TrUE-AD4: Opzelura Shows Rapid, Significant Efficacy in Moderate AD

New data from Incyte’s phase 3b TRuE-AD4 trial show that Opzelura® (ruxolitinib cream 1.5%) improved clinical symptoms of moderate atopic dermatitis (AD) in adults with limited response or intolerance to standard thearpy.

The new 8-week data, presented at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD) 2025, support expanded EU regulatory filings expected by year-end, according to a release from the manufacturer, Incyte.

The researchers reported to the conference that at week 8, 70.0% of patients treated with Opzelura achieved EASI75 (≥75% improvement in Eczema Area and Severity Index) vs. 18.5% with vehicle (P < 0.0001), and 61.3% achieved Investigator’s Global Assessment Treatment Success (IGA-TS) vs. 13.6% with vehicle (P < 0.0001). Improvements were observed early, with some appearing by week 2.

Patients treated with Opzelura also demonstrated significant itch relief. Nearly two-thirds (62.5%) achieved a ≥4-point improvement in Itch Numeric Rating Scale (NRS4) by week 8 (vs. 19.8%; P < 0.0001). Improvement was observed by day 2 (29.1% achieved Itch NRS4 vs. 14.3%; P = 0.0072). The data also showed quality-of-life improvements with treatment: 39.7% achieved clear or almost clear POEM scores vs. 8.6% with vehicle. Mean DLQI scores decreased from 19.3 to 4.3.

There were no serious infections, MACE, malignancies, or thrombotic events occurred during the vehicle-controlled period, with the most common treatment-related adverse event reported as acne at the application site (4.4%).

“TRuE-AD4 offers compelling support for the utility of Opzelura for patients with moderate AD who have limited treatment options,” said Andreas Wollenberg, MD, of Augsburg University Hospital. “These data reinforce Opzelura as an important therapeutic option.”

Source: Incyte press release. October 27, 2025.