VIS2021 David Rosmarin, MD скачать в хорошем качестве

VIS2021 David Rosmarin, MD

2021 Vitiligo International Symposium Invited Speaker Title: Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: 24-Week Results From 2 Randomized, Double-Blind Phase 3 Studies Summary: Two multicenter, phase 3, double-blind, controlled studies (TRuE-V1 [NCT04052425]; TRuE-V2 [NCT04057573]) of ruxolitinib cream, a Janus kinase (JAK)1/JAK2 inhibitor, were conducted in patients greater than or equal to 12 years old with nonsegmental vitiligo in North America and Europe. Patients were randomized 2:1 to receive 1.5% ruxolitinib cream or vehicle twice daily for 24 weeks. TRuE-V1/TRuE-V2 included 221/228 patients who received greater than or equal to 1 dose of ruxolitinib cream; 109/115 patients received vehicle. Mean ages were 40/39 years; 11% of patients in both studies were adolescents. A facial Vitiligo Area Scoring Index improvement of greater than or equal to 75% (F-VASI75) at Week 24 (primary endpoint) was achieved by 29.9%/29.9% of patients who applied ruxolitinib cream vs 7.5%/12.9% who applied vehicle (both P less than 0.01). F-VASI50 at Week 24 was achieved by 51.5%/51.4% and 17.2%/23.4% (both P less than 0.0001). Ruxolitinib cream demonstrated clinically meaningful superiority vs vehicle for all primary and key secondary endpoints and was well tolerated in these large phase 3 studies.