A recent clinical trial has shown promising results for the treatment of severe vitiligo, combining the drug baricitinib with phototherapy. Conducted at four dermatology departments in France between July 2021 and April 2023, the multicenter, double-blind, proof-of-concept phase 2 randomized clinical trial included 49 adults, predominantly women with a median age of 49.9 years, suffering from extensive, active nonsegmental vitiligo. The study's primary focus was to measure the mean percentage change in the total Vitiligo Area Scoring Index (VASI) from baseline at week 36.
Participants were randomly assigned to receive either baricitinib (4 mg/day) or a placebo over a 36-week period, with a 3:1 ratio favoring the baricitinib group. Results indicated a significant improvement in the baricitinib group, which achieved a mean 44.8% reduction in total VASI scores at week 36, compared to just a 9.2% reduction in the placebo group.
"This proof-of-concept randomized clinical trial highlighted the efficacy of combining the JAK1/JAK2 inhibitor baricitinib with narrowband UVB in the treatment of adults with active vitiligo," – the authors
The trial also revealed that at week 36, facial VASI score improvements of ≥75% and ≥90% were observed in 56% and 50% of participants in the baricitinib group, whereas only 9% reached these improvement thresholds in the placebo group. Additionally, secondary outcomes measured changes in total VASI scores from baseline to weeks 12 and 24, facial VASI score, Vitiligo Extent Score, Vitiligo European Task Force assessment–extent, and Vitiligo Signs of Activity Score.
Narrowband UVB, a standard treatment for widespread or active vitiligo, was introduced after 12 weeks for both groups and continued twice weekly for 24 weeks. This combination therapy led to greater improvement in facial VASI scores at weeks 24 and 36 and enhancements in disease activity and quality of life by week 24.
The study found no significant difference in the frequency of adverse events between the two groups, suggesting the combination treatment’s safety profile is comparable to current treatments. At week 36, 53%, 27%, and 6% of participants in the baricitinib group showed ≥50%, ≥75%, and ≥90% improvement in total VASI score, respectively. This contrasted sharply with 9%, 0%, and 0% improvement rates in the placebo group.
Funded by Eli Lilly and Company, this research underlines the potential of baricitinib combined with narrowband UVB as a viable therapeutic approach for vitiligo, supporting further investigation through a larger phase 3 trial.
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