Posters Show Success of Ruxolitinib Cream in Alleviating Facial Vitiligo Symptoms, Reducing Noticeability

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A pair of posters presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting showed the efficacy of ruxolitinib cream in improving symptoms of vitiligo on the face, both as assessed by investigators and by how noticeable the patients felt their vitiligo was.

Both posters reflected a pooled analysis of 2 phase 3 randomized controlled trials, Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1; NCT04052425) and Study 2 (TRuE-V2; NCT04057573). In these trials, adolescent and adult participants with nonsegmental vitiligo received either ruxolitinib cream or placebo for 24 weeks, then those receiving placebo crossed over to receive ruxolitinib cream and both groups continued use for 28 more weeks.

Of the 450 patients randomly assigned to apply ruxolitinib cream in both studies, 449 were included in the safety analysis. In this group, mean (SD) age at baseline was 39.4 (15.4) years, 44.8% of the patients were male, and median (range) duration of vitiligo was 11.9 (0-60.5) years.

The first abstract aimed to assess shifts in response across the 52 weeks of the studies in terms of facial Vitiligo Area Scoring Index (F-VASI).¹ By week 12, of 401 patients evaluated, 29.2% had achieved F-VASI50 or better, indicating at least a 50% improvement from baseline. By week 24, 41.4% of patients saw their response improve since week 12, and 51.1% had their response remain stable. Just 3.7% saw their response decrease, and another 3.7% had missing evaluations. By week 52, 43.1% of the 401 patients had achieved F-VASI75 or better.

Investigators noted that ruxolitinib cream was well tolerated, with application site reactions accounting for the most common treatment-related adverse events; no serious adverse events were considered to be related to the treatment. Low blood platelet counts have been reported as an adverse event related to oral ruxolitinib for treatment of myelofibrosis or polycythemia vera, but there were no clinically significant changes in hemoglobin or platelet levels among the patients applying ruxolitinib cream for their vitiligo in the current studies.

The second abstract analyzed data from the same studies for the outcome of Vitiligo Noticeability Scale (VNS).² In this patient-reported measure of treatment response, patients are given a mirror and a baseline photograph to assess how their facial vitiligo has changed since baseline. This outcome of self-perception is particularly important given that vitiligo can have a strong negative impact on patients’ self-esteem and mental well-being.

Of 402 patients who received ruxolitinib cream who completed a VNS evaluation at week 12, 16.7% said their symptoms had become a lot less noticeable or were no longer noticeable at all. By week 24, 25.1% thought their vitiligo had become less noticeable since week 12, and 55.0% thought their vitiligo was as noticeable as it had been at their week 12 assessment. Only 16.2% reported that their vitiligo was now more noticeable, and 3.7% had missing evaluations.

At week 24, 22.4% of participants said their symptoms had become a lot less noticeable since baseline or were no longer noticeable at all; this percentage increased to 30.8% by week 52 of treatment.

“Adolescents and adults with nonsegmental vitiligo applying ruxolitinib cream largely thought that compared with baseline, their vitiligo was less noticeable or of similar noticeability from week 12 to 24 and from week 24 to 52 per pooled data from the TRuE-V1/TRuE-V2 phase 3 studies,” the poster authors concluded.

References

1. Harris JE, Rosmarin D, Seneschal J, et al. Facial Vitiligo Scoring Area Index response maintenance or shift during 52 weeks of ruxolitinib cream treatment for vitiligo: pooled analysis of the TRuE-V phase 3 studies. Poster presented at: AAD 2023; March 17-21, 2023; New Orleans, LA. Abstract 43912.

2. Ezzedine K, Passeron T, Rosmarin D, et al. Vitiligo Noticeability Scale score maintenance or shift during 52 weeks of ruxolitinib cream treatment for vitiligo: pooled analysis of the TRuE-V phase 3 studies. Poster presented at: AAD 2023; March 17-21, 2023; New Orleans, LA. Abstract 43959.