Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type.

BACKGROUND

Response to abrocitinib treatment for moderate-to-severe atopic dermatitis (AD) has not been evaluated across racial and ethnic subpopulations.

OBJECTIVE

To assess the efficacy and safety of abrocitinib on the basis of patient race, ethnicity, and Fitzpatrick skin type (FST).

METHODS

Data were pooled post hoc from patients treated with abrocitinib 200 mg, 100 mg, or placebo in 3 monotherapy trials (NCT02780167, NCT03349060, and NCT03575871). Race and ethnicity were self-reported; FST was determined by study investigators. Evaluations through Week 12 include the following: (1) Investigator's Global Assessment of clear or almost-clear skin; (2) greater than or equal to 75% improvement in Eczema Area and Severity Index or SCORing AD; (3) a greater-than-or-equal-to 4-point improvement in Peak Pruritus Numerical Rating Scale score; (4) least squares mean changes in Dermatology Life Quality Index and Patient-Oriented Eczema Measure scores; and (5) treatment-emergent adverse events.

RESULTS

The sample comprised 628 White, 204 Asian, and 83 Black patients; 37 were Hispanic or Latino; 624 had FST I to III and 320 had FST IV to VI. Treatment with either abrocitinib dose was associated with greater proportions of patients achieving Investigator's Global Assessment of clear or almost-clear skin, ≥ 75% improvement in Eczema Area and Severity Index, ≥ 75% improvement in SCORing AD, and a ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale, or greater score changes from baseline in Dermatology Life Quality Index and Patient-Oriented Eczema Measure vs placebo regardless of race, ethnicity, or FST. Dose-response was most prominent in White patients. In Black patients, the effects of the 2 doses were similar. Treatment-emergent adverse events were more common in White and Black than in Asian patients.

CONCLUSION

Abrocitinib was more efficacious than placebo across the racial and ethnic groups and ranges of phototypes analyzed. Studies with increased representation of populations of color are warranted to elucidate potential variations in response across diverse populations.

TRIAL REGISTRATION

Clinicaltrials.gov Identifier: NCT02780167 (phase 2b), NCT03349060 (phase 3 MONO-1), and NCT03575871 (phase 3 MONO-2).

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Disclosures Dr Alexis has received grants made to the institution from AbbVie, Almirall, Amgen, Arcutis, Bristol Myers Squibb, Cara Therapeutics, Castle, Dermavant, Galderma, LEO Pharma, Novartis, Valeant (Bausch Health), and Vyne; is an advisory board member or consultant for Pfizer Inc, AbbVie, Allergan, Almirall, Alphyn, Amgen, Apogee, Arcutis, Bausch Health, Beiersdorf, Bristol Myers Squibb, Cara Therapeutics, Canfield, Castle, Cutera, Dermavant, Eli Lilly and Company, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, L'Oreal, Ortho, Sanofi Regeneron, Swiss-American, UCB, VisualDx, and Vyne; and has served as a speaker for Pfizer Inc, Bristol Myers Squibb, Regeneron, and Sanofi-Genzyme. Dr Silverberg served as an investigator for Celgene, Eli Lilly and Company, F. Hoffmann-LaRoche, Menlo Therapeutics, Realm Therapeutics, Regeneron, and Sanofi; as a consultant for Pfizer Inc, AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Dermavant, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron, and Sanofi; and as a speaker for Regeneron and Sanofi. Dr Rice is an advisory board member for Pfizer Inc, Biotech, Cassiopeia, and Medscape; a consultant for Pfizer Inc, Brickell Biotech, Cassiopeia, Dermira, Regeneron, and Sanofi; has received funding from AbbVie, Anacor Pharmaceuticals, Celgene, Galderma, Merck & Co, Regeneron, and Sanofi-Genzyme; and has been a speaker for Pfizer Inc, Dermira, the International Hyperhidrosis Society, PRIME, Regeneron, and Sanofi. Dr Armstrong has served as a research investigator and/or scientific advisor for Pfizer Inc, AbbVie, Boehringer Ingelheim, BMS, Dermavant, Dermira, Eli Lilly and Company, EPI Health, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun, and UCB. Dr Desai is a consultant for AbbVie, Allergan, Eli Lilly and Company, Galderma, LEO Pharma, OrthoDermatologics, Scientis, and UCB. Dr Fonacier has received grants made to the institution from Pfizer Inc, AstraZeneca, Regeneron, and Shire and serves as a consultant for Pfizer Inc, AbbVie, Eli Lilly and Company, and Regeneron. Dr Kabashima received consulting fees or advisory board honoraria from Pfizer Inc, AbbVie, Chugai Pharmaceutical, Eli Lilly and Company, Japan Tobacco Inc, Kao, LEO Pharma, Maruho, Pola Pharma, Sanofi, and Taiho Pharmaceutical and has received research grants from AbbVie, Eli Lilly and Company, Japan Tobacco Inc, Kose, Kyorin Pharmaceutical, Kyowa Kirin, LEO Pharma, Ono Pharmaceutical, Pola Pharmaceutical, Procter & Gamble Company, Sanofi, and Tanabe Mitsubishi. Drs Biswas, Chan, and Levenberg are employees and shareholders of Pfizer Inc. Dr Rojo Cella is a former employee and shareholder of Pfizer Inc.