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Data from the phase 3 TRuE-V clinical program show the topical JAK inhibitor provided substantial repigmentation to more than half of treated patients.
Approximately 3 in 10 patients with vitiligo treated with ruxolitinib cream achieved ≥90% improvement on facial vitiligo regimentation after 52 weeks, according to new phase 3 findings presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting.
In late-breaking abstract research presented by investigator David Rosmarin, MD, Vice Chair for Research and Education at Tufts Medical Center, the investigative topical JAK inhibitor from Incyte provided substantial facial and total body vitiligo repigmentation to adult and adolescent patients across various measures over the TRuE-V1 and TRuE-V2 phase 3 clinical trials.
The new findings come months prior to the anticipated US Food and Drug Administration (FDA) decision for ruxolitinib cream as an approved drug for patients with vitiligo.
In introducing the TRuE-V clinical trial program data, Rosmarin noted ruxolitinib cream’s previous success in the 52-week, phase 2 dose-ranging study assessing its efficacy and safety in adult patients. Previous TRuE-V1 and TRuE-V2 data showed its statistical superiority to vehicle in both adults and adolescents at 24 weeks. These newest findings evaluated the efficacy and safety of the therapy up to 52 weeks in adult and adolescent patients.
The trial consisted of a 24-week double-blinded treatment phase when patients were randomized 2:1 to either 1.5% once-daily ruxolitinib cream or once-daily vehicle. At 24 weeks, patients who completed therapy were invited to a 28-week treatment extension in which all participants received ruxolitinib cream. Investigators followed up with participants for 30 days.
Patients aged ≥12 years old with nonsegmental vitiligo, as well as depgimented areas constituting ≤10% total body surface area (BSA)—both facial and nonfacial. All patients were totally naïve to previous JAK inhibitor therapy, as well as biological therapy within 12 weeks, phototherapy within 8 weeks, immunomodulating treatments within 4 weeks, and topical therapy within 1 week of baseline.
Rosmarin and colleagues sought the following efficacy endpoints:
They additionally assessed participants for safety and tolerability outcomes.
The trial included 330 patients in TRuE-V1 and 343 patients in TRuE-V2. Mean patient age was 40.2 years and 38.9 years, respectively; patients were 56.4% and 50.1% Female, and 63.6% and 60.2% White, respectively.
For the primary outcome of F-VASI75, investigators observed that approximately half of all patients treated with ruxolitinib cream since baseline achieved the metric by week 52—52.8% in TRuE-V1 and 48.0% in TRuE-V2. Treatment benefit was gradual; 29.8% and 30.9%, respectively, achieved F-VASI75 by week 24.
Approximately 30% of patients treated since baseline achieved F-VASI90 by week 52—32.9% in TRuE-V1 and 27.7% in TRuE-V2.
Another three-fourths of patients treated with ruxolitinib cream since baseline achieved F-VASI50 by week 52—75.1% and 74.0%, respectively. T-VASI was achieved by nearly half of all patients treated fully through 52 weeks as well.
Lastly, 39.9% and 32.8% of patients in TRuE-V1 and TRuE-V2, respectively, treated 52 weeks with ruxolitinib cream achieved VNS ratings of “a lot less noticeable” or “no longer noticeable.”
Rosmarin reported that 263 total patients across both trials reported a treatment-emergent adverse event (TEAE). The most common included COVID-19 (n = 33), application site sores (n = 29), and nasopharyngitis (n = 26). Another 11 patients reported serious TEAEs.
That said, hematopoietic TEAEs were infrequent, occurring in <3% of all patients, and all were mild to moderate in severity. Investigators did not observe any clinically significant changes in hemoglobin or platelet levels.
Rosmarin concluded that patients with vitiligo treated with ruxolitinib cream achieved a “substantial” rate of both facial and total body repigmentation by week 24—with an even greater rate of patients doing so by week 52. All the while, the topical JAK inhibitor was well-tolerated and safe.
An FDA decision may shortly follow the new phase 3 findings.
The study, "Efficacy and Safety of Ruxolitinib Cream Monotherapy for the Treatment of Vitiligo: Results From Two 52-Week Phase 3 Studies," was presented at AAD 2022.