Efficacy and Safety of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Results From Two Phase 3, Randomized, Double-Blind Studies

Abstract Background Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD). Objective To evaluate 8-week efficacy and safety in two phase 3 studies of RUX cream in patients with AD Methods TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an IGA score of 2/3, and 3% to 20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was IGA treatment success (IGA-TS) at Week 8 (IGA score of 0/1 and ≥2-grade improvement from baseline). Results In TRuE-AD1/TRuE-AD2, 631/618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved IGA-TS with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P Limitations Longer-term safety data are not yet available. Conclusions RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.