A post-hoc analysis found that acne associated with upadacitinib treatment for atopic dermatitis (AD) was usually mild to moderate and could be managed with topical therapies. These findings were published in the Journal of the American Academy of Dermatology.
Data from 3 studies, the Measure Up 1, Measure Up 2, and AD Up trials were pooled and evaluated in this post-hoc analysis. Patients (N=2583) with moderate to severe AD were randomly assigned in a 1:1:1 ratio to receive 15 mg upadacitinib, 30 mg upadacitinib, or placebo once daily. Participants in the AD Up trial received concomitant topical corticosteroids. Investigators collected data relating to the occurrence and clinical course of acne.
The 15 mg (n=857), 30 mg (n=864), and placebo (n=862) cohorts had acne incidence rates of 9.8%, 15.2%, and 2.2%, respectively. Among patients with acne, 32.8% to 47.4% had a medical history of acne, 25.2% to 29.8% had a family history of acne, 5.3% to 9.5% used concomitant medication associated with acne, and 13.7% to 15.8% had other predisposing factors for acne.
The acne events time to onset was more rapid in the high dose upadacitinib group (mean, 40.3 days) and longer for the placebo recipients (mean, 56.5 days). Acne events lasted the longest for the low-dose group (mean, 104.2 days) and shortest for the placebo recipients (mean, 23.7 days). Most events affected the face (89.5%-96.4%) and presented as inflammatory papules (84.0%-91.7%).
A participant in the low- and high-dose upadacitinib groups discontinued treatment due to acne.
More than half of the placebo group (52.6%) did not use acne medications compared with 40.5% in the low dose and 46.6% in the high dose groups. The remaining patients who used acne medication used topical treatments (26.3%-38.2%) and few used oral (0.0%-7.6%), transdermal (0.0%-5.3%), or cutaneous (0.0%-2.3%) approaches.
Stratified by the presence of acne, there was no significant difference in AD outcomes, quality of life, or treatment satisfaction.
The major limitation of this post-hoc analysis was the small sample size.
The study authors concluded that acne associated with upadacitinib treatment for AD was manageable with topical or no treatments and the occurrence of acne did not affect AD or quality of life outcomes.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, et al. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: a post hoc integrated analysis of three phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022;S0190-9622(22)00996-3. doi:10.1016/j.jaad.2022.06.012