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

    Oh Sang Kwon, Maryanne M. Senna, Rodney Sinclair, Taisuke Ito, Yves Dutronc, Chen-Yen Lin, Guanglei Yu, Chiara Chiasserini, Jill Shwed McCollam, Wen‐Chi Wu, Brett King
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    TLDR Baricitinib improved severe hair loss in adults over 52 weeks and was safe to use.
    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.
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