Ruxolitinib cream in adults with moderate atopic dermatitis after failure of other topicals: A randomized trial

Abstract

Background: In patients with moderate atopic dermatitis (AD), topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) often do not sufficiently control AD signs/symptoms, and escalation to systemic therapy may be required. Objectives: Report 8-week results of ruxolitinib cream in TRuE-AD4 (NCT06238817) in patients with moderate AD who had an inadequate response/intolerance/contraindication to TCS and TCI in the past 12 months (post-TCS and -TCI). Methods: Patients aged ≥18 years with AD, an Investigator's Global Assessment (IGA) of 3, Eczema Area and Severity Index (EASI) >7, itch numerical rating scale (NRS) ≥4, 10%–20% affected body surface area and Dermatology Life Quality Index score > 10 post-TCS and -TCI were randomized (2:1) to twice-daily 1.5% ruxolitinib cream or vehicle for 8 weeks. Coprimary endpoints at Week 8 were ≥75% improvement in EASI from baseline (EASI-75) and IGA score of 0/1 with a ≥ 2-point improvement from baseline (IGA treatment success [TS]). Results: Of 241 randomized patients (mean age, 37.0 y; 54.4% female), mean EASI and itch NRS scores were 12.6 and 7.4, respectively, at baseline. At Week 8, significantly more patients who applied 1.5% ruxolitinib cream versus vehicle achieved IGA-TS (61.3% vs. 13.6%; p < 0.0001) and EASI-75 (70.0% vs. 18.5%; p < 0.0001). Significantly more patients achieved a ≥ 4-point improvement in itch NRS (itch NRS4) at Day 2 (29.8% vs. 13.7%; p = 0.0072); improvement in current itch (no recall) was observed in 15 min after the first application. No treatment-related adverse events were serious, and the most common adverse event occurring with ruxolitinib cream was application site acne (3.8%). Conclusions: In adults with moderate AD post-TCS and -TCI, who may otherwise be eligible for systemic therapy, 1.5% ruxolitinib cream significantly improved clinical signs of AD, rapidly improved itch and was well tolerated. Thus, ruxolitinib cream may represent an effective topical option before escalation to systemic therapy in patients with moderate AD.