"54214 Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermat" by Shari Dermer, Christine Considine et al.
 

54214 Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Previous Medication History: Subgroup Analysis From the Randomized, Phase 3 TRuE-AD3 Study

Document Type

Conference Proceeding

Publication Date

9-1-2024

Publication Title

J Am Acad Dermatol

Abstract

Background: Atopic dermatitis (AD), a highly pruritic inflammatory skin disease, typically develops in childhood and affects up to 23% of children globally. Ruxolitinib cream was effective and well tolerated in adults/adolescents and children (TRuE-AD1/TRuE-AD2/TRuE-AD3; NCT03745638/NCT03745651/NCT04921969); findings were similar regardless of age. Here we report ruxolitinib cream efficacy by previous medication history in children from the phase 3 TRuE-AD3 study. Methods: Patients aged 2‒<12 years with AD ≥3 months, Investigator’s Global Assessment (IGA) score of 2/3, and 3%‒20% affected body surface area (BSA) were randomized (2:2:1) to apply twice-daily ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks. Primary endpoint was IGA treatment success ([IGA-TS]; score 0/1 with ≥2-grade improvement from baseline) at Week 8. Results: 330 patients were randomized; median (range) age, 6 (2‒11) years; mean (SD) BSA, 10.5% (5.40%); 67.3% received AD therapy in the previous 12 months, including topical corticosteroids (TCS; 63.0%), topical calcineurin inhibitors (TCI; 7.3%), and systemic therapies (2.4%). Prior therapies were mainly discontinued for reported lack of efficacy or to comply with study washout periods. IGA-TS at Week 8 was achieved by significantly more patients applying 0.75%/1.5% ruxolitinib cream (36.6%/56.5%) vs vehicle (10.8%; P≤0.0001). IGA-TS rates were higher for 0.75%/1.5% ruxolitinib cream vs vehicle for patients with prior AD therapy (40.7%/54.4% vs 10.9%; P<0.001/TCS [41.0%/54.9% vs 11.6%; P<0.001]/TCI [50.0%/45.5% vs 14.3%]/systemic therapies [50.0%/50.0% vs 0.0%]) or without prior AD therapy (29.2%/61.0% vs 10.5%; P<0.001, 1.5% ruxolitinib cream vs vehicle). Conclusions: Ruxolitinib cream demonstrated efficacy in children with AD, regardless of previous topical or systemic therapy.

Volume

91

Issue

3

First Page

AB38

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