Incyte: Data from Phase 3 TRuE-V demonstrates efficacy of Opzelura treatment

Incyte announced new results of a pooled analysis of long-term extension data from the pivotal Phase 3 TRuE-V program assessing Opzelura 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 at the European Academy of Dermatology and Venereology 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. Key findings from the pooled analysis include: More than half of patients who initially experienced limited or no facial repigmentation at Week 24 achieved greater than or equal to75% improvement in facial repigmentation from baseline with continued treatment with Opzelura at Week 104. Half of the patients who initially experienced limited or no body repigmentation at Week 24 achieved greater than or equal to50% improvement in body repigmentation from baseline 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% and 93.3% 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% and 81.6% of patients at Weeks 52 and 104, respectively.