- 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.
What is the potential of continuing topical ruxolitinib treatment for non-segmental vitiligo in patients with no or poor response measured by VASI at 6 months of cream application? A pooled analysis of patients from the open-label extension (NCT04530344) of the phase 3 TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) trials aimed to clarify this question. It included those who started on ruxolitinib from day 1 in the parent trials and presented no or less than 25% change in their facial or total body (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. 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. 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.
Looking at body repigmentation at weeks 52 and 104, 79.6% and 93.3% of the initial non-repigmenting 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 Albert Wolkerstorfer (Amsterdam University Medical Center, Netherlands) 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.