Doug Brunk

When starting a new loop diuretic for a patient with heart failure, strongly consider torsemide over furosemide, Anthony C. Breu, MD, advised at SHM Converge, the annual conference of the Society of Hospital Medicine.

“Whether or not you take a patient who’s already on furosemide and you make the switch to torsemide is a little bit tougher for me to advocate, though that has happened in clinical trials,” said Dr. Breu, assistant professor of medicine at Harvard Medical School, Boston, who spoke May 5 at the Converge session “Things We Do for No Reason.” He co-presented the session with Leonard Feldman, MD, SFHM, director of the Osler Medical Residency Urban Health Track and associate professor at Johns Hopkins Medicine, Baltimore.

“If you consider doing this it would make sense to do so concert with the outpatient primary doctor and the outpatient cardiologist,” Dr. Breu said. “But in my review of the literature, it’s at least worth having these discussions, particularly for a patient who has multiple readmissions for heart failure. That may be a time to pause and ask: ‘Could torsemide be of benefit here?’ ”

In Dr. Breu’s opinion, there are at least three reasons why consider torsemide should be considered a first-line treatment for heart failure. For one thing, the current evidence says so. In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).

In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).

A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).

According to Dr. Breu, meta-analyses of this topic consistently show that the NYHA class improved more with torsemide than with furosemide. “Some meta-analyses find a mortality benefit, while others find a readmissions benefit,” he said. “None of them show a benefit of furosemide over torsemide.”

A second reason to use torsemide as a first-line treatment for heart failure is that it has superior pharmacokinetics/dynamics, compared with furosemide. “We’ve all heard that furosemide has variable bioavailability,” said Dr. Breu, who also deputy editor of the Journal of Hospital Medicine’s “Things We Do For No Reason” article series. “Torsemide and bumetanide are much more reliably absorbed, partially because they are not affected by food, whereas furosemide is. That could be potentially problematic for patients who take their diuretic with meals. The fact that torsemide has less renal clearance is a benefit, because patients with heart failure have changing renal function.” In addition, the half-life of torsemide is 3-4 hours and the duration of action is 12 hours, “which are both longer than those for furosemide or bumetanide,” he added.

He also pointed out that torsemide has been shown to block the aldosterone receptor in vitro and in rat models – an effect that has not been observed with other loop diuretics. A randomized trial of patients with chronic heart failure found that levels of renin and aldosterone increased more with torsemide, compared with furosemide, supporting the hypothesis of aldosterone receptor blockade.

A third main reason to use torsemide as your go-to for heart failure has to do with its purported antifibrotic effects, “so that it could be more than a diuretic,” Dr. Breu said. “In heart failure, myocardial fibrosis occurs from increased collagen synthesis and turnover. Aldosterone has been shown to play a role in this myocardial fibrosis. Spironolactone has been shown to mitigate this to some extent. If torsemide acts a little like spironolactone, maybe that could explain some of the long-term effects that we see in these studies.”

A study supporting this notion found that torsemide but not furosemide reduced levels of serum carboxyl-terminal peptide of procollagen type I, which is associated with exaggerated myocardial deposition of collagen type I fibers in cardiac diseases.

Going forward, a study known as TRANSFORM-HF, which is currently recruiting about 6,000 patients, should bring more clarity to the topic. The primary objective is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. The estimated completion is mid-2022.

Dr. Breu and Dr. Feldman reported having no relevant financial disclosures.

When starting a new loop diuretic for a patient with heart failure, strongly consider torsemide over furosemide, Anthony C. Breu, MD, advised at SHM Converge, the annual conference of the Society of Hospital Medicine.

“Whether or not you take a patient who’s already on furosemide and you make the switch to torsemide is a little bit tougher for me to advocate, though that has happened in clinical trials,” said Dr. Breu, assistant professor of medicine at Harvard Medical School, Boston, who spoke May 5 at the Converge session “Things We Do for No Reason.” He co-presented the session with Leonard Feldman, MD, SFHM, director of the Osler Medical Residency Urban Health Track and associate professor at Johns Hopkins Medicine, Baltimore.

“If you consider doing this it would make sense to do so concert with the outpatient primary doctor and the outpatient cardiologist,” Dr. Breu said. “But in my review of the literature, it’s at least worth having these discussions, particularly for a patient who has multiple readmissions for heart failure. That may be a time to pause and ask: ‘Could torsemide be of benefit here?’ ”

In Dr. Breu’s opinion, there are at least three reasons why consider torsemide should be considered a first-line treatment for heart failure. For one thing, the current evidence says so. In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).

In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).

A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).

According to Dr. Breu, meta-analyses of this topic consistently show that the NYHA class improved more with torsemide than with furosemide. “Some meta-analyses find a mortality benefit, while others find a readmissions benefit,” he said. “None of them show a benefit of furosemide over torsemide.”

A second reason to use torsemide as a first-line treatment for heart failure is that it has superior pharmacokinetics/dynamics, compared with furosemide. “We’ve all heard that furosemide has variable bioavailability,” said Dr. Breu, who also deputy editor of the Journal of Hospital Medicine’s “Things We Do For No Reason” article series. “Torsemide and bumetanide are much more reliably absorbed, partially because they are not affected by food, whereas furosemide is. That could be potentially problematic for patients who take their diuretic with meals. The fact that torsemide has less renal clearance is a benefit, because patients with heart failure have changing renal function.” In addition, the half-life of torsemide is 3-4 hours and the duration of action is 12 hours, “which are both longer than those for furosemide or bumetanide,” he added.

He also pointed out that torsemide has been shown to block the aldosterone receptor in vitro and in rat models – an effect that has not been observed with other loop diuretics. A randomized trial of patients with chronic heart failure found that levels of renin and aldosterone increased more with torsemide, compared with furosemide, supporting the hypothesis of aldosterone receptor blockade.

A third main reason to use torsemide as your go-to for heart failure has to do with its purported antifibrotic effects, “so that it could be more than a diuretic,” Dr. Breu said. “In heart failure, myocardial fibrosis occurs from increased collagen synthesis and turnover. Aldosterone has been shown to play a role in this myocardial fibrosis. Spironolactone has been shown to mitigate this to some extent. If torsemide acts a little like spironolactone, maybe that could explain some of the long-term effects that we see in these studies.”

A study supporting this notion found that torsemide but not furosemide reduced levels of serum carboxyl-terminal peptide of procollagen type I, which is associated with exaggerated myocardial deposition of collagen type I fibers in cardiac diseases.

Going forward, a study known as TRANSFORM-HF, which is currently recruiting about 6,000 patients, should bring more clarity to the topic. The primary objective is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. The estimated completion is mid-2022.

Dr. Breu and Dr. Feldman reported having no relevant financial disclosures.

When starting a new loop diuretic for a patient with heart failure, strongly consider torsemide over furosemide, Anthony C. Breu, MD, advised at SHM Converge, the annual conference of the Society of Hospital Medicine.

“Whether or not you take a patient who’s already on furosemide and you make the switch to torsemide is a little bit tougher for me to advocate, though that has happened in clinical trials,” said Dr. Breu, assistant professor of medicine at Harvard Medical School, Boston, who spoke May 5 at the Converge session “Things We Do for No Reason.” He co-presented the session with Leonard Feldman, MD, SFHM, director of the Osler Medical Residency Urban Health Track and associate professor at Johns Hopkins Medicine, Baltimore.

“If you consider doing this it would make sense to do so concert with the outpatient primary doctor and the outpatient cardiologist,” Dr. Breu said. “But in my review of the literature, it’s at least worth having these discussions, particularly for a patient who has multiple readmissions for heart failure. That may be a time to pause and ask: ‘Could torsemide be of benefit here?’ ”

In Dr. Breu’s opinion, there are at least three reasons why consider torsemide should be considered a first-line treatment for heart failure. For one thing, the current evidence says so. In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).

In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).

A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).

According to Dr. Breu, meta-analyses of this topic consistently show that the NYHA class improved more with torsemide than with furosemide. “Some meta-analyses find a mortality benefit, while others find a readmissions benefit,” he said. “None of them show a benefit of furosemide over torsemide.”

A second reason to use torsemide as a first-line treatment for heart failure is that it has superior pharmacokinetics/dynamics, compared with furosemide. “We’ve all heard that furosemide has variable bioavailability,” said Dr. Breu, who also deputy editor of the Journal of Hospital Medicine’s “Things We Do For No Reason” article series. “Torsemide and bumetanide are much more reliably absorbed, partially because they are not affected by food, whereas furosemide is. That could be potentially problematic for patients who take their diuretic with meals. The fact that torsemide has less renal clearance is a benefit, because patients with heart failure have changing renal function.” In addition, the half-life of torsemide is 3-4 hours and the duration of action is 12 hours, “which are both longer than those for furosemide or bumetanide,” he added.

He also pointed out that torsemide has been shown to block the aldosterone receptor in vitro and in rat models – an effect that has not been observed with other loop diuretics. A randomized trial of patients with chronic heart failure found that levels of renin and aldosterone increased more with torsemide, compared with furosemide, supporting the hypothesis of aldosterone receptor blockade.

A third main reason to use torsemide as your go-to for heart failure has to do with its purported antifibrotic effects, “so that it could be more than a diuretic,” Dr. Breu said. “In heart failure, myocardial fibrosis occurs from increased collagen synthesis and turnover. Aldosterone has been shown to play a role in this myocardial fibrosis. Spironolactone has been shown to mitigate this to some extent. If torsemide acts a little like spironolactone, maybe that could explain some of the long-term effects that we see in these studies.”

A study supporting this notion found that torsemide but not furosemide reduced levels of serum carboxyl-terminal peptide of procollagen type I, which is associated with exaggerated myocardial deposition of collagen type I fibers in cardiac diseases.

Going forward, a study known as TRANSFORM-HF, which is currently recruiting about 6,000 patients, should bring more clarity to the topic. The primary objective is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. The estimated completion is mid-2022.

Dr. Breu and Dr. Feldman reported having no relevant financial disclosures.

Earlier this spring, Kimberly D. Manning, MD, FACP, FAAP, was caring for an elderly Black man with multiple comorbidities at Grady Memorial Hospital in Atlanta, assembling an order for medications and a discharge plan.

“It was very challenging,” Dr. Manning, professor of medicine and associate vice chair of diversity, equity, and inclusion at Emory University, Atlanta, recalled during a May 4 session at SHM Converge, the annual conference of the Society of Hospital Medicine.

At one point, the patient glanced at her, shrugged, and said: “You know, Doc, we get in where we fit in.”

“He was talking about the idea that people who come from historically disadvantaged backgrounds just have to try to figure it out, have to try to make a dollar out of 15 cents,” Dr. Manning said. “This, to me, really underscores what we mean when we say health disparities, this idea that there are people who are working hard and doing the best that they can but who still are forced to ‘get in where they fit in.’”

The Centers for Disease Control and Prevention defines health disparities as preventable differences in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by socially disadvantaged populations. “When we think about health disparities we often think about many diagnoses,” Dr. Manning continued. “We think about HIV and the disparate care and outcomes we’ve seen in populations of individuals who come from minority backgrounds. We see disparities in obesity, cancer, cardiovascular disease, infant mortality and maternal death, hospital readmissions, and COVID-19. We know that people who do not have access to health care or to healthy neighborhoods and environments or who are economically disadvantaged have poorer outcomes. It plays out with all of these diagnoses.”

In her opinion, health disparities in hospital medicine fall into in one of three buckets: diagnosis and triage, hospital stay and treatment, and sticking the landing – “that is, after a patient leaves the hospital,” Dr. Manning explained. “The hospital stay is the turn on the balance beam. You can do everything perfectly, but then you must dismount. To score a ‘10’ you have to stick the landing. That means being able to get your medications, being able to get to and from clinic appointments, being able to understand the directions you’ve been given. All of these things are intertwined, the inpatient and outpatient care.”

The roots of health disparities in hospitalized patients stem from centuries ago, she said, when America’s health care system was built to benefit white male landowners and their families. Health care for Blacks, on the other hand, “was focused on function, almost like veterinary care, or experimentation,” Dr. Manning said. “After slavery ended, many historically Black institutions of higher learning opened, including medical schools. In 1909, there were seven historically Black medical schools. Acknowledging the history that preceded disparities is essential.”

In her view, the path to improving health care disparities starts with conceding that structural racism exists in the practice of medicine. “This means that health disparities are connected to systemic and individual issues, including our biases,” Dr. Manning said. “Our system was built on this idea that there is greater value of one group of people above others. Access to care, physician workforce, and biases are impacted by system design. Health equity and health equality are not the same.”

She also underscored the importance of the social determinants of health, or “those things we need to be healthy,” including economic stability, neighborhood and physical environment, educational opportunities, access to good food, community and social context, and the idea of health care as a human right and understanding our health care system. “This is what is necessary,” she declared. “Without all of these together, we can’t have the health outcomes that we desire.”

As hospital leaders work to build a more diverse physician workforce, Dr. Manning emphasized the importance of forming antiracism policies by addressing questions such as what will we not stand for? How will we protect and create psychologically safe environments? What is our commitment to diversity in leadership and in trainees? What is our commitment to implicit bias training and bystander training?

“We have to get uncomfortable enough to advocate with urgency because all of these are necessary factors to mitigate health disparities,” she said. “Though the systemic issues are the most urgent, on an individual level, we must continue to disrupt the negative ideology and stereotypes that threaten our environment every day. When we see those negative things, we have to call them out. We need to continue to listen, to humanize those things that are happening around us, and to understand historical context.”

Dr. Manning reported having no financial disclosures.

Earlier this spring, Kimberly D. Manning, MD, FACP, FAAP, was caring for an elderly Black man with multiple comorbidities at Grady Memorial Hospital in Atlanta, assembling an order for medications and a discharge plan.

“It was very challenging,” Dr. Manning, professor of medicine and associate vice chair of diversity, equity, and inclusion at Emory University, Atlanta, recalled during a May 4 session at SHM Converge, the annual conference of the Society of Hospital Medicine.

At one point, the patient glanced at her, shrugged, and said: “You know, Doc, we get in where we fit in.”

“He was talking about the idea that people who come from historically disadvantaged backgrounds just have to try to figure it out, have to try to make a dollar out of 15 cents,” Dr. Manning said. “This, to me, really underscores what we mean when we say health disparities, this idea that there are people who are working hard and doing the best that they can but who still are forced to ‘get in where they fit in.’”

The Centers for Disease Control and Prevention defines health disparities as preventable differences in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by socially disadvantaged populations. “When we think about health disparities we often think about many diagnoses,” Dr. Manning continued. “We think about HIV and the disparate care and outcomes we’ve seen in populations of individuals who come from minority backgrounds. We see disparities in obesity, cancer, cardiovascular disease, infant mortality and maternal death, hospital readmissions, and COVID-19. We know that people who do not have access to health care or to healthy neighborhoods and environments or who are economically disadvantaged have poorer outcomes. It plays out with all of these diagnoses.”

In her opinion, health disparities in hospital medicine fall into in one of three buckets: diagnosis and triage, hospital stay and treatment, and sticking the landing – “that is, after a patient leaves the hospital,” Dr. Manning explained. “The hospital stay is the turn on the balance beam. You can do everything perfectly, but then you must dismount. To score a ‘10’ you have to stick the landing. That means being able to get your medications, being able to get to and from clinic appointments, being able to understand the directions you’ve been given. All of these things are intertwined, the inpatient and outpatient care.”

The roots of health disparities in hospitalized patients stem from centuries ago, she said, when America’s health care system was built to benefit white male landowners and their families. Health care for Blacks, on the other hand, “was focused on function, almost like veterinary care, or experimentation,” Dr. Manning said. “After slavery ended, many historically Black institutions of higher learning opened, including medical schools. In 1909, there were seven historically Black medical schools. Acknowledging the history that preceded disparities is essential.”

In her view, the path to improving health care disparities starts with conceding that structural racism exists in the practice of medicine. “This means that health disparities are connected to systemic and individual issues, including our biases,” Dr. Manning said. “Our system was built on this idea that there is greater value of one group of people above others. Access to care, physician workforce, and biases are impacted by system design. Health equity and health equality are not the same.”

She also underscored the importance of the social determinants of health, or “those things we need to be healthy,” including economic stability, neighborhood and physical environment, educational opportunities, access to good food, community and social context, and the idea of health care as a human right and understanding our health care system. “This is what is necessary,” she declared. “Without all of these together, we can’t have the health outcomes that we desire.”

As hospital leaders work to build a more diverse physician workforce, Dr. Manning emphasized the importance of forming antiracism policies by addressing questions such as what will we not stand for? How will we protect and create psychologically safe environments? What is our commitment to diversity in leadership and in trainees? What is our commitment to implicit bias training and bystander training?

“We have to get uncomfortable enough to advocate with urgency because all of these are necessary factors to mitigate health disparities,” she said. “Though the systemic issues are the most urgent, on an individual level, we must continue to disrupt the negative ideology and stereotypes that threaten our environment every day. When we see those negative things, we have to call them out. We need to continue to listen, to humanize those things that are happening around us, and to understand historical context.”

Dr. Manning reported having no financial disclosures.

Earlier this spring, Kimberly D. Manning, MD, FACP, FAAP, was caring for an elderly Black man with multiple comorbidities at Grady Memorial Hospital in Atlanta, assembling an order for medications and a discharge plan.

“It was very challenging,” Dr. Manning, professor of medicine and associate vice chair of diversity, equity, and inclusion at Emory University, Atlanta, recalled during a May 4 session at SHM Converge, the annual conference of the Society of Hospital Medicine.

At one point, the patient glanced at her, shrugged, and said: “You know, Doc, we get in where we fit in.”

“He was talking about the idea that people who come from historically disadvantaged backgrounds just have to try to figure it out, have to try to make a dollar out of 15 cents,” Dr. Manning said. “This, to me, really underscores what we mean when we say health disparities, this idea that there are people who are working hard and doing the best that they can but who still are forced to ‘get in where they fit in.’”

The Centers for Disease Control and Prevention defines health disparities as preventable differences in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by socially disadvantaged populations. “When we think about health disparities we often think about many diagnoses,” Dr. Manning continued. “We think about HIV and the disparate care and outcomes we’ve seen in populations of individuals who come from minority backgrounds. We see disparities in obesity, cancer, cardiovascular disease, infant mortality and maternal death, hospital readmissions, and COVID-19. We know that people who do not have access to health care or to healthy neighborhoods and environments or who are economically disadvantaged have poorer outcomes. It plays out with all of these diagnoses.”

In her opinion, health disparities in hospital medicine fall into in one of three buckets: diagnosis and triage, hospital stay and treatment, and sticking the landing – “that is, after a patient leaves the hospital,” Dr. Manning explained. “The hospital stay is the turn on the balance beam. You can do everything perfectly, but then you must dismount. To score a ‘10’ you have to stick the landing. That means being able to get your medications, being able to get to and from clinic appointments, being able to understand the directions you’ve been given. All of these things are intertwined, the inpatient and outpatient care.”

The roots of health disparities in hospitalized patients stem from centuries ago, she said, when America’s health care system was built to benefit white male landowners and their families. Health care for Blacks, on the other hand, “was focused on function, almost like veterinary care, or experimentation,” Dr. Manning said. “After slavery ended, many historically Black institutions of higher learning opened, including medical schools. In 1909, there were seven historically Black medical schools. Acknowledging the history that preceded disparities is essential.”

In her view, the path to improving health care disparities starts with conceding that structural racism exists in the practice of medicine. “This means that health disparities are connected to systemic and individual issues, including our biases,” Dr. Manning said. “Our system was built on this idea that there is greater value of one group of people above others. Access to care, physician workforce, and biases are impacted by system design. Health equity and health equality are not the same.”

She also underscored the importance of the social determinants of health, or “those things we need to be healthy,” including economic stability, neighborhood and physical environment, educational opportunities, access to good food, community and social context, and the idea of health care as a human right and understanding our health care system. “This is what is necessary,” she declared. “Without all of these together, we can’t have the health outcomes that we desire.”

As hospital leaders work to build a more diverse physician workforce, Dr. Manning emphasized the importance of forming antiracism policies by addressing questions such as what will we not stand for? How will we protect and create psychologically safe environments? What is our commitment to diversity in leadership and in trainees? What is our commitment to implicit bias training and bystander training?

“We have to get uncomfortable enough to advocate with urgency because all of these are necessary factors to mitigate health disparities,” she said. “Though the systemic issues are the most urgent, on an individual level, we must continue to disrupt the negative ideology and stereotypes that threaten our environment every day. When we see those negative things, we have to call them out. We need to continue to listen, to humanize those things that are happening around us, and to understand historical context.”

Dr. Manning reported having no financial disclosures.

A cohort study of psoriasis patients in Denmark found that a nonmedical switch from brand name adalimumab to adalimumab biosimilars was not associated with drug retention at 1 year. And another study, a small, single-center retrospective study of patients with hidradenitis suppurativa (HS), found that administration of infliximab and biosimilar infliximab were associated with similar and significant improvement in disease.

Both studies were published online in April in JAMA Dermatology and add to mounting evidence that biosimilars may be interchangeable in certain dermatologic conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, assistant professor of dermatology at George Washington University, Washington, said in an interview. “Their efficacy and price point will allow patients greater access to effective treatment.” To date, biosimilars approved in the United States that could be prescribed by dermatologists include those for rituximab, etanercept, adalimumab, and infliximab.

In the trial from Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated outcomes following a mandatory medical switch from the brand name adalimumab, referred to as adalimumab originator, to adalimumab biosimilars among 726 individuals who were enrolled in a Danish nationwide registry of patients treated with biologics since 2007. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator.

The study population consisted of 348 patients with at least 2 years of exposure to adalimumab who had switched from originator to adalimumab biosimilars (a mean age of 52 and 72% male) and 378 patients who served as the adalimumab cohort (a mean age of 51 and 71% male). When the researchers compared the 1-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab originator cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other outcomes were similar as well. Specifically, the crude hazard ratios were 1.02 (P = .94) for all causes of drug discontinuation, 0.82 (P = .60) for insufficient effect, and 1.41 (P = .50) for adverse events (AEs) in the adalimumab biosimilar cohort, compared with the adalimumab originator cohort.

“Overall, results for any AEs were contradicting, but certain AEs were more prevalent in the adalimumab biosimilar cohort,” the authors wrote. Dermatologic AEs and AEs in the “other” category “were more prevalent, which could be attributable to more patients experiencing injection site reactions as a result of larger volumes and differences in excipients and syringes in the adalimumab biosimilars and the adalimumab originator.” Other potential explanations they offered were the nocebo effect and greater awareness of AEs among practitioners and patients.

“This study concludes that, when switched to a biosimilar medication, patients do not have worse control of their psoriasis nor do they switch to other medications,” Dr. Zahn, who was asked to comment about these results, said in the interview. “However, there was a trend toward a higher number of side effects in the biosimilar group. The main takeaway point from this study is that biosimilars of adalimumab seem to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects that lead to a medication change for the patient.”

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AEs could not be examined. “Moreover, the surveillance of AEs is not as vigilant as in clinical trials, and AEs are most likely underreported,” they wrote. “Although no major differences were found when switching from adalimumab originator to adalimumab biosimilar versions, it was not possible to assess the performance of individual adalimumab biosimilar versions in this study.”

In the second study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the effectiveness of infliximab-abda versus infliximab administration in the treatment of 34 patients with HS who were cared for at the university’s dermatology clinic. Patients were treated with either agent for at least 10 weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years who were mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who also were mostly female (13; 93%).

Both groups received loading doses of 10 mg/kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. The patients were followed between February 2016 and June 2020 and the primary outcome measure was Hidradenitis Suppurative Clinical Response (HiSCR), which was defined as at least a 50% decrease in inflammatory nodule count without any increase in the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their counterparts in the infliximab treatment group, a difference that did not reach statistical significance (P = .47). Three patients in the infliximab treatment group experienced AEs, compared with none in the infliximab-abda treatment group.

“The data are promising,” Dr. Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable or possibly even equivalent alternative to infliximab. A larger, prospective trial will be needed before we can be sure the results are equivalent.”

Dr. Sayed and colleagues noted certain limitations of their study, including the retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copay and medication assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In an editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, wrote that the introduction of biosimilars have been justified by “the hope that lower costs” will increase availability of treatments to patients with moderate to severe psoriasis. “Inroads in the U.S. market, however, have been limited,” he added, and there is concern that they “may be used to prevent access to newer interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and that do not carry the boxed warnings found on tumor necrosis factor blockers.”

Dr. Loft reported receiving personal fees from Eli Lilly and Janssen outside of the submitted work. Many of his coauthors reporting having numerous financial conflicts of interest with the pharmaceutical industry. The HS study was supported by a public health service research award from the National Institutes of Health. Dr. Sayed reported receiving personal fees or personal fees paid to the institution from AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx, and UCB. No other disclosures were reported. Dr. Lebwohl disclosed receiving research funds from companies including AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Incyte; and receiving personal fees from multiple companies, outside of the submitted work. Dr. Zahn reported having no disclosures.

[email protected]

A cohort study of psoriasis patients in Denmark found that a nonmedical switch from brand name adalimumab to adalimumab biosimilars was not associated with drug retention at 1 year. And another study, a small, single-center retrospective study of patients with hidradenitis suppurativa (HS), found that administration of infliximab and biosimilar infliximab were associated with similar and significant improvement in disease.

Both studies were published online in April in JAMA Dermatology and add to mounting evidence that biosimilars may be interchangeable in certain dermatologic conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, assistant professor of dermatology at George Washington University, Washington, said in an interview. “Their efficacy and price point will allow patients greater access to effective treatment.” To date, biosimilars approved in the United States that could be prescribed by dermatologists include those for rituximab, etanercept, adalimumab, and infliximab.

In the trial from Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated outcomes following a mandatory medical switch from the brand name adalimumab, referred to as adalimumab originator, to adalimumab biosimilars among 726 individuals who were enrolled in a Danish nationwide registry of patients treated with biologics since 2007. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator.

The study population consisted of 348 patients with at least 2 years of exposure to adalimumab who had switched from originator to adalimumab biosimilars (a mean age of 52 and 72% male) and 378 patients who served as the adalimumab cohort (a mean age of 51 and 71% male). When the researchers compared the 1-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab originator cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other outcomes were similar as well. Specifically, the crude hazard ratios were 1.02 (P = .94) for all causes of drug discontinuation, 0.82 (P = .60) for insufficient effect, and 1.41 (P = .50) for adverse events (AEs) in the adalimumab biosimilar cohort, compared with the adalimumab originator cohort.

“Overall, results for any AEs were contradicting, but certain AEs were more prevalent in the adalimumab biosimilar cohort,” the authors wrote. Dermatologic AEs and AEs in the “other” category “were more prevalent, which could be attributable to more patients experiencing injection site reactions as a result of larger volumes and differences in excipients and syringes in the adalimumab biosimilars and the adalimumab originator.” Other potential explanations they offered were the nocebo effect and greater awareness of AEs among practitioners and patients.

“This study concludes that, when switched to a biosimilar medication, patients do not have worse control of their psoriasis nor do they switch to other medications,” Dr. Zahn, who was asked to comment about these results, said in the interview. “However, there was a trend toward a higher number of side effects in the biosimilar group. The main takeaway point from this study is that biosimilars of adalimumab seem to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects that lead to a medication change for the patient.”

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AEs could not be examined. “Moreover, the surveillance of AEs is not as vigilant as in clinical trials, and AEs are most likely underreported,” they wrote. “Although no major differences were found when switching from adalimumab originator to adalimumab biosimilar versions, it was not possible to assess the performance of individual adalimumab biosimilar versions in this study.”

In the second study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the effectiveness of infliximab-abda versus infliximab administration in the treatment of 34 patients with HS who were cared for at the university’s dermatology clinic. Patients were treated with either agent for at least 10 weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years who were mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who also were mostly female (13; 93%).

Both groups received loading doses of 10 mg/kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. The patients were followed between February 2016 and June 2020 and the primary outcome measure was Hidradenitis Suppurative Clinical Response (HiSCR), which was defined as at least a 50% decrease in inflammatory nodule count without any increase in the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their counterparts in the infliximab treatment group, a difference that did not reach statistical significance (P = .47). Three patients in the infliximab treatment group experienced AEs, compared with none in the infliximab-abda treatment group.

“The data are promising,” Dr. Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable or possibly even equivalent alternative to infliximab. A larger, prospective trial will be needed before we can be sure the results are equivalent.”

Dr. Sayed and colleagues noted certain limitations of their study, including the retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copay and medication assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In an editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, wrote that the introduction of biosimilars have been justified by “the hope that lower costs” will increase availability of treatments to patients with moderate to severe psoriasis. “Inroads in the U.S. market, however, have been limited,” he added, and there is concern that they “may be used to prevent access to newer interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and that do not carry the boxed warnings found on tumor necrosis factor blockers.”

Dr. Loft reported receiving personal fees from Eli Lilly and Janssen outside of the submitted work. Many of his coauthors reporting having numerous financial conflicts of interest with the pharmaceutical industry. The HS study was supported by a public health service research award from the National Institutes of Health. Dr. Sayed reported receiving personal fees or personal fees paid to the institution from AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx, and UCB. No other disclosures were reported. Dr. Lebwohl disclosed receiving research funds from companies including AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Incyte; and receiving personal fees from multiple companies, outside of the submitted work. Dr. Zahn reported having no disclosures.

[email protected]

A cohort study of psoriasis patients in Denmark found that a nonmedical switch from brand name adalimumab to adalimumab biosimilars was not associated with drug retention at 1 year. And another study, a small, single-center retrospective study of patients with hidradenitis suppurativa (HS), found that administration of infliximab and biosimilar infliximab were associated with similar and significant improvement in disease.

Both studies were published online in April in JAMA Dermatology and add to mounting evidence that biosimilars may be interchangeable in certain dermatologic conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, assistant professor of dermatology at George Washington University, Washington, said in an interview. “Their efficacy and price point will allow patients greater access to effective treatment.” To date, biosimilars approved in the United States that could be prescribed by dermatologists include those for rituximab, etanercept, adalimumab, and infliximab.

In the trial from Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated outcomes following a mandatory medical switch from the brand name adalimumab, referred to as adalimumab originator, to adalimumab biosimilars among 726 individuals who were enrolled in a Danish nationwide registry of patients treated with biologics since 2007. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator.

The study population consisted of 348 patients with at least 2 years of exposure to adalimumab who had switched from originator to adalimumab biosimilars (a mean age of 52 and 72% male) and 378 patients who served as the adalimumab cohort (a mean age of 51 and 71% male). When the researchers compared the 1-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab originator cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other outcomes were similar as well. Specifically, the crude hazard ratios were 1.02 (P = .94) for all causes of drug discontinuation, 0.82 (P = .60) for insufficient effect, and 1.41 (P = .50) for adverse events (AEs) in the adalimumab biosimilar cohort, compared with the adalimumab originator cohort.

“Overall, results for any AEs were contradicting, but certain AEs were more prevalent in the adalimumab biosimilar cohort,” the authors wrote. Dermatologic AEs and AEs in the “other” category “were more prevalent, which could be attributable to more patients experiencing injection site reactions as a result of larger volumes and differences in excipients and syringes in the adalimumab biosimilars and the adalimumab originator.” Other potential explanations they offered were the nocebo effect and greater awareness of AEs among practitioners and patients.

“This study concludes that, when switched to a biosimilar medication, patients do not have worse control of their psoriasis nor do they switch to other medications,” Dr. Zahn, who was asked to comment about these results, said in the interview. “However, there was a trend toward a higher number of side effects in the biosimilar group. The main takeaway point from this study is that biosimilars of adalimumab seem to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects that lead to a medication change for the patient.”

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AEs could not be examined. “Moreover, the surveillance of AEs is not as vigilant as in clinical trials, and AEs are most likely underreported,” they wrote. “Although no major differences were found when switching from adalimumab originator to adalimumab biosimilar versions, it was not possible to assess the performance of individual adalimumab biosimilar versions in this study.”

In the second study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the effectiveness of infliximab-abda versus infliximab administration in the treatment of 34 patients with HS who were cared for at the university’s dermatology clinic. Patients were treated with either agent for at least 10 weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years who were mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who also were mostly female (13; 93%).

Both groups received loading doses of 10 mg/kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. The patients were followed between February 2016 and June 2020 and the primary outcome measure was Hidradenitis Suppurative Clinical Response (HiSCR), which was defined as at least a 50% decrease in inflammatory nodule count without any increase in the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their counterparts in the infliximab treatment group, a difference that did not reach statistical significance (P = .47). Three patients in the infliximab treatment group experienced AEs, compared with none in the infliximab-abda treatment group.

“The data are promising,” Dr. Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable or possibly even equivalent alternative to infliximab. A larger, prospective trial will be needed before we can be sure the results are equivalent.”

Dr. Sayed and colleagues noted certain limitations of their study, including the retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copay and medication assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In an editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, wrote that the introduction of biosimilars have been justified by “the hope that lower costs” will increase availability of treatments to patients with moderate to severe psoriasis. “Inroads in the U.S. market, however, have been limited,” he added, and there is concern that they “may be used to prevent access to newer interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and that do not carry the boxed warnings found on tumor necrosis factor blockers.”

Dr. Loft reported receiving personal fees from Eli Lilly and Janssen outside of the submitted work. Many of his coauthors reporting having numerous financial conflicts of interest with the pharmaceutical industry. The HS study was supported by a public health service research award from the National Institutes of Health. Dr. Sayed reported receiving personal fees or personal fees paid to the institution from AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx, and UCB. No other disclosures were reported. Dr. Lebwohl disclosed receiving research funds from companies including AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Incyte; and receiving personal fees from multiple companies, outside of the submitted work. Dr. Zahn reported having no disclosures.

[email protected]

Patients with prurigo nodularis tend to make a greater number of visits to health care specialists and are burdened by a greater number of medical comorbidities, compared with age-matched controls, as well those with atopic dermatitis and psoriasis.

Those are key findings from a retrospective analysis of claims data that was published online April 3, 2021, in the Journal of Investigative Dermatology.

“Prurigo nodularis is a tremendously understudied inflammatory skin disease,” one of the study’s cosenior authors, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said in an interview. “Prurigo nodularis patients have uncontrolled itch, which leads to reduced quality of life, and the association with many disease comorbidities. We focused on better understanding in this work the unique comorbidities of prurigo nodularis, compared to other inflammatory skin diseases.”

For the study, Dr. Kwatra, cosenior author Yevgeniy R. Semenov, MD, of the department of dermatology, Massachusetts General Hospital, Boston, and colleagues evaluated nationally representative, private insurance claims data from October 2015 to December 2019 to identify prurigo nodularis (PN) patients, who were defined as individuals with two or more medical claims for PN using ICD-10-CM codes. For comparison with patients with inflammatory skin diseases, they used the same claims data to identify patients with atopic dermatitis (AD) and psoriasis as well as to select controls who were age and gender matched to PN patients. Next, they quantified the overall comorbidity burden with the Charlson Comorbidity Index (CCI).

In 2016, the claims database included 2,658 patients with PN, 21,482 patients with AD, 21,073 patients with psoriasis, and 13,290 controls. The number of patients in each category rose each subsequent year, so that by the end of 2019 there were 9,426 patients with PN, 70,298 patients with AD, 59,509 patients with psoriasis, and 47,130 controls. Between 2016 and 2019 the mean age of PN patients increased from 57.5 to 59.8 years and the percent of male patients rose from 44.5% to 46.5%.

Between 2016 and 2019, the overall PN prevalence rates rose from 18 per 100,000 to 58 per 100,000, while the PN prevalence rates among adults increased from 22 per 100,000 to 70 per 100,000, and the rates among children rose grew from 2 per 100,000 to 7 per 100,000. “Our report shows an estimated disease prevalence of around 335,000 cases of PN in the United States,” said Dr. Kwatra, who was among a group of researchers to recently report on systemic Th22-polarized inflammation in PN patients.

The researchers also found that patients with PN had the highest mean CCI in both 2016 and 2019. In 2016, their mean CCI was 1.53, compared with 0.98 among controls, 0.53 among those with AD, and 1.16 among those with psoriasis. In 2019, the mean CCI had increased in all groups of patients, to 2.32 among those with PN, 1.57 among controls, 0.75 among those with AD patients, and 1.71 among those with psoriasis.

The top five medical specialties who cared for PN patients, defined as the estimated number of visits per year per patient, were internal medicine (2.01 visits), dermatology (1.87 visits), family practice (1.60 visits), cardiology or cardiovascular disease (0.85 visits), and orthopedics or orthopedic surgery (0.49 visits).

“If you encounter a patient with prurigo nodularis, it’s important to perform a screening for chronic kidney disease, diabetes, and liver disease,” Dr. Kwatra said. “These comorbidities along with emerging studies on circulating blood biomarkers suggest prurigo nodularis is a systemic inflammatory disorder; thus systemic agents are needed for most patients as part of multimodal therapy in prurigo nodularis.”

The researchers acknowledged certain limitations of the study, including its retrospective design and the identification of patients with PN with the ICD-10-CM code, which require further validation. “Furthermore, the increase in annual prevalence estimates for PN, AD, and psoriasis observed in the study could also be a result of increasing coding of these diagnoses in the claims data along with rising awareness by the medical profession,” they wrote.

Dr. Kwatra disclosed that he is an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals, and has received grant funding from Galderma, Pfizer, and Kiniksa. He has also received a Dermatology Foundation Medical Dermatology Career Development Award, a research grant from the Skin of Color Society, and is supported by the National Institutes of Health. One coauthor has been funded by NIH grants.

[email protected]

Patients with prurigo nodularis tend to make a greater number of visits to health care specialists and are burdened by a greater number of medical comorbidities, compared with age-matched controls, as well those with atopic dermatitis and psoriasis.

Those are key findings from a retrospective analysis of claims data that was published online April 3, 2021, in the Journal of Investigative Dermatology.

“Prurigo nodularis is a tremendously understudied inflammatory skin disease,” one of the study’s cosenior authors, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said in an interview. “Prurigo nodularis patients have uncontrolled itch, which leads to reduced quality of life, and the association with many disease comorbidities. We focused on better understanding in this work the unique comorbidities of prurigo nodularis, compared to other inflammatory skin diseases.”

For the study, Dr. Kwatra, cosenior author Yevgeniy R. Semenov, MD, of the department of dermatology, Massachusetts General Hospital, Boston, and colleagues evaluated nationally representative, private insurance claims data from October 2015 to December 2019 to identify prurigo nodularis (PN) patients, who were defined as individuals with two or more medical claims for PN using ICD-10-CM codes. For comparison with patients with inflammatory skin diseases, they used the same claims data to identify patients with atopic dermatitis (AD) and psoriasis as well as to select controls who were age and gender matched to PN patients. Next, they quantified the overall comorbidity burden with the Charlson Comorbidity Index (CCI).

In 2016, the claims database included 2,658 patients with PN, 21,482 patients with AD, 21,073 patients with psoriasis, and 13,290 controls. The number of patients in each category rose each subsequent year, so that by the end of 2019 there were 9,426 patients with PN, 70,298 patients with AD, 59,509 patients with psoriasis, and 47,130 controls. Between 2016 and 2019 the mean age of PN patients increased from 57.5 to 59.8 years and the percent of male patients rose from 44.5% to 46.5%.

Between 2016 and 2019, the overall PN prevalence rates rose from 18 per 100,000 to 58 per 100,000, while the PN prevalence rates among adults increased from 22 per 100,000 to 70 per 100,000, and the rates among children rose grew from 2 per 100,000 to 7 per 100,000. “Our report shows an estimated disease prevalence of around 335,000 cases of PN in the United States,” said Dr. Kwatra, who was among a group of researchers to recently report on systemic Th22-polarized inflammation in PN patients.

The researchers also found that patients with PN had the highest mean CCI in both 2016 and 2019. In 2016, their mean CCI was 1.53, compared with 0.98 among controls, 0.53 among those with AD, and 1.16 among those with psoriasis. In 2019, the mean CCI had increased in all groups of patients, to 2.32 among those with PN, 1.57 among controls, 0.75 among those with AD patients, and 1.71 among those with psoriasis.

The top five medical specialties who cared for PN patients, defined as the estimated number of visits per year per patient, were internal medicine (2.01 visits), dermatology (1.87 visits), family practice (1.60 visits), cardiology or cardiovascular disease (0.85 visits), and orthopedics or orthopedic surgery (0.49 visits).

“If you encounter a patient with prurigo nodularis, it’s important to perform a screening for chronic kidney disease, diabetes, and liver disease,” Dr. Kwatra said. “These comorbidities along with emerging studies on circulating blood biomarkers suggest prurigo nodularis is a systemic inflammatory disorder; thus systemic agents are needed for most patients as part of multimodal therapy in prurigo nodularis.”

The researchers acknowledged certain limitations of the study, including its retrospective design and the identification of patients with PN with the ICD-10-CM code, which require further validation. “Furthermore, the increase in annual prevalence estimates for PN, AD, and psoriasis observed in the study could also be a result of increasing coding of these diagnoses in the claims data along with rising awareness by the medical profession,” they wrote.

Dr. Kwatra disclosed that he is an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals, and has received grant funding from Galderma, Pfizer, and Kiniksa. He has also received a Dermatology Foundation Medical Dermatology Career Development Award, a research grant from the Skin of Color Society, and is supported by the National Institutes of Health. One coauthor has been funded by NIH grants.

[email protected]

Patients with prurigo nodularis tend to make a greater number of visits to health care specialists and are burdened by a greater number of medical comorbidities, compared with age-matched controls, as well those with atopic dermatitis and psoriasis.

Those are key findings from a retrospective analysis of claims data that was published online April 3, 2021, in the Journal of Investigative Dermatology.

“Prurigo nodularis is a tremendously understudied inflammatory skin disease,” one of the study’s cosenior authors, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said in an interview. “Prurigo nodularis patients have uncontrolled itch, which leads to reduced quality of life, and the association with many disease comorbidities. We focused on better understanding in this work the unique comorbidities of prurigo nodularis, compared to other inflammatory skin diseases.”

For the study, Dr. Kwatra, cosenior author Yevgeniy R. Semenov, MD, of the department of dermatology, Massachusetts General Hospital, Boston, and colleagues evaluated nationally representative, private insurance claims data from October 2015 to December 2019 to identify prurigo nodularis (PN) patients, who were defined as individuals with two or more medical claims for PN using ICD-10-CM codes. For comparison with patients with inflammatory skin diseases, they used the same claims data to identify patients with atopic dermatitis (AD) and psoriasis as well as to select controls who were age and gender matched to PN patients. Next, they quantified the overall comorbidity burden with the Charlson Comorbidity Index (CCI).

In 2016, the claims database included 2,658 patients with PN, 21,482 patients with AD, 21,073 patients with psoriasis, and 13,290 controls. The number of patients in each category rose each subsequent year, so that by the end of 2019 there were 9,426 patients with PN, 70,298 patients with AD, 59,509 patients with psoriasis, and 47,130 controls. Between 2016 and 2019 the mean age of PN patients increased from 57.5 to 59.8 years and the percent of male patients rose from 44.5% to 46.5%.

Between 2016 and 2019, the overall PN prevalence rates rose from 18 per 100,000 to 58 per 100,000, while the PN prevalence rates among adults increased from 22 per 100,000 to 70 per 100,000, and the rates among children rose grew from 2 per 100,000 to 7 per 100,000. “Our report shows an estimated disease prevalence of around 335,000 cases of PN in the United States,” said Dr. Kwatra, who was among a group of researchers to recently report on systemic Th22-polarized inflammation in PN patients.

The researchers also found that patients with PN had the highest mean CCI in both 2016 and 2019. In 2016, their mean CCI was 1.53, compared with 0.98 among controls, 0.53 among those with AD, and 1.16 among those with psoriasis. In 2019, the mean CCI had increased in all groups of patients, to 2.32 among those with PN, 1.57 among controls, 0.75 among those with AD patients, and 1.71 among those with psoriasis.

The top five medical specialties who cared for PN patients, defined as the estimated number of visits per year per patient, were internal medicine (2.01 visits), dermatology (1.87 visits), family practice (1.60 visits), cardiology or cardiovascular disease (0.85 visits), and orthopedics or orthopedic surgery (0.49 visits).

“If you encounter a patient with prurigo nodularis, it’s important to perform a screening for chronic kidney disease, diabetes, and liver disease,” Dr. Kwatra said. “These comorbidities along with emerging studies on circulating blood biomarkers suggest prurigo nodularis is a systemic inflammatory disorder; thus systemic agents are needed for most patients as part of multimodal therapy in prurigo nodularis.”

The researchers acknowledged certain limitations of the study, including its retrospective design and the identification of patients with PN with the ICD-10-CM code, which require further validation. “Furthermore, the increase in annual prevalence estimates for PN, AD, and psoriasis observed in the study could also be a result of increasing coding of these diagnoses in the claims data along with rising awareness by the medical profession,” they wrote.

Dr. Kwatra disclosed that he is an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals, and has received grant funding from Galderma, Pfizer, and Kiniksa. He has also received a Dermatology Foundation Medical Dermatology Career Development Award, a research grant from the Skin of Color Society, and is supported by the National Institutes of Health. One coauthor has been funded by NIH grants.

[email protected]

Two recent articles in the medical literature provide new information on mucocutaneous manifestations of COVID-19 in children, which may help guide dermatologists in making accurate diagnoses and stratifying children at risk for serious, systemic illness due to the virus.

In a single-center descriptive study carried out over a 9-month period, researchers in Madrid found that of 50 hospitalized children infected with COVID-19, 21 (42%) had mucocutaneous symptoms, most commonly exanthem, followed by conjunctival hyperemia without secretion and red cracked lips or strawberry tongue. In addition, 18 (36%) fulfilled criteria for Multisystem Inflammatory Syndrome in Children (MIS-C).

“Based on findings in adult patients, the skin manifestations of COVID-19 have been classified under five categories: acral pseudo-chilblain, vesicular eruptions, urticarial lesions, maculopapular eruptions, and livedo or necrosis,” David Andina-Martinez, MD, of Hospital Infantil Universitario Niño Jesús, Madrid, and colleagues wrote in the study, which was published online on April 2 in the Journal of the American Academy of Dermatology.

“Chilblain lesions in healthy children and adolescents have received much attention; these lesions resolve without complications after a few weeks,” they added. “Besides, other cutaneous manifestations of COVID-19 in children have been the matter of case reports or small case series. Nevertheless, the mucocutaneous manifestations in hospitalized children infected with SARS-CoV-2 and their implications on the clinical course have not yet been extensively described.”

In an effort to describe the mucocutaneous manifestations in children hospitalized for COVID-19, the researchers evaluated 50 children up to 18 years of age who were admitted between March 1 and Nov. 30, 2020, to Hospital Infantil Universitario Niño Jesús, which was designated as a pediatric reference center during the peak of the pandemic. The main reasons for admission were respiratory illness (40%) and MIS-C (40%).

Of the 50 patients, 44 (88%) had a positive RT-PCR for SARS-CoV-2 and 6 (12%) met clinical suspicion criteria and had a negative RT-PCR with a positive IgG serology. In 34 patients (68%), a close contact with a suspected or confirmed case of COVID-19 was referred, while the source of the infection remained unknown in the remaining 16 patients (32%).

The researchers reported that 21 patients (42%) had mucocutaneous symptoms, most commonly maculopapular exanthem (86%), conjunctival hyperemia (81%), and red cracked lips or strawberry tongue (43%). In addition, 18 of the 21 patients (86%) fulfilled criteria for MIS-C.

“A tricky thing about MIS-C is that it often manifests 4-5 weeks after a child had COVID-19,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study. “MIS-C is associated with characteristic bright red lips and a red tongue that might resemble a strawberry. Such oral findings should prompt rapid evaluation for other signs and symptoms. There can be redness of the eyes or other more nonspecific skin findings (large or small areas of redness on the trunk or limbs, sometimes with surface change), but more importantly, fever, a rapid heartbeat, diarrhea, or breathing issues. The risk with MIS-C is a rapid decline in a child’s health, with admission to an intensive care unit.”

Dr. Andina-Martinez and his colleagues also contrast the skin findings of MIS-C, which are not generally on the hands or feet, with the so-called “COVID toe” or finger phenomenon, which has also been associated with SARS-CoV-2, particularly in children. “Only one of the patients in this series had skin involvement of a finger, and it only appeared after recovery from MIS-C,” Dr. Ko noted. “Distinguishing COVID toes from MIS-C is important, as COVID toes has a very good outcome, while MIS-C can have severe consequences, including protracted heart disease.”

In other findings, patients who presented with mucocutaneous signs tended to be older than those without skin signs and they presented at the emergency department with poor general status and extreme tachycardia. They also had higher C-reactive protein and D-dimer levels and lower lymphocyte counts and faced a more than a 10-fold increased risk of being admitted to the PICU, compared with patients who did not have skin signs (OR, 10.24; P = .003).

In a separate study published online on April 7 in JAMA Dermatology, Zachary E. Holcomb, MD, of the combined dermatology residency program at Massachusetts General Hospital, Boston, and colleagues presented what is believed to be the first case report of reactive infectious mucocutaneous eruption (RIME) triggered by SARS-CoV-2. RIME is the preferred term for pediatric patients who present with mucositis and rash (often a scant or even absent skin eruption) triggered by various infectious agents.

The patient, a 17-year-old male, presented to the emergency department with 3 days of mouth pain and nonpainful penile erosions. “One week prior, he experienced transient anosmia and ageusia that had since spontaneously resolved,” the researchers wrote. “At that time, he was tested for SARS-CoV-2 infection via nasopharyngeal polymerase chain reaction (PCR), the results of which were positive.”

At presentation, the patient had no fever, his vital signs were normal, and the physical exam revealed shallow erosions of the vermilion lips and hard palate, circumferential erythematous erosions of the periurethral glans penis, and five small vesicles on the trunk and upper extremities. Serum analysis revealed a normal white blood cell count with mild absolute lymphopenia, slightly elevated creatinine level, normal liver function, slightly elevated C-reactive protein level, and normal ferritin level.

Dr. Holcomb and colleagues made a diagnosis of SARS-CoV-2–associated RIME based on microbiological results, which revealed positive repeated SARS-CoV-2 nasopharyngeal PCR and negative nasopharyngeal PCR testing for Mycoplasma pneumoniae, adenovirus, Chlamydophila pneumoniae, human metapneumovirus, influenza A/B, parainfluenza 1 to 4, rhinovirus, and respiratory syncytial virus. In addition, titers of Mycoplasma pneumoniae IgM levels were negative, but Mycoplasma pneumoniae IgG levels were elevated.

The lesions resolved with 60 mg of oral prednisone taken daily for 4 days. A recurrence of oral mucositis 3 months later responded to 80 mg oral prednisone taken daily for 6 days.

“It’s not surprising that SARS-CoV-2 is yet another trigger for RIME,” said Anna Yasmine Kirkorian, MD, chief of the division of dermatology at Children’s National Hospital, Washington, who was asked to comment about the case report.

“The take-home message is for clinicians to be aware of this association and distinguish these patients from those with MIS-C, because patients with MIS-C require monitoring and urgent systemic treatment. RIME and MIS-C may potentially be distinguished clinically based on the nature of the mucositis (hemorrhagic and erosive in RIME, dry, cracked lips with ‘strawberry tongue’ in MIS-C) but more importantly patients with RIME lack laboratory evidence of severe systemic inflammation,” such as ESR, CRP, or ferritin, she said.

“A final interesting point in this article was the recurrence of mucositis in this patient, which could mean that recurrent mucositis/recurrent RIME might be yet another manifestation of ‘long-COVID’ (now called post-Acute Sequelae of SARS-CoV-2 infection) in some patients,” Dr. Kirkorian added. She noted that the American Academy of Dermatology–International League of Dermatologic Societies COVID-19 Dermatology Registry and articles like these “provide invaluable ‘hot off the presses’ information for clinicians who are facing the protean manifestations of a novel viral epidemic.”

The researchers reported having no financial disclosures.
 

[email protected]

Two recent articles in the medical literature provide new information on mucocutaneous manifestations of COVID-19 in children, which may help guide dermatologists in making accurate diagnoses and stratifying children at risk for serious, systemic illness due to the virus.

In a single-center descriptive study carried out over a 9-month period, researchers in Madrid found that of 50 hospitalized children infected with COVID-19, 21 (42%) had mucocutaneous symptoms, most commonly exanthem, followed by conjunctival hyperemia without secretion and red cracked lips or strawberry tongue. In addition, 18 (36%) fulfilled criteria for Multisystem Inflammatory Syndrome in Children (MIS-C).

“Based on findings in adult patients, the skin manifestations of COVID-19 have been classified under five categories: acral pseudo-chilblain, vesicular eruptions, urticarial lesions, maculopapular eruptions, and livedo or necrosis,” David Andina-Martinez, MD, of Hospital Infantil Universitario Niño Jesús, Madrid, and colleagues wrote in the study, which was published online on April 2 in the Journal of the American Academy of Dermatology.

“Chilblain lesions in healthy children and adolescents have received much attention; these lesions resolve without complications after a few weeks,” they added. “Besides, other cutaneous manifestations of COVID-19 in children have been the matter of case reports or small case series. Nevertheless, the mucocutaneous manifestations in hospitalized children infected with SARS-CoV-2 and their implications on the clinical course have not yet been extensively described.”

In an effort to describe the mucocutaneous manifestations in children hospitalized for COVID-19, the researchers evaluated 50 children up to 18 years of age who were admitted between March 1 and Nov. 30, 2020, to Hospital Infantil Universitario Niño Jesús, which was designated as a pediatric reference center during the peak of the pandemic. The main reasons for admission were respiratory illness (40%) and MIS-C (40%).

Of the 50 patients, 44 (88%) had a positive RT-PCR for SARS-CoV-2 and 6 (12%) met clinical suspicion criteria and had a negative RT-PCR with a positive IgG serology. In 34 patients (68%), a close contact with a suspected or confirmed case of COVID-19 was referred, while the source of the infection remained unknown in the remaining 16 patients (32%).

The researchers reported that 21 patients (42%) had mucocutaneous symptoms, most commonly maculopapular exanthem (86%), conjunctival hyperemia (81%), and red cracked lips or strawberry tongue (43%). In addition, 18 of the 21 patients (86%) fulfilled criteria for MIS-C.

“A tricky thing about MIS-C is that it often manifests 4-5 weeks after a child had COVID-19,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study. “MIS-C is associated with characteristic bright red lips and a red tongue that might resemble a strawberry. Such oral findings should prompt rapid evaluation for other signs and symptoms. There can be redness of the eyes or other more nonspecific skin findings (large or small areas of redness on the trunk or limbs, sometimes with surface change), but more importantly, fever, a rapid heartbeat, diarrhea, or breathing issues. The risk with MIS-C is a rapid decline in a child’s health, with admission to an intensive care unit.”

Dr. Andina-Martinez and his colleagues also contrast the skin findings of MIS-C, which are not generally on the hands or feet, with the so-called “COVID toe” or finger phenomenon, which has also been associated with SARS-CoV-2, particularly in children. “Only one of the patients in this series had skin involvement of a finger, and it only appeared after recovery from MIS-C,” Dr. Ko noted. “Distinguishing COVID toes from MIS-C is important, as COVID toes has a very good outcome, while MIS-C can have severe consequences, including protracted heart disease.”

In other findings, patients who presented with mucocutaneous signs tended to be older than those without skin signs and they presented at the emergency department with poor general status and extreme tachycardia. They also had higher C-reactive protein and D-dimer levels and lower lymphocyte counts and faced a more than a 10-fold increased risk of being admitted to the PICU, compared with patients who did not have skin signs (OR, 10.24; P = .003).

In a separate study published online on April 7 in JAMA Dermatology, Zachary E. Holcomb, MD, of the combined dermatology residency program at Massachusetts General Hospital, Boston, and colleagues presented what is believed to be the first case report of reactive infectious mucocutaneous eruption (RIME) triggered by SARS-CoV-2. RIME is the preferred term for pediatric patients who present with mucositis and rash (often a scant or even absent skin eruption) triggered by various infectious agents.

The patient, a 17-year-old male, presented to the emergency department with 3 days of mouth pain and nonpainful penile erosions. “One week prior, he experienced transient anosmia and ageusia that had since spontaneously resolved,” the researchers wrote. “At that time, he was tested for SARS-CoV-2 infection via nasopharyngeal polymerase chain reaction (PCR), the results of which were positive.”

At presentation, the patient had no fever, his vital signs were normal, and the physical exam revealed shallow erosions of the vermilion lips and hard palate, circumferential erythematous erosions of the periurethral glans penis, and five small vesicles on the trunk and upper extremities. Serum analysis revealed a normal white blood cell count with mild absolute lymphopenia, slightly elevated creatinine level, normal liver function, slightly elevated C-reactive protein level, and normal ferritin level.

Dr. Holcomb and colleagues made a diagnosis of SARS-CoV-2–associated RIME based on microbiological results, which revealed positive repeated SARS-CoV-2 nasopharyngeal PCR and negative nasopharyngeal PCR testing for Mycoplasma pneumoniae, adenovirus, Chlamydophila pneumoniae, human metapneumovirus, influenza A/B, parainfluenza 1 to 4, rhinovirus, and respiratory syncytial virus. In addition, titers of Mycoplasma pneumoniae IgM levels were negative, but Mycoplasma pneumoniae IgG levels were elevated.

The lesions resolved with 60 mg of oral prednisone taken daily for 4 days. A recurrence of oral mucositis 3 months later responded to 80 mg oral prednisone taken daily for 6 days.

“It’s not surprising that SARS-CoV-2 is yet another trigger for RIME,” said Anna Yasmine Kirkorian, MD, chief of the division of dermatology at Children’s National Hospital, Washington, who was asked to comment about the case report.

“The take-home message is for clinicians to be aware of this association and distinguish these patients from those with MIS-C, because patients with MIS-C require monitoring and urgent systemic treatment. RIME and MIS-C may potentially be distinguished clinically based on the nature of the mucositis (hemorrhagic and erosive in RIME, dry, cracked lips with ‘strawberry tongue’ in MIS-C) but more importantly patients with RIME lack laboratory evidence of severe systemic inflammation,” such as ESR, CRP, or ferritin, she said.

“A final interesting point in this article was the recurrence of mucositis in this patient, which could mean that recurrent mucositis/recurrent RIME might be yet another manifestation of ‘long-COVID’ (now called post-Acute Sequelae of SARS-CoV-2 infection) in some patients,” Dr. Kirkorian added. She noted that the American Academy of Dermatology–International League of Dermatologic Societies COVID-19 Dermatology Registry and articles like these “provide invaluable ‘hot off the presses’ information for clinicians who are facing the protean manifestations of a novel viral epidemic.”

The researchers reported having no financial disclosures.
 

[email protected]

Two recent articles in the medical literature provide new information on mucocutaneous manifestations of COVID-19 in children, which may help guide dermatologists in making accurate diagnoses and stratifying children at risk for serious, systemic illness due to the virus.

In a single-center descriptive study carried out over a 9-month period, researchers in Madrid found that of 50 hospitalized children infected with COVID-19, 21 (42%) had mucocutaneous symptoms, most commonly exanthem, followed by conjunctival hyperemia without secretion and red cracked lips or strawberry tongue. In addition, 18 (36%) fulfilled criteria for Multisystem Inflammatory Syndrome in Children (MIS-C).

“Based on findings in adult patients, the skin manifestations of COVID-19 have been classified under five categories: acral pseudo-chilblain, vesicular eruptions, urticarial lesions, maculopapular eruptions, and livedo or necrosis,” David Andina-Martinez, MD, of Hospital Infantil Universitario Niño Jesús, Madrid, and colleagues wrote in the study, which was published online on April 2 in the Journal of the American Academy of Dermatology.

“Chilblain lesions in healthy children and adolescents have received much attention; these lesions resolve without complications after a few weeks,” they added. “Besides, other cutaneous manifestations of COVID-19 in children have been the matter of case reports or small case series. Nevertheless, the mucocutaneous manifestations in hospitalized children infected with SARS-CoV-2 and their implications on the clinical course have not yet been extensively described.”

In an effort to describe the mucocutaneous manifestations in children hospitalized for COVID-19, the researchers evaluated 50 children up to 18 years of age who were admitted between March 1 and Nov. 30, 2020, to Hospital Infantil Universitario Niño Jesús, which was designated as a pediatric reference center during the peak of the pandemic. The main reasons for admission were respiratory illness (40%) and MIS-C (40%).

Of the 50 patients, 44 (88%) had a positive RT-PCR for SARS-CoV-2 and 6 (12%) met clinical suspicion criteria and had a negative RT-PCR with a positive IgG serology. In 34 patients (68%), a close contact with a suspected or confirmed case of COVID-19 was referred, while the source of the infection remained unknown in the remaining 16 patients (32%).

The researchers reported that 21 patients (42%) had mucocutaneous symptoms, most commonly maculopapular exanthem (86%), conjunctival hyperemia (81%), and red cracked lips or strawberry tongue (43%). In addition, 18 of the 21 patients (86%) fulfilled criteria for MIS-C.

“A tricky thing about MIS-C is that it often manifests 4-5 weeks after a child had COVID-19,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study. “MIS-C is associated with characteristic bright red lips and a red tongue that might resemble a strawberry. Such oral findings should prompt rapid evaluation for other signs and symptoms. There can be redness of the eyes or other more nonspecific skin findings (large or small areas of redness on the trunk or limbs, sometimes with surface change), but more importantly, fever, a rapid heartbeat, diarrhea, or breathing issues. The risk with MIS-C is a rapid decline in a child’s health, with admission to an intensive care unit.”

Dr. Andina-Martinez and his colleagues also contrast the skin findings of MIS-C, which are not generally on the hands or feet, with the so-called “COVID toe” or finger phenomenon, which has also been associated with SARS-CoV-2, particularly in children. “Only one of the patients in this series had skin involvement of a finger, and it only appeared after recovery from MIS-C,” Dr. Ko noted. “Distinguishing COVID toes from MIS-C is important, as COVID toes has a very good outcome, while MIS-C can have severe consequences, including protracted heart disease.”

In other findings, patients who presented with mucocutaneous signs tended to be older than those without skin signs and they presented at the emergency department with poor general status and extreme tachycardia. They also had higher C-reactive protein and D-dimer levels and lower lymphocyte counts and faced a more than a 10-fold increased risk of being admitted to the PICU, compared with patients who did not have skin signs (OR, 10.24; P = .003).

In a separate study published online on April 7 in JAMA Dermatology, Zachary E. Holcomb, MD, of the combined dermatology residency program at Massachusetts General Hospital, Boston, and colleagues presented what is believed to be the first case report of reactive infectious mucocutaneous eruption (RIME) triggered by SARS-CoV-2. RIME is the preferred term for pediatric patients who present with mucositis and rash (often a scant or even absent skin eruption) triggered by various infectious agents.

The patient, a 17-year-old male, presented to the emergency department with 3 days of mouth pain and nonpainful penile erosions. “One week prior, he experienced transient anosmia and ageusia that had since spontaneously resolved,” the researchers wrote. “At that time, he was tested for SARS-CoV-2 infection via nasopharyngeal polymerase chain reaction (PCR), the results of which were positive.”

At presentation, the patient had no fever, his vital signs were normal, and the physical exam revealed shallow erosions of the vermilion lips and hard palate, circumferential erythematous erosions of the periurethral glans penis, and five small vesicles on the trunk and upper extremities. Serum analysis revealed a normal white blood cell count with mild absolute lymphopenia, slightly elevated creatinine level, normal liver function, slightly elevated C-reactive protein level, and normal ferritin level.

Dr. Holcomb and colleagues made a diagnosis of SARS-CoV-2–associated RIME based on microbiological results, which revealed positive repeated SARS-CoV-2 nasopharyngeal PCR and negative nasopharyngeal PCR testing for Mycoplasma pneumoniae, adenovirus, Chlamydophila pneumoniae, human metapneumovirus, influenza A/B, parainfluenza 1 to 4, rhinovirus, and respiratory syncytial virus. In addition, titers of Mycoplasma pneumoniae IgM levels were negative, but Mycoplasma pneumoniae IgG levels were elevated.

The lesions resolved with 60 mg of oral prednisone taken daily for 4 days. A recurrence of oral mucositis 3 months later responded to 80 mg oral prednisone taken daily for 6 days.

“It’s not surprising that SARS-CoV-2 is yet another trigger for RIME,” said Anna Yasmine Kirkorian, MD, chief of the division of dermatology at Children’s National Hospital, Washington, who was asked to comment about the case report.

“The take-home message is for clinicians to be aware of this association and distinguish these patients from those with MIS-C, because patients with MIS-C require monitoring and urgent systemic treatment. RIME and MIS-C may potentially be distinguished clinically based on the nature of the mucositis (hemorrhagic and erosive in RIME, dry, cracked lips with ‘strawberry tongue’ in MIS-C) but more importantly patients with RIME lack laboratory evidence of severe systemic inflammation,” such as ESR, CRP, or ferritin, she said.

“A final interesting point in this article was the recurrence of mucositis in this patient, which could mean that recurrent mucositis/recurrent RIME might be yet another manifestation of ‘long-COVID’ (now called post-Acute Sequelae of SARS-CoV-2 infection) in some patients,” Dr. Kirkorian added. She noted that the American Academy of Dermatology–International League of Dermatologic Societies COVID-19 Dermatology Registry and articles like these “provide invaluable ‘hot off the presses’ information for clinicians who are facing the protean manifestations of a novel viral epidemic.”

The researchers reported having no financial disclosures.
 

[email protected]

For as many disorders of cornification and types of ichthyosis that have been shown to benefit from retinoids, a seemingly equal number have no data or show no improvement.

According to a consensus statement published in the February issue of Pediatric Dermatology, adequate data exist in the medical literature to demonstrate an improvement in use of systemic retinoids for select genotypes of congenital ichthyosiform erythroderma, epidermolytic ichthyosis, erythrokeratodermia variabilis, harlequin ichthyosis, IFAP syndrome (ichthyosis with confetti, ichthyosis follicularis, atrichia, and photophobia), KID syndrome (keratitis-ichthyosis-deafness), KLICK syndrome (keratosis linearis with ichthyosis congenita and sclerosing keratoderma), lamellar ichthyosis, loricrin keratoderma, neutral lipid storage disease with ichthyosis, recessive X-linked ichthyosis, and Sjögren-Larsson syndrome.

At the same time, limited or no data exist to support the use of systemic retinoids for CHILD syndrome (congenital hemidysplasia with ichthyosiform erythroderma and limb defects), CHIME syndrome (colobomas, heart defects, ichthyosiform dermatosis, intellectual disability, and either ear defects or epilepsy), Conradi-Hunermann-Happle syndrome, ichthyosis-hypotrichosis, ichthyosis-hypotrichosis-sclerosis cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome (mental retardation, enteropathy, deafness, peripheral neuropathy, ichthyosis, and keratoderma), peeling skin disease, Refsum syndrome, and trichothiodystrophy, according to the statement.

“In particular, we did note that, with any disorder that was associated with atopy, the retinoids were often counterproductive,” one of the consensus statement cochairs, Andrea L. Zaenglein, MD, said during the Society for Pediatric Dermatology pre-AAD meeting. “In Netherton syndrome, for example, retinoids seemed to make the skin fragility a lot worse, so typically, they would be avoided in those patients.”

The statement, which she assembled with cochair pediatric dermatologist Moise L. Levy, MD, professor of pediatrics, University of Texas at Austin, and 21 other multidisciplinary experts, recommends considering use of topical retinoids to help decrease scaling of the skin,“but [they] are particularly helpful for more localized complications of ichthyosis, such as digital contractures and ectropion,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey. “A lot of it has to do with the size and the volume of the tubes and getting enough [product] to be able to apply it over larger areas. We do tend to use them more focally.”

While systemic absorption can occur with widespread use, no specific lab monitoring is required. Dr. Zaenglein and her colleagues also recommend avoiding the use of tazarotene during pregnancy, since it is contraindicated in pregnancy (category X), but monthly pregnancy tests are not recommended.

During an overview of the document at the meeting, she noted that the recommended dosing for both isotretinoin and acitretin is 0.5-1.0 mg/kg per day and the side effects tend to be dose dependent, “except teratogenicity, which can occur with even low doses of systemic retinoid exposure and early on in pregnancy.” The authors also advise patients to consider drug holidays or lower doses “especially during warmer, more humid months, where you might not need the higher doses to achieve cutaneous effects,” she said.

They emphasized the importance of avoiding pregnancy for 3 years after completion of treatment with acitretin. “While the half-life of acitretin is 49 hours, it’s easily converted with any alcohol exposure to etretinate,” Dr. Zaenglein noted. “Then, the half-life is 120 days.”

The statement, which was sponsored by the Pediatric Dermatology Research Alliance (PEDRA), also addresses the clinical considerations and consequences of long-term systemic retinoid use on bone health, such as premature epiphyseal closure in preadolescent children. “In general, this risk is greater with higher doses of therapies – above 1 mg/kg per day – and over prolonged periods of time, typically 4-6 years,” she said. Other potential effects on bone health include calcifications of tendons and ligaments, osteophytes or “bone spurs,” DISH (diffuse idiopathic skeletal hyperostosis), and potential alterations in bone density and growth.

“We also have to worry about concomitant effects of contraception, particularly if you’re using progestin-only formulations that carry a black box warning for osteoporosis,” Dr. Zaenglein said. “It is recommended that you limit their use to 3 years.” Other factors to consider include genetic risk and modifiable factors that affect bone health, such as diet and physical activity, which may impact susceptibility to systemic retinoid bone toxicity and should be discussed with the patient.

Recommended bone monitoring in children starts with a comprehensive family and personal medical history for skeletal toxicity risk factors, followed by an annual growth assessment (height, weight, body mass index, and growth curve), asking regularly about musculoskeletal symptoms, and following up with appropriate imaging. “Inquiring about their diet is recommended as well, so making sure they’re getting sufficient amounts of calcium and vitamin D, and no additional vitamin A sources that may compound the side effects from systemic retinoids,” Dr. Zaenglein said.

The document also advises that a baseline skeletal radiographic survey be performed in patients aged 16-18 years. This may include imaging of the lateral cervical and thoracic spine, lateral view of the calcanei to include Achilles tendon, hips and symptomatic areas, and bone density evaluation.

The statement addressed the psychiatric considerations and consequences of long-term systemic retinoid use. One cross-sectional study of children with ichthyosis found that 30% screened positive for depression and 38% screened positive for anxiety, “but the role of retinoids is unclear,” Dr. Zaenglein said. “It’s a complicated matter, but patients with a personal history of depression, anxiety, and other affective disorders prior to initiation of systemic retinoid treatment should be monitored carefully for exacerbation of symptoms. Comanagement with a mental health provider should be considered.”

As for contraception considerations with long-term systemic retinoid therapy use, the authors recommend that two forms of contraception be used. “Consider long-acting reversible contraception, especially in sexually active adolescents who have a history of noncompliance, or to remove the risk of teratogenicity for them,” she said. “We’re not sure what additive effects progestin/lower estrogen have on long-term cardiovascular health, including lipids and bone density.”

The authors noted that iPLEDGE is not designed for long-term use. “It’s really designed for the on-label use of systemic retinoids in severe acne, where you’re using it for 5-6 months, not for 5-6 years,” Dr. Zaenglein said. “iPLEDGE does impose significant and financial barriers for our patients. More advocacy is needed to adapt that program for our patients.”

She and her coauthors acknowledged practice gaps and unmet needs in patients with disorders of cornification/types of ichthyosis, including the optimal formulation of retinoids based on ichthyosis subtype, whether there is a benefit to intermittent therapy with respect to risk of toxicity and maintenance of efficacy, and how to minimize the bone-related changes that can occur with treatment. “These are some of the things that we can look further into,” she said. “For now, though, retinoids can improve function and quality of life in patients with ichthyosis and disorders of cornification. Many questions still exist, and more data and research are needed.”

Sun Pharmaceuticals and the Foundation for Ichthyosis and Related Skin Types (FIRST) provided an unrestricted grant for development of the recommendations.

Dr. Zaenglein disclosed that she is a consultant for Pfizer. She is also an advisory board member for Dermata, Sol-Gel, Regeneron, Verrica, and Cassiopea, and has conducted contracted research for AbbVie, Incyte, Arcutis, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or had other relationships with various pharmaceutical companies.

[email protected]

For as many disorders of cornification and types of ichthyosis that have been shown to benefit from retinoids, a seemingly equal number have no data or show no improvement.

According to a consensus statement published in the February issue of Pediatric Dermatology, adequate data exist in the medical literature to demonstrate an improvement in use of systemic retinoids for select genotypes of congenital ichthyosiform erythroderma, epidermolytic ichthyosis, erythrokeratodermia variabilis, harlequin ichthyosis, IFAP syndrome (ichthyosis with confetti, ichthyosis follicularis, atrichia, and photophobia), KID syndrome (keratitis-ichthyosis-deafness), KLICK syndrome (keratosis linearis with ichthyosis congenita and sclerosing keratoderma), lamellar ichthyosis, loricrin keratoderma, neutral lipid storage disease with ichthyosis, recessive X-linked ichthyosis, and Sjögren-Larsson syndrome.

At the same time, limited or no data exist to support the use of systemic retinoids for CHILD syndrome (congenital hemidysplasia with ichthyosiform erythroderma and limb defects), CHIME syndrome (colobomas, heart defects, ichthyosiform dermatosis, intellectual disability, and either ear defects or epilepsy), Conradi-Hunermann-Happle syndrome, ichthyosis-hypotrichosis, ichthyosis-hypotrichosis-sclerosis cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome (mental retardation, enteropathy, deafness, peripheral neuropathy, ichthyosis, and keratoderma), peeling skin disease, Refsum syndrome, and trichothiodystrophy, according to the statement.

“In particular, we did note that, with any disorder that was associated with atopy, the retinoids were often counterproductive,” one of the consensus statement cochairs, Andrea L. Zaenglein, MD, said during the Society for Pediatric Dermatology pre-AAD meeting. “In Netherton syndrome, for example, retinoids seemed to make the skin fragility a lot worse, so typically, they would be avoided in those patients.”

The statement, which she assembled with cochair pediatric dermatologist Moise L. Levy, MD, professor of pediatrics, University of Texas at Austin, and 21 other multidisciplinary experts, recommends considering use of topical retinoids to help decrease scaling of the skin,“but [they] are particularly helpful for more localized complications of ichthyosis, such as digital contractures and ectropion,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey. “A lot of it has to do with the size and the volume of the tubes and getting enough [product] to be able to apply it over larger areas. We do tend to use them more focally.”

While systemic absorption can occur with widespread use, no specific lab monitoring is required. Dr. Zaenglein and her colleagues also recommend avoiding the use of tazarotene during pregnancy, since it is contraindicated in pregnancy (category X), but monthly pregnancy tests are not recommended.

During an overview of the document at the meeting, she noted that the recommended dosing for both isotretinoin and acitretin is 0.5-1.0 mg/kg per day and the side effects tend to be dose dependent, “except teratogenicity, which can occur with even low doses of systemic retinoid exposure and early on in pregnancy.” The authors also advise patients to consider drug holidays or lower doses “especially during warmer, more humid months, where you might not need the higher doses to achieve cutaneous effects,” she said.

They emphasized the importance of avoiding pregnancy for 3 years after completion of treatment with acitretin. “While the half-life of acitretin is 49 hours, it’s easily converted with any alcohol exposure to etretinate,” Dr. Zaenglein noted. “Then, the half-life is 120 days.”

The statement, which was sponsored by the Pediatric Dermatology Research Alliance (PEDRA), also addresses the clinical considerations and consequences of long-term systemic retinoid use on bone health, such as premature epiphyseal closure in preadolescent children. “In general, this risk is greater with higher doses of therapies – above 1 mg/kg per day – and over prolonged periods of time, typically 4-6 years,” she said. Other potential effects on bone health include calcifications of tendons and ligaments, osteophytes or “bone spurs,” DISH (diffuse idiopathic skeletal hyperostosis), and potential alterations in bone density and growth.

“We also have to worry about concomitant effects of contraception, particularly if you’re using progestin-only formulations that carry a black box warning for osteoporosis,” Dr. Zaenglein said. “It is recommended that you limit their use to 3 years.” Other factors to consider include genetic risk and modifiable factors that affect bone health, such as diet and physical activity, which may impact susceptibility to systemic retinoid bone toxicity and should be discussed with the patient.

Recommended bone monitoring in children starts with a comprehensive family and personal medical history for skeletal toxicity risk factors, followed by an annual growth assessment (height, weight, body mass index, and growth curve), asking regularly about musculoskeletal symptoms, and following up with appropriate imaging. “Inquiring about their diet is recommended as well, so making sure they’re getting sufficient amounts of calcium and vitamin D, and no additional vitamin A sources that may compound the side effects from systemic retinoids,” Dr. Zaenglein said.

The document also advises that a baseline skeletal radiographic survey be performed in patients aged 16-18 years. This may include imaging of the lateral cervical and thoracic spine, lateral view of the calcanei to include Achilles tendon, hips and symptomatic areas, and bone density evaluation.

The statement addressed the psychiatric considerations and consequences of long-term systemic retinoid use. One cross-sectional study of children with ichthyosis found that 30% screened positive for depression and 38% screened positive for anxiety, “but the role of retinoids is unclear,” Dr. Zaenglein said. “It’s a complicated matter, but patients with a personal history of depression, anxiety, and other affective disorders prior to initiation of systemic retinoid treatment should be monitored carefully for exacerbation of symptoms. Comanagement with a mental health provider should be considered.”

As for contraception considerations with long-term systemic retinoid therapy use, the authors recommend that two forms of contraception be used. “Consider long-acting reversible contraception, especially in sexually active adolescents who have a history of noncompliance, or to remove the risk of teratogenicity for them,” she said. “We’re not sure what additive effects progestin/lower estrogen have on long-term cardiovascular health, including lipids and bone density.”

The authors noted that iPLEDGE is not designed for long-term use. “It’s really designed for the on-label use of systemic retinoids in severe acne, where you’re using it for 5-6 months, not for 5-6 years,” Dr. Zaenglein said. “iPLEDGE does impose significant and financial barriers for our patients. More advocacy is needed to adapt that program for our patients.”

She and her coauthors acknowledged practice gaps and unmet needs in patients with disorders of cornification/types of ichthyosis, including the optimal formulation of retinoids based on ichthyosis subtype, whether there is a benefit to intermittent therapy with respect to risk of toxicity and maintenance of efficacy, and how to minimize the bone-related changes that can occur with treatment. “These are some of the things that we can look further into,” she said. “For now, though, retinoids can improve function and quality of life in patients with ichthyosis and disorders of cornification. Many questions still exist, and more data and research are needed.”

Sun Pharmaceuticals and the Foundation for Ichthyosis and Related Skin Types (FIRST) provided an unrestricted grant for development of the recommendations.

Dr. Zaenglein disclosed that she is a consultant for Pfizer. She is also an advisory board member for Dermata, Sol-Gel, Regeneron, Verrica, and Cassiopea, and has conducted contracted research for AbbVie, Incyte, Arcutis, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or had other relationships with various pharmaceutical companies.

[email protected]

For as many disorders of cornification and types of ichthyosis that have been shown to benefit from retinoids, a seemingly equal number have no data or show no improvement.

According to a consensus statement published in the February issue of Pediatric Dermatology, adequate data exist in the medical literature to demonstrate an improvement in use of systemic retinoids for select genotypes of congenital ichthyosiform erythroderma, epidermolytic ichthyosis, erythrokeratodermia variabilis, harlequin ichthyosis, IFAP syndrome (ichthyosis with confetti, ichthyosis follicularis, atrichia, and photophobia), KID syndrome (keratitis-ichthyosis-deafness), KLICK syndrome (keratosis linearis with ichthyosis congenita and sclerosing keratoderma), lamellar ichthyosis, loricrin keratoderma, neutral lipid storage disease with ichthyosis, recessive X-linked ichthyosis, and Sjögren-Larsson syndrome.

At the same time, limited or no data exist to support the use of systemic retinoids for CHILD syndrome (congenital hemidysplasia with ichthyosiform erythroderma and limb defects), CHIME syndrome (colobomas, heart defects, ichthyosiform dermatosis, intellectual disability, and either ear defects or epilepsy), Conradi-Hunermann-Happle syndrome, ichthyosis-hypotrichosis, ichthyosis-hypotrichosis-sclerosis cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome (mental retardation, enteropathy, deafness, peripheral neuropathy, ichthyosis, and keratoderma), peeling skin disease, Refsum syndrome, and trichothiodystrophy, according to the statement.

“In particular, we did note that, with any disorder that was associated with atopy, the retinoids were often counterproductive,” one of the consensus statement cochairs, Andrea L. Zaenglein, MD, said during the Society for Pediatric Dermatology pre-AAD meeting. “In Netherton syndrome, for example, retinoids seemed to make the skin fragility a lot worse, so typically, they would be avoided in those patients.”

The statement, which she assembled with cochair pediatric dermatologist Moise L. Levy, MD, professor of pediatrics, University of Texas at Austin, and 21 other multidisciplinary experts, recommends considering use of topical retinoids to help decrease scaling of the skin,“but [they] are particularly helpful for more localized complications of ichthyosis, such as digital contractures and ectropion,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey. “A lot of it has to do with the size and the volume of the tubes and getting enough [product] to be able to apply it over larger areas. We do tend to use them more focally.”

While systemic absorption can occur with widespread use, no specific lab monitoring is required. Dr. Zaenglein and her colleagues also recommend avoiding the use of tazarotene during pregnancy, since it is contraindicated in pregnancy (category X), but monthly pregnancy tests are not recommended.

During an overview of the document at the meeting, she noted that the recommended dosing for both isotretinoin and acitretin is 0.5-1.0 mg/kg per day and the side effects tend to be dose dependent, “except teratogenicity, which can occur with even low doses of systemic retinoid exposure and early on in pregnancy.” The authors also advise patients to consider drug holidays or lower doses “especially during warmer, more humid months, where you might not need the higher doses to achieve cutaneous effects,” she said.

They emphasized the importance of avoiding pregnancy for 3 years after completion of treatment with acitretin. “While the half-life of acitretin is 49 hours, it’s easily converted with any alcohol exposure to etretinate,” Dr. Zaenglein noted. “Then, the half-life is 120 days.”

The statement, which was sponsored by the Pediatric Dermatology Research Alliance (PEDRA), also addresses the clinical considerations and consequences of long-term systemic retinoid use on bone health, such as premature epiphyseal closure in preadolescent children. “In general, this risk is greater with higher doses of therapies – above 1 mg/kg per day – and over prolonged periods of time, typically 4-6 years,” she said. Other potential effects on bone health include calcifications of tendons and ligaments, osteophytes or “bone spurs,” DISH (diffuse idiopathic skeletal hyperostosis), and potential alterations in bone density and growth.

“We also have to worry about concomitant effects of contraception, particularly if you’re using progestin-only formulations that carry a black box warning for osteoporosis,” Dr. Zaenglein said. “It is recommended that you limit their use to 3 years.” Other factors to consider include genetic risk and modifiable factors that affect bone health, such as diet and physical activity, which may impact susceptibility to systemic retinoid bone toxicity and should be discussed with the patient.

Recommended bone monitoring in children starts with a comprehensive family and personal medical history for skeletal toxicity risk factors, followed by an annual growth assessment (height, weight, body mass index, and growth curve), asking regularly about musculoskeletal symptoms, and following up with appropriate imaging. “Inquiring about their diet is recommended as well, so making sure they’re getting sufficient amounts of calcium and vitamin D, and no additional vitamin A sources that may compound the side effects from systemic retinoids,” Dr. Zaenglein said.

The document also advises that a baseline skeletal radiographic survey be performed in patients aged 16-18 years. This may include imaging of the lateral cervical and thoracic spine, lateral view of the calcanei to include Achilles tendon, hips and symptomatic areas, and bone density evaluation.

The statement addressed the psychiatric considerations and consequences of long-term systemic retinoid use. One cross-sectional study of children with ichthyosis found that 30% screened positive for depression and 38% screened positive for anxiety, “but the role of retinoids is unclear,” Dr. Zaenglein said. “It’s a complicated matter, but patients with a personal history of depression, anxiety, and other affective disorders prior to initiation of systemic retinoid treatment should be monitored carefully for exacerbation of symptoms. Comanagement with a mental health provider should be considered.”

As for contraception considerations with long-term systemic retinoid therapy use, the authors recommend that two forms of contraception be used. “Consider long-acting reversible contraception, especially in sexually active adolescents who have a history of noncompliance, or to remove the risk of teratogenicity for them,” she said. “We’re not sure what additive effects progestin/lower estrogen have on long-term cardiovascular health, including lipids and bone density.”

The authors noted that iPLEDGE is not designed for long-term use. “It’s really designed for the on-label use of systemic retinoids in severe acne, where you’re using it for 5-6 months, not for 5-6 years,” Dr. Zaenglein said. “iPLEDGE does impose significant and financial barriers for our patients. More advocacy is needed to adapt that program for our patients.”

She and her coauthors acknowledged practice gaps and unmet needs in patients with disorders of cornification/types of ichthyosis, including the optimal formulation of retinoids based on ichthyosis subtype, whether there is a benefit to intermittent therapy with respect to risk of toxicity and maintenance of efficacy, and how to minimize the bone-related changes that can occur with treatment. “These are some of the things that we can look further into,” she said. “For now, though, retinoids can improve function and quality of life in patients with ichthyosis and disorders of cornification. Many questions still exist, and more data and research are needed.”

Sun Pharmaceuticals and the Foundation for Ichthyosis and Related Skin Types (FIRST) provided an unrestricted grant for development of the recommendations.

Dr. Zaenglein disclosed that she is a consultant for Pfizer. She is also an advisory board member for Dermata, Sol-Gel, Regeneron, Verrica, and Cassiopea, and has conducted contracted research for AbbVie, Incyte, Arcutis, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or had other relationships with various pharmaceutical companies.

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

Patients at very high risk for melanoma, including those with a family history or with inherited pathogenic variants of genes that increase the risk, likely benefit from routine whole-body screening for melanoma and education about UV protection.

Those are key findings from the first prospective cohort study to quantify the benefit of screening in melanoma-prone families, which was published online April 2 in Cancer Epidemiology, Biomarkers & Prevention.

“Whole-body screening for melanoma is currently routine for individuals at high risk for melanoma, which includes people from melanoma-prone families (at least two relatives who have had melanoma) and those with inherited pathogenic gene variants of the CDKN2A or CDK4 genes, which increase risk for melanoma,” lead author Michael R. Sargen, MD, said in an interview. “In our study, we investigated whether screening and educational interventions, including education about the appearance of melanoma and strategies for protecting skin from ultraviolet damage, contributed to early diagnosis of melanoma in individuals from melanoma-prone families.”

Of the 293 individuals who enrolled in the study between 1976 and 2014, 246 were diagnosed with melanoma before enrollment (the prestudy cohort) and 47 were diagnosed after enrollment (the prospective cohort). The researchers compared differences in melanoma thickness and tumor stage between participants in the prestudy and prospective cohorts, and compared tumor-thickness trends between participants in their study and cases in the general population using data from Surveillance, Epidemiology, and End Results (SEER) registries between 1973 and 2016. Because information on melanoma thickness was missing for 24% of melanoma cases in the NCI Familial Melanoma Study and 8.7% of melanoma cases found in the SEER registry, the researchers imputed the missing data.

After adjusting for gender and age, Dr. Sargen and his colleagues found that participants in the prospective cohort had significantly thinner melanomas, compared with those in the prestudy cohort (0.6 mm vs. 1.1 mm, respectively; P < .001). In addition, 83% of those in the prospective cohort were significantly more likely to be diagnosed at the early T1 stage, compared with 40% of those in the prestudy cohort (P < .001).

In their analysis, they also determined that after adjusting for gender and age, “all NCI family cases had systematically lower thickness than SEER cases during the study period.” The reductions in melanoma thickness and tumor stage, they concluded, “were not fully explained by calendar period effects of decreasing thickness in the general population and point to the potential benefit of skin cancer screening for patients with a family history of melanoma and those with pathogenic germline variants of melanoma-susceptibility genes.”

“Our data provide reassuring evidence that screening, alongside education about proper UV protection and the appearance of melanoma, is likely benefiting patients with a significantly elevated risk for melanoma,” Dr. Sargen said in the interview “Further studies are needed to determine whether individuals without a family history of melanoma may benefit from whole-body screening, and whether the benefits vary by ethnicity.”

He acknowledged certain limitations of the study, including the relatively small sample size of melanoma cases in the NCI Familial Melanoma Study and the imputation of missing melanoma-thickness data. “Additionally, since this was a prospective cohort study, we were not able to distinguish the independent effect of each intervention,” he said. “Randomized controlled studies are needed to understand the impact of each aspect of the intervention, such as whole-body screening, melanoma education, or strategies for skin protection.”

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard University, Boston, called the analysis “well done,” but commented on the potential role of selection bias impacting the findings. “People who have a strong family history of melanoma and who are opting to engage in an NCI study and come in for full-body skin checks and go through that education process may have very different health-seeking behaviors than individuals in the general population that would be reported to SEER,” she said.

She also raised the question of whether the results were driven by the early detection through the NCI’s program of provider screening or through the educational component that enables earlier self-detection. “If you’re an individual involved in a study and that brings attention to your moles and you have a strong family history of melanoma to begin with, it is not surprising that you are going to have heightened awareness of any changing mole and therefore are more likely to have melanoma detected at an earlier stage,” Dr. Asgari said.

The study was supported by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Dr. Sargen reported having no financial disclosures.
Dr. Asgari disclosed that she has received research support from the Melanoma Research Alliance.
 

[email protected]

Patients at very high risk for melanoma, including those with a family history or with inherited pathogenic variants of genes that increase the risk, likely benefit from routine whole-body screening for melanoma and education about UV protection.

Those are key findings from the first prospective cohort study to quantify the benefit of screening in melanoma-prone families, which was published online April 2 in Cancer Epidemiology, Biomarkers & Prevention.

“Whole-body screening for melanoma is currently routine for individuals at high risk for melanoma, which includes people from melanoma-prone families (at least two relatives who have had melanoma) and those with inherited pathogenic gene variants of the CDKN2A or CDK4 genes, which increase risk for melanoma,” lead author Michael R. Sargen, MD, said in an interview. “In our study, we investigated whether screening and educational interventions, including education about the appearance of melanoma and strategies for protecting skin from ultraviolet damage, contributed to early diagnosis of melanoma in individuals from melanoma-prone families.”

Of the 293 individuals who enrolled in the study between 1976 and 2014, 246 were diagnosed with melanoma before enrollment (the prestudy cohort) and 47 were diagnosed after enrollment (the prospective cohort). The researchers compared differences in melanoma thickness and tumor stage between participants in the prestudy and prospective cohorts, and compared tumor-thickness trends between participants in their study and cases in the general population using data from Surveillance, Epidemiology, and End Results (SEER) registries between 1973 and 2016. Because information on melanoma thickness was missing for 24% of melanoma cases in the NCI Familial Melanoma Study and 8.7% of melanoma cases found in the SEER registry, the researchers imputed the missing data.

After adjusting for gender and age, Dr. Sargen and his colleagues found that participants in the prospective cohort had significantly thinner melanomas, compared with those in the prestudy cohort (0.6 mm vs. 1.1 mm, respectively; P < .001). In addition, 83% of those in the prospective cohort were significantly more likely to be diagnosed at the early T1 stage, compared with 40% of those in the prestudy cohort (P < .001).

In their analysis, they also determined that after adjusting for gender and age, “all NCI family cases had systematically lower thickness than SEER cases during the study period.” The reductions in melanoma thickness and tumor stage, they concluded, “were not fully explained by calendar period effects of decreasing thickness in the general population and point to the potential benefit of skin cancer screening for patients with a family history of melanoma and those with pathogenic germline variants of melanoma-susceptibility genes.”

“Our data provide reassuring evidence that screening, alongside education about proper UV protection and the appearance of melanoma, is likely benefiting patients with a significantly elevated risk for melanoma,” Dr. Sargen said in the interview “Further studies are needed to determine whether individuals without a family history of melanoma may benefit from whole-body screening, and whether the benefits vary by ethnicity.”

He acknowledged certain limitations of the study, including the relatively small sample size of melanoma cases in the NCI Familial Melanoma Study and the imputation of missing melanoma-thickness data. “Additionally, since this was a prospective cohort study, we were not able to distinguish the independent effect of each intervention,” he said. “Randomized controlled studies are needed to understand the impact of each aspect of the intervention, such as whole-body screening, melanoma education, or strategies for skin protection.”

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard University, Boston, called the analysis “well done,” but commented on the potential role of selection bias impacting the findings. “People who have a strong family history of melanoma and who are opting to engage in an NCI study and come in for full-body skin checks and go through that education process may have very different health-seeking behaviors than individuals in the general population that would be reported to SEER,” she said.

She also raised the question of whether the results were driven by the early detection through the NCI’s program of provider screening or through the educational component that enables earlier self-detection. “If you’re an individual involved in a study and that brings attention to your moles and you have a strong family history of melanoma to begin with, it is not surprising that you are going to have heightened awareness of any changing mole and therefore are more likely to have melanoma detected at an earlier stage,” Dr. Asgari said.

The study was supported by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Dr. Sargen reported having no financial disclosures.
Dr. Asgari disclosed that she has received research support from the Melanoma Research Alliance.
 

[email protected]

Patients at very high risk for melanoma, including those with a family history or with inherited pathogenic variants of genes that increase the risk, likely benefit from routine whole-body screening for melanoma and education about UV protection.

Those are key findings from the first prospective cohort study to quantify the benefit of screening in melanoma-prone families, which was published online April 2 in Cancer Epidemiology, Biomarkers & Prevention.

“Whole-body screening for melanoma is currently routine for individuals at high risk for melanoma, which includes people from melanoma-prone families (at least two relatives who have had melanoma) and those with inherited pathogenic gene variants of the CDKN2A or CDK4 genes, which increase risk for melanoma,” lead author Michael R. Sargen, MD, said in an interview. “In our study, we investigated whether screening and educational interventions, including education about the appearance of melanoma and strategies for protecting skin from ultraviolet damage, contributed to early diagnosis of melanoma in individuals from melanoma-prone families.”

Of the 293 individuals who enrolled in the study between 1976 and 2014, 246 were diagnosed with melanoma before enrollment (the prestudy cohort) and 47 were diagnosed after enrollment (the prospective cohort). The researchers compared differences in melanoma thickness and tumor stage between participants in the prestudy and prospective cohorts, and compared tumor-thickness trends between participants in their study and cases in the general population using data from Surveillance, Epidemiology, and End Results (SEER) registries between 1973 and 2016. Because information on melanoma thickness was missing for 24% of melanoma cases in the NCI Familial Melanoma Study and 8.7% of melanoma cases found in the SEER registry, the researchers imputed the missing data.

After adjusting for gender and age, Dr. Sargen and his colleagues found that participants in the prospective cohort had significantly thinner melanomas, compared with those in the prestudy cohort (0.6 mm vs. 1.1 mm, respectively; P < .001). In addition, 83% of those in the prospective cohort were significantly more likely to be diagnosed at the early T1 stage, compared with 40% of those in the prestudy cohort (P < .001).

In their analysis, they also determined that after adjusting for gender and age, “all NCI family cases had systematically lower thickness than SEER cases during the study period.” The reductions in melanoma thickness and tumor stage, they concluded, “were not fully explained by calendar period effects of decreasing thickness in the general population and point to the potential benefit of skin cancer screening for patients with a family history of melanoma and those with pathogenic germline variants of melanoma-susceptibility genes.”

“Our data provide reassuring evidence that screening, alongside education about proper UV protection and the appearance of melanoma, is likely benefiting patients with a significantly elevated risk for melanoma,” Dr. Sargen said in the interview “Further studies are needed to determine whether individuals without a family history of melanoma may benefit from whole-body screening, and whether the benefits vary by ethnicity.”

He acknowledged certain limitations of the study, including the relatively small sample size of melanoma cases in the NCI Familial Melanoma Study and the imputation of missing melanoma-thickness data. “Additionally, since this was a prospective cohort study, we were not able to distinguish the independent effect of each intervention,” he said. “Randomized controlled studies are needed to understand the impact of each aspect of the intervention, such as whole-body screening, melanoma education, or strategies for skin protection.”

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard University, Boston, called the analysis “well done,” but commented on the potential role of selection bias impacting the findings. “People who have a strong family history of melanoma and who are opting to engage in an NCI study and come in for full-body skin checks and go through that education process may have very different health-seeking behaviors than individuals in the general population that would be reported to SEER,” she said.

She also raised the question of whether the results were driven by the early detection through the NCI’s program of provider screening or through the educational component that enables earlier self-detection. “If you’re an individual involved in a study and that brings attention to your moles and you have a strong family history of melanoma to begin with, it is not surprising that you are going to have heightened awareness of any changing mole and therefore are more likely to have melanoma detected at an earlier stage,” Dr. Asgari said.

The study was supported by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Dr. Sargen reported having no financial disclosures.
Dr. Asgari disclosed that she has received research support from the Melanoma Research Alliance.
 

[email protected]

If everything goes as planned, the Pfizer and Moderna mRNA COVID-19 vaccines could be granted emergency use authorization (EUA) for children aged 12 years and older by the fall of 2021.

Courtesy Dr. Maldonado

According to Yvonne Maldonado, MD, Pfizer has fully enrolled adolescent trials and Moderna is currently enrolling 3,000 adolescents in a safety and reactogenicity trial known as TeenCOVE, in which participants will receive an intramuscular injection of 100 mcg mRNA-1273 on day 1 and on day 29. Meanwhile, Johnson & Johnson and AstraZeneca will be starting to enroll older children and adolescents into studies within the next several weeks.

The companies are also planning to enroll younger children, Dr. Maldonado, the Taube professor of global health and infectious diseases at Stanford (Calif.) University, said during the Society for Pediatric Dermatology pre-AAD meeting. “At least two of the vaccine companies have indicated that they would like to start enrolling children as young as 2-5 years of age and eventually getting down to infants and toddlers if the vaccines prove to be safe and effective in the older children. Eventually, we hope to get to the level where we can have several vaccine candidates for all children 6 months of age and older.”

In the future, she said, infectious disease experts hope to see antiviral, immunomodulatory, anti-inflammatory, and monoclonal therapies for all populations including children, although trials in this population have not begun. “Clinical trials must be flexible and adaptive to deal with children and adolescents,” added Dr. Maldonado, who is also senior associate dean for faculty development and diversity at Stanford.

“We would ideally like to have new correlates of protection, as well as biomarkers to follow for evidence of effectiveness. We also would love to see vaccines in the pediatric population as soon as possible, because herd immunity is the ultimate goal for protection against this disease and prevention of additional transmission over time.” However, she said, the degree and durability of immunity has yet to be determined, and vaccine-associated immune effects are unknown. In the meantime, infectious disease researchers expect nonpharmacologic interventions, such as wearing face masks and social distancing to continue for an undefined period.

(Less than 2 weeks after Dr. Maldonado spoke at the SPD meeting, Pfizer announced in a press release that, in phase 3 clinical trials, the company’s coronavirus vaccine was 100% effective in protecting children aged 12-15 years from infection, with a “robust” antibody responses and side effects similar to those experienced by those aged 16-25 years. The company also announced that it plans to seek Food and Drug Administration EUA for this age group. Asked to comment on this update, Dr. Maldonado said the results released by Pfizer “suggest that their COVID-19 vaccine is very safe and highly effective in preventing COVID-19 among children 12-15 years of age.” She added that additional data from the Pfizer trials as well as from Moderna and Johnson & Johnson vaccine trials “will hopefully lead to FDA EUA review in the coming weeks,” and that COVID-19 vaccinations for children “may be possible by this summer.”)
 

_{Children with underlying diseases or on immune suppressants}

At the SPD meeting, an attendee asked if there were any pediatric patients for whom she would not recommend receiving a COVID-19 vaccine because of an underlying disease or concurrent therapy with immune suppressants. “We don’t have those data yet,” Dr. Maldonado said. “Based on what we’re seeing with adults, it does appear that those with underlying conditions are at somewhat higher risk of developing severe infection and may therefore most likely to need vaccination. Most of those risks are cardiovascular, obesity, and other factors, but not necessarily immunocompromising conditions. More likely what we’re seeing is that people with underlying immunocompromising conditions may not mount a good response to the vaccines at this time. It doesn’t mean we shouldn’t give the vaccines, but we need to learn more about that.”

Dr. Maldonado went on to note that, as vaccine manufacturers commence pediatric trials, healthy children will be tested first, followed in due time with children who have immunocompromised conditions. “The question will be whether or not we should give monoclonal antibodies to those particular children to help boost their immunity to SARS-CoV-2, because they might not have a good response to the vaccines,” she said. “Those things need to be sorted out, but there’s no safety signal or concerns at this point for vaccine to be given to immunocompromised individuals.”

Another meeting attendee asked Dr. Maldonado if she thinks there is a practical role for assessing markers of T-cell immunity when evaluating suspected COVID-19 patients who may test negative on serology, Dr. Maldonado said that she and her colleagues are seeking pediatric patients who were treated for COVID-19 at Stanford, in an effort to sort this out.

They are checking peripheral blood mononuclear cells in these patients “to try and tease out what the immune response is in kids who have serious disease, versus those who came in with acute disease, versus those who are asymptomatic,” and comparing them with children who don’t have infection, she explained. “The question is, what is the role of T cells and how much do they contribute? One of the biggest questions we have is, do we have an immune correlate? Can we detect a particular level of neutralizing antibody that seems to be protective? If so, how long is it protective, and can we look for T- and B-cell memory cells and effector vector cells and see how long those effector vector cells can be active in protection? Those are studies that are ongoing now.”

Dr. Maldonado disclosed that she is a member of the data safety monitoring board for a non–COVID-19 vaccine being developed by Pfizer.

[email protected]

If everything goes as planned, the Pfizer and Moderna mRNA COVID-19 vaccines could be granted emergency use authorization (EUA) for children aged 12 years and older by the fall of 2021.

Courtesy Dr. Maldonado

According to Yvonne Maldonado, MD, Pfizer has fully enrolled adolescent trials and Moderna is currently enrolling 3,000 adolescents in a safety and reactogenicity trial known as TeenCOVE, in which participants will receive an intramuscular injection of 100 mcg mRNA-1273 on day 1 and on day 29. Meanwhile, Johnson & Johnson and AstraZeneca will be starting to enroll older children and adolescents into studies within the next several weeks.

The companies are also planning to enroll younger children, Dr. Maldonado, the Taube professor of global health and infectious diseases at Stanford (Calif.) University, said during the Society for Pediatric Dermatology pre-AAD meeting. “At least two of the vaccine companies have indicated that they would like to start enrolling children as young as 2-5 years of age and eventually getting down to infants and toddlers if the vaccines prove to be safe and effective in the older children. Eventually, we hope to get to the level where we can have several vaccine candidates for all children 6 months of age and older.”

In the future, she said, infectious disease experts hope to see antiviral, immunomodulatory, anti-inflammatory, and monoclonal therapies for all populations including children, although trials in this population have not begun. “Clinical trials must be flexible and adaptive to deal with children and adolescents,” added Dr. Maldonado, who is also senior associate dean for faculty development and diversity at Stanford.

“We would ideally like to have new correlates of protection, as well as biomarkers to follow for evidence of effectiveness. We also would love to see vaccines in the pediatric population as soon as possible, because herd immunity is the ultimate goal for protection against this disease and prevention of additional transmission over time.” However, she said, the degree and durability of immunity has yet to be determined, and vaccine-associated immune effects are unknown. In the meantime, infectious disease researchers expect nonpharmacologic interventions, such as wearing face masks and social distancing to continue for an undefined period.

(Less than 2 weeks after Dr. Maldonado spoke at the SPD meeting, Pfizer announced in a press release that, in phase 3 clinical trials, the company’s coronavirus vaccine was 100% effective in protecting children aged 12-15 years from infection, with a “robust” antibody responses and side effects similar to those experienced by those aged 16-25 years. The company also announced that it plans to seek Food and Drug Administration EUA for this age group. Asked to comment on this update, Dr. Maldonado said the results released by Pfizer “suggest that their COVID-19 vaccine is very safe and highly effective in preventing COVID-19 among children 12-15 years of age.” She added that additional data from the Pfizer trials as well as from Moderna and Johnson & Johnson vaccine trials “will hopefully lead to FDA EUA review in the coming weeks,” and that COVID-19 vaccinations for children “may be possible by this summer.”)
 

_{Children with underlying diseases or on immune suppressants}

At the SPD meeting, an attendee asked if there were any pediatric patients for whom she would not recommend receiving a COVID-19 vaccine because of an underlying disease or concurrent therapy with immune suppressants. “We don’t have those data yet,” Dr. Maldonado said. “Based on what we’re seeing with adults, it does appear that those with underlying conditions are at somewhat higher risk of developing severe infection and may therefore most likely to need vaccination. Most of those risks are cardiovascular, obesity, and other factors, but not necessarily immunocompromising conditions. More likely what we’re seeing is that people with underlying immunocompromising conditions may not mount a good response to the vaccines at this time. It doesn’t mean we shouldn’t give the vaccines, but we need to learn more about that.”

Dr. Maldonado went on to note that, as vaccine manufacturers commence pediatric trials, healthy children will be tested first, followed in due time with children who have immunocompromised conditions. “The question will be whether or not we should give monoclonal antibodies to those particular children to help boost their immunity to SARS-CoV-2, because they might not have a good response to the vaccines,” she said. “Those things need to be sorted out, but there’s no safety signal or concerns at this point for vaccine to be given to immunocompromised individuals.”

Another meeting attendee asked Dr. Maldonado if she thinks there is a practical role for assessing markers of T-cell immunity when evaluating suspected COVID-19 patients who may test negative on serology, Dr. Maldonado said that she and her colleagues are seeking pediatric patients who were treated for COVID-19 at Stanford, in an effort to sort this out.

They are checking peripheral blood mononuclear cells in these patients “to try and tease out what the immune response is in kids who have serious disease, versus those who came in with acute disease, versus those who are asymptomatic,” and comparing them with children who don’t have infection, she explained. “The question is, what is the role of T cells and how much do they contribute? One of the biggest questions we have is, do we have an immune correlate? Can we detect a particular level of neutralizing antibody that seems to be protective? If so, how long is it protective, and can we look for T- and B-cell memory cells and effector vector cells and see how long those effector vector cells can be active in protection? Those are studies that are ongoing now.”

Dr. Maldonado disclosed that she is a member of the data safety monitoring board for a non–COVID-19 vaccine being developed by Pfizer.

[email protected]

If everything goes as planned, the Pfizer and Moderna mRNA COVID-19 vaccines could be granted emergency use authorization (EUA) for children aged 12 years and older by the fall of 2021.

Courtesy Dr. Maldonado

According to Yvonne Maldonado, MD, Pfizer has fully enrolled adolescent trials and Moderna is currently enrolling 3,000 adolescents in a safety and reactogenicity trial known as TeenCOVE, in which participants will receive an intramuscular injection of 100 mcg mRNA-1273 on day 1 and on day 29. Meanwhile, Johnson & Johnson and AstraZeneca will be starting to enroll older children and adolescents into studies within the next several weeks.

The companies are also planning to enroll younger children, Dr. Maldonado, the Taube professor of global health and infectious diseases at Stanford (Calif.) University, said during the Society for Pediatric Dermatology pre-AAD meeting. “At least two of the vaccine companies have indicated that they would like to start enrolling children as young as 2-5 years of age and eventually getting down to infants and toddlers if the vaccines prove to be safe and effective in the older children. Eventually, we hope to get to the level where we can have several vaccine candidates for all children 6 months of age and older.”

In the future, she said, infectious disease experts hope to see antiviral, immunomodulatory, anti-inflammatory, and monoclonal therapies for all populations including children, although trials in this population have not begun. “Clinical trials must be flexible and adaptive to deal with children and adolescents,” added Dr. Maldonado, who is also senior associate dean for faculty development and diversity at Stanford.

“We would ideally like to have new correlates of protection, as well as biomarkers to follow for evidence of effectiveness. We also would love to see vaccines in the pediatric population as soon as possible, because herd immunity is the ultimate goal for protection against this disease and prevention of additional transmission over time.” However, she said, the degree and durability of immunity has yet to be determined, and vaccine-associated immune effects are unknown. In the meantime, infectious disease researchers expect nonpharmacologic interventions, such as wearing face masks and social distancing to continue for an undefined period.

(Less than 2 weeks after Dr. Maldonado spoke at the SPD meeting, Pfizer announced in a press release that, in phase 3 clinical trials, the company’s coronavirus vaccine was 100% effective in protecting children aged 12-15 years from infection, with a “robust” antibody responses and side effects similar to those experienced by those aged 16-25 years. The company also announced that it plans to seek Food and Drug Administration EUA for this age group. Asked to comment on this update, Dr. Maldonado said the results released by Pfizer “suggest that their COVID-19 vaccine is very safe and highly effective in preventing COVID-19 among children 12-15 years of age.” She added that additional data from the Pfizer trials as well as from Moderna and Johnson & Johnson vaccine trials “will hopefully lead to FDA EUA review in the coming weeks,” and that COVID-19 vaccinations for children “may be possible by this summer.”)
 

_{Children with underlying diseases or on immune suppressants}

At the SPD meeting, an attendee asked if there were any pediatric patients for whom she would not recommend receiving a COVID-19 vaccine because of an underlying disease or concurrent therapy with immune suppressants. “We don’t have those data yet,” Dr. Maldonado said. “Based on what we’re seeing with adults, it does appear that those with underlying conditions are at somewhat higher risk of developing severe infection and may therefore most likely to need vaccination. Most of those risks are cardiovascular, obesity, and other factors, but not necessarily immunocompromising conditions. More likely what we’re seeing is that people with underlying immunocompromising conditions may not mount a good response to the vaccines at this time. It doesn’t mean we shouldn’t give the vaccines, but we need to learn more about that.”

Dr. Maldonado went on to note that, as vaccine manufacturers commence pediatric trials, healthy children will be tested first, followed in due time with children who have immunocompromised conditions. “The question will be whether or not we should give monoclonal antibodies to those particular children to help boost their immunity to SARS-CoV-2, because they might not have a good response to the vaccines,” she said. “Those things need to be sorted out, but there’s no safety signal or concerns at this point for vaccine to be given to immunocompromised individuals.”

Another meeting attendee asked Dr. Maldonado if she thinks there is a practical role for assessing markers of T-cell immunity when evaluating suspected COVID-19 patients who may test negative on serology, Dr. Maldonado said that she and her colleagues are seeking pediatric patients who were treated for COVID-19 at Stanford, in an effort to sort this out.

They are checking peripheral blood mononuclear cells in these patients “to try and tease out what the immune response is in kids who have serious disease, versus those who came in with acute disease, versus those who are asymptomatic,” and comparing them with children who don’t have infection, she explained. “The question is, what is the role of T cells and how much do they contribute? One of the biggest questions we have is, do we have an immune correlate? Can we detect a particular level of neutralizing antibody that seems to be protective? If so, how long is it protective, and can we look for T- and B-cell memory cells and effector vector cells and see how long those effector vector cells can be active in protection? Those are studies that are ongoing now.”

Dr. Maldonado disclosed that she is a member of the data safety monitoring board for a non–COVID-19 vaccine being developed by Pfizer.

[email protected]

Among patients who undergo surgery for hidradenitis suppurativa (HS), wide excision and flap-based reconstruction are associated with lower postsurgical recurrence, yet these options should be balanced against potentially higher morbidity of extensive procedures.

Those are among the key findings of a systematic review and meta-analysis published online in Dermatologic Surgery.

“There is a major need to better understand the best surgical approaches to HS,” one of the study authors, Christopher Sayed, MD, associate professor of dermatology at the University of North Carolina at Chapel Hill, said in an interview. Previous studies have mostly reviewed outcomes for procedure types in individual cohorts, “but no recent reports have combined and analyzed data from recent studies.”

When Dr. Sayed and colleagues set out to summarize the literature on HS surgery regarding patient characteristics, surgical approaches, and study quality, as well as compare postsurgical recurrence rates, the most recent meta-analysis on postoperative recurrence rates of HS included studies published between 1990 and 2015. “In the past few years, surgical management of HS has become an increasingly popular area of study,” corresponding author Ashley Riddle, MD, MPH, who is currently an internal medicine resident at the Carolinas Medical Center, Charlotte, said in an interview. “We sought to provide an updated picture of the HS surgical landscape by analyzing studies published between 2004 to 2019. We also limited our analysis to studies with follow-up periods of greater than 1 year and included information on disease severity, adverse events, and patient satisfaction when available.”

Of 715 relevant studies identified in the medical literature, the researchers included 59 in the review and 33 in the meta-analysis. Of these 59 studies, 56 were case series, 2 were randomized, controlled trials, and one was a retrospective cohort study.

Of the 50 studies reporting gender and age at time of surgery, 61% of patients were female and their average age was 37 years. Of the 25 studies that reported Hurley scores, 73% had Hurley stage 3 HS. Of the 38 studies reporting the number of procedures per anatomic region, the most commonly operated on regions were the axilla (59%) and the inguinal region (20%).

The researchers found that 22 studies of wide excision had the lowest pooled recurrence rate at 8%, while local excision had the highest pooled recurrence rate at 34%. Meanwhile, among studies of wide/radical excision, flap repair had a pooled recurrence rate of 0%, while delayed primary closure had the highest pooled recurrence rate at 38%.

“Extensive excisions of HS seem to portend a lower risk of postoperative recurrence, but there are many approaches available that may be more appropriate for certain patients,” Dr. Riddle said. “The influence of patient factors such as comorbidities and disease severity on surgical outcomes is unclear and is a potential area of future study.”

Dr. Sayed, an author of the 2019 North American guidelines for the clinical management of HS, pointed out that most studies in the review and meta-analysis included patients who had diabetes, were on biologics or other therapy, were actively smoking, or had other comorbidities that sometimes influence surgeons to delay surgical treatment because they consider it elective. “Most studies indicated minimal or no risk of significant complications relating to these factors, so they should ideally not become obstacles for patients interested in surgical care,” he said.

Dr. Riddle said that she was surprised by how relatively few studies had been published on more conservative surgical approaches such as skin tissue–sparing excision with electrosurgical peeling, deroofing, local excision, and CO₂ laser–based evaporation.

The researchers acknowledged certain limitations of their work, including the high risk of bias for most included studies. “Almost all studies were retrospective with substantial methodological limitations, and there were no head-to-head comparisons of different surgical approaches,” Dr. Riddle said. “Patient comorbidities and postoperative complications were variably reported.”

Dr. Sayed disclosed that he is a speaker for AbbVie and Novartis; an investigator for AbbVie, Novartis, InflaRx, and UCB; and on the advisory board of AbbVie and InflaRx. The remaining authors reported having no financial disclosures.

[email protected]

Among patients who undergo surgery for hidradenitis suppurativa (HS), wide excision and flap-based reconstruction are associated with lower postsurgical recurrence, yet these options should be balanced against potentially higher morbidity of extensive procedures.

Those are among the key findings of a systematic review and meta-analysis published online in Dermatologic Surgery.

“There is a major need to better understand the best surgical approaches to HS,” one of the study authors, Christopher Sayed, MD, associate professor of dermatology at the University of North Carolina at Chapel Hill, said in an interview. Previous studies have mostly reviewed outcomes for procedure types in individual cohorts, “but no recent reports have combined and analyzed data from recent studies.”

When Dr. Sayed and colleagues set out to summarize the literature on HS surgery regarding patient characteristics, surgical approaches, and study quality, as well as compare postsurgical recurrence rates, the most recent meta-analysis on postoperative recurrence rates of HS included studies published between 1990 and 2015. “In the past few years, surgical management of HS has become an increasingly popular area of study,” corresponding author Ashley Riddle, MD, MPH, who is currently an internal medicine resident at the Carolinas Medical Center, Charlotte, said in an interview. “We sought to provide an updated picture of the HS surgical landscape by analyzing studies published between 2004 to 2019. We also limited our analysis to studies with follow-up periods of greater than 1 year and included information on disease severity, adverse events, and patient satisfaction when available.”

Of 715 relevant studies identified in the medical literature, the researchers included 59 in the review and 33 in the meta-analysis. Of these 59 studies, 56 were case series, 2 were randomized, controlled trials, and one was a retrospective cohort study.

Of the 50 studies reporting gender and age at time of surgery, 61% of patients were female and their average age was 37 years. Of the 25 studies that reported Hurley scores, 73% had Hurley stage 3 HS. Of the 38 studies reporting the number of procedures per anatomic region, the most commonly operated on regions were the axilla (59%) and the inguinal region (20%).

The researchers found that 22 studies of wide excision had the lowest pooled recurrence rate at 8%, while local excision had the highest pooled recurrence rate at 34%. Meanwhile, among studies of wide/radical excision, flap repair had a pooled recurrence rate of 0%, while delayed primary closure had the highest pooled recurrence rate at 38%.

“Extensive excisions of HS seem to portend a lower risk of postoperative recurrence, but there are many approaches available that may be more appropriate for certain patients,” Dr. Riddle said. “The influence of patient factors such as comorbidities and disease severity on surgical outcomes is unclear and is a potential area of future study.”

Dr. Sayed, an author of the 2019 North American guidelines for the clinical management of HS, pointed out that most studies in the review and meta-analysis included patients who had diabetes, were on biologics or other therapy, were actively smoking, or had other comorbidities that sometimes influence surgeons to delay surgical treatment because they consider it elective. “Most studies indicated minimal or no risk of significant complications relating to these factors, so they should ideally not become obstacles for patients interested in surgical care,” he said.

Dr. Riddle said that she was surprised by how relatively few studies had been published on more conservative surgical approaches such as skin tissue–sparing excision with electrosurgical peeling, deroofing, local excision, and CO₂ laser–based evaporation.

The researchers acknowledged certain limitations of their work, including the high risk of bias for most included studies. “Almost all studies were retrospective with substantial methodological limitations, and there were no head-to-head comparisons of different surgical approaches,” Dr. Riddle said. “Patient comorbidities and postoperative complications were variably reported.”

Dr. Sayed disclosed that he is a speaker for AbbVie and Novartis; an investigator for AbbVie, Novartis, InflaRx, and UCB; and on the advisory board of AbbVie and InflaRx. The remaining authors reported having no financial disclosures.

[email protected]

Among patients who undergo surgery for hidradenitis suppurativa (HS), wide excision and flap-based reconstruction are associated with lower postsurgical recurrence, yet these options should be balanced against potentially higher morbidity of extensive procedures.

Those are among the key findings of a systematic review and meta-analysis published online in Dermatologic Surgery.

“There is a major need to better understand the best surgical approaches to HS,” one of the study authors, Christopher Sayed, MD, associate professor of dermatology at the University of North Carolina at Chapel Hill, said in an interview. Previous studies have mostly reviewed outcomes for procedure types in individual cohorts, “but no recent reports have combined and analyzed data from recent studies.”

When Dr. Sayed and colleagues set out to summarize the literature on HS surgery regarding patient characteristics, surgical approaches, and study quality, as well as compare postsurgical recurrence rates, the most recent meta-analysis on postoperative recurrence rates of HS included studies published between 1990 and 2015. “In the past few years, surgical management of HS has become an increasingly popular area of study,” corresponding author Ashley Riddle, MD, MPH, who is currently an internal medicine resident at the Carolinas Medical Center, Charlotte, said in an interview. “We sought to provide an updated picture of the HS surgical landscape by analyzing studies published between 2004 to 2019. We also limited our analysis to studies with follow-up periods of greater than 1 year and included information on disease severity, adverse events, and patient satisfaction when available.”

Of 715 relevant studies identified in the medical literature, the researchers included 59 in the review and 33 in the meta-analysis. Of these 59 studies, 56 were case series, 2 were randomized, controlled trials, and one was a retrospective cohort study.

Of the 50 studies reporting gender and age at time of surgery, 61% of patients were female and their average age was 37 years. Of the 25 studies that reported Hurley scores, 73% had Hurley stage 3 HS. Of the 38 studies reporting the number of procedures per anatomic region, the most commonly operated on regions were the axilla (59%) and the inguinal region (20%).

The researchers found that 22 studies of wide excision had the lowest pooled recurrence rate at 8%, while local excision had the highest pooled recurrence rate at 34%. Meanwhile, among studies of wide/radical excision, flap repair had a pooled recurrence rate of 0%, while delayed primary closure had the highest pooled recurrence rate at 38%.

“Extensive excisions of HS seem to portend a lower risk of postoperative recurrence, but there are many approaches available that may be more appropriate for certain patients,” Dr. Riddle said. “The influence of patient factors such as comorbidities and disease severity on surgical outcomes is unclear and is a potential area of future study.”

Dr. Sayed, an author of the 2019 North American guidelines for the clinical management of HS, pointed out that most studies in the review and meta-analysis included patients who had diabetes, were on biologics or other therapy, were actively smoking, or had other comorbidities that sometimes influence surgeons to delay surgical treatment because they consider it elective. “Most studies indicated minimal or no risk of significant complications relating to these factors, so they should ideally not become obstacles for patients interested in surgical care,” he said.

Dr. Riddle said that she was surprised by how relatively few studies had been published on more conservative surgical approaches such as skin tissue–sparing excision with electrosurgical peeling, deroofing, local excision, and CO₂ laser–based evaporation.

The researchers acknowledged certain limitations of their work, including the high risk of bias for most included studies. “Almost all studies were retrospective with substantial methodological limitations, and there were no head-to-head comparisons of different surgical approaches,” Dr. Riddle said. “Patient comorbidities and postoperative complications were variably reported.”

Dr. Sayed disclosed that he is a speaker for AbbVie and Novartis; an investigator for AbbVie, Novartis, InflaRx, and UCB; and on the advisory board of AbbVie and InflaRx. The remaining authors reported having no financial disclosures.

[email protected]