Vitiligo: Prolonged facial re-pigmentation maintained with continued ruxolitinib cream

A post-hoc analysis found that longer application of ruxolitinib cream after achieving 90% improvement in the facial Vitiligo Area Scoring Index (F-VASI90) led to more durable and improved repigmentation than shorter application. The rate of participants in the TRuE-V long-term extension study maintaining their F-VASI90 response for ≥6 months was significantly higher in those using the cream for 52 weeks rather than 28 weeks.

“It was a major milestone a few years ago, the approval of ruxolitinib cream a few years ago to repigment patients who are 12 years of age or older with vitiligo on less than 10% of the body,” Dr David Rosmarin (Indiana University School of Medicine, IN, USA) stated [1]. Yet, the question of the durability of treatment response in case of drug withdrawal remained unanswered.

The previous phase 3 TRuE-V1 and TRuE-V2 (NCT04052425 and NCT04057573) studies evaluated participants ≥12 years with nonsegmental vitiligo and ≤10% total body surface area involved up to 52 weeks of treatment with ruxolotinib 1.5% cream. Thereafter, they could roll over into the TRuE-V LTE study (NCT04530344). At this point, participants achieving ≥F-VASI90 were re-randomised to continue either on the study drug or switch to a vehicle. Dr Rosmarin presented a post-hoc analysis of the response durability in this withdrawal group up to week 104.

The 57 participants in the withdrawal cohort were grouped according to the 3 different managements leading up to withdrawal. The VEH/RUX subgroup (n=12) started on vehicle and continued ruxolitinib over 28 weeks, while achieving F-VASI90 after weeks 24. The ≤24RUX/RUX group achieved F-VASI90 ≤24 weeks and received 52 weeks of the JAK inhibitor before withdrawing. The >24RUX/RUX group attained F-VASI90 later than week 24 on continuous 52-week topical ruxolitinib. Among the participants, 25% to 64% were women, the median age of the 3 different trial arm groups ranged from 38 to 47, and the mean F-VASI from 0.7–1.0.

In the ≤24RUX/RUX group, 60% of participants showed a durability of F-VASI90 response beyond 6 months, compared with 18.2% in the VEH/RUX group (P=0.03). The median duration of F-VASI90 response in these 2 groups was 12 months in ≤24RUX/RUX and 3 months in VEH/RUX, with a hazard ratio of 0.45 (95% CI 0.17–1.18). Also, a trend was observed that favoured participants with earlier over later response (P=0.14).

Application site reactions were the main treatment-related adverse events and no serious treatment-emergent adverse events were observed.

“If I had a patient who wants to pause treatment, I would perhaps encourage them to continue on the medicine for at least another 6 months beyond achieving a near complete repigmentation, to give them the best chance at a more durable response,” Prof. Rosmarin concluded from the results. Future studies should evaluate the optimal treatment duration for a durable response.

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   1. Rosmarin D, et al. Impact of treatment duration on response durability: A post hoc analysis of the TRuE-V long-term extension study of ruxolitinib cream in vitiligo. D2T01.3E, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.

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Posted on 6 November 20246 November 2024