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

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,...

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Published in:Journal of the American Academy of Dermatology 2022-10, Vol.87 (4), p.784-791
Main Authors: Mendes-Bastos, Pedro, Ladizinski, Barry, Guttman-Yassky, Emma, Jiang, Ping, Liu, John, Prajapati, Vimal H., Simpson, Eric L., Vigna, Namita, Teixeira, Henrique D., Barbarot, Sebastien
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Language:English
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Life Sciences
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Summary: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.
ISSN:0190-9622
1097-6787
DOI:10.1016/j.jaad.2022.06.012