Positive results for Opzelura as a treatment for moderate atopic dermatitis after topical corticosteroids and calcineurin inhibitors haven’t worked out | AAD 2026
Key Takeaways
- Double-blind randomization used vehicle cream control, with baseline median BSA 15% and 99.6% IGA 3; prior exposure included TCS 96.3%, TCI 80.9%, systemic therapy 29.5%.
- Patient-reported outcomes separated early and widened through week 8, with DLQI 4.3 vs 10.7 and POEM 5.9 vs 13.3 favoring ruxolitinib.
Researchers present two posters based on results from the TRuE-AD4 trial
Patients with moderate atopic dermatitis who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCS) or calcineurin inhibitors (TCI) responded well to treatment with Opzelura (1.5% ruxolitinib), according to results presented at the recent 2026 American Academy of Dermatology (AAD) meeting held in Denver.
Opzelura produced positive results both in a variety of patient-reported outcomes and with respect to standard assessments of atopic dermatitis severity.
The results came from the phase 3b TRuE-AD4 study, funded by Incyte, the maker of Opzelura, a Janus kinase (JAK) inhibitor that has been approved as a treatment for mild to moderate atopic dermatitis and nonsegmental vitiligo. The purpose of the study is to establish that Opzelura was safe and efficacious in people for whom TCS or TCI didn’t work or is not a choice because of side effects or contraindications
The results, which were reported in two posters presented at the meeting, build on previously reported findings from the phase 3b study, a double-blind trial that enrolled 241 patients who had atopic dermatitis for two years or more. The researchers deemed prior systemic therapy or phototherapy as a surrogate for post-TCS or post-TCI status. Of the patients in the trial, 96.3% had been treated previously with TCS, 80.9% with TCI and 29.5% with systemic therapy in the past 12 months. The researchers randomly assigned 160 of the study volunteers to treatment with Opzelura and 81 to treatment with a “vehicle cream,” a common comparator in dermatology clinical trials that is the cream of the treatment under investigation without the active ingredient, which in this case was ruxolitinib. The median age of the patients in the study was 37 and a little more than half (54.4%) were women. The median affected body surface area (BSA) was 15 and virtually all (99.6%) of the patients had an Investigator’s Global Assessment (IGA) score of 3.
Andreas Wollenberg, M.D., Ph.D., of the University Hospital Augsburg in Augsburg, Germany, and his colleagues reported the patient-reported outcome results.
They collected data on a battery of outcomes, including included the Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Patient-Reported Outcomes Measurement Information System (PROMIS), Sleep-Related Impairment and Sleep Disturbance scores. Their results show improvements throughout the eight-week period when Opzelura was compared with the vehicle cream, and the difference between the patients treated with Opzelura and the vehicle cream grew larger: mean DLQI (baseline, 19.3 vs 19.1; Week 2, 6.8 vs 13.7; Week 8, 4.3 vs 10.7), mean POEM score (baseline, 20.5 vs 19.6; Week 2, 8.0 vs 16.0; Week 8, 5.9 vs 13.3), mean PROMIS sleep-related impairment score (baseline, 22.0 vs 21.2; Week 2, 17.5 vs 19.7; Week 8, 15.5 vs 18.2), and mean PROMIS sleep disturbance score (baseline, 24.7 vs 23.7; Week 2, 18.9 vs 21.3; Week 8, 17.4 vs 20.8).
Patients treated with Opzelura experienced a reduction in a standardized score for itch starting on the first day of treatment, Wollenberg and his colleagues reported. The patients treated with Opzelura also experienced improvement on a skin pain score starting in the second week of treatment and reported continuous improvement in that skin pain score.
The safety data was also favorable to Opzelura. The most common treated-emergent adverse events (TEAE) were uncommon and included application-site acne (4.4%), acne (1.3%), application site pain (1.3%) and headache (1.5%). No TEAEs suggestive of JAK inhibition (serious infections, malignancies, or major adverse cardiovascular events),
The other results from the TRuE-AD4 study presented at the meeting were from a subanalysis assessing the proportion of patients who achieved an Investigator’s Global Assessment (IGA) score of 0 or a 2-point or greater improvement from baseline (IGA-TS) or a 75% or greater improvement in Eczema Area and Severity Index (EASI) from baseline (EASI-75). Lead author Pedro Herranz Pinto, M.D., of La Paz University Hospital in Madrid, Spain, and his colleagues analyzed patients by previous therapy and by the severity of their atopic dermatitis. They reported that more patients with prior systemic or phototherapy (n=88) who applied Opzelura achieved EASI-75 (70.5% vs 18.5%) and IGA-TS (55.7% vs 11.1%) than those treated with the vehicle cream at Week 8. The results also favored Opzelura among the 153 patients with no prior systemic or phototherapy. Improvement in atopic dermatitis, as measured by achievement of EASI-75 or IGA-TS at Week 8, was similar in those with less severe atopic dermatitis (baseline EASI under 16) or more severe disease (EASI 16 or greater).
In the abstract summarizing their poster, Pinto and his colleagues wrote that Opzelura “demonstrated substantial improvements” versus the vehicle cream in patients with moderate atopic dermatitis, regardless of baseline disease severity or previous use of systemic therapy or phototherapy. Opzelura may be a “potential treatment option for patients who previously required systemic treatment,” they wrote.
