Acne Among Japanese Patients with Atopic Dermatitis Receiving Upadacitinib in the Phase3 RisingUp Study.

Abstract

Upadacitinib, an oral selective Janus kinase (JAK) inhibitor, is used to treat moderate-to-severe atopic dermatitis (AD). Acne is the most common treatment-emergent adverse event in patients with AD treated with upadacitinib. In this post hoc analysis, we describe the acne events in Japanese patients with AD who received upadacitinib during the RisingUp study. In this phase3, double-blind, 3-year trial evaluating the safety and efficacy of upadacitinib 15mg or 30mg in Japanese patients with moderate-to-severe AD, patients were randomized 1:1:1 to receive upadacitinib 15mg, 30mg, or placebo for up to 16weeks. At week16, placebo-treated patients were re-randomized 1:1 to receive upadacitinib 15mg or 30mg. The incidence, characteristics, and management of treatment-emergent acne events up to the 52-week cutoff date were summarized. Among 272 patients in this analysis, the incidence of acne was higher in patients receiving upadacitinib compared with patients who received placebo. The rate of acne was higher in patients receiving upadacitinib 30mg (32.4%) compared with those taking upadacitinib 15mg (17.3%) during the long-term treatment period. All cases of acne were mild or moderate; no cases led to study drug discontinuation. The mean (range) of acne onset was 135.4 (7-465) days after starting study drug. Most acne occurred on the face; inflammatory papules were the most common morphology. Risk factors for acne included relevant concomitant medications (e.g., corticosteroids) started before acne onset and family and personal history of acne. Acne was generally managed with topical treatments. Mild or moderate acne reported in Japanese patients with AD receiving upadacitinib occurred in a dose-dependent manner and had a variable onset time. Acne was readily managed with topical treatments. Patients and clinicians should be aware of the risk of acne associated with upadacitinib treatment for AD. ClinicalTrials.gov identifier, NCT03661138.