Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata Over 52 Weeks in Phase III Trials

The document presents the results of two Phase III trials, BRAVE-AA1 (465 patients) and BRAVE-AA2 (390 patients), investigating the efficacy and safety of baricitinib, an oral Janus kinase inhibitor, in treating severe alopecia areata (AA) in adults with ≥50% scalp hair loss over 52 weeks. The results showed that 40.9% and 36.8% of patients treated with 4 mg of baricitinib in BRAVE-AA1 and BRAVE-AA2 respectively, achieved a Severity of Alopecia Tool (SALT) score ≤ 20 (≤ 20% scalp hair loss) at Week 52. The most common side effects were upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, creatine phosphokinase elevation, and COVID-19 infection. The study concluded that the efficacy of baricitinib for adults with severe AA continuously improved over 52 weeks, indicating that long-term treatment may be necessary to observe maximum clinical benefit. No new safety concerns were identified.