Abstract
Atopic dermatitis (AD) is an inflammatory skin disease associated with skin pain. Efficacy outcomes, with a focus on skin pain, from a pooled analysis of two phase 3 studies (TRuE-AD1, TRuE-AD2) in 1249 patients (≥12 y) with AD for ≥2 y with Investigator’s Global Assessment (IGA) score 2 or 3 and 3%–20% affected body surface area are reported. Patients were randomized (2:2:1) to twice-daily 0.75% or 1.5% ruxolitinib (RUX; Janus kinase [JAK] 1/JAK2 inhibitor) or vehicle cream for 8 weeks. At Week 8, more patients who applied RUX (0.75%/1.5%) achieved IGA treatment success (IGA of 0/1 and ≥2-grade improvement from baseline) vs vehicle (44.7%/52.6% vs 11.5%; P<0.0001). Significantly greater reductions in itch numerical rate scale (NRS) score were observed within 12 h of first application (mean change from baseline, –0.4/–0.5 vs –0.1; P<0.02). Greater mean reductions from baseline in skin pain NRS scores were observed within 12 h with RUX vs vehicle (−0.3/−0.3 vs −0.04; P<0.03); further reductions were observed over time (Week 8, –2.5/–2.6 vs –1.3; P<0.0001). A substantial proportion of patients who applied RUX achieved ‘no pain/discomfort’ per EQ-5D-5L (fourth dimension) at Week 2 (57.8%/61.8% vs 36.3%), which was sustained through Week 8 (67.0%/69.4% vs 42.8%). In summary, RUX cream significantly decreased inflammation, itch, and skin pain in patients with AD.
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