Ruxolitinib Cream As-Needed Monotherapy Demonstrates Sustained Disease and Symptom Control in Patients with Mild to Moderate Atopic Dermatitis: Pooled Analysis from Two Phase 3 Studies

INTRODUCTION: Long-term disease and symptom control is a goal of atopic dermatitis (AD) therapy. This study assessed the long-term maintenance of disease and symptom control with as-needed application of ruxolitinib cream. METHODS: Patients aged ≥ 12 years with AD, an Investigator's Global Assessment (IGA) score of 2/3, and 3-20% affected body surface area were included in the phase 3 TRuE-AD1 and TRuE-AD2 studies. This analysis included patients randomized to twice-daily (BID) 1.5% ruxolitinib cream for 8 weeks and then as-needed (IGA ≥ 1) BID for up to 44 weeks (long-term safety [LTS] period). RESULTS: Among patients evaluated for disease control in the as-needed period (N = 428), IGA 0/1 (skin/almost clear skin) was achieved by 67.1% of patients at week 8. From week 8, 80-90% of patients with IGA 0/1 at a given visit maintained or improved their response at the next visit. Median time to worsening disease (IGA ≥ 2) was 36.1 weeks during the as-needed period, and IGA 0/1 was quickly recaptured. Patients spent a median 43.9% of the as-needed period off treatment due to lesion clearance. No itch/no sleep disturbance (Patient-Oriented Eczema Measure questions 1 and 2) was reported in 32.7%/71.8% of patients at week 8 and 36.2%/74.5% of patients at week 52. No new safety concerns emerged in the LTS period. CONCLUSION: Continued disease and symptom control with substantial time off treatment makes 1.5% ruxolitinib cream an effective long-term option for patients with mild to moderate AD. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03745638 and NCT03745651 (studies registered November 19, 2018).