Oral tofacitinib in comparison with dexamethasone oral mini-pulse therapy for the treatment of active nonsegmental vitiligo: A randomized controlled trial

Abstract

Background: There is a lack of literature on stabilizing and repigmenting potential of oral tofacitinib in active vitiligo.

Objective: To compare the efficacy of oral tofacitinib with oral mini-pulse therapy in active vitiligo.

Methods: This prospective, randomized, investigator-blinded trial recruited patients aged 18-60 with active nonsegmental vitiligo. Participants were randomized to receive dexamethasone 2.5 mg twice a week (group A) or oral tofacitinib 5 mg twice daily (group B) for 24 weeks, followed by 12 weeks of observation. The primary outcome was the proportion of patients showing ≥50% improvement in vitiligo extent score (VES) at 24 weeks.

Results: Sixty patients were recruited (30 per group), with 49 completing 36 weeks. At 24 weeks, the proportion achieving ≥50% VES improvement was similar (16.7% vs 20.0%, P = .833). By 36 weeks, group B had a significantly greater VES decrease (31.5 ± 24.9% vs 16.7 ± 34.8%, P = .031). Group A had higher treatment failure at 12 weeks (20% vs 3.3%, P = .049), but comparable stabilization rates at 24 weeks (63.3% vs 83.3%, P = .171).

Limitations: Limited sample size, single-center design, and lack of double-blinding.

Conclusion: Tofacitinib is more effective than oral mini-pulse (dexamethasone 2.5 mg twice a week) for treating active nonsegmental vitiligo.

Keywords: JAK-STAT inhibitors; active; dexamethasone mini-pulse; nonsegmental vitiligo; repigmentation; stabilization; tofacitinib.