Dermatology

Treatment with bimekizumab significantly improved symptoms in adults with palmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules, in a case series of 21 individuals.

PPP is a type of pustular psoriasis that remains a treatment challenge, and available treatments for palmoplantar plaque psoriasis with pustules also “remain unsatisfactory,” according to Thierry Passeron, MD, PhD, of the dermatology service at Centre Hospitalier Universitaire de Nice (France), and colleagues. Bimekizumab, an anti-interleukin (IL)-17A and anti-IL-17F antibody therapy, has been used for psoriasis and psoriatic arthritis (PsA), but its effectiveness for PPP has not been studied, they said. In the United States, bimekizumab (Bimzelx), administered subcutaneously, was recently approved for treating moderate to severe plaque psoriasis in adults; in the European Union, it is approved for treating psoriasis, in addition to psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis.

In the case series published in JAMA Dermatology, Dr. Passeron and coinvestigators identified 11 adults with PPP and 10 with palmoplantar plaque psoriasis with pustules who were treated at one of seven tertiary dermatology centers in France from September 2022 through June 2023. PPP also has been associated with bone and joint inflammation in SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome.

All patients received bimekizumab for at least 3 months. The patients — 19 women and 2 men — ranged in age from 24 to 68 years (mean age, 46 years). The primary outcome was complete clearance, defined as an Investigator Global Assessment (IGA) score of 0.

A total of 17 patients achieved an IGA score of zero in 1-4 months. Over 3-6 months, three patients achieved an IGA score of 1 (almost clear), and one patient achieved an IGA score of 2 (mild).

Three patients with PPP also had acrodermatitis continua of Hallopeau; in these patients, nail involvement improved by 50%-70% after 4-6 months of bimekizumab use. Two patients with SAPHO experienced complete clearance of skin lesions associated with improvement in joint pain.

Four patients developed oral and genital candidiasis during treatment, but all were treated successfully with antifungals. None of the patients discontinued bimekizumab because of adverse events. “All patients are still receiving treatment, and their psoriatic lesions remain controlled,” the authors wrote.

“The rapid and consistent improvement observed in the present case series supports the effectiveness of bimekizumab therapy in managing PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome,” they said in their discussion.

The study findings were limited by several factors including the small sample size and short follow-up period, and by the inclusion of only patients with severe disease; and prospective, placebo-controlled studies are needed to confirm the results, the researchers noted.

However, the results suggest that bimekizumab could be a treatment approach for PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome, and warrant a prospective, randomized, placebo-controlled, randomized clinical trial to confirm the findings, they concluded.

Dr. Passeron disclosed fees from AbbVie, ACM Pharma, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Roivant Sciences, Sun Pharmaceuticals, and VYNE Therapeutics outside the current study; he is a cofounder of Yukin Therapeutics. Three authors disclosed receiving personal fees from UCB, manufacturer of bimekizumab, outside of the submitted work, another author disclosed receiving personal fees from UCB during the conduct of the study, and another reported receiving grants from UCB and several other companies, outside the submitted work.

The study findings were also presented at a meeting, Les Journées Dermatologiques de Paris 2023, on December 6, in Paris.

Treatment with bimekizumab significantly improved symptoms in adults with palmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules, in a case series of 21 individuals.

PPP is a type of pustular psoriasis that remains a treatment challenge, and available treatments for palmoplantar plaque psoriasis with pustules also “remain unsatisfactory,” according to Thierry Passeron, MD, PhD, of the dermatology service at Centre Hospitalier Universitaire de Nice (France), and colleagues. Bimekizumab, an anti-interleukin (IL)-17A and anti-IL-17F antibody therapy, has been used for psoriasis and psoriatic arthritis (PsA), but its effectiveness for PPP has not been studied, they said. In the United States, bimekizumab (Bimzelx), administered subcutaneously, was recently approved for treating moderate to severe plaque psoriasis in adults; in the European Union, it is approved for treating psoriasis, in addition to psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis.

In the case series published in JAMA Dermatology, Dr. Passeron and coinvestigators identified 11 adults with PPP and 10 with palmoplantar plaque psoriasis with pustules who were treated at one of seven tertiary dermatology centers in France from September 2022 through June 2023. PPP also has been associated with bone and joint inflammation in SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome.

All patients received bimekizumab for at least 3 months. The patients — 19 women and 2 men — ranged in age from 24 to 68 years (mean age, 46 years). The primary outcome was complete clearance, defined as an Investigator Global Assessment (IGA) score of 0.

A total of 17 patients achieved an IGA score of zero in 1-4 months. Over 3-6 months, three patients achieved an IGA score of 1 (almost clear), and one patient achieved an IGA score of 2 (mild).

Three patients with PPP also had acrodermatitis continua of Hallopeau; in these patients, nail involvement improved by 50%-70% after 4-6 months of bimekizumab use. Two patients with SAPHO experienced complete clearance of skin lesions associated with improvement in joint pain.

Four patients developed oral and genital candidiasis during treatment, but all were treated successfully with antifungals. None of the patients discontinued bimekizumab because of adverse events. “All patients are still receiving treatment, and their psoriatic lesions remain controlled,” the authors wrote.

“The rapid and consistent improvement observed in the present case series supports the effectiveness of bimekizumab therapy in managing PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome,” they said in their discussion.

The study findings were limited by several factors including the small sample size and short follow-up period, and by the inclusion of only patients with severe disease; and prospective, placebo-controlled studies are needed to confirm the results, the researchers noted.

However, the results suggest that bimekizumab could be a treatment approach for PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome, and warrant a prospective, randomized, placebo-controlled, randomized clinical trial to confirm the findings, they concluded.

Dr. Passeron disclosed fees from AbbVie, ACM Pharma, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Roivant Sciences, Sun Pharmaceuticals, and VYNE Therapeutics outside the current study; he is a cofounder of Yukin Therapeutics. Three authors disclosed receiving personal fees from UCB, manufacturer of bimekizumab, outside of the submitted work, another author disclosed receiving personal fees from UCB during the conduct of the study, and another reported receiving grants from UCB and several other companies, outside the submitted work.

The study findings were also presented at a meeting, Les Journées Dermatologiques de Paris 2023, on December 6, in Paris.

Treatment with bimekizumab significantly improved symptoms in adults with palmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules, in a case series of 21 individuals.

PPP is a type of pustular psoriasis that remains a treatment challenge, and available treatments for palmoplantar plaque psoriasis with pustules also “remain unsatisfactory,” according to Thierry Passeron, MD, PhD, of the dermatology service at Centre Hospitalier Universitaire de Nice (France), and colleagues. Bimekizumab, an anti-interleukin (IL)-17A and anti-IL-17F antibody therapy, has been used for psoriasis and psoriatic arthritis (PsA), but its effectiveness for PPP has not been studied, they said. In the United States, bimekizumab (Bimzelx), administered subcutaneously, was recently approved for treating moderate to severe plaque psoriasis in adults; in the European Union, it is approved for treating psoriasis, in addition to psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis.

In the case series published in JAMA Dermatology, Dr. Passeron and coinvestigators identified 11 adults with PPP and 10 with palmoplantar plaque psoriasis with pustules who were treated at one of seven tertiary dermatology centers in France from September 2022 through June 2023. PPP also has been associated with bone and joint inflammation in SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome.

All patients received bimekizumab for at least 3 months. The patients — 19 women and 2 men — ranged in age from 24 to 68 years (mean age, 46 years). The primary outcome was complete clearance, defined as an Investigator Global Assessment (IGA) score of 0.

A total of 17 patients achieved an IGA score of zero in 1-4 months. Over 3-6 months, three patients achieved an IGA score of 1 (almost clear), and one patient achieved an IGA score of 2 (mild).

Three patients with PPP also had acrodermatitis continua of Hallopeau; in these patients, nail involvement improved by 50%-70% after 4-6 months of bimekizumab use. Two patients with SAPHO experienced complete clearance of skin lesions associated with improvement in joint pain.

Four patients developed oral and genital candidiasis during treatment, but all were treated successfully with antifungals. None of the patients discontinued bimekizumab because of adverse events. “All patients are still receiving treatment, and their psoriatic lesions remain controlled,” the authors wrote.

“The rapid and consistent improvement observed in the present case series supports the effectiveness of bimekizumab therapy in managing PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome,” they said in their discussion.

The study findings were limited by several factors including the small sample size and short follow-up period, and by the inclusion of only patients with severe disease; and prospective, placebo-controlled studies are needed to confirm the results, the researchers noted.

However, the results suggest that bimekizumab could be a treatment approach for PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome, and warrant a prospective, randomized, placebo-controlled, randomized clinical trial to confirm the findings, they concluded.

Dr. Passeron disclosed fees from AbbVie, ACM Pharma, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Roivant Sciences, Sun Pharmaceuticals, and VYNE Therapeutics outside the current study; he is a cofounder of Yukin Therapeutics. Three authors disclosed receiving personal fees from UCB, manufacturer of bimekizumab, outside of the submitted work, another author disclosed receiving personal fees from UCB during the conduct of the study, and another reported receiving grants from UCB and several other companies, outside the submitted work.

The study findings were also presented at a meeting, Les Journées Dermatologiques de Paris 2023, on December 6, in Paris.

Tape stripping, which allows sampling of the epidermis to the midgranular layer, is a valid, minimally invasive way to identify cutaneous biomarkers in patients with hidradenitis suppurative (HS), results from a novel study showed.

“Tape strips can provide important clues to when and which drugs to use in HS in patients with both early and late disease, which can change clinical practice,” corresponding study author Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview. “It is noninvasive and nonscarring,” she added.

Tape stripping has been validated in atopic dermatitis, psoriasis, and other dermatologic conditions in recent years. For the current study, which was published online in the Journal of the American Academy of Dermatology, and is believed to be the first of its kind, Dr. Guttman-Yassky and colleagues performed RNA sequencing from large D-Squame tape strips collected from lesional and nonlesional skin of 22 patients with HS and from 21 age- and sex-matched healthy controls. They correlated the expression of skin biomarkers between tape strips and a previously published gene-signature of HS biopsies. The mean age of patients with HS was 43 years, while the mean age of healthy controls was 35. The average International Hidradenitis Suppurativa Severity Score System (IHS4) score of the HS cohort was 36.

Consistent with published studies, the researchers found that tape strips identified an overall higher inflammatory burden in HS. Specifically, they observed an upregulation of known cytokines within the following pathways: Th1 (such as IFNG, CXCL9/10/11, and CCR5); Th17 (such as interleukin [IL]-17A/F, IL12B, IL23A, CAMP, and CCL20); Th2 (such as IL4R, IL13/IL31/IL10, CCR4, CCL7/CCL13/CCL24, TNFSF4/OX40L, and TNFRSF4/OX40); and Th22 (such as IL22 and IL32).

The researchers also found that the expression of Th17 and tumor necrosis factor (TNF)–alpha pathways were highly correlated between tape strips and biopsies and that HS clinical severity was significantly associated with expression of biomarkers, such as TNF-alpha, IL17A/F, OX40, JAK1-3, and IL4R in HS lesional and/or nonlesional skin.

“It was quite unexpected that we are able to identify, using a minimally invasive approach that samples only the upper layers of the epidermis, products and processes that are considered to be deeper-situated, such as IL-17, and other immune markers,” Dr. Guttman-Yassky said in the interview. “We were also surprised to see how well the tape-stripped–derived skin molecular profile correlated with that of biopsies, as well as how well it correlated with the clinical disease severity of HS.”

Also surprising, she added, was that the biomarkers in nonlesional tape-stripped skin, such as IL-17 and TNF alpha, “show high correlations with disease severity and provide clues to early disease.”

If using tape strips in HS is validated in larger cohort studies, the potential cost implications of using this approach in practice remain unclear, Dr. Guttman-Yassky said. “It is currently not cheap, but we are hoping that one day, we can provide a means to diagnose the disease and treat it early, and appropriately, utilizing this approach,” she commented. “We are excited about the applicability of this study to the early treatment and longitudinal follow up of HS with drugs that are targeting specific immune molecules and pathways,” she said, adding that it will also be useful for helping determine which drug should be used for which patient.

She and her co-authors acknowledged certain limitations of the study, including its small sample size and the fact that tape stripping is limited to the epidermis.

Asked to comment on the study, Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, said the findings “have important potential implications for our ability to one day personalize treatments for a patient with early HS in a minimally invasive way.”

As the study authors point out, she added, “tape strips only allow sampling of the epidermis, which is limiting in a disease like HS where much of the disruption is in the dermis with deep nodules and dermal tunnels. However, our overall goal should be to catch patients in the early stages of their disease before the occurrence of irreversible tissue damage such as dermal tunnels. Thus, the ongoing campaign for early diagnosis and early intervention by various stakeholders in the field of HS can help mitigate the impact of this inherent limitation of tape strips. It will be exciting to see larger studies that investigate tape strip results in relation to clinical phenotypes, disease progression, and therapeutic responses.”

The study was funded by an International Dermatology Outcome Measures Hidradenitis Suppurativa Grant. Dr. Guttman-Yassky disclosed that she has been a consultant to, an adviser for, and has received research grants from many pharmaceutical companies. Of the remaining authors, 2 also had multiple disclosures and 11 had no disclosures. 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; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

Tape stripping, which allows sampling of the epidermis to the midgranular layer, is a valid, minimally invasive way to identify cutaneous biomarkers in patients with hidradenitis suppurative (HS), results from a novel study showed.

“Tape strips can provide important clues to when and which drugs to use in HS in patients with both early and late disease, which can change clinical practice,” corresponding study author Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview. “It is noninvasive and nonscarring,” she added.

Tape stripping has been validated in atopic dermatitis, psoriasis, and other dermatologic conditions in recent years. For the current study, which was published online in the Journal of the American Academy of Dermatology, and is believed to be the first of its kind, Dr. Guttman-Yassky and colleagues performed RNA sequencing from large D-Squame tape strips collected from lesional and nonlesional skin of 22 patients with HS and from 21 age- and sex-matched healthy controls. They correlated the expression of skin biomarkers between tape strips and a previously published gene-signature of HS biopsies. The mean age of patients with HS was 43 years, while the mean age of healthy controls was 35. The average International Hidradenitis Suppurativa Severity Score System (IHS4) score of the HS cohort was 36.

Consistent with published studies, the researchers found that tape strips identified an overall higher inflammatory burden in HS. Specifically, they observed an upregulation of known cytokines within the following pathways: Th1 (such as IFNG, CXCL9/10/11, and CCR5); Th17 (such as interleukin [IL]-17A/F, IL12B, IL23A, CAMP, and CCL20); Th2 (such as IL4R, IL13/IL31/IL10, CCR4, CCL7/CCL13/CCL24, TNFSF4/OX40L, and TNFRSF4/OX40); and Th22 (such as IL22 and IL32).

The researchers also found that the expression of Th17 and tumor necrosis factor (TNF)–alpha pathways were highly correlated between tape strips and biopsies and that HS clinical severity was significantly associated with expression of biomarkers, such as TNF-alpha, IL17A/F, OX40, JAK1-3, and IL4R in HS lesional and/or nonlesional skin.

“It was quite unexpected that we are able to identify, using a minimally invasive approach that samples only the upper layers of the epidermis, products and processes that are considered to be deeper-situated, such as IL-17, and other immune markers,” Dr. Guttman-Yassky said in the interview. “We were also surprised to see how well the tape-stripped–derived skin molecular profile correlated with that of biopsies, as well as how well it correlated with the clinical disease severity of HS.”

Also surprising, she added, was that the biomarkers in nonlesional tape-stripped skin, such as IL-17 and TNF alpha, “show high correlations with disease severity and provide clues to early disease.”

If using tape strips in HS is validated in larger cohort studies, the potential cost implications of using this approach in practice remain unclear, Dr. Guttman-Yassky said. “It is currently not cheap, but we are hoping that one day, we can provide a means to diagnose the disease and treat it early, and appropriately, utilizing this approach,” she commented. “We are excited about the applicability of this study to the early treatment and longitudinal follow up of HS with drugs that are targeting specific immune molecules and pathways,” she said, adding that it will also be useful for helping determine which drug should be used for which patient.

She and her co-authors acknowledged certain limitations of the study, including its small sample size and the fact that tape stripping is limited to the epidermis.

Asked to comment on the study, Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, said the findings “have important potential implications for our ability to one day personalize treatments for a patient with early HS in a minimally invasive way.”

As the study authors point out, she added, “tape strips only allow sampling of the epidermis, which is limiting in a disease like HS where much of the disruption is in the dermis with deep nodules and dermal tunnels. However, our overall goal should be to catch patients in the early stages of their disease before the occurrence of irreversible tissue damage such as dermal tunnels. Thus, the ongoing campaign for early diagnosis and early intervention by various stakeholders in the field of HS can help mitigate the impact of this inherent limitation of tape strips. It will be exciting to see larger studies that investigate tape strip results in relation to clinical phenotypes, disease progression, and therapeutic responses.”

The study was funded by an International Dermatology Outcome Measures Hidradenitis Suppurativa Grant. Dr. Guttman-Yassky disclosed that she has been a consultant to, an adviser for, and has received research grants from many pharmaceutical companies. Of the remaining authors, 2 also had multiple disclosures and 11 had no disclosures. 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; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

Tape stripping, which allows sampling of the epidermis to the midgranular layer, is a valid, minimally invasive way to identify cutaneous biomarkers in patients with hidradenitis suppurative (HS), results from a novel study showed.

“Tape strips can provide important clues to when and which drugs to use in HS in patients with both early and late disease, which can change clinical practice,” corresponding study author Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview. “It is noninvasive and nonscarring,” she added.

Tape stripping has been validated in atopic dermatitis, psoriasis, and other dermatologic conditions in recent years. For the current study, which was published online in the Journal of the American Academy of Dermatology, and is believed to be the first of its kind, Dr. Guttman-Yassky and colleagues performed RNA sequencing from large D-Squame tape strips collected from lesional and nonlesional skin of 22 patients with HS and from 21 age- and sex-matched healthy controls. They correlated the expression of skin biomarkers between tape strips and a previously published gene-signature of HS biopsies. The mean age of patients with HS was 43 years, while the mean age of healthy controls was 35. The average International Hidradenitis Suppurativa Severity Score System (IHS4) score of the HS cohort was 36.

Consistent with published studies, the researchers found that tape strips identified an overall higher inflammatory burden in HS. Specifically, they observed an upregulation of known cytokines within the following pathways: Th1 (such as IFNG, CXCL9/10/11, and CCR5); Th17 (such as interleukin [IL]-17A/F, IL12B, IL23A, CAMP, and CCL20); Th2 (such as IL4R, IL13/IL31/IL10, CCR4, CCL7/CCL13/CCL24, TNFSF4/OX40L, and TNFRSF4/OX40); and Th22 (such as IL22 and IL32).

The researchers also found that the expression of Th17 and tumor necrosis factor (TNF)–alpha pathways were highly correlated between tape strips and biopsies and that HS clinical severity was significantly associated with expression of biomarkers, such as TNF-alpha, IL17A/F, OX40, JAK1-3, and IL4R in HS lesional and/or nonlesional skin.

“It was quite unexpected that we are able to identify, using a minimally invasive approach that samples only the upper layers of the epidermis, products and processes that are considered to be deeper-situated, such as IL-17, and other immune markers,” Dr. Guttman-Yassky said in the interview. “We were also surprised to see how well the tape-stripped–derived skin molecular profile correlated with that of biopsies, as well as how well it correlated with the clinical disease severity of HS.”

Also surprising, she added, was that the biomarkers in nonlesional tape-stripped skin, such as IL-17 and TNF alpha, “show high correlations with disease severity and provide clues to early disease.”

If using tape strips in HS is validated in larger cohort studies, the potential cost implications of using this approach in practice remain unclear, Dr. Guttman-Yassky said. “It is currently not cheap, but we are hoping that one day, we can provide a means to diagnose the disease and treat it early, and appropriately, utilizing this approach,” she commented. “We are excited about the applicability of this study to the early treatment and longitudinal follow up of HS with drugs that are targeting specific immune molecules and pathways,” she said, adding that it will also be useful for helping determine which drug should be used for which patient.

She and her co-authors acknowledged certain limitations of the study, including its small sample size and the fact that tape stripping is limited to the epidermis.

Asked to comment on the study, Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, said the findings “have important potential implications for our ability to one day personalize treatments for a patient with early HS in a minimally invasive way.”

As the study authors point out, she added, “tape strips only allow sampling of the epidermis, which is limiting in a disease like HS where much of the disruption is in the dermis with deep nodules and dermal tunnels. However, our overall goal should be to catch patients in the early stages of their disease before the occurrence of irreversible tissue damage such as dermal tunnels. Thus, the ongoing campaign for early diagnosis and early intervention by various stakeholders in the field of HS can help mitigate the impact of this inherent limitation of tape strips. It will be exciting to see larger studies that investigate tape strip results in relation to clinical phenotypes, disease progression, and therapeutic responses.”

The study was funded by an International Dermatology Outcome Measures Hidradenitis Suppurativa Grant. Dr. Guttman-Yassky disclosed that she has been a consultant to, an adviser for, and has received research grants from many pharmaceutical companies. Of the remaining authors, 2 also had multiple disclosures and 11 had no disclosures. 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; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

TOPLINE:

Patients with psoriasis had a 1.77-fold increased risk of having obstructive sleep apnea, in a study comparing patients with psoriasis with controls.

METHODOLOGY:

• Prior studies have established a link between psoriasis and obstructive sleep apnea (OSA), but some have suggested that confounders may drive the association.
• Using a case-control design, researchers analyzed data from 156,707 participants in the National Institutes of Health’s : 5140 with psoriasis and 151,567 controls.
• They used Pearson’s x 2 test to compare the prevalence of OSA among cases and controls, logistic regression to calculate odds ratios (ORs) in multivariable analysis, and two-sided t-tests to evaluate the significance between continuous variables.

TAKEAWAY:

• Compared with controls, patients with psoriasis were older (a mean of 62.4 vs 57.3 years, respectively), more likely to be White (86.1% vs 70.6%), reported higher annual household incomes (59.9% vs 52.6%), and were more likely to smoke (48.2% vs 43.4%).
• The rate of OSA was significantly higher among patients with psoriasis compared with controls (29.3% vs 17.1%; P < .001).
• On unadjusted multivariable logistic regression controlling for age, gender, and race, psoriasis was significantly associated with OSA (OR, 1.77, 95% CI, 1.66 - 1.89; P < .001).
• Psoriasis was also significantly associated with OSA in the adjusted model controlling for age, gender, race, BMI, and smoking status (OR, 1.66, 95% CI, 1.55 - 1.77; P < .001) and in the adjusted model controlling for age, gender, race, BMI, smoking status, type 2 diabetes, congestive heart failure, hypertension, history of myocardial infarction, angina, and peripheral artery disease (OR, 1.45, 95% CI, 1.35 - 1.55; P <.001).

IN PRACTICE:

“This study further substantiates the association between psoriasis and OSA, reinforcing the importance of evaluation for OSA when clinically appropriate given that both psoriasis and OSA contribute to adverse health outcomes,” the authors conclude.

SOURCE:

Corresponding author Jeffrey M. Cohen, MD, of the Department of Dermatology at Yale University, New Haven, Connecticut, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Study limitations included the use of electronic health record data, a potential lack of generalizability to the US population, and reliance on survey data for certain variables such as income and smoking status.

DISCLOSURES:

The All of Us Research Program is supported by the National Institutes of Health. Cohen disclosed that he serves on a data safety and monitoring board for Advarra.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with psoriasis had a 1.77-fold increased risk of having obstructive sleep apnea, in a study comparing patients with psoriasis with controls.

METHODOLOGY:

• Prior studies have established a link between psoriasis and obstructive sleep apnea (OSA), but some have suggested that confounders may drive the association.
• Using a case-control design, researchers analyzed data from 156,707 participants in the National Institutes of Health’s : 5140 with psoriasis and 151,567 controls.
• They used Pearson’s x 2 test to compare the prevalence of OSA among cases and controls, logistic regression to calculate odds ratios (ORs) in multivariable analysis, and two-sided t-tests to evaluate the significance between continuous variables.

TAKEAWAY:

• Compared with controls, patients with psoriasis were older (a mean of 62.4 vs 57.3 years, respectively), more likely to be White (86.1% vs 70.6%), reported higher annual household incomes (59.9% vs 52.6%), and were more likely to smoke (48.2% vs 43.4%).
• The rate of OSA was significantly higher among patients with psoriasis compared with controls (29.3% vs 17.1%; P < .001).
• On unadjusted multivariable logistic regression controlling for age, gender, and race, psoriasis was significantly associated with OSA (OR, 1.77, 95% CI, 1.66 - 1.89; P < .001).
• Psoriasis was also significantly associated with OSA in the adjusted model controlling for age, gender, race, BMI, and smoking status (OR, 1.66, 95% CI, 1.55 - 1.77; P < .001) and in the adjusted model controlling for age, gender, race, BMI, smoking status, type 2 diabetes, congestive heart failure, hypertension, history of myocardial infarction, angina, and peripheral artery disease (OR, 1.45, 95% CI, 1.35 - 1.55; P <.001).

IN PRACTICE:

“This study further substantiates the association between psoriasis and OSA, reinforcing the importance of evaluation for OSA when clinically appropriate given that both psoriasis and OSA contribute to adverse health outcomes,” the authors conclude.

SOURCE:

Corresponding author Jeffrey M. Cohen, MD, of the Department of Dermatology at Yale University, New Haven, Connecticut, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Study limitations included the use of electronic health record data, a potential lack of generalizability to the US population, and reliance on survey data for certain variables such as income and smoking status.

DISCLOSURES:

The All of Us Research Program is supported by the National Institutes of Health. Cohen disclosed that he serves on a data safety and monitoring board for Advarra.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with psoriasis had a 1.77-fold increased risk of having obstructive sleep apnea, in a study comparing patients with psoriasis with controls.

METHODOLOGY:

• Prior studies have established a link between psoriasis and obstructive sleep apnea (OSA), but some have suggested that confounders may drive the association.
• Using a case-control design, researchers analyzed data from 156,707 participants in the National Institutes of Health’s : 5140 with psoriasis and 151,567 controls.
• They used Pearson’s x 2 test to compare the prevalence of OSA among cases and controls, logistic regression to calculate odds ratios (ORs) in multivariable analysis, and two-sided t-tests to evaluate the significance between continuous variables.

TAKEAWAY:

• Compared with controls, patients with psoriasis were older (a mean of 62.4 vs 57.3 years, respectively), more likely to be White (86.1% vs 70.6%), reported higher annual household incomes (59.9% vs 52.6%), and were more likely to smoke (48.2% vs 43.4%).
• The rate of OSA was significantly higher among patients with psoriasis compared with controls (29.3% vs 17.1%; P < .001).
• On unadjusted multivariable logistic regression controlling for age, gender, and race, psoriasis was significantly associated with OSA (OR, 1.77, 95% CI, 1.66 - 1.89; P < .001).
• Psoriasis was also significantly associated with OSA in the adjusted model controlling for age, gender, race, BMI, and smoking status (OR, 1.66, 95% CI, 1.55 - 1.77; P < .001) and in the adjusted model controlling for age, gender, race, BMI, smoking status, type 2 diabetes, congestive heart failure, hypertension, history of myocardial infarction, angina, and peripheral artery disease (OR, 1.45, 95% CI, 1.35 - 1.55; P <.001).

IN PRACTICE:

“This study further substantiates the association between psoriasis and OSA, reinforcing the importance of evaluation for OSA when clinically appropriate given that both psoriasis and OSA contribute to adverse health outcomes,” the authors conclude.

SOURCE:

Corresponding author Jeffrey M. Cohen, MD, of the Department of Dermatology at Yale University, New Haven, Connecticut, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Study limitations included the use of electronic health record data, a potential lack of generalizability to the US population, and reliance on survey data for certain variables such as income and smoking status.

DISCLOSURES:

The All of Us Research Program is supported by the National Institutes of Health. Cohen disclosed that he serves on a data safety and monitoring board for Advarra.

A version of this article appeared on Medscape.com.

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

SAN DIEGO — Women with autoimmune skin diseases are at increased risk of adverse pregnancy outcomes and may benefit from multidisciplinary care with maternal-fetal medicine specialists, results from a large case-control study suggest.

Patients with systemic autoimmune conditions are known to have an increased risk for adverse pregnancy outcomes, “but we weren’t sure if that was the case for patients with autoimmune skin conditions,” presenting study author Heejo Keum, a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas, said in an interview during a poster session at the American College of Rheumatology (ACR) 2023 annual meeting. “There are case reports or nationwide population-based studies on patients with alopecia areata and vitiligo, but those were outside of the US, so we wanted to see if these outcomes could be studied in a larger population-based study in the US.”

Doug Brunk/MDedge News

Drawing from the TriNetX US Collaborative Network, a database of electronic medical records of 94 million patients in the United States, the researchers identified pregnant patients aged 15-44 years between January 1, 2016, and December 31, 2021. Cases were defined as patients diagnosed with at least one autoimmune skin disease (ASD) prior to the end of pregnancy, including alopecia areata, bullous pemphigoid, cicatricial pemphigoid, dermatitis herpetiformis, cutaneous lupus erythematosus, epidermolysis bullosa acquisita, morphea, pemphigus foliaceus, pemphigus vulgaris, vitiligo, and amyopathic DM. There were two control groups: healthy controls (those without ASDs, systemic lupus erythematosus or rheumatoid arthritis) and disease controls (those with SLE or RA). The researchers used ICD-10 codes to identify pregnancy endpoints, including live births, spontaneous abortion, and stillbirth. Patients with a history of hidradenitis suppurative were excluded from the analysis, as were those with common autoimmune disease such as Hashimoto’s thyroiditis, Grave’s disease, and type 1 diabetes.

The primary outcomes were adverse pregnancy outcomes defined as spontaneous abortion, gestational hypertension, preeclampsia/eclampsia, gestational diabetes, intrauterine growth restriction (IUGR), preterm premature rupture of membranes (PPROM), and preterm birth. The researchers used 1:1 propensity scoring to match patients with ASDs to controls by age, race, ethnicity, comorbidities, obesity, and substance use, and used odds ratio (OR) analysis with a 95% confidence interval (CI) to calculate each outcome.

Ms. Keum reported results from 3,654 women with ASDs, 3,654 healthy controls, 2,147 women with SLE, and 889 women with RA.

The three most common ASDs were vitiligo (30%), alopecia areata (30%), and cutaneous lupus erythematosus (27%). Compared with healthy controls, patients with ASDs were more likely to have spontaneous abortions (OR=1.5 [1.4-1.7], P<.001), and preeclampsia/eclampsia (OR=1.2 [1.0-1.3], P=.04). Compared with women with SLE, women with ASDs were less likely to have preeclampsia/eclampsia (OR=0.7 [0.6-0.9, P=.001); preterm birth (OR= 0.5 [0.4-0.7], P<.001); PPROM (OR=0.6 [0.4-0.9], P=.004), or an infant with IUGR (OR=0.6 [0.5-0.8], P<.001), but they were more likely to have a spontaneous abortion (OR=1.2 [1.1-1.3], P=.003). Overall, patients with ASDs had similar risks for adverse pregnancy outcomes as patients with RA.

“We found that patients with cutaneous lupus and vitiligo had higher rates of spontaneous abortion, which is interesting because we didn’t expect that,” Ms. Keum told this news organization. “Studies have shown that vitiligo patients might have an increased risk of pregnancy loss, so I think it’s important to have that discussion with those patients. It might benefit them to talk to a maternal-fetal medicine specialist. As for next steps, we want to look at how medication use and disease flare or disease severity play a role in APOs.”

In their poster, the researchers acknowledged limitations of the study, including the inability to verify diagnoses or assess disease severity. Also, while medication use and concomitant antiphospholipid syndrome were evaluated as risk factors for advanced pregnancy outcomes, the number of patients per group was too small for analysis.

Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that in his view, the choice of disease states included in the analysis “is a bit arbitrary.” He added that “it would have been more helpful to compare controls versus discoid lupus versus systemic lupus or controls versus amyopathic dermatomyositis versus dermatomyositis with myopathy.”

The study received funding support from the Rheumatology Research Foundation and the UT Southwestern Dean’s Research Scholar program. Neither Ms. Keum nor Dr. Saardi reported having relevant disclosures.

SAN DIEGO — Women with autoimmune skin diseases are at increased risk of adverse pregnancy outcomes and may benefit from multidisciplinary care with maternal-fetal medicine specialists, results from a large case-control study suggest.

Patients with systemic autoimmune conditions are known to have an increased risk for adverse pregnancy outcomes, “but we weren’t sure if that was the case for patients with autoimmune skin conditions,” presenting study author Heejo Keum, a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas, said in an interview during a poster session at the American College of Rheumatology (ACR) 2023 annual meeting. “There are case reports or nationwide population-based studies on patients with alopecia areata and vitiligo, but those were outside of the US, so we wanted to see if these outcomes could be studied in a larger population-based study in the US.”

Doug Brunk/MDedge News

Drawing from the TriNetX US Collaborative Network, a database of electronic medical records of 94 million patients in the United States, the researchers identified pregnant patients aged 15-44 years between January 1, 2016, and December 31, 2021. Cases were defined as patients diagnosed with at least one autoimmune skin disease (ASD) prior to the end of pregnancy, including alopecia areata, bullous pemphigoid, cicatricial pemphigoid, dermatitis herpetiformis, cutaneous lupus erythematosus, epidermolysis bullosa acquisita, morphea, pemphigus foliaceus, pemphigus vulgaris, vitiligo, and amyopathic DM. There were two control groups: healthy controls (those without ASDs, systemic lupus erythematosus or rheumatoid arthritis) and disease controls (those with SLE or RA). The researchers used ICD-10 codes to identify pregnancy endpoints, including live births, spontaneous abortion, and stillbirth. Patients with a history of hidradenitis suppurative were excluded from the analysis, as were those with common autoimmune disease such as Hashimoto’s thyroiditis, Grave’s disease, and type 1 diabetes.

The primary outcomes were adverse pregnancy outcomes defined as spontaneous abortion, gestational hypertension, preeclampsia/eclampsia, gestational diabetes, intrauterine growth restriction (IUGR), preterm premature rupture of membranes (PPROM), and preterm birth. The researchers used 1:1 propensity scoring to match patients with ASDs to controls by age, race, ethnicity, comorbidities, obesity, and substance use, and used odds ratio (OR) analysis with a 95% confidence interval (CI) to calculate each outcome.

Ms. Keum reported results from 3,654 women with ASDs, 3,654 healthy controls, 2,147 women with SLE, and 889 women with RA.

The three most common ASDs were vitiligo (30%), alopecia areata (30%), and cutaneous lupus erythematosus (27%). Compared with healthy controls, patients with ASDs were more likely to have spontaneous abortions (OR=1.5 [1.4-1.7], P<.001), and preeclampsia/eclampsia (OR=1.2 [1.0-1.3], P=.04). Compared with women with SLE, women with ASDs were less likely to have preeclampsia/eclampsia (OR=0.7 [0.6-0.9, P=.001); preterm birth (OR= 0.5 [0.4-0.7], P<.001); PPROM (OR=0.6 [0.4-0.9], P=.004), or an infant with IUGR (OR=0.6 [0.5-0.8], P<.001), but they were more likely to have a spontaneous abortion (OR=1.2 [1.1-1.3], P=.003). Overall, patients with ASDs had similar risks for adverse pregnancy outcomes as patients with RA.

“We found that patients with cutaneous lupus and vitiligo had higher rates of spontaneous abortion, which is interesting because we didn’t expect that,” Ms. Keum told this news organization. “Studies have shown that vitiligo patients might have an increased risk of pregnancy loss, so I think it’s important to have that discussion with those patients. It might benefit them to talk to a maternal-fetal medicine specialist. As for next steps, we want to look at how medication use and disease flare or disease severity play a role in APOs.”

In their poster, the researchers acknowledged limitations of the study, including the inability to verify diagnoses or assess disease severity. Also, while medication use and concomitant antiphospholipid syndrome were evaluated as risk factors for advanced pregnancy outcomes, the number of patients per group was too small for analysis.

Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that in his view, the choice of disease states included in the analysis “is a bit arbitrary.” He added that “it would have been more helpful to compare controls versus discoid lupus versus systemic lupus or controls versus amyopathic dermatomyositis versus dermatomyositis with myopathy.”

The study received funding support from the Rheumatology Research Foundation and the UT Southwestern Dean’s Research Scholar program. Neither Ms. Keum nor Dr. Saardi reported having relevant disclosures.

SAN DIEGO — Women with autoimmune skin diseases are at increased risk of adverse pregnancy outcomes and may benefit from multidisciplinary care with maternal-fetal medicine specialists, results from a large case-control study suggest.

Patients with systemic autoimmune conditions are known to have an increased risk for adverse pregnancy outcomes, “but we weren’t sure if that was the case for patients with autoimmune skin conditions,” presenting study author Heejo Keum, a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas, said in an interview during a poster session at the American College of Rheumatology (ACR) 2023 annual meeting. “There are case reports or nationwide population-based studies on patients with alopecia areata and vitiligo, but those were outside of the US, so we wanted to see if these outcomes could be studied in a larger population-based study in the US.”

Doug Brunk/MDedge News

Drawing from the TriNetX US Collaborative Network, a database of electronic medical records of 94 million patients in the United States, the researchers identified pregnant patients aged 15-44 years between January 1, 2016, and December 31, 2021. Cases were defined as patients diagnosed with at least one autoimmune skin disease (ASD) prior to the end of pregnancy, including alopecia areata, bullous pemphigoid, cicatricial pemphigoid, dermatitis herpetiformis, cutaneous lupus erythematosus, epidermolysis bullosa acquisita, morphea, pemphigus foliaceus, pemphigus vulgaris, vitiligo, and amyopathic DM. There were two control groups: healthy controls (those without ASDs, systemic lupus erythematosus or rheumatoid arthritis) and disease controls (those with SLE or RA). The researchers used ICD-10 codes to identify pregnancy endpoints, including live births, spontaneous abortion, and stillbirth. Patients with a history of hidradenitis suppurative were excluded from the analysis, as were those with common autoimmune disease such as Hashimoto’s thyroiditis, Grave’s disease, and type 1 diabetes.

The primary outcomes were adverse pregnancy outcomes defined as spontaneous abortion, gestational hypertension, preeclampsia/eclampsia, gestational diabetes, intrauterine growth restriction (IUGR), preterm premature rupture of membranes (PPROM), and preterm birth. The researchers used 1:1 propensity scoring to match patients with ASDs to controls by age, race, ethnicity, comorbidities, obesity, and substance use, and used odds ratio (OR) analysis with a 95% confidence interval (CI) to calculate each outcome.

Ms. Keum reported results from 3,654 women with ASDs, 3,654 healthy controls, 2,147 women with SLE, and 889 women with RA.

The three most common ASDs were vitiligo (30%), alopecia areata (30%), and cutaneous lupus erythematosus (27%). Compared with healthy controls, patients with ASDs were more likely to have spontaneous abortions (OR=1.5 [1.4-1.7], P<.001), and preeclampsia/eclampsia (OR=1.2 [1.0-1.3], P=.04). Compared with women with SLE, women with ASDs were less likely to have preeclampsia/eclampsia (OR=0.7 [0.6-0.9, P=.001); preterm birth (OR= 0.5 [0.4-0.7], P<.001); PPROM (OR=0.6 [0.4-0.9], P=.004), or an infant with IUGR (OR=0.6 [0.5-0.8], P<.001), but they were more likely to have a spontaneous abortion (OR=1.2 [1.1-1.3], P=.003). Overall, patients with ASDs had similar risks for adverse pregnancy outcomes as patients with RA.

“We found that patients with cutaneous lupus and vitiligo had higher rates of spontaneous abortion, which is interesting because we didn’t expect that,” Ms. Keum told this news organization. “Studies have shown that vitiligo patients might have an increased risk of pregnancy loss, so I think it’s important to have that discussion with those patients. It might benefit them to talk to a maternal-fetal medicine specialist. As for next steps, we want to look at how medication use and disease flare or disease severity play a role in APOs.”

In their poster, the researchers acknowledged limitations of the study, including the inability to verify diagnoses or assess disease severity. Also, while medication use and concomitant antiphospholipid syndrome were evaluated as risk factors for advanced pregnancy outcomes, the number of patients per group was too small for analysis.

Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that in his view, the choice of disease states included in the analysis “is a bit arbitrary.” He added that “it would have been more helpful to compare controls versus discoid lupus versus systemic lupus or controls versus amyopathic dermatomyositis versus dermatomyositis with myopathy.”

The study received funding support from the Rheumatology Research Foundation and the UT Southwestern Dean’s Research Scholar program. Neither Ms. Keum nor Dr. Saardi reported having relevant disclosures.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Dietary supplements have a role in the integrative treatment of vitiligo, largely through antioxidant pathways and as an adjuvant to phototherapy, Ammar Ahmed, MD, associate professor of dermatology at Dell Medical School at the University of Texas, Austin, said at the annual Integrative Dermatology Symposium.

Data on the use of dietary supplements for vitiligo are scarce and of limited quality, but existing studies and current understanding of the pathogenesis of vitiligo have convinced Dr. Ahmed to recommend oral Ginkgo biloba, vitamin C, vitamin E, and alpha-lipoic acid – as well as vitamin D if levels are insufficient – for patients receiving phototherapy, and outside of phototherapy when patients express interest, he said.

Sally Kubetin/MDedge News

Vitamins C and E, and alpha-lipoic acid: In a randomized controlled trial of 35 patients with nonsegmental vitiligo conducted at the San Gallicano Dermatological Institute in Rome, those who received an antioxidant cocktail (alpha-lipoic acid, 100 mg; vitamin C, 100 mg; vitamin E, 40 mg; and polyunsaturated fatty acids) for 2 months before and during narrow-band ultraviolet-B (NB-UVB) therapy had significantly more repigmentation than that of patients who received NB-UVB alone. Forty-seven percent of those in the antioxidant group obtained greater than 75% repigmentation at 6 months vs. 18% in the control arm.

“This is a pretty high-quality trial. They even did in-vitro analysis showing that the antioxidant group had decreased measures of oxidative stress in the melanocytes,” Dr. Ahmed said. A handout he provided to patients receiving UVB therapy includes recommendations for vitamin C, vitamin E, and alpha-lipoic acid supplementation.

Another controlled prospective study of 130 patients with vitiligo, also conducted in Italy, utilized a different antioxidant cocktail in a tablet – Phyllanthus emblica (known as Indian gooseberry), vitamin E, and carotenoids – taken three times a day, in conjunction with standard topical therapy and phototherapy. At 6 months, a significantly higher number of patients receiving the cocktail had mild repigmentation and were less likely to have no repigmentation compared with patients who did not receive the antioxidants. “Nobody did really great, but the cocktail group did a little better,” he said. “So there’s promise.”
 

Vitamin D: In-vitro studies show that vitamin D may protect melanocytes against oxidative stress, and two small controlled trials showed improvement in vitiligo with vitamin D supplementation (1,500-5,000 IU daily) and no NB-UVB therapy. However, a recent, higher-quality 6-month trial that evaluated 5,000 IU/day of vitamin D in patients with generalized vitiligo showed no advantage over NB-UVB therapy alone. “I tell patients, if you’re insufficient, take vitamin D (supplements) to get your levels up,” Dr. Ahmed sad. “But if you’re already sufficient, I’m not confident there will be a significant benefit.”

Ginkgo biloba: A small double-blind controlled trial randomized 47 patients with limited and slow-spreading vitiligo to receive Ginkgo biloba extract 40 mg three times a day or placebo. At 6 months, 10 patients who received the extract had greater than 75% repigmentation compared with 2 patients in the placebo group. Patients receiving Ginkgo biloba, which has immunomodulatory and antioxidant properties, were also significantly more likely to have disease stabilization.

“I tend to recommend it to patients not doing phototherapy, as well as those receiving phototherapy, especially since the study showed benefit as a monotherapy,” Dr. Ahmed said in an interview after the meeting.

Phenylalanine: Various oral and/or topical formulations of this amino acid and precursor to tyrosine/melanin have been shown to have repigmentation effects when combined with UVA phototherapy or sunlight, but the studies are of limited quality and the oral dosages studied (50 mg/kg per day to 100 mg/kg per day) appear to be a bit high, Dr. Ahmed said at the meeting. “It can add up in cost, and I worry a little about side effects, so I don’t recommend it as much.”

Polypodium leucotomos (PL): This plant extract, from a fern native to Central America and parts of South America, is familiar as a photoprotective supplement, he said, and a few randomized controlled trials show that it may improve repigmentation outcomes, especially on the hands and neck, when combined with NB-UVB in patients with vitiligo.

One of these trials, published in 2021, showed greater than 50% repigmentation at 6 months in 48% of patients with generalized vitiligo who received oral PL (480 mg twice a day) and NB-UVB, versus 22% in patients receiving NB-UVB alone. PL may be “reasonable to consider, though it can get a little pricey,” he said.

Other supplements: Nigella sativa seed oil (black seed oil) and the Ayurvedic herb Picrorhiza kurroa (also known as kutki), have shown some promise and merit further study in vitiligo, Dr. Ahmed said. Data on vitamin B12 and folate are mixed, and there is no evidence of a helpful role of zinc for vitiligo, he noted at the meeting.

Overall, there is a “paucity of large, high-quality trials for [complementary] therapies for vitiligo,” Dr. Ahmed said. “We need big randomized controlled trials ... and we need stratification. The problem is a lot of these studies don’t stratify: Is the patient active or inactive, for instance? Do they have poliosis or not?” Also missing in many studies are data on safety and adverse events. “Is that because of an excellent safety profile or lack of scientific rigor? I don’t know.”

Future approaches to vitiligo management will likely integrate alternative/nutritional modalities with conventional medical treatments, newer targeted therapies, and surgery when necessary, he said. In the case of surgery, he referred to the June 2023 Food and Drug Administration approval of the RECELL Autologous Cell Harvesting Device for repigmentation of stable depigmented vitiligo lesions, an office-based grafting procedure.

The topical Janus kinase (JAK) inhibitor ruxolitinib (Opzelura) approved in 2022 for nonsegmental vitiligo, he said, produced “good, not great” results in two pivotal phase 3 trials . At 24 weeks, about 30% of patients on the treatment achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 10% of patients in the placebo groups.

Asked to comment on antioxidant pathways and the potential of complementary therapies for vitiligo, Jason Hawkes, MD, a dermatologist in Rocklin, Calif., who also spoke at the IDS meeting, said that oxidative stress is among the processes that may contribute to melanocyte degeneration seen in vitiligo.

The immunopathogenesis of vitiligo is “multilayered and complex,” he said. “While the T lymphocyte plays a central role in this disease, there are other genetic and biologic processes [including oxidative stress] that also contribute to the destruction of melanocytes.”

Reducing oxidative stress in the body and skin via supplements such as vitamin E, coenzyme Q10, and alpha-lipoic acid “may represent complementary treatments used for the treatment of vitiligo,” said Dr. Hawkes. And as more is learned about the pathogenic role of oxidative stress and its impact on diseases of pigmentation, “therapeutic targeting of the antioxidation-related signaling pathways in the skin may represent a novel treatment for vitiligo or other related conditions.”

Dr. Hawkes disclosed ties with AbbVie, Arcutis, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, LEO, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr. Hawkes disclosed serving as an investigator and advisory board member for Avita and an investigator for Pfizer.

Dietary supplements have a role in the integrative treatment of vitiligo, largely through antioxidant pathways and as an adjuvant to phototherapy, Ammar Ahmed, MD, associate professor of dermatology at Dell Medical School at the University of Texas, Austin, said at the annual Integrative Dermatology Symposium.

Data on the use of dietary supplements for vitiligo are scarce and of limited quality, but existing studies and current understanding of the pathogenesis of vitiligo have convinced Dr. Ahmed to recommend oral Ginkgo biloba, vitamin C, vitamin E, and alpha-lipoic acid – as well as vitamin D if levels are insufficient – for patients receiving phototherapy, and outside of phototherapy when patients express interest, he said.

Sally Kubetin/MDedge News

Vitamins C and E, and alpha-lipoic acid: In a randomized controlled trial of 35 patients with nonsegmental vitiligo conducted at the San Gallicano Dermatological Institute in Rome, those who received an antioxidant cocktail (alpha-lipoic acid, 100 mg; vitamin C, 100 mg; vitamin E, 40 mg; and polyunsaturated fatty acids) for 2 months before and during narrow-band ultraviolet-B (NB-UVB) therapy had significantly more repigmentation than that of patients who received NB-UVB alone. Forty-seven percent of those in the antioxidant group obtained greater than 75% repigmentation at 6 months vs. 18% in the control arm.

“This is a pretty high-quality trial. They even did in-vitro analysis showing that the antioxidant group had decreased measures of oxidative stress in the melanocytes,” Dr. Ahmed said. A handout he provided to patients receiving UVB therapy includes recommendations for vitamin C, vitamin E, and alpha-lipoic acid supplementation.

Another controlled prospective study of 130 patients with vitiligo, also conducted in Italy, utilized a different antioxidant cocktail in a tablet – Phyllanthus emblica (known as Indian gooseberry), vitamin E, and carotenoids – taken three times a day, in conjunction with standard topical therapy and phototherapy. At 6 months, a significantly higher number of patients receiving the cocktail had mild repigmentation and were less likely to have no repigmentation compared with patients who did not receive the antioxidants. “Nobody did really great, but the cocktail group did a little better,” he said. “So there’s promise.”
 

Vitamin D: In-vitro studies show that vitamin D may protect melanocytes against oxidative stress, and two small controlled trials showed improvement in vitiligo with vitamin D supplementation (1,500-5,000 IU daily) and no NB-UVB therapy. However, a recent, higher-quality 6-month trial that evaluated 5,000 IU/day of vitamin D in patients with generalized vitiligo showed no advantage over NB-UVB therapy alone. “I tell patients, if you’re insufficient, take vitamin D (supplements) to get your levels up,” Dr. Ahmed sad. “But if you’re already sufficient, I’m not confident there will be a significant benefit.”

Ginkgo biloba: A small double-blind controlled trial randomized 47 patients with limited and slow-spreading vitiligo to receive Ginkgo biloba extract 40 mg three times a day or placebo. At 6 months, 10 patients who received the extract had greater than 75% repigmentation compared with 2 patients in the placebo group. Patients receiving Ginkgo biloba, which has immunomodulatory and antioxidant properties, were also significantly more likely to have disease stabilization.

“I tend to recommend it to patients not doing phototherapy, as well as those receiving phototherapy, especially since the study showed benefit as a monotherapy,” Dr. Ahmed said in an interview after the meeting.

Phenylalanine: Various oral and/or topical formulations of this amino acid and precursor to tyrosine/melanin have been shown to have repigmentation effects when combined with UVA phototherapy or sunlight, but the studies are of limited quality and the oral dosages studied (50 mg/kg per day to 100 mg/kg per day) appear to be a bit high, Dr. Ahmed said at the meeting. “It can add up in cost, and I worry a little about side effects, so I don’t recommend it as much.”

Polypodium leucotomos (PL): This plant extract, from a fern native to Central America and parts of South America, is familiar as a photoprotective supplement, he said, and a few randomized controlled trials show that it may improve repigmentation outcomes, especially on the hands and neck, when combined with NB-UVB in patients with vitiligo.

One of these trials, published in 2021, showed greater than 50% repigmentation at 6 months in 48% of patients with generalized vitiligo who received oral PL (480 mg twice a day) and NB-UVB, versus 22% in patients receiving NB-UVB alone. PL may be “reasonable to consider, though it can get a little pricey,” he said.

Other supplements: Nigella sativa seed oil (black seed oil) and the Ayurvedic herb Picrorhiza kurroa (also known as kutki), have shown some promise and merit further study in vitiligo, Dr. Ahmed said. Data on vitamin B12 and folate are mixed, and there is no evidence of a helpful role of zinc for vitiligo, he noted at the meeting.

Overall, there is a “paucity of large, high-quality trials for [complementary] therapies for vitiligo,” Dr. Ahmed said. “We need big randomized controlled trials ... and we need stratification. The problem is a lot of these studies don’t stratify: Is the patient active or inactive, for instance? Do they have poliosis or not?” Also missing in many studies are data on safety and adverse events. “Is that because of an excellent safety profile or lack of scientific rigor? I don’t know.”

Future approaches to vitiligo management will likely integrate alternative/nutritional modalities with conventional medical treatments, newer targeted therapies, and surgery when necessary, he said. In the case of surgery, he referred to the June 2023 Food and Drug Administration approval of the RECELL Autologous Cell Harvesting Device for repigmentation of stable depigmented vitiligo lesions, an office-based grafting procedure.

The topical Janus kinase (JAK) inhibitor ruxolitinib (Opzelura) approved in 2022 for nonsegmental vitiligo, he said, produced “good, not great” results in two pivotal phase 3 trials . At 24 weeks, about 30% of patients on the treatment achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 10% of patients in the placebo groups.

Asked to comment on antioxidant pathways and the potential of complementary therapies for vitiligo, Jason Hawkes, MD, a dermatologist in Rocklin, Calif., who also spoke at the IDS meeting, said that oxidative stress is among the processes that may contribute to melanocyte degeneration seen in vitiligo.

The immunopathogenesis of vitiligo is “multilayered and complex,” he said. “While the T lymphocyte plays a central role in this disease, there are other genetic and biologic processes [including oxidative stress] that also contribute to the destruction of melanocytes.”

Reducing oxidative stress in the body and skin via supplements such as vitamin E, coenzyme Q10, and alpha-lipoic acid “may represent complementary treatments used for the treatment of vitiligo,” said Dr. Hawkes. And as more is learned about the pathogenic role of oxidative stress and its impact on diseases of pigmentation, “therapeutic targeting of the antioxidation-related signaling pathways in the skin may represent a novel treatment for vitiligo or other related conditions.”

Dr. Hawkes disclosed ties with AbbVie, Arcutis, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, LEO, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr. Hawkes disclosed serving as an investigator and advisory board member for Avita and an investigator for Pfizer.

Dietary supplements have a role in the integrative treatment of vitiligo, largely through antioxidant pathways and as an adjuvant to phototherapy, Ammar Ahmed, MD, associate professor of dermatology at Dell Medical School at the University of Texas, Austin, said at the annual Integrative Dermatology Symposium.

Data on the use of dietary supplements for vitiligo are scarce and of limited quality, but existing studies and current understanding of the pathogenesis of vitiligo have convinced Dr. Ahmed to recommend oral Ginkgo biloba, vitamin C, vitamin E, and alpha-lipoic acid – as well as vitamin D if levels are insufficient – for patients receiving phototherapy, and outside of phototherapy when patients express interest, he said.

Sally Kubetin/MDedge News

Vitamins C and E, and alpha-lipoic acid: In a randomized controlled trial of 35 patients with nonsegmental vitiligo conducted at the San Gallicano Dermatological Institute in Rome, those who received an antioxidant cocktail (alpha-lipoic acid, 100 mg; vitamin C, 100 mg; vitamin E, 40 mg; and polyunsaturated fatty acids) for 2 months before and during narrow-band ultraviolet-B (NB-UVB) therapy had significantly more repigmentation than that of patients who received NB-UVB alone. Forty-seven percent of those in the antioxidant group obtained greater than 75% repigmentation at 6 months vs. 18% in the control arm.

“This is a pretty high-quality trial. They even did in-vitro analysis showing that the antioxidant group had decreased measures of oxidative stress in the melanocytes,” Dr. Ahmed said. A handout he provided to patients receiving UVB therapy includes recommendations for vitamin C, vitamin E, and alpha-lipoic acid supplementation.

Another controlled prospective study of 130 patients with vitiligo, also conducted in Italy, utilized a different antioxidant cocktail in a tablet – Phyllanthus emblica (known as Indian gooseberry), vitamin E, and carotenoids – taken three times a day, in conjunction with standard topical therapy and phototherapy. At 6 months, a significantly higher number of patients receiving the cocktail had mild repigmentation and were less likely to have no repigmentation compared with patients who did not receive the antioxidants. “Nobody did really great, but the cocktail group did a little better,” he said. “So there’s promise.”
 

Vitamin D: In-vitro studies show that vitamin D may protect melanocytes against oxidative stress, and two small controlled trials showed improvement in vitiligo with vitamin D supplementation (1,500-5,000 IU daily) and no NB-UVB therapy. However, a recent, higher-quality 6-month trial that evaluated 5,000 IU/day of vitamin D in patients with generalized vitiligo showed no advantage over NB-UVB therapy alone. “I tell patients, if you’re insufficient, take vitamin D (supplements) to get your levels up,” Dr. Ahmed sad. “But if you’re already sufficient, I’m not confident there will be a significant benefit.”

Ginkgo biloba: A small double-blind controlled trial randomized 47 patients with limited and slow-spreading vitiligo to receive Ginkgo biloba extract 40 mg three times a day or placebo. At 6 months, 10 patients who received the extract had greater than 75% repigmentation compared with 2 patients in the placebo group. Patients receiving Ginkgo biloba, which has immunomodulatory and antioxidant properties, were also significantly more likely to have disease stabilization.

“I tend to recommend it to patients not doing phototherapy, as well as those receiving phototherapy, especially since the study showed benefit as a monotherapy,” Dr. Ahmed said in an interview after the meeting.

Phenylalanine: Various oral and/or topical formulations of this amino acid and precursor to tyrosine/melanin have been shown to have repigmentation effects when combined with UVA phototherapy or sunlight, but the studies are of limited quality and the oral dosages studied (50 mg/kg per day to 100 mg/kg per day) appear to be a bit high, Dr. Ahmed said at the meeting. “It can add up in cost, and I worry a little about side effects, so I don’t recommend it as much.”

Polypodium leucotomos (PL): This plant extract, from a fern native to Central America and parts of South America, is familiar as a photoprotective supplement, he said, and a few randomized controlled trials show that it may improve repigmentation outcomes, especially on the hands and neck, when combined with NB-UVB in patients with vitiligo.

One of these trials, published in 2021, showed greater than 50% repigmentation at 6 months in 48% of patients with generalized vitiligo who received oral PL (480 mg twice a day) and NB-UVB, versus 22% in patients receiving NB-UVB alone. PL may be “reasonable to consider, though it can get a little pricey,” he said.

Other supplements: Nigella sativa seed oil (black seed oil) and the Ayurvedic herb Picrorhiza kurroa (also known as kutki), have shown some promise and merit further study in vitiligo, Dr. Ahmed said. Data on vitamin B12 and folate are mixed, and there is no evidence of a helpful role of zinc for vitiligo, he noted at the meeting.

Overall, there is a “paucity of large, high-quality trials for [complementary] therapies for vitiligo,” Dr. Ahmed said. “We need big randomized controlled trials ... and we need stratification. The problem is a lot of these studies don’t stratify: Is the patient active or inactive, for instance? Do they have poliosis or not?” Also missing in many studies are data on safety and adverse events. “Is that because of an excellent safety profile or lack of scientific rigor? I don’t know.”

Future approaches to vitiligo management will likely integrate alternative/nutritional modalities with conventional medical treatments, newer targeted therapies, and surgery when necessary, he said. In the case of surgery, he referred to the June 2023 Food and Drug Administration approval of the RECELL Autologous Cell Harvesting Device for repigmentation of stable depigmented vitiligo lesions, an office-based grafting procedure.

The topical Janus kinase (JAK) inhibitor ruxolitinib (Opzelura) approved in 2022 for nonsegmental vitiligo, he said, produced “good, not great” results in two pivotal phase 3 trials . At 24 weeks, about 30% of patients on the treatment achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 10% of patients in the placebo groups.

Asked to comment on antioxidant pathways and the potential of complementary therapies for vitiligo, Jason Hawkes, MD, a dermatologist in Rocklin, Calif., who also spoke at the IDS meeting, said that oxidative stress is among the processes that may contribute to melanocyte degeneration seen in vitiligo.

The immunopathogenesis of vitiligo is “multilayered and complex,” he said. “While the T lymphocyte plays a central role in this disease, there are other genetic and biologic processes [including oxidative stress] that also contribute to the destruction of melanocytes.”

Reducing oxidative stress in the body and skin via supplements such as vitamin E, coenzyme Q10, and alpha-lipoic acid “may represent complementary treatments used for the treatment of vitiligo,” said Dr. Hawkes. And as more is learned about the pathogenic role of oxidative stress and its impact on diseases of pigmentation, “therapeutic targeting of the antioxidation-related signaling pathways in the skin may represent a novel treatment for vitiligo or other related conditions.”

Dr. Hawkes disclosed ties with AbbVie, Arcutis, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, LEO, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr. Hawkes disclosed serving as an investigator and advisory board member for Avita and an investigator for Pfizer.