313 Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream

Abstract

Atopic dermatitis (AD) is a highly pruritic, inflammatory skin disease. In two phase 3 studies (TRuE-AD1, TRuE-AD2), 1249 patients (≥12 y) with AD for ≥2 y, an Investigator’s Global Assessment (IGA) score of 2 or 3, and 3%–20% affected body surface area were randomized (2:2:1) to twice-daily 0.75% or 1.5% ruxolitinib (RUX) cream (Janus kinase [JAK] 1/JAK2 inhibitor) or vehicle cream for 8 weeks. In this pooled analysis, effects of RUX on itch were assessed by the proportion of patients achieving an itch Numerical Rating Scale score of 0 or 1 (NRS 0/1) and no days of itch per Item 1 (frequency of itch) of the Patient-Oriented Eczema Measure (POEM). At Week 8, more patients who applied RUX (0.75%/1.5%) vs vehicle achieved NRS 0/1 (45.5%/51.5% vs 23.1%; P<0.0001); median time to NRS 0/1 was significantly shorter with RUX vs vehicle (12/8 days vs 51 days; P<0.0001). More patients achieved no days of itch per POEM with RUX (28.3%/32.9%) vs vehicle (9.0%; both P<0.0001). As assessed by NRS 0/1 or POEM, more patients achieved itch-free status at Week 8 with RUX vs vehicle (47.7%/52.0% vs 23.4%; both P<0.0001) regardless of baseline itch score (NRS <6: 57.4%/58.1% vs 27.5%, P<0.0001; NRS ≥6: 34.2%/41.3% vs 17.7%, P<0.01). In summary, a significant number of patients with AD treated with RUX cream achieved and sustained an itch-free state.