64656 52-Week Disease Control and Safety With As-Needed Application of Ruxolitinib Cream in Children Aged 2 to 11 Years With Moderate and/or More Extensive Atopic Dermatitis: Subgroup Analysis From the TRuE-AD3 Study

Document Type

Conference Proceeding

Publication Date

9-1-2025

Publication Title

J Am Acad Dermatol

Abstract

Ruxolitinib cream demonstrated efficacy and safety at Week 8 in children aged 2‒11 years with atopic dermatitis (AD) in TRuE-AD3 (NCT04921969), including in a subset of patients with moderate and/or more extensive AD. Here, we report long-term disease control and safety in this subpopulation. Children aged 2–11 years with AD, an Investigator’s Global Assessment (IGA) score of 2/3, and 3%‒20% affected body surface area (BSA) were randomized 2:2:1 to twice-daily ruxolitinib cream (0.75% or 1.5%) or vehicle for 8 weeks and then remained on ruxolitinib cream or were rerandomized to either ruxolitinib cream regimen for 44 weeks of as-needed treatment. Among 180 patients with a baseline IGA of 3 who were initially randomized to ruxolitinib cream, disease control at Week 8 was maintained or further improved in the long-term period as assessed by the proportion of patients who achieved an IGA score of 0/1 (Week 52: 0.75% ruxolitinib cream, 74.6%; 1.5% ruxolitinib cream, 71.4%) and mean affected BSA (Week 52: 0.75% ruxolitinib cream, 2.3%; 1.5% ruxolitinib cream, 2.0%). Similar results were observed among patients with ≥10% affected BSA at baseline and a combined IGA=3 and ≥10% BSA. Both ruxolitinib cream strengths were similarly well tolerated among patients with baseline IGA=3; no serious treatment-related adverse events occurred during the 52-week study. In summary, ruxolitinib cream monotherapy demonstrated substantial disease control and was well tolerated with as-needed use out to Week 52 in a subset of children with moderate and/or more extensive AD, consistent with the full TRuE-AD3 study population.

Volume

93

First Page

AB100

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