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
Recommended Citation
Eichenfield LF, Simpson EL, Armstrong AW, Stein Gold LF, Lee LW, Brar KK, Joyce JC, Angel B, Sturm D, Ren H, Zaenglein A. 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. J Am Acad Dermatol 2025; 93:AB100.
Document Type
Conference Proceeding
Publication Date
9-1-2025
Publication Title
J Am Acad Dermatol
Keywords
ruxolitinib, atopic dermatitis, body surface, child, cohort analysis, conference abstract, controlled study, cream, diagnosis, disease control, drug therapy, drug withdrawal, female, human, major clinical study, male, monotherapy, preschool child, topical drug administration
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
