Ruxolitinib Cream Led to Meaningful Repigmentation Across Different Body Regions

A new pooled analysis of the TRuE-V1/TRuE-V2 phase 3 studies suggests that ruxolitinib treatment of individuals with vitiligo over 52 weeks resulted in meaningful repigmentation across body regions.¹

These conclusions represented the results of an analysis which was led by Thierry Passeron, from the Centre Hospitalier Universitaire de Nice at the Université Côte d'Azur in France. Passeron et al. noted the importance of repigmentation as a treatment goal, adding that repigmentation likelihood is impacted by the location of vitiligo lesions.²

“Ruxolitinib cream, a topical Janus kinase (JAK) 1/JAK2 inhibitor and the first approved repigmentation therapy for vitiligo, was statistically superior to vehicle at Week 24 and was well tolerated in two Phase 3 studies of adults and adolescents ≥12 years with nonsegmental vitiligo…” Passeron and colleagues wrote.³

The research team thus assessed ruxolitinib cream’s impact on patients’ achievement of ≥50% improvement in their Vitiligo Area Scoring Index (VASI) scores from the point of baseline (VASI50), specifically with assessments of bodily region, hands, trunk, upper extremities, lower extremities, and feet. They also looked at all bodily regions combined, excluding patients’ faces, using pooled data drawn from the TRuE-V trials.

Design and Results

In the initial vehicle-controlled, double-blind period lasting 24 weeks, there had been 661 participants, with those treated with ruxolitinib totalling 443 and those utilizing the vehicle totalling 218. After the conclusion of this phase, there were 569 subjects who entered the 28-week open-label extension study period.

At this point, there were 385 who elected to continue treatment with ruxolitinib cream. There were 184 who crossed over from the vehicle arm of the study. The baseline mean facial and total Vitiligo Area Scoring Index (VASI) scores were found by the research team to have been 0.92 and 6.66, respectively.

VASI50 response rates throughout the 52 weeks were found by the team to have increased progressively for all bodily areas, excluding the face, among individuals who had been solely treated with ruxolitinib cream.

These subjects had achieved 8.7% at the 12-week mark, 20.8% at the 24-week mark, 37.0% at the 40-week mark, and 47.7% at the 52-week mark. The investigators noted that a similar upward trend had been seen among those who switched from the vehicle following the 24-week mark.

The investigators found there were specific VASI50 response rates of 28.3%, 45.3%, 60.0%, and 68.1% at the 12, 24, 40, and 52-week points, respectively. These rates of VASI50 responses were shown to have risen consistently among participants treated only with ruxolitinib cream through to the 52-week mark for the neck and head regions (not including the face).

A comparable trend was noted by the research team in subjects’ trunk response rates, with percentages being 15.5%, 26.4%, 38.8%, and 48.4% at the aforementioned corresponding weeks. The team reported that there were similar upper and lower extremities rates of VASI50 response, adding that subjects’ upper extremities had successfully gotten to 14.1%, 33.2%, 50.2%, and 56.7%, and lower extremities reaching 15.1%, 29.5%, 46.1%, and 54.5% by the 12, 24, 40, and 52-week marks, respectively.

A typically lower rate of response was reported by the investigators for subjects’ hands and feet, with peaks occurring at the 46-week mark with 40.5% and 30.7% for hands and for feet, respectively. They found that these rates slightly diminished thereafter.

They highlighted that 38.2% of participants succeeded in achieving VASI50 for hands at the 52-week mark, in addition to 29.3% for feet. The team added that regimentation had mostly taken place upon subjects’ dorsal regions instead of the tips of their toes and fingers.

“The causes of repigmentation resistance are likely complex, and further research to identify additional targets for achieving optimal repigmentation is warranted,” they wrote. “Furthermore, studies assessing the efficacy of combination therapy (e.g. ruxolitinib cream and phototherapy) or newer topical drugs targeting alternative pathways are warranted, particularly for patients with vitiligo in areas most difficult to repigment.”

References

1. ^{Passeron T, Harris JE, Rosmarin D, et al. (2024), Repigmentation by body region in patients with vitiligo treated with ruxolitinib cream over 52 weeks. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.20236.}
2. ^{Esmat SM, El-Tawdy AM, Hafez GA, Zeid OA, Abdel Halim DM, Saleh MA, et al. Acral lesions of vitiligo: why are they resistant to photochemotherapy? J Eur Acad Dermatol Venereol. 2012; 26: 1097–1104.}
3. ^{Rosmarin D, Passeron T, Desai SR, et al. Two phase 3, randomized, controlled trials of ruxolitinib cream for vitiligo. N Engl J Med. 2022; 387: 1445–1455.}