Efficacy and Safety of Ruxolitinib Cream Monotherapy in Patients Aged 2 Years and Older With Mild-to-Moderate Atopic Dermatitis: Results From 3 Large Randomized Phase 3 Studies
Recommended Citation
Simpson E, Eichenfield L, Papp K, Kircik L, Blauvelt A, Stein Gold LF, Zaenglein A, Lee LW, Bunick C, Forman S, Holl K, Kallender H, Sturm D, Ren H, Armstrong A. Efficacy and Safety of Ruxolitinib Cream Monotherapy in Patients Aged 2 Years and Older With Mild-to-Moderate Atopic Dermatitis: Results From 3 Large Randomized Phase 3 Studies. J Allergy Clin Immunol 2025; 155(2):1.
Document Type
Conference Proceeding
Publication Date
2-1-2025
Publication Title
J Allergy Clin Immunol
Abstract
Rationale Ruxolitinib cream was evaluated in children (aged 2–11 y), adolescents (aged 12–17 y), and adults (aged ≥ 18 y) with mild-to-moderate atopic dermatitis (AD). Here, an 8-week comparative analysis of ruxolitinib cream efficacy and safety by age group from 3 randomized, phase 3 studies is presented. Methods Children (TRuE-AD3 [NCT04921969]) and adolescents and adults (TRuE-AD1 [NCT03745638], TRuE-AD2 [NCT03745651]) with AD, an Investigator’s Global Assessment (IGA) score of 2/3, and a 3%–20% affected body surface area were randomized 2:2:1 to apply twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks. Efficacy was assessed as proportions of patients who achieved IGA treatment success (IGA-TS; score of 0/1 with a ≥ 2-grade improvement from baseline) and ≥ 75%/≥ 90% improvement from baseline in the Eczema Area and Severity Index (EASI-75/EASI-90) at Week 8. Results This analysis evaluated 330 children, 236 adolescents, and 972 adults. At Week 8, significantly ( P <0.01 for all) more children, adolescents, and adults who applied 1.5% ruxolitinib cream versus vehicle achieved IGA-TS (56.5% vs 10.8%, 50.6% vs 14.0%, 53.0% vs 10.9%, respectively), EASI-75 (67.2% vs 15.4%, 60.9% vs 34.9%, 62.2% vs 16.4%), and EASI-90 (43.5% vs 10.8%, 39.1% vs 7.0%, 44.9% vs 7.0%). Both strengths of ruxolitinib cream were well tolerated across age groups, with few application site reactions and no safety findings suggestive of systemic JAK inhibition. Conclusions Following 8 weeks of twice-daily ruxolitinib cream monotherapy, the majority of patients aged ≥ 2 years met key clinically relevant AD endpoints. Efficacy and safety results were consistent across age groups.
Volume
155
Issue
2
First Page
1
