Comparison of Oral Azathioprine and Oral Mini Pulse Steroid in the Treatment of Vitiligo: An Open-Label Randomized Controlled Trial

Abstract

Abstract Background: Vitiligo is a common acquired depigmentory skin disorder supposed to be of autoimmune aetiology. Different immunosuppressants have been tried with varying success. Azathioprine has been less studied in vitiligo. Aims and Objectives: To study the efficacy of oral azathioprine and compare with systemic steroid in the treatment of vitiligo. Materials and Methods: It was an interventional study with multi-armed (three), parallel group, an open-label, randomized controlled trial with allocation ratio of 1:1:1. Patients of vitiligo aged between 18 and 60 years having more than 5% body surface involvement were included in the study. Patients were divided into three groups. Group A—patients received oral azathioprine 50 mg OD daily, group B—patients received combination of oral azathioprine 50 mg OD and PUVASOL and group C—patients received combination of betamethasone oral mini pulse (OMP) and PUVASOL. All the groups were treated for 1 year. Repigmentation was evaluated by vitiligo area severity index (VASI), and stabilization was evaluated by vitiligo disease activity (VIDA). Results: Group A, group B and group C showed 24.24%, 53.24% and 47.28% improvement in VASI score, respectively, at the end of 1 year. Group B and group C showed statistically significant superior repigmentation as compared to azathioprine monotherapy. Though azathioprine and betamethasone showed equivalent efficacy, azathioprine has a better safety profile. Side effects were minimal in azathioprine groups, whereas 50% patients developed various side effects in group C. Conclusion: Azathioprine is safe and effective option in the treatment of vitiligo.