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Bimekizumab Gains FDA Approval for Psoriatic Arthritis, Axial Spondyloarthritis
The Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).
The drug, an interleukin (IL)–17A and IL-17F inhibitor, was first approved in October 2023 for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years,” said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB in a press release.
The recommended dosage of bimekizumab for adult patients with active PsA, nr-axSpA, or AS is 160 mg by subcutaneous injection every 4 weeks. For patients with PsA and coexistent moderate to severe plaque psoriasis, the dosage is the same as for patients with plaque psoriasis. The dosing for plaque psoriasis is to administer 320 mg (two 160-mg injections) by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.
PsA Clinical Trials
The approval for PsA was based on data from two phase 3 clinical trials, including 852 participants naive to biologics (BE OPTIMAL) and 400 participants with inadequate response to treatment with one or two tumor necrosis factor (TNF) inhibitors (BE COMPLETE). Both studies met their primary endpoint, 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks, as well as ranked secondary endpoints. Secondary endpoints included minimal disease activity (MDA) and Psoriasis Area and Severity Index 100 (complete skin clearance) at week 16.
At 16 weeks:
- About 44% of both the biologic-naive (189 of 431) and TNF inhibitor–resistant (116 of 267) groups receiving bimekizumab achieved ACR50 response, compared with 10% (28 of 281) and 7% (9 of 133) receiving placebo, respectively.
- About 45% of all patients treated with bimekizumab achieved MDA.
- Nearly 60% of TNF inhibitor–resistant patients had complete skin clearance.
These responses generally were sustained for 1 year. The most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
NR-axSpA and AS Clinical Trials
The approval for active nr-axSpA and active AS was based on data from two clinical studies, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Both studies met their primary endpoint, 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks.
Key findings included:
- In nr-axSpA patients, 47.7% (61 of 128) receiving bimekizumab achieved ASAS40 at week 16, compared with 21.4% (27 of 126) receiving placebo.
- In AS patients, 44.8% (99 of 221) in the bimekizumab group achieved ASAS40 response at week 16 vs 22.5% (25 of 111) receiving placebo.
- At 1 year in both groups, 60% treated with bimekizumab achieved an Ankylosing Spondylitis Disease Activity Score < 2.1.
In nr-axSpA, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, increase in transaminase, and urinary tract infection. In AS, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection-site pain, rash, and vulvovaginal mycotic infection.
Bimekizumab was approved by the European Commission for the same rheumatologic indications in June 2023.
Bimekizumab is currently available to eligible patients in the United States, according to the press release.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).
The drug, an interleukin (IL)–17A and IL-17F inhibitor, was first approved in October 2023 for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years,” said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB in a press release.
The recommended dosage of bimekizumab for adult patients with active PsA, nr-axSpA, or AS is 160 mg by subcutaneous injection every 4 weeks. For patients with PsA and coexistent moderate to severe plaque psoriasis, the dosage is the same as for patients with plaque psoriasis. The dosing for plaque psoriasis is to administer 320 mg (two 160-mg injections) by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.
PsA Clinical Trials
The approval for PsA was based on data from two phase 3 clinical trials, including 852 participants naive to biologics (BE OPTIMAL) and 400 participants with inadequate response to treatment with one or two tumor necrosis factor (TNF) inhibitors (BE COMPLETE). Both studies met their primary endpoint, 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks, as well as ranked secondary endpoints. Secondary endpoints included minimal disease activity (MDA) and Psoriasis Area and Severity Index 100 (complete skin clearance) at week 16.
At 16 weeks:
- About 44% of both the biologic-naive (189 of 431) and TNF inhibitor–resistant (116 of 267) groups receiving bimekizumab achieved ACR50 response, compared with 10% (28 of 281) and 7% (9 of 133) receiving placebo, respectively.
- About 45% of all patients treated with bimekizumab achieved MDA.
- Nearly 60% of TNF inhibitor–resistant patients had complete skin clearance.
These responses generally were sustained for 1 year. The most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
NR-axSpA and AS Clinical Trials
The approval for active nr-axSpA and active AS was based on data from two clinical studies, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Both studies met their primary endpoint, 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks.
Key findings included:
- In nr-axSpA patients, 47.7% (61 of 128) receiving bimekizumab achieved ASAS40 at week 16, compared with 21.4% (27 of 126) receiving placebo.
- In AS patients, 44.8% (99 of 221) in the bimekizumab group achieved ASAS40 response at week 16 vs 22.5% (25 of 111) receiving placebo.
- At 1 year in both groups, 60% treated with bimekizumab achieved an Ankylosing Spondylitis Disease Activity Score < 2.1.
In nr-axSpA, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, increase in transaminase, and urinary tract infection. In AS, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection-site pain, rash, and vulvovaginal mycotic infection.
Bimekizumab was approved by the European Commission for the same rheumatologic indications in June 2023.
Bimekizumab is currently available to eligible patients in the United States, according to the press release.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).
The drug, an interleukin (IL)–17A and IL-17F inhibitor, was first approved in October 2023 for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years,” said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB in a press release.
The recommended dosage of bimekizumab for adult patients with active PsA, nr-axSpA, or AS is 160 mg by subcutaneous injection every 4 weeks. For patients with PsA and coexistent moderate to severe plaque psoriasis, the dosage is the same as for patients with plaque psoriasis. The dosing for plaque psoriasis is to administer 320 mg (two 160-mg injections) by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.
PsA Clinical Trials
The approval for PsA was based on data from two phase 3 clinical trials, including 852 participants naive to biologics (BE OPTIMAL) and 400 participants with inadequate response to treatment with one or two tumor necrosis factor (TNF) inhibitors (BE COMPLETE). Both studies met their primary endpoint, 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks, as well as ranked secondary endpoints. Secondary endpoints included minimal disease activity (MDA) and Psoriasis Area and Severity Index 100 (complete skin clearance) at week 16.
At 16 weeks:
- About 44% of both the biologic-naive (189 of 431) and TNF inhibitor–resistant (116 of 267) groups receiving bimekizumab achieved ACR50 response, compared with 10% (28 of 281) and 7% (9 of 133) receiving placebo, respectively.
- About 45% of all patients treated with bimekizumab achieved MDA.
- Nearly 60% of TNF inhibitor–resistant patients had complete skin clearance.
These responses generally were sustained for 1 year. The most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
NR-axSpA and AS Clinical Trials
The approval for active nr-axSpA and active AS was based on data from two clinical studies, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Both studies met their primary endpoint, 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks.
Key findings included:
- In nr-axSpA patients, 47.7% (61 of 128) receiving bimekizumab achieved ASAS40 at week 16, compared with 21.4% (27 of 126) receiving placebo.
- In AS patients, 44.8% (99 of 221) in the bimekizumab group achieved ASAS40 response at week 16 vs 22.5% (25 of 111) receiving placebo.
- At 1 year in both groups, 60% treated with bimekizumab achieved an Ankylosing Spondylitis Disease Activity Score < 2.1.
In nr-axSpA, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, increase in transaminase, and urinary tract infection. In AS, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection-site pain, rash, and vulvovaginal mycotic infection.
Bimekizumab was approved by the European Commission for the same rheumatologic indications in June 2023.
Bimekizumab is currently available to eligible patients in the United States, according to the press release.
A version of this article first appeared on Medscape.com.
Biomarkers in Cord Blood May Predict AD Onset in Newborns, Study Suggests
TOPLINE:
and interleukin (IL) 31.
METHODOLOGY:
- Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
- Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
- TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.
TAKEAWAY:
- At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
- Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
- Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
- A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.
IN PRACTICE:
“,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.
SOURCE:
The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.
LIMITATIONS:
The limitations included the observational design and small sample size, and it was a single-center study.
DISCLOSURES:
The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article appeared on Medscape.com.
TOPLINE:
and interleukin (IL) 31.
METHODOLOGY:
- Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
- Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
- TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.
TAKEAWAY:
- At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
- Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
- Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
- A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.
IN PRACTICE:
“,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.
SOURCE:
The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.
LIMITATIONS:
The limitations included the observational design and small sample size, and it was a single-center study.
DISCLOSURES:
The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article appeared on Medscape.com.
TOPLINE:
and interleukin (IL) 31.
METHODOLOGY:
- Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
- Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
- TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.
TAKEAWAY:
- At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
- Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
- Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
- A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.
IN PRACTICE:
“,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.
SOURCE:
The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.
LIMITATIONS:
The limitations included the observational design and small sample size, and it was a single-center study.
DISCLOSURES:
The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article appeared on Medscape.com.
New Options for Treating Atopic Dermatitis Available, and in Development
HUNTINGTON BEACH, CALIFORNIA — If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.
“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)
In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.
“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.
In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.
Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)
In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.
Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
A version of this article appeared on Medscape.com.
HUNTINGTON BEACH, CALIFORNIA — If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.
“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)
In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.
“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.
In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.
Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)
In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.
Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
A version of this article appeared on Medscape.com.
HUNTINGTON BEACH, CALIFORNIA — If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.
“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)
In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.
“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.
In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.
Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)
In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.
Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
A version of this article appeared on Medscape.com.
FROM PDA 2024
Seborrheic Dermatitis in Black Patients: New Therapies Offer Hope
NEW YORK — not only in this group but also overall, now that there is an approved therapy with an array of alternatives and adjunctive medications, according to Shawn Kwatra, MD.
The list of therapies effective against SD, often employed in combination, is lengthy, but topical 0.3% roflumilast foam (Zoryve), approved by the Food and Drug Administration (FDA) late last year for treating SD, has a high rate of efficacy and should now be considered a first-line treatment option, according to Dr. Kwatra, professor and chair of the Department of Dermatology, University of Maryland School of Medicine, Baltimore.
New Approved Therapy Draws Attention to SD
Emphasizing that topical roflumilast does not necessarily replace the use of over-the-counter shampoos and emollients or a list of prescription drugs used off-label to control this condition, he said it is also important for another reason.
“It shines a light on this disease,” said Dr. Kwatra, speaking at the 2024 Skin of Color Update. While his comments were focused primarily on individuals with darker skin, his major take home messages were broadly relevant across skin types.
He acknowledged that for years he “had not given seborrheic dermatitis the respect that it deserves” even though this condition comes after only acne and eczema as chief complaints among Black individuals seeing a dermatologist. The estimated global incidence is 5%, according to Dr. Kwatra, but he considers this estimate of an often “forgotten disease” too low.
One reason is that many individuals self-treat with over-the-counter solutions and never bring the complaint to a clinician. Dr. Kwatra said that he now looks for it routinely and points it out to patients who have come to him for another reason.
In patients with darker skin, the signs of SD can differ. While scalp involvement is generally easy to identify across skin types, the inflammation and erythema, sebum production, scaling and itch, and Malassezia that accompanies and drives SD might be missed in a patient with darker skin without specifically looking for these signs.
Skin and Gut Microbiome Involvement Suspected
The underlying causes of SD are understood as an inflammatory process involving keratinocyte disruption and proliferation that ultimately impairs skin barrier function, causes water loss, and produces scale stemming from stratum corneum, but Dr. Kwatra said that there is increasing evidence of a major role for both the skin and gut microbiome.
In regard to the skin microbiome, Malassezia has long been recognized as linked to SD and is a target of treatment, but evidence that the gut microbiome might be participating is relatively new. One clue comes from the fact that oral antifungal therapies, such as itraconazole, are known to reduce risk for SD relapse, an effect that might be a function of their ability to modulate the gut microbiome, according to Dr. Kwatra.
Topical roflumilast, a phosphodiesterase-4 inhibitor, was effective for SD in a vehicle-controlled phase 3 trial published in 2023. He characterized the adverse event profile as “pretty clean,” but he emphasized that a role for many other strategies remains. This is particularly true for challenging forms of SD. For example, topical tacrolimus provided meaningful protection against relapse over a period of more than 6 months in a 2021 trial that enrolled patients with severe facial SD.
The topical Janus kinase inhibitor ruxolitinib, 1.5%, (approved for atopic dermatitis and vitiligo) has also been reported to be effective for refractory facial SD. It is being evaluated in a phase 2 study of SD, according to Dr. Kwatra. A topical PDE4 inhibitor is also being evaluated for SD in a phase 2 study, he said.
Given the heterogeneity of the presentation of SD and the value of combining different mechanisms of action, Dr. Kwatra does not think any drug by itself will be a cure for SD. However, the chances of success with current drug combinations are high.
It is for this reason that Dr. Kwatra encourages clinicians to look for this disease routinely, including among patients who have a different presenting complaint. “Patients do not always bring it up, so bring it up,” he said.
This is good advice, according to Andrew F. Alexis, MD, MPH, professor of clinical dermatology and Vice-chair for Diversity and Inclusion of the Department of Dermatology, Weill Cornell Medicine, New York City. He agreed that the recent introduction of a therapy approved by the FDA is an impetus to look for SD and to talk with patients about treatment options.
In addition, while he also considers roflumilast foam to be a first-line drug, he agreed that combination therapies might be needed to increase the likely of rapid control of scalp and skin involvement. “SD is probably underestimated as a clinical problem, and we do have good treatments to offer for the patients who are affected,” he said at the meeting.
Dr. Kwatra reported no relevant disclosures. Dr. Alexis reported financial relationships with more than 25 pharmaceutical companies.
A version of this article appeared on Medscape.com.
NEW YORK — not only in this group but also overall, now that there is an approved therapy with an array of alternatives and adjunctive medications, according to Shawn Kwatra, MD.
The list of therapies effective against SD, often employed in combination, is lengthy, but topical 0.3% roflumilast foam (Zoryve), approved by the Food and Drug Administration (FDA) late last year for treating SD, has a high rate of efficacy and should now be considered a first-line treatment option, according to Dr. Kwatra, professor and chair of the Department of Dermatology, University of Maryland School of Medicine, Baltimore.
New Approved Therapy Draws Attention to SD
Emphasizing that topical roflumilast does not necessarily replace the use of over-the-counter shampoos and emollients or a list of prescription drugs used off-label to control this condition, he said it is also important for another reason.
“It shines a light on this disease,” said Dr. Kwatra, speaking at the 2024 Skin of Color Update. While his comments were focused primarily on individuals with darker skin, his major take home messages were broadly relevant across skin types.
He acknowledged that for years he “had not given seborrheic dermatitis the respect that it deserves” even though this condition comes after only acne and eczema as chief complaints among Black individuals seeing a dermatologist. The estimated global incidence is 5%, according to Dr. Kwatra, but he considers this estimate of an often “forgotten disease” too low.
One reason is that many individuals self-treat with over-the-counter solutions and never bring the complaint to a clinician. Dr. Kwatra said that he now looks for it routinely and points it out to patients who have come to him for another reason.
In patients with darker skin, the signs of SD can differ. While scalp involvement is generally easy to identify across skin types, the inflammation and erythema, sebum production, scaling and itch, and Malassezia that accompanies and drives SD might be missed in a patient with darker skin without specifically looking for these signs.
Skin and Gut Microbiome Involvement Suspected
The underlying causes of SD are understood as an inflammatory process involving keratinocyte disruption and proliferation that ultimately impairs skin barrier function, causes water loss, and produces scale stemming from stratum corneum, but Dr. Kwatra said that there is increasing evidence of a major role for both the skin and gut microbiome.
In regard to the skin microbiome, Malassezia has long been recognized as linked to SD and is a target of treatment, but evidence that the gut microbiome might be participating is relatively new. One clue comes from the fact that oral antifungal therapies, such as itraconazole, are known to reduce risk for SD relapse, an effect that might be a function of their ability to modulate the gut microbiome, according to Dr. Kwatra.
Topical roflumilast, a phosphodiesterase-4 inhibitor, was effective for SD in a vehicle-controlled phase 3 trial published in 2023. He characterized the adverse event profile as “pretty clean,” but he emphasized that a role for many other strategies remains. This is particularly true for challenging forms of SD. For example, topical tacrolimus provided meaningful protection against relapse over a period of more than 6 months in a 2021 trial that enrolled patients with severe facial SD.
The topical Janus kinase inhibitor ruxolitinib, 1.5%, (approved for atopic dermatitis and vitiligo) has also been reported to be effective for refractory facial SD. It is being evaluated in a phase 2 study of SD, according to Dr. Kwatra. A topical PDE4 inhibitor is also being evaluated for SD in a phase 2 study, he said.
Given the heterogeneity of the presentation of SD and the value of combining different mechanisms of action, Dr. Kwatra does not think any drug by itself will be a cure for SD. However, the chances of success with current drug combinations are high.
It is for this reason that Dr. Kwatra encourages clinicians to look for this disease routinely, including among patients who have a different presenting complaint. “Patients do not always bring it up, so bring it up,” he said.
This is good advice, according to Andrew F. Alexis, MD, MPH, professor of clinical dermatology and Vice-chair for Diversity and Inclusion of the Department of Dermatology, Weill Cornell Medicine, New York City. He agreed that the recent introduction of a therapy approved by the FDA is an impetus to look for SD and to talk with patients about treatment options.
In addition, while he also considers roflumilast foam to be a first-line drug, he agreed that combination therapies might be needed to increase the likely of rapid control of scalp and skin involvement. “SD is probably underestimated as a clinical problem, and we do have good treatments to offer for the patients who are affected,” he said at the meeting.
Dr. Kwatra reported no relevant disclosures. Dr. Alexis reported financial relationships with more than 25 pharmaceutical companies.
A version of this article appeared on Medscape.com.
NEW YORK — not only in this group but also overall, now that there is an approved therapy with an array of alternatives and adjunctive medications, according to Shawn Kwatra, MD.
The list of therapies effective against SD, often employed in combination, is lengthy, but topical 0.3% roflumilast foam (Zoryve), approved by the Food and Drug Administration (FDA) late last year for treating SD, has a high rate of efficacy and should now be considered a first-line treatment option, according to Dr. Kwatra, professor and chair of the Department of Dermatology, University of Maryland School of Medicine, Baltimore.
New Approved Therapy Draws Attention to SD
Emphasizing that topical roflumilast does not necessarily replace the use of over-the-counter shampoos and emollients or a list of prescription drugs used off-label to control this condition, he said it is also important for another reason.
“It shines a light on this disease,” said Dr. Kwatra, speaking at the 2024 Skin of Color Update. While his comments were focused primarily on individuals with darker skin, his major take home messages were broadly relevant across skin types.
He acknowledged that for years he “had not given seborrheic dermatitis the respect that it deserves” even though this condition comes after only acne and eczema as chief complaints among Black individuals seeing a dermatologist. The estimated global incidence is 5%, according to Dr. Kwatra, but he considers this estimate of an often “forgotten disease” too low.
One reason is that many individuals self-treat with over-the-counter solutions and never bring the complaint to a clinician. Dr. Kwatra said that he now looks for it routinely and points it out to patients who have come to him for another reason.
In patients with darker skin, the signs of SD can differ. While scalp involvement is generally easy to identify across skin types, the inflammation and erythema, sebum production, scaling and itch, and Malassezia that accompanies and drives SD might be missed in a patient with darker skin without specifically looking for these signs.
Skin and Gut Microbiome Involvement Suspected
The underlying causes of SD are understood as an inflammatory process involving keratinocyte disruption and proliferation that ultimately impairs skin barrier function, causes water loss, and produces scale stemming from stratum corneum, but Dr. Kwatra said that there is increasing evidence of a major role for both the skin and gut microbiome.
In regard to the skin microbiome, Malassezia has long been recognized as linked to SD and is a target of treatment, but evidence that the gut microbiome might be participating is relatively new. One clue comes from the fact that oral antifungal therapies, such as itraconazole, are known to reduce risk for SD relapse, an effect that might be a function of their ability to modulate the gut microbiome, according to Dr. Kwatra.
Topical roflumilast, a phosphodiesterase-4 inhibitor, was effective for SD in a vehicle-controlled phase 3 trial published in 2023. He characterized the adverse event profile as “pretty clean,” but he emphasized that a role for many other strategies remains. This is particularly true for challenging forms of SD. For example, topical tacrolimus provided meaningful protection against relapse over a period of more than 6 months in a 2021 trial that enrolled patients with severe facial SD.
The topical Janus kinase inhibitor ruxolitinib, 1.5%, (approved for atopic dermatitis and vitiligo) has also been reported to be effective for refractory facial SD. It is being evaluated in a phase 2 study of SD, according to Dr. Kwatra. A topical PDE4 inhibitor is also being evaluated for SD in a phase 2 study, he said.
Given the heterogeneity of the presentation of SD and the value of combining different mechanisms of action, Dr. Kwatra does not think any drug by itself will be a cure for SD. However, the chances of success with current drug combinations are high.
It is for this reason that Dr. Kwatra encourages clinicians to look for this disease routinely, including among patients who have a different presenting complaint. “Patients do not always bring it up, so bring it up,” he said.
This is good advice, according to Andrew F. Alexis, MD, MPH, professor of clinical dermatology and Vice-chair for Diversity and Inclusion of the Department of Dermatology, Weill Cornell Medicine, New York City. He agreed that the recent introduction of a therapy approved by the FDA is an impetus to look for SD and to talk with patients about treatment options.
In addition, while he also considers roflumilast foam to be a first-line drug, he agreed that combination therapies might be needed to increase the likely of rapid control of scalp and skin involvement. “SD is probably underestimated as a clinical problem, and we do have good treatments to offer for the patients who are affected,” he said at the meeting.
Dr. Kwatra reported no relevant disclosures. Dr. Alexis reported financial relationships with more than 25 pharmaceutical companies.
A version of this article appeared on Medscape.com.
FROM SOC 2024
Melanoma: Neoadjuvant Immunotherapy Provides Optimal Survival Results
BARCELONA, SPAIN — with immunotherapy or a targeted agent or targeted therapy plus immunotherapy, according to a large-scale pooled analysis from the International Neoadjuvant Melanoma Consortium.
Importantly, the analysis — presented at the annual meeting of the European Society for Medical Oncology — showed that achieving a major pathological response to neoadjuvant therapy is a key indicator of survival outcomes.
After 3 years of follow-up, the results showed that neoadjuvant therapy is not delaying melanoma recurrence, “it’s actually preventing it,” coinvestigator Hussein A. Tawbi, MD, PhD, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, said in an interview. That’s “a big deal.”
Since 2010, the introduction of novel adjuvant and neoadjuvant therapies for high-risk stage III resectable melanoma has led to incremental gains for patients, said Georgina V. Long, MD, PhD, BSc, chair of Melanoma Medical Oncology and Translational Research at the University of Sydney in Australia, who presented the results.
The first pooled analysis of neoadjuvant therapy in 189 patients, published in 2021, indicated that those who achieved a major pathological response — defined as either a pathological complete response (with no remaining vital tumor) or a near-complete pathological response (with vital tumor ≤ 10%) — had the best recurrence-free survival rates.
In the current study, the researchers expanded their cohort to include 818 patients from 18 centers. Patients received at least one dose of neoadjuvant therapy — either combination immunotherapy, combination of targeted and immunotherapy agents, or monotherapy with either an immune checkpoint inhibitor or a targeted agent.
The median age was 59 years, and 38% of patients were women. The median follow-up so far is 38.8 months.
Overall, the 3-year event-free survival was 74% in patients who received any immunotherapy, 72% in those who received immunotherapy plus a targeted BRAF/MEK therapy, and just 37% in those who received targeted therapy alone. Similarly, 3-year recurrence-free survival rates were highest in patients who received immunotherapy at 77% vs 73% in those who received immunotherapy plus a targeted BRAF/MEK therapy and just 37% in those who received targeted therapy alone.
Looking specifically at progressive death 1 (PD-1)–based immunotherapy regimens, combination therapy led to a 3-year event-free survival rate between 77% and 95%, depending on the specific combinations, vs 64% with PD-1 monotherapy and 37% with combination targeted therapy.
Overall, patients who had a major pathological response were more likely to be recurrence free at 3 years. The 3-year recurrence-free survival was 88% in patients with a complete response, 68% in those with a partial pathological response, and 40% in those without a response.
Patients who received immunotherapy were more likely to have major pathological response. The 3-year recurrence-free survival was about 94% in patients who received combination or monotherapy with immune checkpoint inhibition, and about 87% in those who received immunotherapy plus targeted therapy. The recurrence-free survival rate was much lower in patients given only BRAF/MEK inhibitors.
The current overall survival data, which are still immature, suggested a few differences when stratifying the patients by treatment. Almost all patients with a major pathological response were alive at 3 years, compared with 86% of those with a partial pathological response and 70% of those without a pathological response.
Overall, the results showed that immunotherapy — as either combination or monotherapy — is “quite a bit” better than targeted therapy with BRAF/MEK agents, which offers no substantial benefit, said Dr. Twabi.
“When you see the same pattern happening in study after study, in a very clear, robust way, it actually becomes very powerful,” he explained.
Rebecca A. Dent, MD, MSc, chair of the ESMO Scientific Committee who was not involved in the study, told a press conference that the introduction of immunotherapy and combination immunotherapy has dramatically changed outcomes in melanoma.
Commenting on the current study results, Dr. Dent said that “combination immunotherapy is clearly showing exceptional stability in terms of long-term benefits.”
The question now is what are the toxicities and costs that come with combination immunotherapy, said Dr. Dent, from National Cancer Centre Singapore and Duke-NUS Medical School, Singapore.
No funding source was declared. Dr. Long declared relationships with a variety of companies, including AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, and Regeneron. Dr. Twabi declared relationships with Bristol-Myers Squibb, Novartis, Merck, Genentech, GlaxoSmithKline, Eisai, and others. Dr. Dent declared relationships with AstraZeneca, Roche, Eisai, Gilead Sciences, Eli Lilly, Merck, and Pfizer.
A version of this article appeared on Medscape.com.
BARCELONA, SPAIN — with immunotherapy or a targeted agent or targeted therapy plus immunotherapy, according to a large-scale pooled analysis from the International Neoadjuvant Melanoma Consortium.
Importantly, the analysis — presented at the annual meeting of the European Society for Medical Oncology — showed that achieving a major pathological response to neoadjuvant therapy is a key indicator of survival outcomes.
After 3 years of follow-up, the results showed that neoadjuvant therapy is not delaying melanoma recurrence, “it’s actually preventing it,” coinvestigator Hussein A. Tawbi, MD, PhD, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, said in an interview. That’s “a big deal.”
Since 2010, the introduction of novel adjuvant and neoadjuvant therapies for high-risk stage III resectable melanoma has led to incremental gains for patients, said Georgina V. Long, MD, PhD, BSc, chair of Melanoma Medical Oncology and Translational Research at the University of Sydney in Australia, who presented the results.
The first pooled analysis of neoadjuvant therapy in 189 patients, published in 2021, indicated that those who achieved a major pathological response — defined as either a pathological complete response (with no remaining vital tumor) or a near-complete pathological response (with vital tumor ≤ 10%) — had the best recurrence-free survival rates.
In the current study, the researchers expanded their cohort to include 818 patients from 18 centers. Patients received at least one dose of neoadjuvant therapy — either combination immunotherapy, combination of targeted and immunotherapy agents, or monotherapy with either an immune checkpoint inhibitor or a targeted agent.
The median age was 59 years, and 38% of patients were women. The median follow-up so far is 38.8 months.
Overall, the 3-year event-free survival was 74% in patients who received any immunotherapy, 72% in those who received immunotherapy plus a targeted BRAF/MEK therapy, and just 37% in those who received targeted therapy alone. Similarly, 3-year recurrence-free survival rates were highest in patients who received immunotherapy at 77% vs 73% in those who received immunotherapy plus a targeted BRAF/MEK therapy and just 37% in those who received targeted therapy alone.
Looking specifically at progressive death 1 (PD-1)–based immunotherapy regimens, combination therapy led to a 3-year event-free survival rate between 77% and 95%, depending on the specific combinations, vs 64% with PD-1 monotherapy and 37% with combination targeted therapy.
Overall, patients who had a major pathological response were more likely to be recurrence free at 3 years. The 3-year recurrence-free survival was 88% in patients with a complete response, 68% in those with a partial pathological response, and 40% in those without a response.
Patients who received immunotherapy were more likely to have major pathological response. The 3-year recurrence-free survival was about 94% in patients who received combination or monotherapy with immune checkpoint inhibition, and about 87% in those who received immunotherapy plus targeted therapy. The recurrence-free survival rate was much lower in patients given only BRAF/MEK inhibitors.
The current overall survival data, which are still immature, suggested a few differences when stratifying the patients by treatment. Almost all patients with a major pathological response were alive at 3 years, compared with 86% of those with a partial pathological response and 70% of those without a pathological response.
Overall, the results showed that immunotherapy — as either combination or monotherapy — is “quite a bit” better than targeted therapy with BRAF/MEK agents, which offers no substantial benefit, said Dr. Twabi.
“When you see the same pattern happening in study after study, in a very clear, robust way, it actually becomes very powerful,” he explained.
Rebecca A. Dent, MD, MSc, chair of the ESMO Scientific Committee who was not involved in the study, told a press conference that the introduction of immunotherapy and combination immunotherapy has dramatically changed outcomes in melanoma.
Commenting on the current study results, Dr. Dent said that “combination immunotherapy is clearly showing exceptional stability in terms of long-term benefits.”
The question now is what are the toxicities and costs that come with combination immunotherapy, said Dr. Dent, from National Cancer Centre Singapore and Duke-NUS Medical School, Singapore.
No funding source was declared. Dr. Long declared relationships with a variety of companies, including AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, and Regeneron. Dr. Twabi declared relationships with Bristol-Myers Squibb, Novartis, Merck, Genentech, GlaxoSmithKline, Eisai, and others. Dr. Dent declared relationships with AstraZeneca, Roche, Eisai, Gilead Sciences, Eli Lilly, Merck, and Pfizer.
A version of this article appeared on Medscape.com.
BARCELONA, SPAIN — with immunotherapy or a targeted agent or targeted therapy plus immunotherapy, according to a large-scale pooled analysis from the International Neoadjuvant Melanoma Consortium.
Importantly, the analysis — presented at the annual meeting of the European Society for Medical Oncology — showed that achieving a major pathological response to neoadjuvant therapy is a key indicator of survival outcomes.
After 3 years of follow-up, the results showed that neoadjuvant therapy is not delaying melanoma recurrence, “it’s actually preventing it,” coinvestigator Hussein A. Tawbi, MD, PhD, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, said in an interview. That’s “a big deal.”
Since 2010, the introduction of novel adjuvant and neoadjuvant therapies for high-risk stage III resectable melanoma has led to incremental gains for patients, said Georgina V. Long, MD, PhD, BSc, chair of Melanoma Medical Oncology and Translational Research at the University of Sydney in Australia, who presented the results.
The first pooled analysis of neoadjuvant therapy in 189 patients, published in 2021, indicated that those who achieved a major pathological response — defined as either a pathological complete response (with no remaining vital tumor) or a near-complete pathological response (with vital tumor ≤ 10%) — had the best recurrence-free survival rates.
In the current study, the researchers expanded their cohort to include 818 patients from 18 centers. Patients received at least one dose of neoadjuvant therapy — either combination immunotherapy, combination of targeted and immunotherapy agents, or monotherapy with either an immune checkpoint inhibitor or a targeted agent.
The median age was 59 years, and 38% of patients were women. The median follow-up so far is 38.8 months.
Overall, the 3-year event-free survival was 74% in patients who received any immunotherapy, 72% in those who received immunotherapy plus a targeted BRAF/MEK therapy, and just 37% in those who received targeted therapy alone. Similarly, 3-year recurrence-free survival rates were highest in patients who received immunotherapy at 77% vs 73% in those who received immunotherapy plus a targeted BRAF/MEK therapy and just 37% in those who received targeted therapy alone.
Looking specifically at progressive death 1 (PD-1)–based immunotherapy regimens, combination therapy led to a 3-year event-free survival rate between 77% and 95%, depending on the specific combinations, vs 64% with PD-1 monotherapy and 37% with combination targeted therapy.
Overall, patients who had a major pathological response were more likely to be recurrence free at 3 years. The 3-year recurrence-free survival was 88% in patients with a complete response, 68% in those with a partial pathological response, and 40% in those without a response.
Patients who received immunotherapy were more likely to have major pathological response. The 3-year recurrence-free survival was about 94% in patients who received combination or monotherapy with immune checkpoint inhibition, and about 87% in those who received immunotherapy plus targeted therapy. The recurrence-free survival rate was much lower in patients given only BRAF/MEK inhibitors.
The current overall survival data, which are still immature, suggested a few differences when stratifying the patients by treatment. Almost all patients with a major pathological response were alive at 3 years, compared with 86% of those with a partial pathological response and 70% of those without a pathological response.
Overall, the results showed that immunotherapy — as either combination or monotherapy — is “quite a bit” better than targeted therapy with BRAF/MEK agents, which offers no substantial benefit, said Dr. Twabi.
“When you see the same pattern happening in study after study, in a very clear, robust way, it actually becomes very powerful,” he explained.
Rebecca A. Dent, MD, MSc, chair of the ESMO Scientific Committee who was not involved in the study, told a press conference that the introduction of immunotherapy and combination immunotherapy has dramatically changed outcomes in melanoma.
Commenting on the current study results, Dr. Dent said that “combination immunotherapy is clearly showing exceptional stability in terms of long-term benefits.”
The question now is what are the toxicities and costs that come with combination immunotherapy, said Dr. Dent, from National Cancer Centre Singapore and Duke-NUS Medical School, Singapore.
No funding source was declared. Dr. Long declared relationships with a variety of companies, including AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, and Regeneron. Dr. Twabi declared relationships with Bristol-Myers Squibb, Novartis, Merck, Genentech, GlaxoSmithKline, Eisai, and others. Dr. Dent declared relationships with AstraZeneca, Roche, Eisai, Gilead Sciences, Eli Lilly, Merck, and Pfizer.
A version of this article appeared on Medscape.com.
FROM ESMO 2024
Identifying Drug-Induced Rashes in Skin of Color: Heightened Awareness Can Accelerate Diagnosis
NEW YORK — Because of their heterogeneity in appearance, to speed the diagnosis.
This risk for a delayed or missed diagnosis in patients with darker skin is shared across skin rashes, but drug-induced hypersensitivity syndrome (DIHS) is a telling example, according to Joanna Harp, MD, director of the Inpatient Dermatology Consult Service, NewYork–Presbyterian Hospital, New York City.
DIHS, also known as a drug reaction with eosinophilia and systemic symptoms, is a type IV hypersensitivity reaction, Dr. Harp explained. While the fact that this disorder does not always include eosinophilia prompted the DIHS acronym, the maculopapular rash often serves as a critical clue of the underlying etiology.
In patients with darker skin, DIHS skin manifestations “can look different, can be more severe, and can have worse outcomes,” Dr. Harp said. As with other skin rashes that are primarily erythematous, the DIHS rash is often more subtle in Black-skinned patients, typically appearing gray or violaceous rather than red.
“The high amount of scale can be a clue,” said Dr. Harp, speaking at the 2024 Skin of Color Update. Scale is particularly prominent among Black patients, she said, because of the greater relative transepidermal water loss than lighter skin, increasing dryness and susceptibility to scale.
The maculopapular rash is “similar to a simple drug eruption, although it is usually more impressive,” she said. Emphasizing that DIHS is a systemic disease, she noted that the characteristic rash is typically accompanied by inflammation in multiple organs that not only includes the mucous membranes but can include major organs such as the lungs, kidneys, and heart.
In patients with DIHS and many of the even more serious types of rashes traced to drug exposures, such as Stevens-Johnson syndrome (SJS) or erythema multiforme, the delay to appearance of the rash from the time of exposure can be the most confusing element.
“It can be months for some drugs such as allopurinol,” said Dr. Harp, pointing out that Black and Asian patients are more likely to carry the HLA-B*5801 genotype, a known risk factor for allopurinol hypersensitivity.
Signs of AGEP Can Be Subtle in Black Patients
Some of the same principles for diagnosing drug-induced rash in darker skin can also be applied to acute generalized exanthematous pustulosis (AGEP), another type IV hypersensitivity reaction. Like all drug-induced rashes, the earlier AGEP is recognized and treated, the better the outcome, but in Black patients, the signs can be subtle.
“The onset is usually fast and occurs in 1-2 days after [the causative drug] exposure,” said Dr. Harp, adding that antibiotics, such as cephalosporins or penicillin, and calcium channel blockers are among the prominent causes of AGEP.
One of the hallmark signs of early-onset AGEP are tiny erythematous pustules in flexural areas, such as the neck or the armpits. The issue of detecting erythema in darker skin is also relevant to this area, but there is an additional problem, according to Dr. Harp. The pustules often dry up quickly, leaving a neutrophilic scale that further complicates the effort to see the characteristic erythema.
“If you see a lot of scale, look for erythema underneath. Think of inflammation,” Dr. Harp said, explaining that the clinical appearance evolves quickly. “If you do not see the pustules, it does not mean they were not there; you just missed them.”
In addition to the flexural areas, “AGEP loves the ears, the face, and the geographic tongue,” she said, offering several pearls to help with the diagnosis. These include side lighting to make papules easier to see, pressing on the skin to highlight the difference between erythematous skin and blanched skin, and checking less pigmented skin, such as on the hands and feet, which makes erythema easier to see.
Steroids are often the first-line treatment for drug-induced skin rashes, but Dr. Harp moves to etanercept or cyclosporine for the most serious drug reactions, such as SJS and toxic epidermal necrolysis.
Etanercept is typically her first choice because patients with systemic hypersensitivity reactions with major organ involvement are often quite ill, making cyclosporine harder to use. In her experience, etanercept has been well tolerated.
Conversely, she cautioned against the use of intravenous immunoglobulin (IVIG). Although this has been used traditionally for severe drug hypersensitivity reactions, “the data are not there,” she said. The data are stronger for a combination of high-dose steroids and IVIG, but she thinks even these data are inconsistent and not as strong as the data supporting etanercept or cyclosporine. She encouraged centers still using IVIG to consider alternatives.
After drug sensitivity reactions are controlled, follow-up care is particularly important for Black patients who face greater risks for sequelae, such as hypopigmentation, hyperpigmentation, or keloids. She recommended aggressive use of emollients and sunscreens for an extended period after lesions resolve to lessen these risks.
Differences in the manifestations of drug-induced skin rashes by race and ethnicity are important and perhaps underappreciated, agreed Shawn Kwatra, MD, professor and chairman of the Department of Dermatology, University of Maryland, Baltimore.
Asked to comment at the meeting, Dr. Kwatra said that he appreciated Dr. Harp’s effort to translate published data and her experience into an overview that increases awareness of the risk for missed or delayed diagnoses of drug-induced rashes in skin of color. He noted that the strategies to identify erythema and pustules, such as increased suspicion in skin of color and the extra steps to rule them out, such as the use of side lighting in the case of pustules for AGEP, are simple and practical.
Dr. Harp and Dr. Kwatra had no relevant disclosures.
A version of this article appeared on Medscape.com.
NEW YORK — Because of their heterogeneity in appearance, to speed the diagnosis.
This risk for a delayed or missed diagnosis in patients with darker skin is shared across skin rashes, but drug-induced hypersensitivity syndrome (DIHS) is a telling example, according to Joanna Harp, MD, director of the Inpatient Dermatology Consult Service, NewYork–Presbyterian Hospital, New York City.
DIHS, also known as a drug reaction with eosinophilia and systemic symptoms, is a type IV hypersensitivity reaction, Dr. Harp explained. While the fact that this disorder does not always include eosinophilia prompted the DIHS acronym, the maculopapular rash often serves as a critical clue of the underlying etiology.
In patients with darker skin, DIHS skin manifestations “can look different, can be more severe, and can have worse outcomes,” Dr. Harp said. As with other skin rashes that are primarily erythematous, the DIHS rash is often more subtle in Black-skinned patients, typically appearing gray or violaceous rather than red.
“The high amount of scale can be a clue,” said Dr. Harp, speaking at the 2024 Skin of Color Update. Scale is particularly prominent among Black patients, she said, because of the greater relative transepidermal water loss than lighter skin, increasing dryness and susceptibility to scale.
The maculopapular rash is “similar to a simple drug eruption, although it is usually more impressive,” she said. Emphasizing that DIHS is a systemic disease, she noted that the characteristic rash is typically accompanied by inflammation in multiple organs that not only includes the mucous membranes but can include major organs such as the lungs, kidneys, and heart.
In patients with DIHS and many of the even more serious types of rashes traced to drug exposures, such as Stevens-Johnson syndrome (SJS) or erythema multiforme, the delay to appearance of the rash from the time of exposure can be the most confusing element.
“It can be months for some drugs such as allopurinol,” said Dr. Harp, pointing out that Black and Asian patients are more likely to carry the HLA-B*5801 genotype, a known risk factor for allopurinol hypersensitivity.
Signs of AGEP Can Be Subtle in Black Patients
Some of the same principles for diagnosing drug-induced rash in darker skin can also be applied to acute generalized exanthematous pustulosis (AGEP), another type IV hypersensitivity reaction. Like all drug-induced rashes, the earlier AGEP is recognized and treated, the better the outcome, but in Black patients, the signs can be subtle.
“The onset is usually fast and occurs in 1-2 days after [the causative drug] exposure,” said Dr. Harp, adding that antibiotics, such as cephalosporins or penicillin, and calcium channel blockers are among the prominent causes of AGEP.
One of the hallmark signs of early-onset AGEP are tiny erythematous pustules in flexural areas, such as the neck or the armpits. The issue of detecting erythema in darker skin is also relevant to this area, but there is an additional problem, according to Dr. Harp. The pustules often dry up quickly, leaving a neutrophilic scale that further complicates the effort to see the characteristic erythema.
“If you see a lot of scale, look for erythema underneath. Think of inflammation,” Dr. Harp said, explaining that the clinical appearance evolves quickly. “If you do not see the pustules, it does not mean they were not there; you just missed them.”
In addition to the flexural areas, “AGEP loves the ears, the face, and the geographic tongue,” she said, offering several pearls to help with the diagnosis. These include side lighting to make papules easier to see, pressing on the skin to highlight the difference between erythematous skin and blanched skin, and checking less pigmented skin, such as on the hands and feet, which makes erythema easier to see.
Steroids are often the first-line treatment for drug-induced skin rashes, but Dr. Harp moves to etanercept or cyclosporine for the most serious drug reactions, such as SJS and toxic epidermal necrolysis.
Etanercept is typically her first choice because patients with systemic hypersensitivity reactions with major organ involvement are often quite ill, making cyclosporine harder to use. In her experience, etanercept has been well tolerated.
Conversely, she cautioned against the use of intravenous immunoglobulin (IVIG). Although this has been used traditionally for severe drug hypersensitivity reactions, “the data are not there,” she said. The data are stronger for a combination of high-dose steroids and IVIG, but she thinks even these data are inconsistent and not as strong as the data supporting etanercept or cyclosporine. She encouraged centers still using IVIG to consider alternatives.
After drug sensitivity reactions are controlled, follow-up care is particularly important for Black patients who face greater risks for sequelae, such as hypopigmentation, hyperpigmentation, or keloids. She recommended aggressive use of emollients and sunscreens for an extended period after lesions resolve to lessen these risks.
Differences in the manifestations of drug-induced skin rashes by race and ethnicity are important and perhaps underappreciated, agreed Shawn Kwatra, MD, professor and chairman of the Department of Dermatology, University of Maryland, Baltimore.
Asked to comment at the meeting, Dr. Kwatra said that he appreciated Dr. Harp’s effort to translate published data and her experience into an overview that increases awareness of the risk for missed or delayed diagnoses of drug-induced rashes in skin of color. He noted that the strategies to identify erythema and pustules, such as increased suspicion in skin of color and the extra steps to rule them out, such as the use of side lighting in the case of pustules for AGEP, are simple and practical.
Dr. Harp and Dr. Kwatra had no relevant disclosures.
A version of this article appeared on Medscape.com.
NEW YORK — Because of their heterogeneity in appearance, to speed the diagnosis.
This risk for a delayed or missed diagnosis in patients with darker skin is shared across skin rashes, but drug-induced hypersensitivity syndrome (DIHS) is a telling example, according to Joanna Harp, MD, director of the Inpatient Dermatology Consult Service, NewYork–Presbyterian Hospital, New York City.
DIHS, also known as a drug reaction with eosinophilia and systemic symptoms, is a type IV hypersensitivity reaction, Dr. Harp explained. While the fact that this disorder does not always include eosinophilia prompted the DIHS acronym, the maculopapular rash often serves as a critical clue of the underlying etiology.
In patients with darker skin, DIHS skin manifestations “can look different, can be more severe, and can have worse outcomes,” Dr. Harp said. As with other skin rashes that are primarily erythematous, the DIHS rash is often more subtle in Black-skinned patients, typically appearing gray or violaceous rather than red.
“The high amount of scale can be a clue,” said Dr. Harp, speaking at the 2024 Skin of Color Update. Scale is particularly prominent among Black patients, she said, because of the greater relative transepidermal water loss than lighter skin, increasing dryness and susceptibility to scale.
The maculopapular rash is “similar to a simple drug eruption, although it is usually more impressive,” she said. Emphasizing that DIHS is a systemic disease, she noted that the characteristic rash is typically accompanied by inflammation in multiple organs that not only includes the mucous membranes but can include major organs such as the lungs, kidneys, and heart.
In patients with DIHS and many of the even more serious types of rashes traced to drug exposures, such as Stevens-Johnson syndrome (SJS) or erythema multiforme, the delay to appearance of the rash from the time of exposure can be the most confusing element.
“It can be months for some drugs such as allopurinol,” said Dr. Harp, pointing out that Black and Asian patients are more likely to carry the HLA-B*5801 genotype, a known risk factor for allopurinol hypersensitivity.
Signs of AGEP Can Be Subtle in Black Patients
Some of the same principles for diagnosing drug-induced rash in darker skin can also be applied to acute generalized exanthematous pustulosis (AGEP), another type IV hypersensitivity reaction. Like all drug-induced rashes, the earlier AGEP is recognized and treated, the better the outcome, but in Black patients, the signs can be subtle.
“The onset is usually fast and occurs in 1-2 days after [the causative drug] exposure,” said Dr. Harp, adding that antibiotics, such as cephalosporins or penicillin, and calcium channel blockers are among the prominent causes of AGEP.
One of the hallmark signs of early-onset AGEP are tiny erythematous pustules in flexural areas, such as the neck or the armpits. The issue of detecting erythema in darker skin is also relevant to this area, but there is an additional problem, according to Dr. Harp. The pustules often dry up quickly, leaving a neutrophilic scale that further complicates the effort to see the characteristic erythema.
“If you see a lot of scale, look for erythema underneath. Think of inflammation,” Dr. Harp said, explaining that the clinical appearance evolves quickly. “If you do not see the pustules, it does not mean they were not there; you just missed them.”
In addition to the flexural areas, “AGEP loves the ears, the face, and the geographic tongue,” she said, offering several pearls to help with the diagnosis. These include side lighting to make papules easier to see, pressing on the skin to highlight the difference between erythematous skin and blanched skin, and checking less pigmented skin, such as on the hands and feet, which makes erythema easier to see.
Steroids are often the first-line treatment for drug-induced skin rashes, but Dr. Harp moves to etanercept or cyclosporine for the most serious drug reactions, such as SJS and toxic epidermal necrolysis.
Etanercept is typically her first choice because patients with systemic hypersensitivity reactions with major organ involvement are often quite ill, making cyclosporine harder to use. In her experience, etanercept has been well tolerated.
Conversely, she cautioned against the use of intravenous immunoglobulin (IVIG). Although this has been used traditionally for severe drug hypersensitivity reactions, “the data are not there,” she said. The data are stronger for a combination of high-dose steroids and IVIG, but she thinks even these data are inconsistent and not as strong as the data supporting etanercept or cyclosporine. She encouraged centers still using IVIG to consider alternatives.
After drug sensitivity reactions are controlled, follow-up care is particularly important for Black patients who face greater risks for sequelae, such as hypopigmentation, hyperpigmentation, or keloids. She recommended aggressive use of emollients and sunscreens for an extended period after lesions resolve to lessen these risks.
Differences in the manifestations of drug-induced skin rashes by race and ethnicity are important and perhaps underappreciated, agreed Shawn Kwatra, MD, professor and chairman of the Department of Dermatology, University of Maryland, Baltimore.
Asked to comment at the meeting, Dr. Kwatra said that he appreciated Dr. Harp’s effort to translate published data and her experience into an overview that increases awareness of the risk for missed or delayed diagnoses of drug-induced rashes in skin of color. He noted that the strategies to identify erythema and pustules, such as increased suspicion in skin of color and the extra steps to rule them out, such as the use of side lighting in the case of pustules for AGEP, are simple and practical.
Dr. Harp and Dr. Kwatra had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM SOC 2024
Expert Warns of Problems with Large Language Models in Dermatology
HUNTINGTON BEACH, CALIF. — and alarmed.
Of the 134 respondents who completed the survey, 87 (65%) reported using LLMs in a clinical setting. Of those 87 respondents, 17 (20%) used LMMs daily, 28 (32%) weekly, 5 (6%) monthly, and 37 (43%) rarely. That represents “pretty significant usage,” Dr. Daneshjou, assistant professor of biomedical data science and dermatology at Stanford University, Palo Alto, California, said at the annual meeting of the Pacific Dermatologic Association.
Most of the respondents reported using LLMs for patient care (79%), followed by administrative tasks (74%), medical records (43%), and education (18%), “which can be problematic,” she said. “These models are not appropriate to use for patient care.”
When asked about their thoughts on the accuracy of LLMs, 58% of respondents deemed them to be “somewhat accurate” and 7% viewed them as “extremely accurate.”
The overall survey responses raise concern because LLMs “are not trained for accuracy; they are trained initially as a next-word predictor on large bodies of tech data,” Dr. Daneshjou said. “LLMs are already being implemented but have the potential to cause harm and bias, and I believe they will if we implement them the way things are rolling out right now. I don’t understand why we’re implementing something without any clinical trial or showing that it improves care before we throw untested technology into our healthcare system.”
Meanwhile, Epic and Microsoft are collaborating to bring AI technology to electronic health records, she said, and Epic is building more than 100 new AI features for physicians and patients. “I think it’s important for every physician and trainee to understand what is going on in the realm of AI,” said Dr. Daneshjou, who is an associate editor for the monthly journal NEJM AI. “Be involved in the conversation because we are the clinical experts, and a lot of people making decisions and building tools do not have the clinical expertise.”
To further illustrate her concerns, Dr. Daneshjou referenced a red teaming event she and her colleagues held with computer scientists, biomedical data scientists, engineers, and physicians across multiple specialties to identify issues related to safety, bias, factual errors, and/or security issues in GPT-3.5, GPT-4, and GPT-4 with internet. The goal was to mimic clinical health scenarios, ask the LLM to respond, and have the team members review the accuracy of LLM responses.
The participants found that nearly 20% of LLM responses were inappropriate. For example, in one task, an LLM was asked to calculate a RegiSCAR score for Drug Reaction With Eosinophilia and Systemic Symptoms for a patient, but the response included an incorrect score for eosinophilia. “That’s why these tools can be so dangerous because you’re reading along and everything seems right, but there might be something so minor that can impact patient care and you might miss it,” Dr. Daneshjou said.
On a related note, she advised against dermatologists uploading images into GPT-4 Vision, an LLM that can analyze images and provide textual responses to questions about them, and she recommends not using GPT-4 Vision for any diagnostic support. At this time, “GPT-4 Vision overcalls malignancies, and the specificity and sensitivity are not very good,” she explained.
Dr. Daneshjou disclosed that she has served as an adviser to MDalgorithms and Revea and has received consulting fees from Pfizer, L’Oréal, Frazier Healthcare Partners, and DWA and research funding from UCB.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIF. — and alarmed.
Of the 134 respondents who completed the survey, 87 (65%) reported using LLMs in a clinical setting. Of those 87 respondents, 17 (20%) used LMMs daily, 28 (32%) weekly, 5 (6%) monthly, and 37 (43%) rarely. That represents “pretty significant usage,” Dr. Daneshjou, assistant professor of biomedical data science and dermatology at Stanford University, Palo Alto, California, said at the annual meeting of the Pacific Dermatologic Association.
Most of the respondents reported using LLMs for patient care (79%), followed by administrative tasks (74%), medical records (43%), and education (18%), “which can be problematic,” she said. “These models are not appropriate to use for patient care.”
When asked about their thoughts on the accuracy of LLMs, 58% of respondents deemed them to be “somewhat accurate” and 7% viewed them as “extremely accurate.”
The overall survey responses raise concern because LLMs “are not trained for accuracy; they are trained initially as a next-word predictor on large bodies of tech data,” Dr. Daneshjou said. “LLMs are already being implemented but have the potential to cause harm and bias, and I believe they will if we implement them the way things are rolling out right now. I don’t understand why we’re implementing something without any clinical trial or showing that it improves care before we throw untested technology into our healthcare system.”
Meanwhile, Epic and Microsoft are collaborating to bring AI technology to electronic health records, she said, and Epic is building more than 100 new AI features for physicians and patients. “I think it’s important for every physician and trainee to understand what is going on in the realm of AI,” said Dr. Daneshjou, who is an associate editor for the monthly journal NEJM AI. “Be involved in the conversation because we are the clinical experts, and a lot of people making decisions and building tools do not have the clinical expertise.”
To further illustrate her concerns, Dr. Daneshjou referenced a red teaming event she and her colleagues held with computer scientists, biomedical data scientists, engineers, and physicians across multiple specialties to identify issues related to safety, bias, factual errors, and/or security issues in GPT-3.5, GPT-4, and GPT-4 with internet. The goal was to mimic clinical health scenarios, ask the LLM to respond, and have the team members review the accuracy of LLM responses.
The participants found that nearly 20% of LLM responses were inappropriate. For example, in one task, an LLM was asked to calculate a RegiSCAR score for Drug Reaction With Eosinophilia and Systemic Symptoms for a patient, but the response included an incorrect score for eosinophilia. “That’s why these tools can be so dangerous because you’re reading along and everything seems right, but there might be something so minor that can impact patient care and you might miss it,” Dr. Daneshjou said.
On a related note, she advised against dermatologists uploading images into GPT-4 Vision, an LLM that can analyze images and provide textual responses to questions about them, and she recommends not using GPT-4 Vision for any diagnostic support. At this time, “GPT-4 Vision overcalls malignancies, and the specificity and sensitivity are not very good,” she explained.
Dr. Daneshjou disclosed that she has served as an adviser to MDalgorithms and Revea and has received consulting fees from Pfizer, L’Oréal, Frazier Healthcare Partners, and DWA and research funding from UCB.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIF. — and alarmed.
Of the 134 respondents who completed the survey, 87 (65%) reported using LLMs in a clinical setting. Of those 87 respondents, 17 (20%) used LMMs daily, 28 (32%) weekly, 5 (6%) monthly, and 37 (43%) rarely. That represents “pretty significant usage,” Dr. Daneshjou, assistant professor of biomedical data science and dermatology at Stanford University, Palo Alto, California, said at the annual meeting of the Pacific Dermatologic Association.
Most of the respondents reported using LLMs for patient care (79%), followed by administrative tasks (74%), medical records (43%), and education (18%), “which can be problematic,” she said. “These models are not appropriate to use for patient care.”
When asked about their thoughts on the accuracy of LLMs, 58% of respondents deemed them to be “somewhat accurate” and 7% viewed them as “extremely accurate.”
The overall survey responses raise concern because LLMs “are not trained for accuracy; they are trained initially as a next-word predictor on large bodies of tech data,” Dr. Daneshjou said. “LLMs are already being implemented but have the potential to cause harm and bias, and I believe they will if we implement them the way things are rolling out right now. I don’t understand why we’re implementing something without any clinical trial or showing that it improves care before we throw untested technology into our healthcare system.”
Meanwhile, Epic and Microsoft are collaborating to bring AI technology to electronic health records, she said, and Epic is building more than 100 new AI features for physicians and patients. “I think it’s important for every physician and trainee to understand what is going on in the realm of AI,” said Dr. Daneshjou, who is an associate editor for the monthly journal NEJM AI. “Be involved in the conversation because we are the clinical experts, and a lot of people making decisions and building tools do not have the clinical expertise.”
To further illustrate her concerns, Dr. Daneshjou referenced a red teaming event she and her colleagues held with computer scientists, biomedical data scientists, engineers, and physicians across multiple specialties to identify issues related to safety, bias, factual errors, and/or security issues in GPT-3.5, GPT-4, and GPT-4 with internet. The goal was to mimic clinical health scenarios, ask the LLM to respond, and have the team members review the accuracy of LLM responses.
The participants found that nearly 20% of LLM responses were inappropriate. For example, in one task, an LLM was asked to calculate a RegiSCAR score for Drug Reaction With Eosinophilia and Systemic Symptoms for a patient, but the response included an incorrect score for eosinophilia. “That’s why these tools can be so dangerous because you’re reading along and everything seems right, but there might be something so minor that can impact patient care and you might miss it,” Dr. Daneshjou said.
On a related note, she advised against dermatologists uploading images into GPT-4 Vision, an LLM that can analyze images and provide textual responses to questions about them, and she recommends not using GPT-4 Vision for any diagnostic support. At this time, “GPT-4 Vision overcalls malignancies, and the specificity and sensitivity are not very good,” she explained.
Dr. Daneshjou disclosed that she has served as an adviser to MDalgorithms and Revea and has received consulting fees from Pfizer, L’Oréal, Frazier Healthcare Partners, and DWA and research funding from UCB.
A version of this article first appeared on Medscape.com.
FROM PDA 2024
Diabetes Drug Improved Symptoms in Small Study of Women With Central Centrifugal Cicatricial Alopecia
TOPLINE:
in a retrospective case series.
METHODOLOGY:
- Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
- Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
- Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
- Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.
TAKEAWAY:
- Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
- Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
- Transcriptomic analysis revealed 34 up-regulated genes, which included up-regulated of 23 hair keratin–associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were down-regulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
- Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.
IN PRACTICE:
“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”
SOURCE:
The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and was published online on September 4 in JAMA Dermatology.
LIMITATIONS:
A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. Additionally, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.
DISCLOSURES:
The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
in a retrospective case series.
METHODOLOGY:
- Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
- Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
- Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
- Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.
TAKEAWAY:
- Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
- Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
- Transcriptomic analysis revealed 34 up-regulated genes, which included up-regulated of 23 hair keratin–associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were down-regulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
- Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.
IN PRACTICE:
“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”
SOURCE:
The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and was published online on September 4 in JAMA Dermatology.
LIMITATIONS:
A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. Additionally, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.
DISCLOSURES:
The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
in a retrospective case series.
METHODOLOGY:
- Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
- Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
- Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
- Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.
TAKEAWAY:
- Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
- Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
- Transcriptomic analysis revealed 34 up-regulated genes, which included up-regulated of 23 hair keratin–associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were down-regulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
- Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.
IN PRACTICE:
“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”
SOURCE:
The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and was published online on September 4 in JAMA Dermatology.
LIMITATIONS:
A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. Additionally, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.
DISCLOSURES:
The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Study Helps Define Patient-Centered Definition of Atopic Dermatitis Flares
TOPLINE:
, which most agreed would help when communicating with their healthcare providers (HCPs).
METHODOLOGY:
- To develop a patient-centered definition of AD flare, researchers used a modified eDelphi method, which involved a focus group and survey to reach consensus on key aspects of an AD flare.
- The focus group included 26 US adults aged ≥ 18 years with AD who had experienced a flare within the past 12 months. The survey was conducted among 631 adults with AD to validate the identified concepts and assess their agreement with the consensus statements.
- Participants rated 98 statements on a scale from 1 to 9, with consensus defined as at least 70% rating a statement as 7-9 and less than 15% rating it as 1-3.
- In focus groups, participants identified six key concepts for a patient-centered definition of flare, including changes from baseline, mental and emotional consequences, and physical changes in skin.
TAKEAWAY:
- The focus group reached consensus on 15 statements, and survey participants reached consensus on 12 of those statements defining an AD flare, with the highest agreement on symptoms taking more attention than normal, worsening of physical symptoms associated with AD, and worsening of itching associated with AD.
- The statement “acute worsening of symptoms of AD” was ranked as the most important, while “a worsening of physical symptoms” was ranked the least important.
- Most participants (79.7%) reported that prior definitions of AD flare did not resonate with them.
- More than half (52.9%) agreed with their HCP on what constitutes an AD flare, and the majority (77.6%) indicated that a patient-centered definition would be useful for communication with their HCP and for self-management.
IN PRACTICE:
“In this consensus survey study, we identified statements that are critical to the definition of an AD flare from the patient perspective,” the authors wrote. These findings, they added, “may be useful in clinical practice to improve communication between patients and HCPs who may be using the term flare without a mutual understanding of its meaning” and “may also be applied to the development of outcome measures focused on AD flares, which is an important treatment outcome for people with AD.”
SOURCE:
The study was led by Aaron M. Drucker, MD, ScM, of the Division of Dermatology, Department of Medicine, University of Toronto, Ontario, Canada, and was published online September 11 in JAMA Dermatology.
LIMITATIONS:
Participants had higher-than-average knowledge about AD, and the study’s findings may not be generalizable to all people with AD. The study included a higher proportion of moderate to severe AD cases than the general population, which may introduce responder bias. The findings may not be applicable to children, caregivers, or individuals in other countries.
DISCLOSURES:
This work was supported by a grant to the National Eczema Association from Pfizer. Dr. Drucker disclosed received compensation from the British Journal of Dermatology, American Academy of Dermatology, and Canadian Dermatology Today, and consultant fees from the National Eczema Association and Canadian Agency for Drugs and Technologies in Health. Another author reported receiving personal fees from pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
, which most agreed would help when communicating with their healthcare providers (HCPs).
METHODOLOGY:
- To develop a patient-centered definition of AD flare, researchers used a modified eDelphi method, which involved a focus group and survey to reach consensus on key aspects of an AD flare.
- The focus group included 26 US adults aged ≥ 18 years with AD who had experienced a flare within the past 12 months. The survey was conducted among 631 adults with AD to validate the identified concepts and assess their agreement with the consensus statements.
- Participants rated 98 statements on a scale from 1 to 9, with consensus defined as at least 70% rating a statement as 7-9 and less than 15% rating it as 1-3.
- In focus groups, participants identified six key concepts for a patient-centered definition of flare, including changes from baseline, mental and emotional consequences, and physical changes in skin.
TAKEAWAY:
- The focus group reached consensus on 15 statements, and survey participants reached consensus on 12 of those statements defining an AD flare, with the highest agreement on symptoms taking more attention than normal, worsening of physical symptoms associated with AD, and worsening of itching associated with AD.
- The statement “acute worsening of symptoms of AD” was ranked as the most important, while “a worsening of physical symptoms” was ranked the least important.
- Most participants (79.7%) reported that prior definitions of AD flare did not resonate with them.
- More than half (52.9%) agreed with their HCP on what constitutes an AD flare, and the majority (77.6%) indicated that a patient-centered definition would be useful for communication with their HCP and for self-management.
IN PRACTICE:
“In this consensus survey study, we identified statements that are critical to the definition of an AD flare from the patient perspective,” the authors wrote. These findings, they added, “may be useful in clinical practice to improve communication between patients and HCPs who may be using the term flare without a mutual understanding of its meaning” and “may also be applied to the development of outcome measures focused on AD flares, which is an important treatment outcome for people with AD.”
SOURCE:
The study was led by Aaron M. Drucker, MD, ScM, of the Division of Dermatology, Department of Medicine, University of Toronto, Ontario, Canada, and was published online September 11 in JAMA Dermatology.
LIMITATIONS:
Participants had higher-than-average knowledge about AD, and the study’s findings may not be generalizable to all people with AD. The study included a higher proportion of moderate to severe AD cases than the general population, which may introduce responder bias. The findings may not be applicable to children, caregivers, or individuals in other countries.
DISCLOSURES:
This work was supported by a grant to the National Eczema Association from Pfizer. Dr. Drucker disclosed received compensation from the British Journal of Dermatology, American Academy of Dermatology, and Canadian Dermatology Today, and consultant fees from the National Eczema Association and Canadian Agency for Drugs and Technologies in Health. Another author reported receiving personal fees from pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
, which most agreed would help when communicating with their healthcare providers (HCPs).
METHODOLOGY:
- To develop a patient-centered definition of AD flare, researchers used a modified eDelphi method, which involved a focus group and survey to reach consensus on key aspects of an AD flare.
- The focus group included 26 US adults aged ≥ 18 years with AD who had experienced a flare within the past 12 months. The survey was conducted among 631 adults with AD to validate the identified concepts and assess their agreement with the consensus statements.
- Participants rated 98 statements on a scale from 1 to 9, with consensus defined as at least 70% rating a statement as 7-9 and less than 15% rating it as 1-3.
- In focus groups, participants identified six key concepts for a patient-centered definition of flare, including changes from baseline, mental and emotional consequences, and physical changes in skin.
TAKEAWAY:
- The focus group reached consensus on 15 statements, and survey participants reached consensus on 12 of those statements defining an AD flare, with the highest agreement on symptoms taking more attention than normal, worsening of physical symptoms associated with AD, and worsening of itching associated with AD.
- The statement “acute worsening of symptoms of AD” was ranked as the most important, while “a worsening of physical symptoms” was ranked the least important.
- Most participants (79.7%) reported that prior definitions of AD flare did not resonate with them.
- More than half (52.9%) agreed with their HCP on what constitutes an AD flare, and the majority (77.6%) indicated that a patient-centered definition would be useful for communication with their HCP and for self-management.
IN PRACTICE:
“In this consensus survey study, we identified statements that are critical to the definition of an AD flare from the patient perspective,” the authors wrote. These findings, they added, “may be useful in clinical practice to improve communication between patients and HCPs who may be using the term flare without a mutual understanding of its meaning” and “may also be applied to the development of outcome measures focused on AD flares, which is an important treatment outcome for people with AD.”
SOURCE:
The study was led by Aaron M. Drucker, MD, ScM, of the Division of Dermatology, Department of Medicine, University of Toronto, Ontario, Canada, and was published online September 11 in JAMA Dermatology.
LIMITATIONS:
Participants had higher-than-average knowledge about AD, and the study’s findings may not be generalizable to all people with AD. The study included a higher proportion of moderate to severe AD cases than the general population, which may introduce responder bias. The findings may not be applicable to children, caregivers, or individuals in other countries.
DISCLOSURES:
This work was supported by a grant to the National Eczema Association from Pfizer. Dr. Drucker disclosed received compensation from the British Journal of Dermatology, American Academy of Dermatology, and Canadian Dermatology Today, and consultant fees from the National Eczema Association and Canadian Agency for Drugs and Technologies in Health. Another author reported receiving personal fees from pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Imaging Tool Helps Identify Features of Nail Disorders
TOPLINE:
METHODOLOGY:
- The single-center, observational cross-sectional pilot study evaluated patients aged ≥ 7 years with newly diagnosed nail disorders between January 2022 and May 2023.
- A total of 128 patients (average age, 46.1 years; range, 8-84 years) with nail psoriasis, onychomycosis, idiopathic/traumatic onycholysis, brittle nail syndrome, nail lichen planus, retronychia, and other nail conditions and those with no nail findings (controls) were enrolled.
- Researchers performed nailfold capillaroscopy imaging and compared capillary features between patients with nail conditions and the controls.
TAKEAWAY:
- Patients with nail psoriasis had decreased capillary density and length (P < .001), more crossed and tortuous capillaries (P < .02), and increased abnormal capillary morphology (P = .03) compared with controls. Specific abnormalities, such as branching and meandering capillaries, were more common among those with nail psoriasis (both 26.5%).
- Patients with fingernail and toenail onychomycosis had a higher frequency of abnormal capillary morphology (P < .02), particularly meandering capillaries (75.0% for fingernails and 76.9% for toenails). However, other abnormalities were less frequently observed.
- Patients with nail lichen planus (P < .01), onychopapilloma (P = .01), and retronychia (P = .03) showed significantly shorter capillaries than controls. Retronychia was also associated with increased disorganized polymorphic capillaries (P = .02).
- Patients with brittle nail syndrome and eczema showed no significant differences compared with controls.
IN PRACTICE:
“Our findings highlight nailfold capillaroscopy as a potentially quick, cost-effective, and noninvasive imaging modality as an adjunct for diagnosis and treatment initiation for patients with onychodystrophies,” the authors wrote.
SOURCE:
This study was led by Jonathan K. Hwang, MD, Weill Cornell Medicine, New York City, and was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The study’s limitations included a small sample size for certain nail conditions and the single-center design, which limited generalizability. Additionally, the uneven surface, scaling, onycholysis, and thickening of toenails made some capillaroscopy images difficult to capture and interpret.
DISCLOSURES:
The study did not receive any funding. One author reported serving as a consultant for Eli Lilly, Ortho-Dermatologics, BelleTorus, and Moberg Pharma.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The single-center, observational cross-sectional pilot study evaluated patients aged ≥ 7 years with newly diagnosed nail disorders between January 2022 and May 2023.
- A total of 128 patients (average age, 46.1 years; range, 8-84 years) with nail psoriasis, onychomycosis, idiopathic/traumatic onycholysis, brittle nail syndrome, nail lichen planus, retronychia, and other nail conditions and those with no nail findings (controls) were enrolled.
- Researchers performed nailfold capillaroscopy imaging and compared capillary features between patients with nail conditions and the controls.
TAKEAWAY:
- Patients with nail psoriasis had decreased capillary density and length (P < .001), more crossed and tortuous capillaries (P < .02), and increased abnormal capillary morphology (P = .03) compared with controls. Specific abnormalities, such as branching and meandering capillaries, were more common among those with nail psoriasis (both 26.5%).
- Patients with fingernail and toenail onychomycosis had a higher frequency of abnormal capillary morphology (P < .02), particularly meandering capillaries (75.0% for fingernails and 76.9% for toenails). However, other abnormalities were less frequently observed.
- Patients with nail lichen planus (P < .01), onychopapilloma (P = .01), and retronychia (P = .03) showed significantly shorter capillaries than controls. Retronychia was also associated with increased disorganized polymorphic capillaries (P = .02).
- Patients with brittle nail syndrome and eczema showed no significant differences compared with controls.
IN PRACTICE:
“Our findings highlight nailfold capillaroscopy as a potentially quick, cost-effective, and noninvasive imaging modality as an adjunct for diagnosis and treatment initiation for patients with onychodystrophies,” the authors wrote.
SOURCE:
This study was led by Jonathan K. Hwang, MD, Weill Cornell Medicine, New York City, and was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The study’s limitations included a small sample size for certain nail conditions and the single-center design, which limited generalizability. Additionally, the uneven surface, scaling, onycholysis, and thickening of toenails made some capillaroscopy images difficult to capture and interpret.
DISCLOSURES:
The study did not receive any funding. One author reported serving as a consultant for Eli Lilly, Ortho-Dermatologics, BelleTorus, and Moberg Pharma.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The single-center, observational cross-sectional pilot study evaluated patients aged ≥ 7 years with newly diagnosed nail disorders between January 2022 and May 2023.
- A total of 128 patients (average age, 46.1 years; range, 8-84 years) with nail psoriasis, onychomycosis, idiopathic/traumatic onycholysis, brittle nail syndrome, nail lichen planus, retronychia, and other nail conditions and those with no nail findings (controls) were enrolled.
- Researchers performed nailfold capillaroscopy imaging and compared capillary features between patients with nail conditions and the controls.
TAKEAWAY:
- Patients with nail psoriasis had decreased capillary density and length (P < .001), more crossed and tortuous capillaries (P < .02), and increased abnormal capillary morphology (P = .03) compared with controls. Specific abnormalities, such as branching and meandering capillaries, were more common among those with nail psoriasis (both 26.5%).
- Patients with fingernail and toenail onychomycosis had a higher frequency of abnormal capillary morphology (P < .02), particularly meandering capillaries (75.0% for fingernails and 76.9% for toenails). However, other abnormalities were less frequently observed.
- Patients with nail lichen planus (P < .01), onychopapilloma (P = .01), and retronychia (P = .03) showed significantly shorter capillaries than controls. Retronychia was also associated with increased disorganized polymorphic capillaries (P = .02).
- Patients with brittle nail syndrome and eczema showed no significant differences compared with controls.
IN PRACTICE:
“Our findings highlight nailfold capillaroscopy as a potentially quick, cost-effective, and noninvasive imaging modality as an adjunct for diagnosis and treatment initiation for patients with onychodystrophies,” the authors wrote.
SOURCE:
This study was led by Jonathan K. Hwang, MD, Weill Cornell Medicine, New York City, and was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The study’s limitations included a small sample size for certain nail conditions and the single-center design, which limited generalizability. Additionally, the uneven surface, scaling, onycholysis, and thickening of toenails made some capillaroscopy images difficult to capture and interpret.
DISCLOSURES:
The study did not receive any funding. One author reported serving as a consultant for Eli Lilly, Ortho-Dermatologics, BelleTorus, and Moberg Pharma.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.