Press release
Incyte Announces 52-Week Data From the Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo
- Use of ruxolitinib cream (Opzelura™) resulted in further improvement in facial and total body repigmentation at Week 52 - Results will be featured as an
About this update from Incyte Corporation
[{"type":"text","content":"\n- Use of ruxolitinib cream (Opzelura™) resulted in further improvement in facial and total body repigmentation at Week 52\n\n- Results will be featured as an oral presentation in a late-breaking abstract session at the 2022 American Academy of Dermatology (AAD) Annual Meeting\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced new 52-week results from its pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream (Opzelura™), a topical JAK1/JAK2 inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data were presented today as an oral presentation in a late-breaking abstract session (Session #S026 – Late-Breaking Research: Clinical Trials) at the 2022 American Academy of Dermatology (AAD) Annual Meeting, held from March 25-29 in Boston.\n\nThe 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. Findings from the Week 52 analysis showed that patients applying 1.5% ruxolitinib cream twice daily (BID) had clinically meaningful facial and total body repigmentation as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring (F-VASI and T-VASI, respectively) endpoints at Week 52.\n\nSpecifically, efficacy results of patients who applied ruxolitinib cream from Day 1 showed:\n\n\nAt Week 52, approximately 50% of patients achieved ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared to the F-VASI75 improvement from baseline reported for these patients at Week 24 (the primary endpoint of the study) which was approximately 30%.\n\n\nAt 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.\n\n\nAdditionally, a greater proportion of patients at Week 52 achieved ≥50% improvement in total body Vitiligo Area Scoring Index (T-VASI50), and over one-third of patients achieved a Vitiligo Noticeability Scale (VNS) response. Further improvement on percentage change from baseline in facial body surface area (F-BSA) wit...