Opzelura Shows Benefit in 52-Week Phase 3 Vitiligo Study

New 52-week results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Incyte's topical JAK1/JAK2 inhibitor ruxolitinib cream (Opzelura™) in adolescent and adult patients with nonsegmental vitiligo show that twice daily application was associated with clinically meaningful facial and total body repigmentation. Presented in a late-breaking abstract session at the 2022 American Academy of Dermatology (AAD) Annual Meeting, the data show a greater proportion of treated patients reached the facial and total body Vitiligo Area Scoring (F-VASI and T-VASI, respectively) endpoints at Week 52.

The 52-week results build on the previously announced positive 24-week results and include data from the 24-week double-blind and 28-week treatment extension periods of the Phase 3 TRuE-V1 and TRuE-V2 studies. 

Among patients who applied ruxolitinib cream from Day 1 showed, at Week 52, approximately 50% of patients achieved ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared to approximately 30 percent improvement in the F-VASI75 improvement from baseline reported for these patients at Week 24 (the primary endpoint of the study).

At Week 52, approximately 75% of patients achieved ≥50% improvement in F-VASI (F-VASI50), and nearly one-third (approximately 30%) achieved ≥90% improvement in F-VASI (F-VASI90) compared to the Week 24 response rates for F-VASI50 and F-VASI90 which were approximately 51% and 15%, respectively.

Results at Week 52 in crossover patients (those who received 28 weeks of treatment with ruxolitinib cream after initial treatment with vehicle cream) were consistent with Week 24 data in patients who applied ruxolitinib cream from Day 1.

The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. No clinically significant application site reactions or serious treatment-related adverse events related to ruxolitinib cream were observed.

 “Vitiligo is a serious and chronic autoimmune condition that can severely impact a person’s life and has very limited treatments,” says David Rosmarin, MD, Vice Chair of Research and Education, Department of Dermatology at Tufts Medical Center. “These results are extremely encouraging and highlight the clinical potential of ruxolitinib cream for patients with vitiligo.”

 Incyte submitted marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age ≥12 years) to FDA and the European Medicines Agency (EMA). The FDA Prescription Drug User Fee Act (PDUFA) target action date is July 18, 2022.