Phase 3 Ruxolitinib Study Shows Higher Rates of Adolescent Repigmentation

David Rosmarin, MD

Data presented at the 2024 Society for Pediatric Dermatology meeting in Toronto, Canada, found that adolescents with vitiligo achieved higher rates of more complete repigmentation than adults.

A new post hoc analysis of the TRuE-V1 and TRuE-V2 Phase 3 studies demonstrated patients aged ≥12 years with nonsegmental vitiligo had statistically significant repigmentation with twice-daily application of 1.5% ruxolitinib cream vs vehicle (non-medicated cream) at week 24 with continued improvements observed through Week 52, as measured by the Vitiligo Area Scoring Index (VASI).

Researchers reported rates of complete facial or near-complete total body repigmentation were higher among adolescents vs adults who applied 1.5% ruxolitinib cream. They also stated that adolescents tended to repigment faster than adults and were more likely to achieve VASI50 of the lower extremities and feet within 52 weeks.

David Rosmarin, MD, chair of the department dermatology at the Indiana University School of Medicine in Indianapolis, gave his insights on the study in a recent Q&A with Dermatology Times.

Q&A:

Dermatology Times: What criteria were used to select patients aged ≥12 years for inclusion in the TRuE-V1 and TRuE-V2 phase 3 studies, and how do these criteria align with current clinical practice?

Rosmarin: This study compares the efficacy of ruxolitinib cream within the adolescent (12 to 17) and adult (18+) populations with nonsegmental vitiligo for the phase 3 program TRUE-V1 and 2. Patients were selected if they had non-segmental vitiligo on less than 10% of the body with involvement of both body and face. Adolescents repigmented more rapidly than adults, so that at 24 weeks more teens had complete facial repigmentation and T-VASI75 and T-VASI90 results.

DT: Can you provide detailed insights into the Vitiligo Area Scoring Index (VASI) and its role in quantifying repigmentation outcomes in this study?

Rosmarin: The VASI is a standardized tool that helps quantify improvement in repigmentation. While not all patients have face and body vitiligo, having these anatomic locations represented in the study helps derive data for locations important to patients.

DT: The study results indicate that adolescents experienced faster and more significant repigmentation than adults. What underlying factors could explain these differences in response to 1.5% ruxolitinib cream?

Rosmarin: We consider repigmenting vitiligo a 2-step process where the overactive immune system needs to be calmed down and then the melanocytes need to repopulate to the white areas. In younger patients, it may be that the melanocytes are more rapidly repigmenting the patches which is why we see this effect.

DT: How did the safety and tolerability profiles of 1.5% ruxolitinib cream compare between adolescent and adult populations in the study, and were there any age-specific adverse events observed?

Rosmarin: Safety was similar in both populations with a favorable profile for both groups.

DT: Given the study's findings, what recommendations can you offer for integrating 1.5% ruxolitinib cream into clinical practice for treating nonsegmental vitiligo in both adolescent and adult patients?

Rosmarin: The take home message is that ruxolitinib cream can effectively and safely help many patients, including adolescents repigment. Limitations include that the study was only vehicle controlled up through 24 weeks and that after week 52, there are fewer patients who completed the long-term extension.

Reference

Rosmarin D. Adolescents with vitiligo achieved higher rates of more complete repigmentation than adults: post hoc analysis from the phase 3 TRuE-V studies of ruxolitinib cream. Data presented at: 2024 Society for Pediatric Dermatology Meeting; July 11-14, 2024; Toronto, Canada.