O12 Efficacy of ruxolitinib cream for the treatment of moderate atopic dermatitis across anatomic regions in the phase IIIb TRuE-AD4 study

Abstract

Ruxolitinib is an inhibitor of Janus kinases 1 and 2. Ruxolitinib cream demonstrated efficacy and safety in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) in the randomized, phase IIIb TRuE-AD4 study (NCT06238817). This analysis evaluated the efficacy of ruxolitinib cream by anatomical region during the 8-week, double-blind, vehicle-controlled period of the study. Patients were recruited with age ≥ 18 years, AD for ≥ 2 years, Investigator’s Global Assessment of 3, Eczema Area and Severity Index (EASI) > 7, itch numerical rating scale ≥ 4, 10–20% affected body surface area (excluding scalp) and Dermatology Life Quality Index > 10 who had inadequate response, intolerance or contraindication to TCSs or TCIs. The participants were randomized 2 : 1 to apply twice-daily ruxolitinib 1.5% cream or vehicle for 8 weeks. EASI, SCORing Atopic Dermatitis (SCORAD) and the proportion of patients with affected skin were all assessed as anatomical region subscores. Overall, 241 patients were randomized to ruxolitinib cream (n = 160) or vehicle (n = 81). Improvements in EASI subscores were observed with ruxolitinib cream vs. vehicle by the first assessment at week 2 in all regions evaluated, including the head/neck (mean percentage change from baseline −63.5% vs. −12.3%), trunk (−64.9% vs. −9.7%), upper limbs (−58.8% vs. −1.4%) and lower limbs (−56.6% vs. −11.9%). Improvements were generally sustained through week 8. Similar results were observed with SCORAD subscores. The proportions of patients with affected skin were reduced with ruxolitinib cream vs. vehicle across anatomical regions, including the face (baseline, 63.1% vs. 62%; week 8, 18.2% vs. 55%) and hands (baseline, 66.3% vs. 67%; week 8, 24.7% vs. 53%). Overall, ruxolitinib cream was well tolerated, with few application-site reactions (5.6%) and no serious treatment-related adverse events. In conclusions, among patients with moderate AD inadequate response, intolerance or contraindication to TCSs or TCIs, ruxolitinib cream substantially improved disease severity and extent across all anatomical regions.