Incyte has announced promising new data from its phase 3b TRuE-AD4 trial of Opzelura (ruxolitinib cream) in adults with moderate atopic dermatitis (AD), revealing significant improvements in clinical signs and symptoms, including itch relief as early as day 2.
The trial met its co-primary endpoints at week 8, with 70% of patients treated with Opzelura achieving a ≥75% improvement in Eczema Area and Severity Index (EASI75) and 61.3% reaching Investigator’s Global Assessment Treatment Success (IGA-TS). These results were significantly higher than those observed in the vehicle group.
Jim Lee, Group Vice President, Inflammation & Autoimmunity at Incyte, said: “The TRuE-AD4 data further reinforce the safety and efficacy profile of Opzelura and its ability to control key signs and symptoms of moderate AD, including improvement in bothersome symptoms like itch. These data will support the filing of a Type-II variation application for ruxolitinib cream 1.5% (Opzelura) in Europe, as we seek to meet the needs of more patients around the world who require nonsteroidal topical treatments for moderate AD.”
Additional findings showed that 62.5% of patients achieved a ≥4-point improvement in Itch Numeric Rating Scale by week 8. Significant itch relief was also noted at day 2 and within 15 minutes of application. Improvements were seen in Patient-Oriented Eczema Measure and Dermatology Life Quality Index scores.
Dr Andreas Wollenberg, Professor of Dermatology and Allergy at Augsburg University Hospital, explained: “TRuE-AD4 offers compelling support for the utility of Opzelura for patients with moderate AD who have limited treatment options due to inadequate responses or intolerances to TCS and TCI-based topical therapies, who may otherwise be recommended for systemic therapy.”
