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.

• Authors: Pedro Mendes-Bastos, Barry Ladizinski, Emma Guttman-Yassky, Ping Jiang, John Liu, Vimal H Prajapati, Eric L Simpson, Namita Vigna, Henrique D Teixeira, Sebastien Barbarot
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 87 Issue 4 Pg. 784-791 (10 2022) ISSN: 1097-6787 [Electronic] United States
• PMID: 35714786 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Adrenal Cortex Hormones
• Anti-Bacterial Agents
• Heterocyclic Compounds, 3-Ring
• Retinoids
• upadacitinib
• Benzoyl Peroxide

Topics

• Acne Vulgaris (chemically induced, drug therapy)
• Adrenal Cortex Hormones (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Benzoyl Peroxide (therapeutic use)
• Dermatitis, Atopic (chemically induced, drug therapy)
• Double-Blind Method
• Female
• Heterocyclic Compounds, 3-Ring
• Humans
• Retinoids (therapeutic use)
• Severity of Illness Index
• Treatment Outcome