Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials

Abstract

Background: Acne is the most frequent adverse event associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis.

Objective: To characterize the adverse event of acne associated with upadacitinib.

Methods: This was a post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials of upadacitinib, alone (NCT03569293 and NCT03607422) or in combination with topical corticosteroids (NCT03568318). Data included were from the 16-week placebo-controlled period.

Results: Over 16 weeks, 84 of 857 (9.8%), 131 of 864 (15.2%), and 19 of 862 (2.2%) patients randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, and placebo, respectively, experienced acne. All cases of acne, except 1, were mild/moderate in severity; 2 patients discontinued treatment due to moderate acne. Acne occurred at higher rates among younger, female, and non-White patients. Acne required no intervention in 40.5% and 46.6% of patients receiving upadacitinib 15 and 30 mg, respectively; most remaining cases were managed with topical antibiotics, benzoyl peroxide, and/or retinoids. Acne also had no impact on patient-reported outcomes.

Limitations: This study was relatively short in duration and had a small patient population.

Conclusions: Acne associated with upadacitinib for atopic dermatitis treatment is usually mild/moderate in severity and managed with topical therapies or no intervention.

Keywords: acne; adverse event; atopic dermatitis; topical corticosteroids; upadacitinib.

Conflict of interest statement

Conflicts of interest Dr Mendes-Bastos has received honoraria for consulting and/or speaker services from AbbVie, Novartis, Janssen, LEO Pharma, Almirall, Sanofi, Viatris, L’Oreal, and Cantabria Labs. He has also worked as a principal investigator in clinical trials supported by AbbVie, Sanofi, and Novartis. Dr Guttman-Yassky is employed by Mount Sinai and is a researcher and/or consultant for AbbVie, Anacor Pharmaceuticals, AnaptysBio, Asana Biosciences, Botanix Pharmaceuticals, Celgene, DBV Technologies, Dermira, Dr Reddy’s Laboratories (Promius Pharma), DS Biopharma, Escalier Biosciences, Galderma, Glenmark, Innovaderm, Janssen, Kyowa Kirin, LEO Pharma, Lilly, MedImmune, Mitsubishi Tanabe Pharma, Novan, Novartis, Pfizer, Ralexar Therapeutics, Regeneron, Sanofi, Stiefel/GlaxoSmithKline, UCB, and Vitae Pharmaceuticals. Ms Jiang, Dr Ladizinski, Dr Liu, Dr Teixeira, and Dr Vigna are full-time employees of AbbVie and may hold AbbVie stock or stock options. Dr Prajapati has served as an investigator for AbbVie, Amgen, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, Sanofi Genzyme, UCB Pharma, and Valeant. He has served as a consultant, advisor, and/or speaker for AbbVie, Actelion, Amgen, Aralez, Arcutis, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Janssen, LEO Pharma, L’Oreal, Medexus, Novartis, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, UCB Pharma, and Valeant. Dr Simpson has received grants, personal fees, and/or nonfinancial support from AbbVie, Amgen, Arena Pharmaceuticals, BenevolentAI Bio, BiomX, Bluefin Biomedicine, Boehringer Ingelheim, Boston Consulting Group, Collective Acumen, Coronado, Dermira, Evidera, ExcerptaMedica, Forte Biosciences, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Medscape, Merck, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi-Genzyme, SPARC India, Tioga Pharmaceuticals, and Vanda Pharmaceuticals. He has also served on advisory boards for AMAZE, FRED, Harmonising Outcome Measures for Eczema (HOME), Janssen, Kyowa Kirin, LEO Pharma, Lilly, National Eczema Association, NIH MOSS Special Emphasis Panel Study Section, Pfizer, and TARGET PharmaSolutions. Dr Barbarot has received personal fees from AbbVie, Almirall, Janssen, LEO Pharma, Lilly, Pfizer, Sanofi-Genzyme, and UCB; nonfinancial support from Novartis; and grants from LEO Pharma.

Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.