EADV News: Continued Treatment with Opzelura (Ruxolitinib) Cream Shows Efficacy in Nonsegmental Vitiligo

Nonsegmental vitiligo patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with Opzelura (Ruxolitinib) Cream for up to two years.

Nonsegmental vitiligo patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with Opzelura (Ruxolitinib) Cream for up to two years, according to new results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program. 

The research was presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin.

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 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. There were 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, the study showed.

“With this analysis, we were able to more closely examine the impact of continued treatment with Opzelura in patients who showed limited to no improvements in facial or total body repigmentation following an initial six-month course of treatment,” says Dr. Albert Wolkerstorfer, Netherlands Institute for Pigment Disorders, Department of Dermatology, University of Amsterdam, in a news release. “These data highlight the importance of continuing treatment with Opzelura in patients with vitiligo, even when minimal or no repigmentation is achieved after six months of treatment.“