Efficacy and safety of tofacitinib in patients with alopecia areata

Abstract

Background: Alopecia areata (AA) is an autoimmune disorder causing non-scarring hair loss with major quality-of-life impact. Tofacitinib, a Janus kinase inhibitor, has shown promise for AA, though long-term safety, durability, and data from South Asian populations remain limited. Objective: To evaluate efficacy, safety, and relapse patterns of oral tofacitinib in AA. Methods: In this prospective quasi-experimental study, 59 patients aged 12–60 years with ≥30% scalp involvement or alopecia totalis/universalis, refractory to first-line therapy, received tofacitinib 5 mg twice daily for 24 weeks. Primary endpoint was change in Severity of Alopecia Tool (SALT) score. Secondary endpoints included response rates (≥71% regrowth), safety, and relapse after discontinuation. Results: Mean SALT score improved significantly from 59.98 ± 24.47 to 17.48 ± 26.58 at week 24 (p < 0.001). Perfect response occurred in 45.1% of patients, good in 21.6%, moderate in 15.7%, weak in 9.8%, and none in 7.8%. Outcomes were best in ages 20–39 years and patchy AA, with 82.6% of perfect responders showing ≥90% regrowth. Adverse events were generally mild (headache 11.9%, upper respiratory infection 10.1%, acne 6.8%). Laboratory abnormalities were rare and reversible. Relapse occurred in 45.7% within 1–2 months, 38.9% within 4–6 months, and 9.6% by 10–12 months after discontinuation. Conclusion: Tofacitinib produced substantial regrowth with acceptable safety in AA patients. However, high relapse rates after withdrawal highlight the need for maintenance strategies. This study provides real-world evidence from an underrepresented South Asian population.