasis treatments.
 

Pustular psoriasis is a rare condition that presents significant challenges to clinicians, not least because it comes in varied forms that are not well understood.

It has various dermatologic and rheumatologic manifestations and sometimes overlaps with plaque psoriasis. Pustular palmoplantar psoriasis (PPP) affects the palmar and plantar areas of the skin, while generalized pustular psoriasis (GPP) can affect large areas of skin and tends to be more severe, even life threatening. PPP can accompany psoriatic arthritis or can be a side effect of tumor necrosis factor (TNF) inhibitor therapy, or a non–drug-induced component of rheumatologic syndromes, according to Kristina Callis Duffin, MD, an associate professor and chair of dermatology at the University of Utah, Salt Lake City.

“Each phenotype could be considered an orphan disease, and the response to therapy is often unpredictable,” Dr. Duffin said during a session on pustular psoriasis at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

But there is some positive news. A study in 2011 of several people with GPP opened the door to better understanding the pathophysiology of pustular psoriasis. Researchers identified a causal autosomal mutation in the IL36RN gene, which encodes an antagonist to the interleukin-36 receptor (Am J Hum Genet. 2011 Sep 9;89[3]:432-7). “As a result of this paper and others, drug development in this space has recently accelerated,” Dr. Duffin said.

In fact, she added,“it’s my opinion that pustular psoriasis is now where plaque psoriasis was 20 years ago, when accelerated drug development was driving a better understanding of the pathogenesis of psoriatic disease and its comorbidities, and also driving outcome measure development.”

In another presentation at the meeting, Hervé Bachelez, MD, PhD, professor of dermatology and immunologist at the University of Paris and Saint-Louis Hospital, Paris, discussed recent advances in drug development for pustular psoriasis. He noted other recent findings of genetic variants related to the disease, including AP1S3, CARD14, and SERPINA3.

For GPP, he said, the current algorithm for management is based on weak evidence for treatments like acitretin, cyclosporine, methotrexate, and infliximab. The story is similar for other biologics, with evidence in the form of case series; open-label studies; controlled, prospective studies; or retrospective analyses. Most of the evidence has been amassed for TNF inhibitors. A retrospective study of all TNF inhibitors suggested they may be effective as induction and maintenance therapy, he noted.

Among IL-17A inhibitors, a prospective study of 12 patients in Japan found secukinumab showed efficacy against GPP, as did studies of ixekizumab and brodalumab. A small phase 3 study in Japan demonstrated efficacy for the IL-23 inhibitor guselkumab in patients with erythrodermic psoriasis and GPP (J Dermatol. 2018 May;45[5]:529-39).

The limited data are a reflection in part of the difficulty in studying GPP, since its flares tend to be more self-remitting than with psoriasis vulgaris or PPP.

There are two monoclonal antibodies against the IL-36 receptor currently being developed. A proof-of-concept study of one of them, spesolimab, showed promise against GPP, with five of seven patients reaching “clear” or “almost clear” scores on the Generalized Pustular Psoriasis Physician Global Assessment within a week after infusion and in all seven by the fourth week (N Engl J Med. 2019 Mar 7;380[10]:981-3).

With respect to PPP, the strongest evidence for conventional therapies comes from two randomized, controlled trials of cyclosporine, with response rates of 48% and 89%, compared with 19% and 21%, respectively, in the placebo groups, although the primary endpoint was poorly designed, according to Dr. Bachelez. Retinoids like etretinate and acitretin, combined with psoralen and UVA, also have some supporting evidence regarding efficacy.

Among biologics, secukinumab did not fare well in a phase 3 study of patients with PPP. A subset of patients may benefit from it, but there are no biomarkers available to identify them, Dr. Bachelez said. A phase 2 study of guselkumab in Japan told a similar story, with only weak signs of efficacy. While there are many more ongoing clinical trials evaluating treatments for PPP, which is encouraging, PPP seems to be more challenging at this stage to tackle than GPP, Dr. Bachelez added. “The genetically inherited IL-36 antagonist abnormalities are clearly driving the advances regarding the pathogenesis of the disease, mainly for GPP rather than PPP.”

Part of the efforts to develop therapies for pustular psoriasis relies on the development of new outcome measures, or adaptation of existing ones. “We have a need to adapt or develop new investigator-reported measures, we need to adapt or develop new patient-reported outcomes,” Dr. Duffin said.

Many existing measures use inconsistent language and anchoring definitions, and some may be proprietary, she added. “The language varies by sponsor and is sometimes tweaked or modified by the agencies. Often synonyms are being used … it raises questions, does it change the validity of the instrument?”

Dr. Duffin called for the research community to use the pause in clinical research during the COVID-19 pandemic to reassess the research agenda, develop consensus on performing and training for GPP and PPP assessments, develop patient-reported outcomes, and strengthen connections to industry.

Dr. Duffin and Dr. Bachelez have consulted, served on the advisory board, been a speaker for, and/or received research support from a wide range of pharmaceutical companies, including those that manufacture and develop psoriasis treatments.
 

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).