Vitiligo: Continuation of topical ruxolitinib successful in many initial non-responders

In patients with vitiligo with limited or no response after the first 6 months, prolonged treatment with ruxolitinib cream induced repigmentation in a considerable proportion after 1 and 2 years. Improvements were observed in facial (F) as well as total body (T) Vitiligo Area Scoring Index (VASI).

“Ruxolitinib cream has recently been approved by the EMA in 2023, and before by the FDA, as the first drug for repigmentation in vitiligo, and that approval was based on 2 randomised, double-blind, vehicle-controlled phase 3 studies,” Dr Albert Wolkerstorfer (Amsterdam University Medical Centers, the Netherlands) said referring to the TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) studies [1].

The current analysis presented by Dr Wolkerstorfer delved into the remaining question of the potential of continuing topical ruxolitinib treatment for non-segmental vitiligo in patients without or with poor response measured by VASI at 6 months. The pooled analysis included participants from the open-label extension of TRuE-V1 and TRuE-V2 who started on ruxolitinib from day 1 in the parent trials and presented no or less than 25% change in their F-VASI or T-VASI at week 24 and who then continued topical therapy for 80 more weeks.

Baseline characteristics of the analysed cohort included a median age of 39 years, 57.6% women, and a mean T-VASI of 6.73. The results were assessed at weeks 52 and 104 and grouped by prior absent or limited facial as well as body repigmentation. Overall, 71.7% (week 52) and 90.1% (week 104) F-VASI improvements were observed. Among those without any repigmentation at week 24, 77.8% and 97.1% experienced an F-VASI amelioration at weeks 52 and 104 (see Figure). The corresponding rates for F-VASI in the group with ≤25% repigmentation after 6 months were 64.0% and 83.3%. Taking both groups together, a facial repigmentation of at least 75% was achieved by 54.9% after 2 years in the prior non-responders.

Figure: F-VASI response with ruxolitinib in patients with no or limited repigmentation at week 24 [1]



Looking at body repigmentation at weeks 52 and 104, 79.6% and 93.3% of the initial non-responders demonstrated a T-VASI enhancement. Within the group with some but less than 25% repigmentation, 81.6% attained a T-VASI response at week 104. T-VASI50 was seen in 50% across both groups.

“Ruxolitinib cream was well-tolerated over 104 weeks, there were no serious treatment-related adverse events, and application site pruritus was the only treatment-related adverse event that occurred in more than 1 patient,” Dr Wolkerstorfer stated.

“The impact of these results is that it might challenge our current practice because I see that many patients stop treatment after 3–6 weeks when there is no improvement,” he concluded, adding that dermatologists also often stop therapy after 6–8 weeks in this situation.

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   1. Wolkerstorfer A. Efficacy of prolonged ruxolitinib cream treatment for vitiligo among patients with limited or no initial response at 6 months. D1T01.1I, EADV Congress 2023, 11–14 October, Berlin, Germany.

 

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Posted on 28 November 202317 May 2024