28194 Patient-reported outcomes of ruxolitinib cream for the treatment of atopic dermatitis: Pooled results from two phase 3 studies

Abstract

Atopic dermatitis (AD) is a chronic inflammatory skin disease that often negatively impacts quality of life. Ruxolitinib cream is a Janus kinase (JAK) 1/JAK2 inhibitor in development for AD. Here, patient-reported outcomes (PROs) are reported from two randomized phase 3 studies (TRuE-AD1 [NCT03745638]; TRuE-AD2 [NCT03745651]) that enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator’s Global Assessment score of 2 or 3, and 3%–20% affected body surface area. Patients (N = 1249 in both studies combined; median age, 32 years; aged 12–15 years, n = 118) were randomized (2:2:1) to 0.75% ruxolitinib, 1.5% ruxolitinib, or vehicle cream (all twice daily) for 8 weeks of double-blind treatment. Patients on ruxolitinib reported significant mean change from baseline (ie, improvement) at Week 8 in the Patient-Oriented Eczema Measure (POEM; –10.5/–11.0 for 0.75%/1.5% ruxolitinib; vehicle, –4.2; both P ˂ .0001), Dermatology Life Quality Index (DLQI; –7.2/–7.1 for 0.75%/1.5% ruxolitinib; vehicle, –3.1; both P ˂ .0001) and children’s DLQI (–5.3/–6.0 for 0.75%/1.5% ruxolitinib; vehicle, –2.3; both P ˂ .01). Significantly greater reductions in skin pain numerical rating scale score were observed within 12 hours of the first application of ruxolitinib (P ˂ .05), with further reductions at Week 8 (mean change from baseline, –2.5/–2.6 for 0.75%/1.5% ruxolitinib) vs vehicle (–1.3; both P ˂ .0001). Significantly more patients on ruxolitinib reported much or very much improvement in their Patient Global Impression of Change at Week 8 (80.0%/84.9% for 0.75%/1.5% ruxolitinib; vehicle, 41.3%; both P ˂ .0001). In summary, ruxolitinib cream brought about substantial and clinically meaningful improvements in multiple PROs.