307 High-threshold responses to ruxolitinib cream in adolescents and adults with atopic dermatitis

Abstract

Atopic dermatitis (AD) is a highly pruritic, inflammatory skin disease that can have a significant impact on patient quality of life. Ruxolitinib cream is a topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor. In two phase 3 AD studies of identical design (TRuE-AD1 [NCT03745638]/TRuE-AD2 [NCT03745651]), patients (≥12 years old with AD for ≥2 years, Investigator’s Global Assessment [IGA] score 2/3, 3%–20% affected body surface area) were randomized (2:2:1) to twice-daily 0.75% or 1.5% ruxolitinib cream or vehicle for an 8-week, double-blinded, vehicle-controlled period. Here, we describe the effect of ruxolitinib cream on achievement of multiple high-threshold responses in patients with AD (itch numerical rating scale [NRS] score of 0/1 [range 0–10]; IGA score of 0/1 [clear/almost clear skin]; Dermatology Life Quality Index [DLQI] or the children’s version [cDLQI] score of 0/1 [no effect of AD on quality of life]) using pooled data from the 2 studies. A total of 1208 patients were evaluated (vehicle/0.75% ruxolitinib cream/1.5% ruxolitinib cream, n=244/483/481). At Week 8, more patients applying 0.75%/1.5% ruxolitinib cream vs vehicle achieved itch NRS 0/1 (35.2%/42.8% vs 16.4%), IGA score 0/1 (55.1%/62.6% vs 20.1%), or DLQI/cDLQI score 0/1 (48.9%/53.8% vs 20.1%). Considerably more patients applying 0.75%/1.5% ruxolitinib cream achieved ≥2 responses at Week 8 vs vehicle (44.9%/54.9% vs 15.6%) or all 3 responses (22.4%/27.0% vs 6.6%). Overall, treatment with ruxolitinib cream over 8 weeks was associated with achievement of multiple high-threshold responses in patients with AD.