TRuE-AD4: Ruxolitinib Cream Improves QoL and Sleep in Moderate AD

Key Takeaways

• Ruxolitinib cream improved multiple patient-reported outcomes in moderate atopic dermatitis refractory to topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), according to new data presented at AAD 2026.
• Clinically meaningful gains in quality of life, symptoms, and sleep were observed as early as Week 2.
• Benefits were sustained through 8 weeks across DLQI, POEM, and PROMIS sleep measures.

Ruxolitinib cream 1.5% demonstrated consistent improvements in patient-reported outcomes among adults with moderate atopic dermatitis (AD) who previously had inadequate response, intolerance, or contraindications to topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), according to results from the phase 3b TRuE-AD4 trial presented at AAD 2026 in Denver.

Investigators for the randomized, double-blind, vehicle-controlled study looked at outcomes over an 8-week period in 241 adults with longstanding disease (≥2 years), IGA score of 3, Eczema Area and Severity Index (EASI) >7, and ≥10% to 20% body surface area involvement. Patients were randomized (2:1) to twice-daily ruxolitinib cream or vehicle. Baseline disease burden was high; the mean Dermatology Life Quality Index (DLQI) scores of approximately 19 in both groups. By week 2, DLQI improved to 6.8 with ruxolitinib versus 13.7 with vehicle, with further reduction to 4.3 versus 10.7 at Week 8. Similar trends were observed for the Patient-Oriented Eczema Measure (POEM), which decreased from 20.5 to 5.9 with active treatment compared with 19.6 to 13.3 for vehicle.

Sleep-related outcomes also improved. PROMIS Sleep-Related Impairment scores declined from 22.0 to 15.5 with ruxolitinib vs 21.2 to 18.2 with vehicle at week 8, while Sleep Disturbance scores decreased from 24.7 to 17.4 versus 23.7 to 20.8, respectively.

“Ruxolitinib cream demonstrated robust and consistent improvements vs vehicle in multiple quality of life domains and symptom control measures among patients with moderate AD post TCS/TCI, with improvements observed as early as week 2,” the authors wrote in the study abstract.

Source: Wollenberg A, et al. Ruxolitinib Cream Improves Patient-Reported Outcomes in Adults With Moderate Atopic Dermatitis (TRuE-AD4). Abstract 75312. Presented at: American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver.