Ruxolitinib Shows Consistent Results Across Vitiligo Groups

TOPLINE:

Ruxolitinib cream was well tolerated, and the application of the cream led to clinically meaningful repigmentation in patients with vitiligo at 1 year, regardless of their baseline demographic and clinical characteristics.

METHODOLOGY:

• This post hoc analysis included pooled data from two phase 3 studies (TRuE-V1 and TRuE-V2) in which adults and adolescents (aged ≥ 12 years) with non-segmental vitiligo received 1.5% ruxolitinib cream or vehicle cream twice daily for 24 weeks, followed by ruxolitinib cream for another 28 weeks.
• A total of 674 patients were randomly assigned to apply either ruxolitinib cream (n = 450) or vehicle cream (n = 224), of whom 673 and 661 were included in safety and efficacy analyses, respectively.
• Researchers evaluated outcomes on the basis of age groups, sex, geographic region, race, Fitzpatrick skin type, facial body surface area, disease stability, autoimmune disorders, disease duration, and previous therapy.
• Efficacy was evaluated using the achievement of a 75% or greater improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI75) at week 52.

TAKEAWAY:

• At week 52, F-VASI75 was achieved by 50.3% of patients who applied ruxolitinib cream throughout and 28.2% of patients who crossed over from vehicle to ruxolitinib cream after week 24.
• Response rates were comparable between patients with facial body surface area < 1.5% and ≥ 1.5% (49.1% vs 55.2%) and between those with stable and progressive disease at baseline (49.4% vs 52.7%).
• Response rates were higher in female than in male patients (55.2% vs 43.6%) and in patients with Fitzpatrick skin types IV-VI than in those with Fitzpatrick skin types I-III (57.4% vs 47.4%).
• Treatment-emergent adverse events occurred in 52.1% of patients, and treatment-related adverse events occurred in 13.7% of patients, with rates being generally similar across demographic subgroups.

IN PRACTICE:

“Adolescent and adult patients with vitiligo applying ruxolitinib cream could achieve efficacy per F-VASI75 response at 1 year regardless of demographics or clinical characteristics, confirming earlier phase 2 findings. Ruxolitinib cream was well tolerated, with a similar incidence of treatment-emergent and treatment-related AEs [adverse events] across subgroups,” the authors concluded.

SOURCE:

This study was led by Julien Seneschal, CHU de Bordeaux, Dermatology and Pediatric Dermatology, National Reference Center for Rare 25 Skin Disorders, Hôpital Saint-André, Bordeaux, France. It was published online on March 29, 2025, in Dermatology and Therapy.

LIMITATIONS:

The exploratory post hoc design, small sample sizes in some subgroups, and lack of multiplicity adjustment limited meaningful interpretation and generalisability. The pooled data from clinical trials may not reflect real-world settings, and trends identified may require confirmation in larger real-world populations. Additionally, data were limited to week 52 outcomes, with longer-term follow-up needed to understand repigmentation maintenance with prolonged ruxolitinib cream application.

DISCLOSURES:

This study was funded by Incyte Corporation (Wilmington, Delaware, United States). Two authors reported being employees and shareholders of Incyte. The other authors reported receiving grants or honoraria and having other ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.