Positive Results Observed with Baricitinib, Phototherapy for Severe Vitiligo

Treatment of severe, active vitiligo with baricitinib combined with narrowband UV-B phototherapy diminishes disease activity, according to new findings, resulting in clinically meaningful repigmentation among adults patients.1

These data were the conclusion of a new analysis looking into the efficacy and tolerance of treatment with oral baricitinib along with phototherapy among those with the most severe form of vitiligo. This study’s investigators noted that prior case series had been published on phototherapy’s use with Janus kinase (JAK) inhibitors for vitiligo.2

Nevertheless, they highlighted that there had not yet been research into systemic, oral JAK inhibitors with concomitant phototherapy. This analysis was authored in part by Julien Seneschal, MD, PhD, from the department of dermatology and pediatric dermatology at the Hôpital Saint-André’s National Reference Center for Rare Skin Diseases in France.

“The aim of this study was to assess the efficacy and adverse events of the combination of baricitinib and narrowband UV-B in adults with severe, active, nonsegmental vitiligo in a double-blind, proof-of-concept phase 2 randomized clinical trial,” Seneschal and colleagues wrote.1

Trial Design Details

The research team carried out a multicenter, double-blind, phase 2 randomized clinical trial, with their research taking place within the dermatology departments of 4 hospitals in France between July 2021 - April 2023. The team worked to evaluate baricitinib’s efficacy when combined with narrowband UV-B therapy in the treatment of individuals with diagnoses of nonsegmental vitiligo.

Subjects were included if they were in the age range of 18 - 75 years, in addition to having active non-segmental vitiligo impacting over 5% of their body surface area. The investigators excluded participants’ feet and hands from this body surface area requirement.

The individuals included were also required to have exhibited new or expanding lesions within the past 6-month period. This would be accompanied by hypochromic areas or perifollicular hypopigmentation that the research team identified.

A 3:1 randomization design was implemented for this study, with 37 participants being assigned by the ream to be treated with baricitinib at a rate of 4 mg per day and 12 individuals being assigned to a placebo cohort. A total of 36 weeks were used for the treatment period, and the initial 12 weeks involved using baricitinib or placebo alone.

This 12-week period was then followed by a combination of the assigned intervention with narrowband UV-B therapy, being provided for subjects twice each week from the 12 - 36-week marks.

In terms of primary objectives, the investigators sought to specifically assess the mean percentage change in trial participants’ total Vitiligo Area Scoring Index (VASI) score at the 36-week mark. They would compare outcomes against a predefined threshold of a 42.9% reduction in repigmented surface which had been linked with narrowband UV-B therapy alone previously.

In their analysis, the research team’s secondary endpoints included shifts in quality of life (QOL), disease activity, and adverse events. They also used post-hoc analyses for the purposes of making additional comparisons.

Notable Findings on Baricitinib and Phototherapy

The investigative team had involved 49 participants in this analysis, noting that 71% had been reported to be female and that subjects’ median age had been 49.9 years. The baricitinib treatment arm was shown, at the 36-week mark, to have had a mean reduction in their total VASI score of 44.8% (95% CI, −58.4% to −31.3%).

This was compared to a reduction of only 9.2% (95% CI, −27.7% to 24.7%) among those featured in the placebo arm of the study. Despite the fact that the baricitinib cohort’s score reduction did not surpass the aforementioned repigmentation threshold of 42.9%, the investigators’ post-hoc analysis led to the conclusion that there was a significant difference between those in the baricitinib plus narrowband UV-B arm and the placebo plus narrowband UV-B arm (P = .02).

The research team also reported that baricitinib cohort members were shown to have greater improvements in their disease activity and life quality than the subjects included in the placebo arm. The team added that there was no statistically significant distinction in the frequency of adverse events between the cohorts.

“This proof-of-concept randomized clinical trial highlighted the efficacy of combining the JAK1/JAK2 inhibitor baricitinib with narrowband UV-B in the treatment of adults with active vitiligo,” they wrote. “It is a valuable contribution to the growing interest in the use of JAK inhibitors to treat autoimmune conditions and justifies the completion of a larger confirmatory phase 3 trial in the future.”1

References

1. Seneschal J, Guyon M, Merhi R, et al. Combination of Baricitinib and Phototherapy in Adults With Active Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. Published online January 22, 2025. doi:10.1001/jamadermatol.2024.5737.
2. Liu LY, Strassner JP, Refat MA, Harris JE, King BA. Repigmentation in vitiligo using the Janus kinase inhibitor tofacitinib may require concomitant light exposure. J Am Acad Dermatol. 2017;77(4):675-682.e1. doi:10.1016/j.jaad.2017.05.043.