A Randomized Controlled Trial Comparing the Efficacy and Safety of Oral Tofacitinib vs. Methotrexate in Moderate-to-Severe Alopecia Areata

This randomized controlled trial compared the efficacy and safety of oral tofacitinib and methotrexate in treating moderate-to-severe alopecia areata in 36 patients. Participants were divided into two groups: Group A received tofacitinib, and Group B received methotrexate, over a 6-month period with a 3-month follow-up. The primary outcome was achieving a SALT score ≤ 20, with 50% of Group A and 33% of Group B reaching this target. Tofacitinib showed greater efficacy, with 33% of patients achieving more than 90% improvement in SALT score compared to 11% in the methotrexate group. Both treatments improved scalp hair assessment PRO scores and reduced psychological distress, with no significant adverse effects. However, tofacitinib was associated with higher rates of dyslipidaemia and other mild adverse events. The study suggests that tofacitinib may be more effective than methotrexate, but larger studies are needed to confirm these findings and investigate the role of alkaline phosphatase activity.