Incyte Announces Positive 52-Week Results From a Randomized Phase 2 Study of Ruxolitinib Cream in Patients With Vitiligo
Incyte (Nasdaq:INCY) today announces positive 52-week results from its randomized, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo.
As previously announced, the study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50 percent improvement from baseline in the facial vitiligo area severity index (F-VASI50) score compared to patients treated with a vehicle control (non-medicated cream).
Updated results at week 52 show substantial improvements in total body repigmentation with ruxolitinib cream, measured by the proportion of patients achieving a ≥50 percent improvement from baseline in the total vitiligo area severity index (T-VASI50), a key secondary endpoint. In addition, after 52 weeks of treatment with ruxolitinib cream 1.5 percent administered twice daily (BID), 58 percent of patients achieved F-VASI50 and 51 percent of patients achieved a ≥75 percent improvement (F-VASI75). F-VASI75 after 24 weeks is the primary outcome measure of both the TRuE-V1 and TRuE-V2 randomized Phase 3 trials that are already underway.
The 52-week results are being shared at the 28th European Academy of Dermatology and Venereology (EADV) congress in Madrid, Spain, during a late-breaking research session today, October 12, 2019, from 11:30 a.m. CEST to 11:45 a.m. CEST (Location: Hall 10 Dalí; Late Breaking News, Abstract #D3T01.1L).
“We are very encouraged about the positive updated data presented at EADV, which demonstrate substantial facial and total body repigmentation of vitiligo lesions in patients treated with ruxolitinib cream, and continued improvements with longer duration of treatment,” said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “As we seek to offer a much-needed option for those patients impacted by this life-altering disease, we are excited that the pivotal Phase 3 studies evaluating ruxolitinib cream in patients with vitiligo are underway, with results expected in 2021.”
Key 52-week results include:
- A longer duration of therapy, from week 24 to week 52, was associated with greater repigmentation, as objectively assessed using the VASI.
- The percentage of patients receiving 1.5 percent ruxolitinib cream BID who achieved F-VASI50 increased from Week 24 to Week 52 (45.5 percent to 57.6 percent, respectively).
- A ≥75 percent (F-VASI75) and ≥90 percent (F-VASI90) improvement from baseline in F-VASI score was achieved by 51.5 percent and 33.3 percent of patients treated with 1.5 percent ruxolitinib cream BID at 52 weeks, compared to 30 percent and 12 percent of patients at 24 weeks, respectively.
- Among all patients treated with 1.5 percent ruxolitinib cream BID, the proportion of patients achieving T-VASI50 at Week 52 was 36.4 percent. Among patients with a baseline total body surface area of <20 percent (the body surface area limited for treatment), 45.0 percent receiving the 1.5 percent BID dose achieved a T-VASI50 response at 52 weeks.
- The proportion of patients receiving ruxolitinib cream 1.5 percent BID who achieved Facial Physician Global Vitiligo Assessment (F-PhGVA) scores of clear (no signs of vitiligo) or almost clear (only specks of depigmentation present) skin increased from Week 24 to Week 52 (9.1 percent and 21.2 percent, respectively).
- Ruxolitinib cream was generally well-tolerated at all dosage strengths and no treatment-related serious adverse events were reported.
“Many patients with vitiligo seek treatments that can repigment vitiligo lesions but, unfortunately, current therapeutic options are limited by poor efficacy, burdensome treatment regimens or side-effects,” said Amit Pandya, M.D., Clinical Professor at the University of Texas Southwestern Medical Center. “The updated results from this study are encouraging as they demonstrate ruxolitinib cream’s potential to become an effective treatment option for individuals with vitiligo.”