27482 Efficacy of ruxolitinib cream among patients with atopic dermatitis based on previous medication history: Pooled results from two phase 3 studies

Abstract

Treatments for atopic dermatitis (AD) include topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), and systemic immunomodulatory agents; however, their clinical benefit may be inadequate because of duration-of-use limitations and/or adverse reactions. Here, we report the efficacy of ruxolitinib cream, a Janus kinase (JAK) 1/JAK2 inhibitor, in patients with AD by previous medication history. Two phase 3, randomized studies (TRuE-AD1 [NCT03745638]; TRuE-AD2 [NCT03745651]) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator’s Global Assessment (IGA) score of 2 or 3, and 3%–20% affected body surface area. The washout period for prior therapies was 1 week for topical AD treatments and 4 weeks for systemic corticosteroids or other conventional immunomodulating agents. A total of 1249 patients (both studies combined; median age, 32 y) were randomized (2:2:1) to 0.75% ruxolitinib, 1.5% ruxolitinib, or vehicle cream (all twice daily) for 8 weeks of double-blinded treatment. At Week 8, IGA treatment success ([IGA-TS]; score of 0/1 with a ≥2-grade improvement from baseline) was achieved by significantly more patients who applied 0.75%/1.5% ruxolitinib (44.7%/52.6%) vs vehicle (11.5%; P ˂ .0001). IGA-TS rates were higher among patients who applied ruxolitinib (0.75%/1.5%) vs vehicle regardless of previous medication history, including TCS (n = 383/384/199, 46.2%/55.5% vs 10.6%), TCI (n = 106/101/60, 62.3%/69.3% vs 6.7%), and systemic therapies (n = 91/91/46, 56.0%/59.3% vs 10.9%). Similar findings were observed when efficacy was assessed by ≥75% improvement in Eczema Area and Severity Index. In summary, ruxolitinib cream demonstrated a high level of efficacy in patients with AD regardless of previous topical or systemic therapy.