27716 Efficacy of ruxolitinib cream for the treatment of atopic dermatitis by baseline clinical characteristics: Pooled subgroup analysis from two randomized phase 3 studies

Abstract

Ruxolitinib cream is a Janus kinase (JAK) 1/JAK2 inhibitor in development for atopic dermatitis (AD), a highly pruritic, chronic inflammatory skin disease. 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 (BSA). Patients (N = 1249 in both studies combined; median age, 32 years) 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 and thereafter continued in a long-term period of the studies (44 weeks). Efficacy data by baseline clinical characteristic in patients who applied 1.5% ruxolitinib (n = 481) are reported here. At Week 8, IGA treatment success ([IGA-TS]; score of 0/1 with a ≥2-grade improvement from baseline) was achieved by 52.6% of patients who applied 1.5% ruxolitinib. Clinically significant IGA-TS rates were observed regardless of AD severity measure at baseline, including IGA score of 2 and 3 (25.2% and 62.0%, respectively), Eczema Area and Severity Index (EASI) score ≤7 and >7 (44.8% and 60.3%), itch numerical rating scale (NRS) score <4 and ≥4 (51.0% and 53.7%), and BSA <10% and ≥10% (48.4% and 58.8%). Efficacy responses were equally clinically meaningful for ≥75% improvement in EASI score and ≥4-point improvement in itch NRS. In summary, ruxolitinib cream has the potential to be an effective treatment for AD irrespective of patients’ pretreatment characteristics, with higher responses observed in patients with more severe disease.