The characteristics of acne associated with upadacitinib treatment were outlined in results from an analysis published in the Journal of the American Academy of Dermatology. In a trial of patients receiving upadacitinib for atopic dermatitis (AD), a minority developed acne. Most cases of acne were mild to moderate in severity and resolved with topical treatment.
Investigators conducted a post hoc integrated analysis of 3 randomized clinical trials of upadacitinib in patients with AD. Data were extracted from the 16-week placebo-controlled periods of each trial, during which patients received once-daily upadacitinib 15 mg, upadacitinib 30 mg, or placebo. Enrolled patients were adolescents or adults with moderate to severe AD for whom topical therapy was ineffective or medically inadvisable. The incidence of acne was ascertained by reviewing adverse event reports. Acne was graded based on the percentage of body surface area affected. Acne rates and severity were compared between treatment groups.
The pooled cohort comprised 2583 patients with AD who received at least 1 dose of upadacitinib or placebo. Mean age was 34.2 ± 15.5 years. Overall, acne was observed in 9.8% of patients randomly assigned to upadacitinib 15 mg; 131 15.2% randomly assigned to upadacitinib 30 mg; and 2.2% of patients randomly assigned to placebo. Nearly all patients with acne were mild or moderate in severity, although 1 patient with severe acne was reported. It was noted that 2 patients discontinued upadacitinib due to acne-related adverse events.
Average time to first acne report was 43.5 ± 29.9, 40.3 ± 27.8, and 56.5 ± 37.3 days in the upadacitinib 15 mg, upadacitinib 30 mg, and placebo groups, respectively. Mean duration of acne symptoms was 104.2 ± 100.9 and 93.2 ± 88.2 days in the upadacitinib 15 mg and 30 mg dose groups, respectively. Duration was much lower in the placebo group, at 23.7 ± 13.7 days. Acne resolved without treatment in 40.5% and 46.6% of patients in the upadacitinib 15 mg and 30 mg groups, respectively. Of patients who required intervention, most received topical therapies, including antibiotics, benzoyl peroxide, and retinoids. Acne occurred in higher rates in women, non-White patients, and younger patients.
Data from this analysis contribute to clinical understanding of upadacitinib-associated acne. As study limitations, investigators noted that short follow-up duration and limited patient population. Further study is needed to assess the long-term dermatological effects of upadacitinib treatment, they suggest.
The researchers summarized, “…acne is one of the most common [adverse events] seen with upadacitinib treatment in adolescents and adults with moderate-to-severe AD, affecting about 10% of patients in the first blinded 16-week phase 3 trials.” They continued, “In our studies, all cases except one were mild or moderate in severity, and either did not require treatment or were clinically manageable with topical therapies.”
Disclosure: This research was supported AbbVie, Inc. Please see the original reference 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. Published online June 14, 2022. doi:10.1016/j.jaad.2022.06.012