35163 Ruxolitinib cream provided progressive improvement in patients with atopic dermatitis who did not achieve Investigator’s Global Assessment treatment success at week 8: Pooled results from 2 phase 3 studies

Atopic dermatitis (AD) is a highly pruritic inflammatory skin disease. In 2 phase 3 studies (TRuE-AD1/TRuE-AD2), 1249 patients (≥12 years old with AD for ≥2 years, Investigator’s Global Assessment [IGA] score 2/3, and 3%–20% affected body surface area) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream, 1.5% ruxolitinib cream, or vehicle cream for an 8-week, double-blinded, vehicle-controlled period followed by a double-blinded long-term safety period (LTS; as-needed treatment; assessments every 4 weeks) to Week 52. Patients initially randomized to ruxolitinib remained on their regimen during the LTS; patients initially on vehicle were re-randomized (1:1) to either ruxolitinib strength. During the LTS, patients treated areas with active AD only, stopped treatment 3 days after lesion clearance, and restarted treatment at first sign of recurrence; rescue therapy was not permitted. Of 409/428 patients initially assigned to 0.75%/1.5% ruxolitinib who continued into the LTS and were evaluated for disease control, 205 (50.1%)/184 (43.0%) did not achieve IGA treatment success at Week 8 (IGA-TS; IGA score 0/1 and ≥2-point improvement from baseline). Among these patients, the proportion achieving IGA-TS increased during the LTS (range of values, 20.8%–55.2%/27.6%–56.3%). Over 52 weeks, 67.3%/56.0% of these patients experienced a treatment-emergent adverse event; 6.8%/5.4% experienced a treatment-related adverse event. The incidence of application site reactions was low (2.9%/1.1%). In summary, a substantial proportion of patients not achieving IGA-TS at Week 8 achieved it in the LTS with as-needed ruxolitinib cream monotherapy up to Week 52, which was well tolerated.