Dermatology

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — The investigative oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib shows promise in patients with moderate to severe hidradenitis suppurativa (HS), results from a randomized 16-week phase 2 trial showed.

“Research shows that the TNF-alpha and IL-17 signaling pathways have important roles in HS,” lead investigator Alexa B. Kimball, MD, MPH, from the Clinical Laboratory for Epidemiology and Applied Research in Skin at Beth Israel Deaconess Medical Center, Boston, said at the annual meeting of the American Academy of Dermatology. “However, several additional pathways are thought to contribute to disease pathogenesis.”

“We will see if phase 3 trials with more balanced demographics across remibrutinib and placebo arms will reproduce these outcomes,” she continued, “It is exciting to see this potential new medication for HS under continued investigation, especially in light of the current gap in oral therapeutic options for the HS patient community.” Dr. Hsiao was not involved with the study.

Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies, including the receipt of research grants and consulting fees from Novartis. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com.

SAN DIEGO — The investigative oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib shows promise in patients with moderate to severe hidradenitis suppurativa (HS), results from a randomized 16-week phase 2 trial showed.

“Research shows that the TNF-alpha and IL-17 signaling pathways have important roles in HS,” lead investigator Alexa B. Kimball, MD, MPH, from the Clinical Laboratory for Epidemiology and Applied Research in Skin at Beth Israel Deaconess Medical Center, Boston, said at the annual meeting of the American Academy of Dermatology. “However, several additional pathways are thought to contribute to disease pathogenesis.”

“We will see if phase 3 trials with more balanced demographics across remibrutinib and placebo arms will reproduce these outcomes,” she continued, “It is exciting to see this potential new medication for HS under continued investigation, especially in light of the current gap in oral therapeutic options for the HS patient community.” Dr. Hsiao was not involved with the study.

Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies, including the receipt of research grants and consulting fees from Novartis. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com.

SAN DIEGO — The investigative oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib shows promise in patients with moderate to severe hidradenitis suppurativa (HS), results from a randomized 16-week phase 2 trial showed.

“Research shows that the TNF-alpha and IL-17 signaling pathways have important roles in HS,” lead investigator Alexa B. Kimball, MD, MPH, from the Clinical Laboratory for Epidemiology and Applied Research in Skin at Beth Israel Deaconess Medical Center, Boston, said at the annual meeting of the American Academy of Dermatology. “However, several additional pathways are thought to contribute to disease pathogenesis.”

“We will see if phase 3 trials with more balanced demographics across remibrutinib and placebo arms will reproduce these outcomes,” she continued, “It is exciting to see this potential new medication for HS under continued investigation, especially in light of the current gap in oral therapeutic options for the HS patient community.” Dr. Hsiao was not involved with the study.

Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies, including the receipt of research grants and consulting fees from Novartis. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

SAN DIEGO — Transmasculine patients with acne require unique care that not only is sensitive but also reflects an understanding about factors that can affect their skin such as hormone therapy, a dermatologist told colleagues in a session at the American Academy of Dermatology annual meeting.

In these patients, treatment of acne is crucial, said Howa Yeung, MD, MSc, assistant professor of dermatology, Emory University, Atlanta. “These are patients who are suffering and reporting that they’re having mental health impacts” related to acne.

In transmasculine patients — those who were biologically female at birth but identify as masculine — testosterone therapy greatly boosts the risk for acne, even in adults who are long past adolescence, Dr. Yeung said. Data suggest that acne appears within the first 6 months after testosterone therapy begins, he said, “and the maximal and complete effect occurs within 1-2 years.”

A 2021 study tracked 988 transgender patients receiving testosterone at Fenway Health in Boston and found that 31% had a diagnosis of acne, up from 6.3% prior to taking hormones. And 2 years following the start of therapy, 25.1% had acne, with cases especially common among those aged 18-20.75 years (29.6%). Even among those aged 28.25-66.5 years, 17.1% had acne.

Transmasculine patients may develop acne in areas across the body “in places that you normally won’t see by just looking at the patient,” Dr. Yeung said. Excoriation in addition to comedones, papules, pustules, and nodules can be common, he added.

Dr. Yeung highlighted a 2019 study of transgender men that linked higher levels of acne to higher levels of serum testosterone, higher body mass index, and current smoking. And in a 2014 study, 6% of 50 transmasculine patients had moderate to severe acne after an average of 10 years on testosterone therapy.

A 2020 study of 696 transgender adults surveyed in California and Georgia found that 14% of transmasculine patients had moderate to severe acne — two thirds attributed it to hormone therapy — vs 1% of transfeminine patients, said Dr. Yeung, the lead author of the study. However, transmasculine patients were less likely to have seen a dermatologist.

Dr. Yeung also highlighted a 2021 study he coauthored that linked current moderate to severe acne in transmasculine patients taking testosterone to higher levels of depression and anxiety vs counterparts who had never had those forms of acne.

Another factor affecting acne in transmasculine patients is the use of chest binders to reduce breast size. “Wearing a chest binder is really helpful for a lot of our patients and is associated with improved self-esteem, mood, mental health, and safety in public,” Dr. Yeung said. However, the binders can contribute to skin problems.

Dr. Yeung said he and his colleagues emphasize the importance of breathable material in binders and suggest to patients that they not wear them when they’re in “safe spaces.”

Isotretinoin, Contraception Considerations

As for treatment of acne in transgender patients, Dr. Yeung cautioned colleagues to not automatically reject isotretinoin as an option for transgender patients who have a history of depression. Dermatologists may be tempted to avoid the drug in these patients because of its link to suicide, he said. (This apparent association has long been debated.) But, Dr. Yeung said, it’s important to consider that many of these patients suffered from anxiety and depression because of the lack of access to proper gender-reassignment treatment.

When using isotretinoin, he emphasized, it’s crucial to consider whether transmasculine patients could become pregnant while on this therapy. Consider whether the patient has the organs needed to become pregnant and ask questions about the potential that they could be impregnated.

“Remember that sexual behavior is different from gender identity,” Dr. Yeung said. A transmasculine person with a uterus and vagina, for example, may still have vaginal intercourse with males and potentially become pregnant. “So, we need to assess what kind of sexual behavior our patients are taking part in.”

Contraceptives such as intrauterine devices, implants, and injectable options may be helpful for transmasculine patients because they can reduce menstrual symptoms like spotting that can be distressing to them, he said. By helping a patient take a contraceptive, “you may actually be helping with their gender dysphoria and helping them get on isotretinoin.”

Dr. Yeung disclosed fees from JAMA and American Academy of Dermatology; grants/research funding from the American Acne & Rosacea Society, Dermatology Foundation, Department of Veterans Affairs, National Eczema Association, and National Institutes of Health; and speaker/faculty education honoraria from Dermatology Digest.

A version of this article appeared on Medscape.com.

SAN DIEGO — Transmasculine patients with acne require unique care that not only is sensitive but also reflects an understanding about factors that can affect their skin such as hormone therapy, a dermatologist told colleagues in a session at the American Academy of Dermatology annual meeting.

In these patients, treatment of acne is crucial, said Howa Yeung, MD, MSc, assistant professor of dermatology, Emory University, Atlanta. “These are patients who are suffering and reporting that they’re having mental health impacts” related to acne.

In transmasculine patients — those who were biologically female at birth but identify as masculine — testosterone therapy greatly boosts the risk for acne, even in adults who are long past adolescence, Dr. Yeung said. Data suggest that acne appears within the first 6 months after testosterone therapy begins, he said, “and the maximal and complete effect occurs within 1-2 years.”

A 2021 study tracked 988 transgender patients receiving testosterone at Fenway Health in Boston and found that 31% had a diagnosis of acne, up from 6.3% prior to taking hormones. And 2 years following the start of therapy, 25.1% had acne, with cases especially common among those aged 18-20.75 years (29.6%). Even among those aged 28.25-66.5 years, 17.1% had acne.

Transmasculine patients may develop acne in areas across the body “in places that you normally won’t see by just looking at the patient,” Dr. Yeung said. Excoriation in addition to comedones, papules, pustules, and nodules can be common, he added.

Dr. Yeung highlighted a 2019 study of transgender men that linked higher levels of acne to higher levels of serum testosterone, higher body mass index, and current smoking. And in a 2014 study, 6% of 50 transmasculine patients had moderate to severe acne after an average of 10 years on testosterone therapy.

A 2020 study of 696 transgender adults surveyed in California and Georgia found that 14% of transmasculine patients had moderate to severe acne — two thirds attributed it to hormone therapy — vs 1% of transfeminine patients, said Dr. Yeung, the lead author of the study. However, transmasculine patients were less likely to have seen a dermatologist.

Dr. Yeung also highlighted a 2021 study he coauthored that linked current moderate to severe acne in transmasculine patients taking testosterone to higher levels of depression and anxiety vs counterparts who had never had those forms of acne.

Another factor affecting acne in transmasculine patients is the use of chest binders to reduce breast size. “Wearing a chest binder is really helpful for a lot of our patients and is associated with improved self-esteem, mood, mental health, and safety in public,” Dr. Yeung said. However, the binders can contribute to skin problems.

Dr. Yeung said he and his colleagues emphasize the importance of breathable material in binders and suggest to patients that they not wear them when they’re in “safe spaces.”

Isotretinoin, Contraception Considerations

As for treatment of acne in transgender patients, Dr. Yeung cautioned colleagues to not automatically reject isotretinoin as an option for transgender patients who have a history of depression. Dermatologists may be tempted to avoid the drug in these patients because of its link to suicide, he said. (This apparent association has long been debated.) But, Dr. Yeung said, it’s important to consider that many of these patients suffered from anxiety and depression because of the lack of access to proper gender-reassignment treatment.

When using isotretinoin, he emphasized, it’s crucial to consider whether transmasculine patients could become pregnant while on this therapy. Consider whether the patient has the organs needed to become pregnant and ask questions about the potential that they could be impregnated.

“Remember that sexual behavior is different from gender identity,” Dr. Yeung said. A transmasculine person with a uterus and vagina, for example, may still have vaginal intercourse with males and potentially become pregnant. “So, we need to assess what kind of sexual behavior our patients are taking part in.”

Contraceptives such as intrauterine devices, implants, and injectable options may be helpful for transmasculine patients because they can reduce menstrual symptoms like spotting that can be distressing to them, he said. By helping a patient take a contraceptive, “you may actually be helping with their gender dysphoria and helping them get on isotretinoin.”

Dr. Yeung disclosed fees from JAMA and American Academy of Dermatology; grants/research funding from the American Acne & Rosacea Society, Dermatology Foundation, Department of Veterans Affairs, National Eczema Association, and National Institutes of Health; and speaker/faculty education honoraria from Dermatology Digest.

A version of this article appeared on Medscape.com.

SAN DIEGO — Transmasculine patients with acne require unique care that not only is sensitive but also reflects an understanding about factors that can affect their skin such as hormone therapy, a dermatologist told colleagues in a session at the American Academy of Dermatology annual meeting.

In these patients, treatment of acne is crucial, said Howa Yeung, MD, MSc, assistant professor of dermatology, Emory University, Atlanta. “These are patients who are suffering and reporting that they’re having mental health impacts” related to acne.

In transmasculine patients — those who were biologically female at birth but identify as masculine — testosterone therapy greatly boosts the risk for acne, even in adults who are long past adolescence, Dr. Yeung said. Data suggest that acne appears within the first 6 months after testosterone therapy begins, he said, “and the maximal and complete effect occurs within 1-2 years.”

A 2021 study tracked 988 transgender patients receiving testosterone at Fenway Health in Boston and found that 31% had a diagnosis of acne, up from 6.3% prior to taking hormones. And 2 years following the start of therapy, 25.1% had acne, with cases especially common among those aged 18-20.75 years (29.6%). Even among those aged 28.25-66.5 years, 17.1% had acne.

Transmasculine patients may develop acne in areas across the body “in places that you normally won’t see by just looking at the patient,” Dr. Yeung said. Excoriation in addition to comedones, papules, pustules, and nodules can be common, he added.

Dr. Yeung highlighted a 2019 study of transgender men that linked higher levels of acne to higher levels of serum testosterone, higher body mass index, and current smoking. And in a 2014 study, 6% of 50 transmasculine patients had moderate to severe acne after an average of 10 years on testosterone therapy.

A 2020 study of 696 transgender adults surveyed in California and Georgia found that 14% of transmasculine patients had moderate to severe acne — two thirds attributed it to hormone therapy — vs 1% of transfeminine patients, said Dr. Yeung, the lead author of the study. However, transmasculine patients were less likely to have seen a dermatologist.

Dr. Yeung also highlighted a 2021 study he coauthored that linked current moderate to severe acne in transmasculine patients taking testosterone to higher levels of depression and anxiety vs counterparts who had never had those forms of acne.

Another factor affecting acne in transmasculine patients is the use of chest binders to reduce breast size. “Wearing a chest binder is really helpful for a lot of our patients and is associated with improved self-esteem, mood, mental health, and safety in public,” Dr. Yeung said. However, the binders can contribute to skin problems.

Dr. Yeung said he and his colleagues emphasize the importance of breathable material in binders and suggest to patients that they not wear them when they’re in “safe spaces.”

Isotretinoin, Contraception Considerations

As for treatment of acne in transgender patients, Dr. Yeung cautioned colleagues to not automatically reject isotretinoin as an option for transgender patients who have a history of depression. Dermatologists may be tempted to avoid the drug in these patients because of its link to suicide, he said. (This apparent association has long been debated.) But, Dr. Yeung said, it’s important to consider that many of these patients suffered from anxiety and depression because of the lack of access to proper gender-reassignment treatment.

When using isotretinoin, he emphasized, it’s crucial to consider whether transmasculine patients could become pregnant while on this therapy. Consider whether the patient has the organs needed to become pregnant and ask questions about the potential that they could be impregnated.

“Remember that sexual behavior is different from gender identity,” Dr. Yeung said. A transmasculine person with a uterus and vagina, for example, may still have vaginal intercourse with males and potentially become pregnant. “So, we need to assess what kind of sexual behavior our patients are taking part in.”

Contraceptives such as intrauterine devices, implants, and injectable options may be helpful for transmasculine patients because they can reduce menstrual symptoms like spotting that can be distressing to them, he said. By helping a patient take a contraceptive, “you may actually be helping with their gender dysphoria and helping them get on isotretinoin.”

Dr. Yeung disclosed fees from JAMA and American Academy of Dermatology; grants/research funding from the American Acne & Rosacea Society, Dermatology Foundation, Department of Veterans Affairs, National Eczema Association, and National Institutes of Health; and speaker/faculty education honoraria from Dermatology Digest.

A version of this article appeared on Medscape.com.

SAN DIEGO — After 24 weeks of treatment with subcutaneously administered sonelokimab 120 mg, about 43% of patients with moderate to severe hidradenitis suppurativa (HS) achieved a Hidradenitis Suppurativa Clinical Response (HiSCR75), defined as at least a 75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline, results from a randomized clinical trial showed.

Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author Brian Kirby, MD, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland

Ted Bosworth/MDedge News

According to a press release from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.

In a phase 2 study known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.

Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.

At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.

In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.

In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.
 

No Serious Safety Signals Noted

There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said.

“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”

Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.

One of the session moderators, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose.

“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”

Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.

SAN DIEGO — After 24 weeks of treatment with subcutaneously administered sonelokimab 120 mg, about 43% of patients with moderate to severe hidradenitis suppurativa (HS) achieved a Hidradenitis Suppurativa Clinical Response (HiSCR75), defined as at least a 75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline, results from a randomized clinical trial showed.

Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author Brian Kirby, MD, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland

Ted Bosworth/MDedge News

According to a press release from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.

In a phase 2 study known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.

Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.

At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.

In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.

In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.
 

No Serious Safety Signals Noted

There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said.

“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”

Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.

One of the session moderators, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose.

“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”

Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.

SAN DIEGO — After 24 weeks of treatment with subcutaneously administered sonelokimab 120 mg, about 43% of patients with moderate to severe hidradenitis suppurativa (HS) achieved a Hidradenitis Suppurativa Clinical Response (HiSCR75), defined as at least a 75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline, results from a randomized clinical trial showed.

Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author Brian Kirby, MD, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland

Ted Bosworth/MDedge News

According to a press release from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.

In a phase 2 study known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.

Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.

At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.

In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.

In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.
 

No Serious Safety Signals Noted

There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said.

“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”

Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.

One of the session moderators, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose.

“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”

Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.

SAN DIEGO — Treatment with topical roflumilast, 0.05%, approved at a higher concentration for treating psoriasis, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD), according to the results of a phase 3 study reported at the annual meeting of the American Academy of Dermatology.

Among patients treated with roflumilast cream, 0.05%, 25.4% reached the primary endpoint of “clear” or “almost clear” plus a two-grade improvement from baseline at week 4 vs 10.7% among those in the vehicle group (P < .0001) in a phase 3 randomized controlled trial of children. The findings were released in a late-breaker session at the meeting.

Roflumilast cream, 0.3% (Zoryve), is approved by the Food and Drug Administration (FDA) for treating psoriasis in patients 6 years and older, and lower doses are being evaluated for AD: 0.15% for adults and children ages 6 and older, and 0.05% for ages 2-5. Roflumilast is a phosphodiesterase-4 inhibitor. In 2023, the FDA accepted a supplemental drug application from the manufacturer, Arcutis, for roflumilast, 0.15%, for treating AD in patients ages 6 and older, based on the results from two recently published phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2.

The study of younger children, INTEGUMENT-PED, recruited 652 patients aged 2-5 with mild to moderate AD, with a Validated Investigator Global Assessment scale for AD (vlGA-AD) score of 2 or 3, a mean body surface area of 22% overall (range, 3%-82%), and an Eczema Area and Severity Index (EASI) score of at least 5. Of the patients enrolled, 437 were assigned to 0.05% roflumilast cream, applied once a day for 4 weeks (mean age, 3.3 years; 51.6% male; 67.4% White; 15.6% Black; 8.5% Asian; 8.5% other or more than one race; 80.5% not Latino/Hispanic). The remaining 215 children were assigned to vehicle cream and had similar characteristics.

About 52% of the patients in both groups had an inadequate response, intolerance, or contraindications to topical corticosteroids (and about 17% for topical calcineurin inhibitors and about 9% for crisaborole).

The proportions of patients who reached “clear” (0) or “almost clear” (1) on the vlGA-AD scale were 35.4% and 14.6%, respectively, at week 4 (P < .0001) for roflumilast and vehicle, respectively, according to the lead author of the study, Lawrence M. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, who presented the results at the meeting. In addition, 39.4% and 20.6% achieved an EASI-75 (a secondary endpoint), respectively (P < .0001), and itch also improved within 24 hours of starting treatment.

With regard to safety, 29.7% of patients taking roflumilast had treatment-emergent adverse effects (including upper respiratory tract infections in 4.1%) vs 21.9% of those in the vehicle arm (including upper respiratory tract infections in 1.4%). Reports of pain at the administration site were low (1.6% for roflumilast vs 1.9% for vehicle). Only one patient, a 2-year-old girl, had a treatment-emergent serious adverse event. The child, who was in the roflumilast group, had cellulitis involving noneczematous skin and was treated with antibiotics in the hospital for 3 days. The event was not attributed to roflumilast, which was stopped for 5 days, according to Dr. Eichenfield.

In an interview, Fairfield, Connecticut–based dermatologist Brittany Craiglow, MD, who was not involved in the study, said topical roflumilast would be an “important” new treatment because there are still few nonsteroidal options for the treatment of AD in children under 12. “The excellent local tolerability combined with early improvements in itch and skin clearance will make this a particularly attractive option, if approved,” she said.

Dr. Eichenfield disclosed multiple relationships with various drugmakers. He and several other study authors are investigators and/or consultants for Arcutis and received grants/research funding and/or honoraria. Two authors are Arcutis employees. Other disclosure information for the authors was not immediately available. Dr. Craiglow had no disclosures.

A version of this article appeared on Medscape.com .

SAN DIEGO — Treatment with topical roflumilast, 0.05%, approved at a higher concentration for treating psoriasis, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD), according to the results of a phase 3 study reported at the annual meeting of the American Academy of Dermatology.

Among patients treated with roflumilast cream, 0.05%, 25.4% reached the primary endpoint of “clear” or “almost clear” plus a two-grade improvement from baseline at week 4 vs 10.7% among those in the vehicle group (P < .0001) in a phase 3 randomized controlled trial of children. The findings were released in a late-breaker session at the meeting.

Roflumilast cream, 0.3% (Zoryve), is approved by the Food and Drug Administration (FDA) for treating psoriasis in patients 6 years and older, and lower doses are being evaluated for AD: 0.15% for adults and children ages 6 and older, and 0.05% for ages 2-5. Roflumilast is a phosphodiesterase-4 inhibitor. In 2023, the FDA accepted a supplemental drug application from the manufacturer, Arcutis, for roflumilast, 0.15%, for treating AD in patients ages 6 and older, based on the results from two recently published phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2.

The study of younger children, INTEGUMENT-PED, recruited 652 patients aged 2-5 with mild to moderate AD, with a Validated Investigator Global Assessment scale for AD (vlGA-AD) score of 2 or 3, a mean body surface area of 22% overall (range, 3%-82%), and an Eczema Area and Severity Index (EASI) score of at least 5. Of the patients enrolled, 437 were assigned to 0.05% roflumilast cream, applied once a day for 4 weeks (mean age, 3.3 years; 51.6% male; 67.4% White; 15.6% Black; 8.5% Asian; 8.5% other or more than one race; 80.5% not Latino/Hispanic). The remaining 215 children were assigned to vehicle cream and had similar characteristics.

About 52% of the patients in both groups had an inadequate response, intolerance, or contraindications to topical corticosteroids (and about 17% for topical calcineurin inhibitors and about 9% for crisaborole).

The proportions of patients who reached “clear” (0) or “almost clear” (1) on the vlGA-AD scale were 35.4% and 14.6%, respectively, at week 4 (P < .0001) for roflumilast and vehicle, respectively, according to the lead author of the study, Lawrence M. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, who presented the results at the meeting. In addition, 39.4% and 20.6% achieved an EASI-75 (a secondary endpoint), respectively (P < .0001), and itch also improved within 24 hours of starting treatment.

With regard to safety, 29.7% of patients taking roflumilast had treatment-emergent adverse effects (including upper respiratory tract infections in 4.1%) vs 21.9% of those in the vehicle arm (including upper respiratory tract infections in 1.4%). Reports of pain at the administration site were low (1.6% for roflumilast vs 1.9% for vehicle). Only one patient, a 2-year-old girl, had a treatment-emergent serious adverse event. The child, who was in the roflumilast group, had cellulitis involving noneczematous skin and was treated with antibiotics in the hospital for 3 days. The event was not attributed to roflumilast, which was stopped for 5 days, according to Dr. Eichenfield.

In an interview, Fairfield, Connecticut–based dermatologist Brittany Craiglow, MD, who was not involved in the study, said topical roflumilast would be an “important” new treatment because there are still few nonsteroidal options for the treatment of AD in children under 12. “The excellent local tolerability combined with early improvements in itch and skin clearance will make this a particularly attractive option, if approved,” she said.

Dr. Eichenfield disclosed multiple relationships with various drugmakers. He and several other study authors are investigators and/or consultants for Arcutis and received grants/research funding and/or honoraria. Two authors are Arcutis employees. Other disclosure information for the authors was not immediately available. Dr. Craiglow had no disclosures.

A version of this article appeared on Medscape.com .

SAN DIEGO — Treatment with topical roflumilast, 0.05%, approved at a higher concentration for treating psoriasis, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD), according to the results of a phase 3 study reported at the annual meeting of the American Academy of Dermatology.

Among patients treated with roflumilast cream, 0.05%, 25.4% reached the primary endpoint of “clear” or “almost clear” plus a two-grade improvement from baseline at week 4 vs 10.7% among those in the vehicle group (P < .0001) in a phase 3 randomized controlled trial of children. The findings were released in a late-breaker session at the meeting.

Roflumilast cream, 0.3% (Zoryve), is approved by the Food and Drug Administration (FDA) for treating psoriasis in patients 6 years and older, and lower doses are being evaluated for AD: 0.15% for adults and children ages 6 and older, and 0.05% for ages 2-5. Roflumilast is a phosphodiesterase-4 inhibitor. In 2023, the FDA accepted a supplemental drug application from the manufacturer, Arcutis, for roflumilast, 0.15%, for treating AD in patients ages 6 and older, based on the results from two recently published phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2.

The study of younger children, INTEGUMENT-PED, recruited 652 patients aged 2-5 with mild to moderate AD, with a Validated Investigator Global Assessment scale for AD (vlGA-AD) score of 2 or 3, a mean body surface area of 22% overall (range, 3%-82%), and an Eczema Area and Severity Index (EASI) score of at least 5. Of the patients enrolled, 437 were assigned to 0.05% roflumilast cream, applied once a day for 4 weeks (mean age, 3.3 years; 51.6% male; 67.4% White; 15.6% Black; 8.5% Asian; 8.5% other or more than one race; 80.5% not Latino/Hispanic). The remaining 215 children were assigned to vehicle cream and had similar characteristics.

About 52% of the patients in both groups had an inadequate response, intolerance, or contraindications to topical corticosteroids (and about 17% for topical calcineurin inhibitors and about 9% for crisaborole).

The proportions of patients who reached “clear” (0) or “almost clear” (1) on the vlGA-AD scale were 35.4% and 14.6%, respectively, at week 4 (P < .0001) for roflumilast and vehicle, respectively, according to the lead author of the study, Lawrence M. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, who presented the results at the meeting. In addition, 39.4% and 20.6% achieved an EASI-75 (a secondary endpoint), respectively (P < .0001), and itch also improved within 24 hours of starting treatment.

With regard to safety, 29.7% of patients taking roflumilast had treatment-emergent adverse effects (including upper respiratory tract infections in 4.1%) vs 21.9% of those in the vehicle arm (including upper respiratory tract infections in 1.4%). Reports of pain at the administration site were low (1.6% for roflumilast vs 1.9% for vehicle). Only one patient, a 2-year-old girl, had a treatment-emergent serious adverse event. The child, who was in the roflumilast group, had cellulitis involving noneczematous skin and was treated with antibiotics in the hospital for 3 days. The event was not attributed to roflumilast, which was stopped for 5 days, according to Dr. Eichenfield.

In an interview, Fairfield, Connecticut–based dermatologist Brittany Craiglow, MD, who was not involved in the study, said topical roflumilast would be an “important” new treatment because there are still few nonsteroidal options for the treatment of AD in children under 12. “The excellent local tolerability combined with early improvements in itch and skin clearance will make this a particularly attractive option, if approved,” she said.

Dr. Eichenfield disclosed multiple relationships with various drugmakers. He and several other study authors are investigators and/or consultants for Arcutis and received grants/research funding and/or honoraria. Two authors are Arcutis employees. Other disclosure information for the authors was not immediately available. Dr. Craiglow had no disclosures.

A version of this article appeared on Medscape.com .

SAN DIEGO — In published trials, both an interleukin (IL)–17 inhibitor and an IL-23 inhibitor achieved impressive rates of clear or almost clear responses in patients with moderate to severe plaque psoriasis, but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.

Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City

A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier. 

Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.

No Apparent Loss of Benefit Over Time

“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.

Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021. 

In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.

The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.

Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
 

JNJ-2113 Is First Potential Oral IL-23 Inhibitor

JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%. 

“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA. 

Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.

JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.

There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”

Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113. 

A version of this article appeared on Medscape.com.

SAN DIEGO — In published trials, both an interleukin (IL)–17 inhibitor and an IL-23 inhibitor achieved impressive rates of clear or almost clear responses in patients with moderate to severe plaque psoriasis, but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.

Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City

A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier. 

Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.

No Apparent Loss of Benefit Over Time

“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.

Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021. 

In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.

The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.

Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
 

JNJ-2113 Is First Potential Oral IL-23 Inhibitor

JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%. 

“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA. 

Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.

JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.

There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”

Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113. 

A version of this article appeared on Medscape.com.

SAN DIEGO — In published trials, both an interleukin (IL)–17 inhibitor and an IL-23 inhibitor achieved impressive rates of clear or almost clear responses in patients with moderate to severe plaque psoriasis, but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.

Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City

A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier. 

Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.

No Apparent Loss of Benefit Over Time

“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.

Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021. 

In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.

The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.

Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
 

JNJ-2113 Is First Potential Oral IL-23 Inhibitor

JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%. 

“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA. 

Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.

JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.

There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”

Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113. 

A version of this article appeared on Medscape.com.

TOPLINE:

A study found that 94% of best-selling baby cleansers contain allergens, despite their hypoallergenic claims.

METHODOLOGY:

• Many baby cleansers are marketed as “hypoallergenic,” but these claims are not validated. 
• This study assessed the potential allergens and marketing claims in best-selling baby cleansers. 
• The researchers collected ingredients and marketing claims of the top 50 best-selling baby body wash products sold on Amazon on April 4, 2023. 
• Ingredient lists were checked for potential allergens using the 2020 American Contact Dermatitis Society (ACDS) core allergen series, which lists 90 common allergens for adults and children.

TAKEAWAY:

• In the 50 cleansers tested, 10 allergens were identified. Overall, 94% of the cleansers contained at least one allergen, averaging 2.9 allergens per product; cocamidopropyl betaine  (72%), fragrance (64%), and sodium benzoate (54%) were the most common allergens. 
• All cleansers had at least five marketing claims, with an average of 10.9 claims per product; the most common claims were “paraben-free” (88%), “phthalate-free” (84%), “tear-free” (74%), and “hypoallergenic” or “allergy-tested” (74%). 
• There was no significant difference in the number of allergens in the cleansers marketed as “hypoallergenic” or “allergy tested” compared with cleansers that did not have these claims (P = .843).
• Fewer allergens were found in cleansers endorsed by the National Eczema Association (P = .004) or labeled “synthetic fragrance-free” (P = .003).
• There was a positive correlation between a greater number of allergens and an increased number of marketing claims (r = 0.547, P < .001) and a negative correlation between cost and number of allergens (r = −0.450, P = .001).

IN PRACTICE:

Because marketing claims like “hypoallergenic” may be misleading, “clinicians should counsel parents to carefully examine cleanser ingredients or consider selecting cleansers” endorsed by the National Eczema Association or another international eczema organization, especially for infants and children with a history of atopic dermatitis, the authors wrote. 

SOURCE:

The study, led by Sasan D. Noveir, BA, from the University of California, Los Angeles, and coauthors from the division of dermatology at UCLA, was published online in Pediatric Dermatology.

LIMITATIONS:

The study only evaluated top-selling products from a single online source at a specific time, which may limit generalizability. Potential allergens not included in the ACDS core series may be present.

DISCLOSURES:

The study did not disclose any funding source. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A study found that 94% of best-selling baby cleansers contain allergens, despite their hypoallergenic claims.

METHODOLOGY:

• Many baby cleansers are marketed as “hypoallergenic,” but these claims are not validated. 
• This study assessed the potential allergens and marketing claims in best-selling baby cleansers. 
• The researchers collected ingredients and marketing claims of the top 50 best-selling baby body wash products sold on Amazon on April 4, 2023. 
• Ingredient lists were checked for potential allergens using the 2020 American Contact Dermatitis Society (ACDS) core allergen series, which lists 90 common allergens for adults and children.

TAKEAWAY:

• In the 50 cleansers tested, 10 allergens were identified. Overall, 94% of the cleansers contained at least one allergen, averaging 2.9 allergens per product; cocamidopropyl betaine  (72%), fragrance (64%), and sodium benzoate (54%) were the most common allergens. 
• All cleansers had at least five marketing claims, with an average of 10.9 claims per product; the most common claims were “paraben-free” (88%), “phthalate-free” (84%), “tear-free” (74%), and “hypoallergenic” or “allergy-tested” (74%). 
• There was no significant difference in the number of allergens in the cleansers marketed as “hypoallergenic” or “allergy tested” compared with cleansers that did not have these claims (P = .843).
• Fewer allergens were found in cleansers endorsed by the National Eczema Association (P = .004) or labeled “synthetic fragrance-free” (P = .003).
• There was a positive correlation between a greater number of allergens and an increased number of marketing claims (r = 0.547, P < .001) and a negative correlation between cost and number of allergens (r = −0.450, P = .001).

IN PRACTICE:

Because marketing claims like “hypoallergenic” may be misleading, “clinicians should counsel parents to carefully examine cleanser ingredients or consider selecting cleansers” endorsed by the National Eczema Association or another international eczema organization, especially for infants and children with a history of atopic dermatitis, the authors wrote. 

SOURCE:

The study, led by Sasan D. Noveir, BA, from the University of California, Los Angeles, and coauthors from the division of dermatology at UCLA, was published online in Pediatric Dermatology.

LIMITATIONS:

The study only evaluated top-selling products from a single online source at a specific time, which may limit generalizability. Potential allergens not included in the ACDS core series may be present.

DISCLOSURES:

The study did not disclose any funding source. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A study found that 94% of best-selling baby cleansers contain allergens, despite their hypoallergenic claims.

METHODOLOGY:

• Many baby cleansers are marketed as “hypoallergenic,” but these claims are not validated. 
• This study assessed the potential allergens and marketing claims in best-selling baby cleansers. 
• The researchers collected ingredients and marketing claims of the top 50 best-selling baby body wash products sold on Amazon on April 4, 2023. 
• Ingredient lists were checked for potential allergens using the 2020 American Contact Dermatitis Society (ACDS) core allergen series, which lists 90 common allergens for adults and children.

TAKEAWAY:

• In the 50 cleansers tested, 10 allergens were identified. Overall, 94% of the cleansers contained at least one allergen, averaging 2.9 allergens per product; cocamidopropyl betaine  (72%), fragrance (64%), and sodium benzoate (54%) were the most common allergens. 
• All cleansers had at least five marketing claims, with an average of 10.9 claims per product; the most common claims were “paraben-free” (88%), “phthalate-free” (84%), “tear-free” (74%), and “hypoallergenic” or “allergy-tested” (74%). 
• There was no significant difference in the number of allergens in the cleansers marketed as “hypoallergenic” or “allergy tested” compared with cleansers that did not have these claims (P = .843).
• Fewer allergens were found in cleansers endorsed by the National Eczema Association (P = .004) or labeled “synthetic fragrance-free” (P = .003).
• There was a positive correlation between a greater number of allergens and an increased number of marketing claims (r = 0.547, P < .001) and a negative correlation between cost and number of allergens (r = −0.450, P = .001).

IN PRACTICE:

Because marketing claims like “hypoallergenic” may be misleading, “clinicians should counsel parents to carefully examine cleanser ingredients or consider selecting cleansers” endorsed by the National Eczema Association or another international eczema organization, especially for infants and children with a history of atopic dermatitis, the authors wrote. 

SOURCE:

The study, led by Sasan D. Noveir, BA, from the University of California, Los Angeles, and coauthors from the division of dermatology at UCLA, was published online in Pediatric Dermatology.

LIMITATIONS:

The study only evaluated top-selling products from a single online source at a specific time, which may limit generalizability. Potential allergens not included in the ACDS core series may be present.

DISCLOSURES:

The study did not disclose any funding source. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

FROM AAD 2024

SAN DIEGO — In separate studies evaluating treatments for severe forms of alopecia, inhibitors of Janus kinases (JAKs) produced clinically meaningful hair regrowth, according to late-breaking data presented at the annual meeting of  the American Academy of Dermatology.

In one study of brepocitinib, the target was cicatricial alopecia (CA), a form of hair loss for which there are no approved therapies. In the other, a subanalysis from phase 3 trials of ritlecitinib for alopecia areata (AA), hair regrowth was shown in the subset of patients who entered the study with alopecia totalis or alopecia universalis (AT/AU).

Reflecting comments from several experts, including one of the late-breaking session moderators, April W. Armstrong, MD, MPH, professor and chief of dermatology, University of California, Los Angeles, said that the CA study, which matched clinical response to changes in CA biomarkers, suggested that the results are a potential breakthrough.

“This is the first placebo-controlled study with an oral JAK inhibitor that not only shows that scarring alopecia can be reversible but also gives insights to the mechanism of action and which patients might respond best,” Emma Guttman-Yassky, MD, PhD, said in an interview. Dr. Guttman-Yassky, professor of Dermatology and Immunology, and director of the Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York City, was the study’s senior investigator.

Scarring Alopecia and Brepocitinib

For the study of scarring alopecia, 49 patients with CA were randomized in a 3:1 ratio to brepocitinib, a first-in-class inhibitor that targets both JAK1 and TYK2, or placebo. Because of the small size of the study, the primary endpoint was the change in CA biomarkers. The secondary outcome was clinical response, but because of a correlation between the two, these were mutually reinforcing.

Of the subtypes, nine patients enrolled in the study had frontal fibrosing alopecia (FFA), 16 had lichen planopilaris (LPP) alopecia, and 24 had central centrifugal cicatricial alopecia (CCCA). All of the forms of CA are more common in women overall and women of color specifically, particularly CCCA. For this analysis, the FFA and LPP subtypes were considered similar for assessing response and were combined.

The data included a comparison of response and safety during the 24-week randomization phase, as well as an additional follow-up conducted after another 24 weeks of open-label treatment. During the second phase, all patients on placebo were switched to active treatment.

Overall, there was a reduction in all four of the key scalp inflammatory biomarkers measured among those in the combined FFA/LLP group. In the placebo group, each of these markers — interferon gamma (IFN-gamma), CCLS, CXCL10, and STAT1 — increased over the same time period. In almost all cases, the differences were statistically significant.

In the CCCA subgroup, the same pattern (an increase among those on placebo but a decrease among those on brepocitinib) was observed for CCLS and CXCL10. For IFN-gamma and STAT1, a rise was observed among those on placebo and those on active treatment, although the rise was greater for placebo.

For clinical response, improvement on brepocitinib was observed on disease activity indexes, particularly among those in the FFA/LLP group, according to Marguerite Meariman, MD, a dermatology resident at Mount Sinai, who presented the results. She called the improvement in clinical activity scores at 48 weeks “dramatic.” Moreover, improvement was apparent within 4 weeks of starting therapy.

For CCCA, a more challenging condition to treat, Dr. Meariman said that no further progression might represent an acceptable response for many patients, but there were also cases of hair regrowth in this subset. Although improvement was not generally on the order seen among those with FFA/LLP, she suggested that there is promise even in these more difficult patients.

Further studies are planned, but Dr. Meariman said that it might be important to focus on early treatment regardless of CA subtype. She noted that patients with less than 5 years disease duration typically did better than those with longer durations.

Ritlecitinib for AT/AU

The analysis of patients with AT/AU was based on a subset analysis from the ALLEGRO phase 2b/3 study of ritlecitinib, which targets JAK3 and TEC kinases. The full results of the ALLEGRO trial were published last year in The Lancet. In the new late-breaker analysis, Severity of Alopecia Tool (SALT) scores were evaluated on an observed or last-observation-carried-forward basis. Generally, responses in the subgroup of patients with AT/AU, who had a median SALT score of 80.3 (signifying 80.3% hair loss) at baseline, were only modestly lower than those in the overall trial.

At 24 months, about 50% of patients achieved a SALT score of 20, according to Melissa Piliang, MD, chair of Dermatology at the Cleveland Clinic, Cleveland, Ohio, who presented the data. In this group, as in the non-AT/AU population, responses climbed over time, and these responses have been maintained for as long as patients have remained on therapy.

At the more rigorous threshold of SALT < 10, the proportion of responders was only slightly lower, meaning a substantial proportion of patients with AT/AU “are achieving 90% or more of hair regrowth, so really an excellent response,” Dr. Piliang said.

For the subgroup with AU, specifically, regrowth of eyebrows and eyelashes was also observed in a substantial proportion, according to Dr. Piliang. Attributed to the often-devastating psychological burden of hair loss, patient-reported assessments of these responses global were generally “even better” than those reported by the investigators.

However, Dr. Piliang advised clinicians to treat AA as early as possible. Despite the benefits seen in the AT/AU subgroup, she pointed out that starting treatment before total hair loss is associated with a higher likelihood of complete or nearly complete hair regrowth.

There are no data from the ALLEGRO trial to determine how long hair regrowth persists after discontinuation of ritlecitinib, which has been approved for the treatment of AA, but Dr. Piliang said that patients should be told that lifelong therapy should be expected in the vast majority of individuals, whether or not AA has advanced to AT/AU.

“In my experience with JAK inhibitors, you lose response when you come off these drugs,” she said.

Dr. Meariman reported a financial relationship with AbbVie. Dr. Piliang reported financial relationships with Eli Lilly, Pfizer, and Proctor & Gamble. Dr. Armstrong reported financial relationships with more than 30 pharmaceutical companies, including those that manufacture JAK inhibitors. Dr. Guttman-Yassky reported financial relationships with more than 30 companies, including those that manufacture JAK inhibitors.

A version of this article appeared on Medscape.com.

FROM AAD 2024

SAN DIEGO — In separate studies evaluating treatments for severe forms of alopecia, inhibitors of Janus kinases (JAKs) produced clinically meaningful hair regrowth, according to late-breaking data presented at the annual meeting of  the American Academy of Dermatology.

In one study of brepocitinib, the target was cicatricial alopecia (CA), a form of hair loss for which there are no approved therapies. In the other, a subanalysis from phase 3 trials of ritlecitinib for alopecia areata (AA), hair regrowth was shown in the subset of patients who entered the study with alopecia totalis or alopecia universalis (AT/AU).

Reflecting comments from several experts, including one of the late-breaking session moderators, April W. Armstrong, MD, MPH, professor and chief of dermatology, University of California, Los Angeles, said that the CA study, which matched clinical response to changes in CA biomarkers, suggested that the results are a potential breakthrough.

“This is the first placebo-controlled study with an oral JAK inhibitor that not only shows that scarring alopecia can be reversible but also gives insights to the mechanism of action and which patients might respond best,” Emma Guttman-Yassky, MD, PhD, said in an interview. Dr. Guttman-Yassky, professor of Dermatology and Immunology, and director of the Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York City, was the study’s senior investigator.

Scarring Alopecia and Brepocitinib

For the study of scarring alopecia, 49 patients with CA were randomized in a 3:1 ratio to brepocitinib, a first-in-class inhibitor that targets both JAK1 and TYK2, or placebo. Because of the small size of the study, the primary endpoint was the change in CA biomarkers. The secondary outcome was clinical response, but because of a correlation between the two, these were mutually reinforcing.

Of the subtypes, nine patients enrolled in the study had frontal fibrosing alopecia (FFA), 16 had lichen planopilaris (LPP) alopecia, and 24 had central centrifugal cicatricial alopecia (CCCA). All of the forms of CA are more common in women overall and women of color specifically, particularly CCCA. For this analysis, the FFA and LPP subtypes were considered similar for assessing response and were combined.

The data included a comparison of response and safety during the 24-week randomization phase, as well as an additional follow-up conducted after another 24 weeks of open-label treatment. During the second phase, all patients on placebo were switched to active treatment.

Overall, there was a reduction in all four of the key scalp inflammatory biomarkers measured among those in the combined FFA/LLP group. In the placebo group, each of these markers — interferon gamma (IFN-gamma), CCLS, CXCL10, and STAT1 — increased over the same time period. In almost all cases, the differences were statistically significant.

In the CCCA subgroup, the same pattern (an increase among those on placebo but a decrease among those on brepocitinib) was observed for CCLS and CXCL10. For IFN-gamma and STAT1, a rise was observed among those on placebo and those on active treatment, although the rise was greater for placebo.

For clinical response, improvement on brepocitinib was observed on disease activity indexes, particularly among those in the FFA/LLP group, according to Marguerite Meariman, MD, a dermatology resident at Mount Sinai, who presented the results. She called the improvement in clinical activity scores at 48 weeks “dramatic.” Moreover, improvement was apparent within 4 weeks of starting therapy.

For CCCA, a more challenging condition to treat, Dr. Meariman said that no further progression might represent an acceptable response for many patients, but there were also cases of hair regrowth in this subset. Although improvement was not generally on the order seen among those with FFA/LLP, she suggested that there is promise even in these more difficult patients.

Further studies are planned, but Dr. Meariman said that it might be important to focus on early treatment regardless of CA subtype. She noted that patients with less than 5 years disease duration typically did better than those with longer durations.

Ritlecitinib for AT/AU

The analysis of patients with AT/AU was based on a subset analysis from the ALLEGRO phase 2b/3 study of ritlecitinib, which targets JAK3 and TEC kinases. The full results of the ALLEGRO trial were published last year in The Lancet. In the new late-breaker analysis, Severity of Alopecia Tool (SALT) scores were evaluated on an observed or last-observation-carried-forward basis. Generally, responses in the subgroup of patients with AT/AU, who had a median SALT score of 80.3 (signifying 80.3% hair loss) at baseline, were only modestly lower than those in the overall trial.

At 24 months, about 50% of patients achieved a SALT score of 20, according to Melissa Piliang, MD, chair of Dermatology at the Cleveland Clinic, Cleveland, Ohio, who presented the data. In this group, as in the non-AT/AU population, responses climbed over time, and these responses have been maintained for as long as patients have remained on therapy.

At the more rigorous threshold of SALT < 10, the proportion of responders was only slightly lower, meaning a substantial proportion of patients with AT/AU “are achieving 90% or more of hair regrowth, so really an excellent response,” Dr. Piliang said.

For the subgroup with AU, specifically, regrowth of eyebrows and eyelashes was also observed in a substantial proportion, according to Dr. Piliang. Attributed to the often-devastating psychological burden of hair loss, patient-reported assessments of these responses global were generally “even better” than those reported by the investigators.

However, Dr. Piliang advised clinicians to treat AA as early as possible. Despite the benefits seen in the AT/AU subgroup, she pointed out that starting treatment before total hair loss is associated with a higher likelihood of complete or nearly complete hair regrowth.

There are no data from the ALLEGRO trial to determine how long hair regrowth persists after discontinuation of ritlecitinib, which has been approved for the treatment of AA, but Dr. Piliang said that patients should be told that lifelong therapy should be expected in the vast majority of individuals, whether or not AA has advanced to AT/AU.

“In my experience with JAK inhibitors, you lose response when you come off these drugs,” she said.

Dr. Meariman reported a financial relationship with AbbVie. Dr. Piliang reported financial relationships with Eli Lilly, Pfizer, and Proctor & Gamble. Dr. Armstrong reported financial relationships with more than 30 pharmaceutical companies, including those that manufacture JAK inhibitors. Dr. Guttman-Yassky reported financial relationships with more than 30 companies, including those that manufacture JAK inhibitors.

A version of this article appeared on Medscape.com.

FROM AAD 2024

SAN DIEGO — In separate studies evaluating treatments for severe forms of alopecia, inhibitors of Janus kinases (JAKs) produced clinically meaningful hair regrowth, according to late-breaking data presented at the annual meeting of  the American Academy of Dermatology.

In one study of brepocitinib, the target was cicatricial alopecia (CA), a form of hair loss for which there are no approved therapies. In the other, a subanalysis from phase 3 trials of ritlecitinib for alopecia areata (AA), hair regrowth was shown in the subset of patients who entered the study with alopecia totalis or alopecia universalis (AT/AU).

Reflecting comments from several experts, including one of the late-breaking session moderators, April W. Armstrong, MD, MPH, professor and chief of dermatology, University of California, Los Angeles, said that the CA study, which matched clinical response to changes in CA biomarkers, suggested that the results are a potential breakthrough.

“This is the first placebo-controlled study with an oral JAK inhibitor that not only shows that scarring alopecia can be reversible but also gives insights to the mechanism of action and which patients might respond best,” Emma Guttman-Yassky, MD, PhD, said in an interview. Dr. Guttman-Yassky, professor of Dermatology and Immunology, and director of the Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York City, was the study’s senior investigator.

Scarring Alopecia and Brepocitinib

For the study of scarring alopecia, 49 patients with CA were randomized in a 3:1 ratio to brepocitinib, a first-in-class inhibitor that targets both JAK1 and TYK2, or placebo. Because of the small size of the study, the primary endpoint was the change in CA biomarkers. The secondary outcome was clinical response, but because of a correlation between the two, these were mutually reinforcing.

Of the subtypes, nine patients enrolled in the study had frontal fibrosing alopecia (FFA), 16 had lichen planopilaris (LPP) alopecia, and 24 had central centrifugal cicatricial alopecia (CCCA). All of the forms of CA are more common in women overall and women of color specifically, particularly CCCA. For this analysis, the FFA and LPP subtypes were considered similar for assessing response and were combined.

The data included a comparison of response and safety during the 24-week randomization phase, as well as an additional follow-up conducted after another 24 weeks of open-label treatment. During the second phase, all patients on placebo were switched to active treatment.

Overall, there was a reduction in all four of the key scalp inflammatory biomarkers measured among those in the combined FFA/LLP group. In the placebo group, each of these markers — interferon gamma (IFN-gamma), CCLS, CXCL10, and STAT1 — increased over the same time period. In almost all cases, the differences were statistically significant.

In the CCCA subgroup, the same pattern (an increase among those on placebo but a decrease among those on brepocitinib) was observed for CCLS and CXCL10. For IFN-gamma and STAT1, a rise was observed among those on placebo and those on active treatment, although the rise was greater for placebo.

For clinical response, improvement on brepocitinib was observed on disease activity indexes, particularly among those in the FFA/LLP group, according to Marguerite Meariman, MD, a dermatology resident at Mount Sinai, who presented the results. She called the improvement in clinical activity scores at 48 weeks “dramatic.” Moreover, improvement was apparent within 4 weeks of starting therapy.

For CCCA, a more challenging condition to treat, Dr. Meariman said that no further progression might represent an acceptable response for many patients, but there were also cases of hair regrowth in this subset. Although improvement was not generally on the order seen among those with FFA/LLP, she suggested that there is promise even in these more difficult patients.

Further studies are planned, but Dr. Meariman said that it might be important to focus on early treatment regardless of CA subtype. She noted that patients with less than 5 years disease duration typically did better than those with longer durations.

Ritlecitinib for AT/AU

The analysis of patients with AT/AU was based on a subset analysis from the ALLEGRO phase 2b/3 study of ritlecitinib, which targets JAK3 and TEC kinases. The full results of the ALLEGRO trial were published last year in The Lancet. In the new late-breaker analysis, Severity of Alopecia Tool (SALT) scores were evaluated on an observed or last-observation-carried-forward basis. Generally, responses in the subgroup of patients with AT/AU, who had a median SALT score of 80.3 (signifying 80.3% hair loss) at baseline, were only modestly lower than those in the overall trial.

At 24 months, about 50% of patients achieved a SALT score of 20, according to Melissa Piliang, MD, chair of Dermatology at the Cleveland Clinic, Cleveland, Ohio, who presented the data. In this group, as in the non-AT/AU population, responses climbed over time, and these responses have been maintained for as long as patients have remained on therapy.

At the more rigorous threshold of SALT < 10, the proportion of responders was only slightly lower, meaning a substantial proportion of patients with AT/AU “are achieving 90% or more of hair regrowth, so really an excellent response,” Dr. Piliang said.

For the subgroup with AU, specifically, regrowth of eyebrows and eyelashes was also observed in a substantial proportion, according to Dr. Piliang. Attributed to the often-devastating psychological burden of hair loss, patient-reported assessments of these responses global were generally “even better” than those reported by the investigators.

However, Dr. Piliang advised clinicians to treat AA as early as possible. Despite the benefits seen in the AT/AU subgroup, she pointed out that starting treatment before total hair loss is associated with a higher likelihood of complete or nearly complete hair regrowth.

There are no data from the ALLEGRO trial to determine how long hair regrowth persists after discontinuation of ritlecitinib, which has been approved for the treatment of AA, but Dr. Piliang said that patients should be told that lifelong therapy should be expected in the vast majority of individuals, whether or not AA has advanced to AT/AU.

“In my experience with JAK inhibitors, you lose response when you come off these drugs,” she said.

Dr. Meariman reported a financial relationship with AbbVie. Dr. Piliang reported financial relationships with Eli Lilly, Pfizer, and Proctor & Gamble. Dr. Armstrong reported financial relationships with more than 30 pharmaceutical companies, including those that manufacture JAK inhibitors. Dr. Guttman-Yassky reported financial relationships with more than 30 companies, including those that manufacture JAK inhibitors.

A version of this article appeared on Medscape.com.