Maintenance of long-term efficacy with continuous baricitinib treatment in patients with severe alopecia areata: 3-year results from BRAVE-AA1 and BRAVE-AA2.

Abstract

Baricitinib, a Janus kinase inhibitor with an established safety profile across multiple indications, has demonstrated efficacy in the treatment of severe alopecia areata with high maintenance of response during the initial treatment extension period. To evaluate efficacy and safety of baricitinib for adults with severe alopecia areata through 152 weeks of continuous therapy. The analysis includes patients from the BRAVE-AA1 and BRAVE-AA2 phase 3, randomized, double-blind, clinical trials: adults with Severity of Alopecia Tool (SALT) scores ≥50 who achieved SALT score ≤20 at week 52 (responders) and were continued on the same dose of baricitinib up to 152 weeks. Among week 52 responders who were continuously treated with baricitinib 4 mg or baricitinib 2 mg, 115 of 129 (89.1%) and 56 of 67 (83.6%), respectively, maintained SALT score ≤20 at week 152. The incidence rate of adverse events of special interest relative to earlier safety reports, remained consistent. The analysis does not include outcomes of patients without SALT score ≤20 response at week 52, who continued therapy post-week 52. Over 152 weeks, patients stably maintained and extended their regrowth across scalp, eyebrows, and eyelashes with continued baricitinib treatment. There were no new safety signals.