New Long-Term Data from Incyte Phase 3 TRuE-V Program Demonstrates Efficacy of Continued Treatment with Opzelura (Ruxolitinib) Cream in Nonsegmental Vitiligo Patients

Incyte (Nasdaq:INCY) today announced new results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program assessing Opzelura (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo who previously experienced limited or no response to treatment at Week 24. These data were presented today in a late-breaking oral presentation (Abstract #6479; Session: D1T01.1I: Late Breaking News) at the European Academy of Dermatology and Venereology (EADV) Congress 2023, held from October 11-14 in Berlin.

“We are excited by the TRuE-V LTE study data presented today during a late-breaking session at EADV. These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte. “The pooled analysis builds on the positive LTE data previously presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting earlier this year and underscores the long-term potential of this treatment for people with vitiligo who are seeking repigmentation.”

The analysis assessed participants initially randomized to apply Opzelura twice-daily (BID) from the TRuE-V1 and TRuE-V2 studies who had <25% improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI) or total body Vitiligo Area Scoring Index (T-VASI) at Week 24 and had non-missing VASI assessments at the evaluated time points.

Key findings from the pooled analysis include:

• More than half of patients (54.9%) who initially experienced limited or no facial repigmentation at Week 24 achieved ≥75% improvement in facial repigmentation from baseline (F-VASI75) with continued treatment with Opzelura at Week 104.
  • For patients with no initial facial repigmentation at Week 24, improvements in F-VASI were observed in 77.8% (49/63) and 97.1% (34/35) of patients at Weeks 52 and 104, respectively.
  • For patients with limited facial repigmentation at Week 24, F-VASI improvements were observed in 64.0% (32/50) and 83.3% (30/36) of patients at Weeks 52 and 104, respectively.
• Half of the patients (50.0%) who initially experienced limited or no body repigmentation at Week 24 achieved ≥50% improvement in body repigmentation from baseline (T-VASI50) with continued treatment with Opzelura at Week 104.
  • Among patients with no body repigmentation at Week 24, T-VASI improvements were observed in 79.6% (39/49) and 93.3% (28/30) of patients at Weeks 52 and 104, respectively.
  • Among patients with limited body repigmentation at Week 24, T-VASI improvements were observed in 64.5% (80/124) and 81.6% (62/76) of patients at Weeks 52 and 104, respectively.
• Opzelura was well-tolerated – no serious treatment-related adverse events (TEAEs) occurred among patients using Opzelura from Day 1; 6.3% (n=14/224) of these patients experienced ≥1 treatment-related TEAE. Application site pruritus was the only TEAE that occurred in >1 patient (n=2; 0.9%).

Opzelura is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.