Ruxolitinib cream (RUX) is a Janus kinase (JAK) 1/JAK2 inhibitor in development for treating atopic dermatitis (AD). In two phase 3 studies, 1249 patients (≥12 y, Investigator’s Global Assessment [IGA] score of 2/3, 3%–20% affected body surface area [BSA]) were randomized 2:2:1 to twice-daily 0.75% RUX/1.5% RUX/vehicle cream for an 8-wk, double-blind, vehicle-controlled period (continuous treatment) followed by a double-blind long-term safety (LTS) period (assessments every 4 wk) to Wk 52. Patients on RUX remained on their regimen during the LTS period; patients initially on vehicle were rerandomized 1:1 to either RUX strength. In the LTS period, patients treated areas with active AD only and stopped treatment 3 days after clearance of lesions, resuming treatment upon recurrence. Here, long-term safety and disease control of 0.75%/1.5% RUX in patients initially randomized to RUX in TRuE-AD1 (n=222/225) and TRuE-AD2 (n=204/221) were evaluated. Most patients on 0.75%/1.5% RUX had no or minimal lesions (IGA 0/1) during Wk 12–52 in TRuE-AD1 (range, 62.4%–76.9%/66.5%–77.3%) and TRuE-AD2 (59.6%–76.7%/72.0%–80.1%). Mean total affected BSA from Wk 12–52 was generally <3% for both RUX strengths. In a pooled safety analysis, 256 (60.1%) and 240 (53.8%) patients who applied 0.75% (n=426) or 1.5% (n=446) RUX, respectively, reported treatment-emergent adverse events (AEs) over the LTS period. Frequency of application site reactions remained low. No treatment-related serious AEs were reported. In summary, ruxolitinib cream demonstrated long-term disease control and was well tolerated.

ESDR208 - Long-Term Safety and Disease Control With Ruxolitinib Cream in Atopic Dermatitis: Results From Two Phase 3 Studies

50th Annual Meeting of the European Society for Dermatological Research. VIRTUAL MEETING