P157 Oral tofacitinib vs. betamethasone oral minipulse therapy in progressive nonsegmental vitiligo: a randomized investigator-blinded clinical trial

Abstract

Oral corticosteroid minipulse (OMP) therapy is a mainstay for progressive vitiligo but is limited by adverse effects. Janus kinase inhibitors have shown promising results but with limited random­ized comparative data. The aim of this study was to compare the efficacy and safety of oral tofacitinib with betamethasone OMP in progressive vitiligo. Fifty-four patients with progressive vitiligo were randomized to receive oral betamethasone OMP (5 mg on two consecutive days weekly; n = 25) or oral tofacitinib (5 mg twice daily; n = 29) for 24 weeks. Disease activity was assessed using new lesion counts, Vitiligo Disease Activity Score (VDAS) and Vitiligo Signs of Activity Score; repigmentation using facial and total Vitiligo Area Scoring Index (VASI) and site-specific Likert scales; overall change in disease using VDAS and Vitiligo Disease Improvement Score; and quality of life using Vitiligo Impact Scale (VIS)-22. Baseline characteristics were comparable between groups. Disease arrest at week 12 maintained through week 24 was achieved in 79% of patients receiving tofacitinib and 70% receiving OMP (P = 0.52), with similar mean time to arrest (10.0 vs. 9.25 weeks; P = 0.94). Disease activity reduced in both groups, with no intergroup differences. Repigmentation outcomes were modest, with a trend favouring tofacitinib. Facial VASI improved more with tofacitinib (median reduction 12%; P = 0.07) than with OMP (median reduction 0%; P = 0.7), while total VASI decreased more with tofacitinib (median reduction 6.8%; P = 0.008) than with OMP (median reduction 0.3%; P = 0.28). Improvement in facial VASI by ≥ 75% was achieved in 25% with tofacitinib and 11% with OMP (P = 0.41). VIS-22 scores improved significantly only with tofacitinib (−3.14; P = 0.02) and not OMP (−2.0; P = 0.87). Adverse-event rates were similar, but steroid-related effects such as weight gain > 5 kg (25% vs. 3.6%) and cushingoid features (20% vs. 0%) were more frequent with OMP. Oral tofacitinib appears comparable with OMP in achieving disease arrest, with a favourable ­steroid-sparing safety profile and a trend towards better repigmentation and quality of life.