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著者: Brett King, Justin Ko, Seth Forman, Manabu Ohyama, Natasha Mesinkovska, Guanglei Yu, Jill McCollam, Margaret Gamalo, Jonathan Janes, Emily Edson-Heredia, Katrin Holzwarth, Yves Dutronc
雑誌名: J Am Acad Dermatol. 2021 Oct;85(4):847-853. doi: 10.1016/j.jaad.2021.05.050. Epub 2021 Jun 16.
Abstract/Text
BACKGROUND: There are no treatments approved by the Food and Drug Administration for alopecia areata.
OBJECTIVE: To evaluate the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss in a phase 2 study of adults with alopecia areata (BRAVE-AA1).
METHODS: Patients were randomized 1:1:1:1 to receive placebo or baricitinib 1 mg, 2 mg, or 4 mg once daily. Two consecutive interim analyses were performed after all patients completed weeks 12 and 36 or had discontinued treatment prior to these time points. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score ≤20 at week 36. Logistic regression was used with nonresponder imputation for missing data.
RESULTS: A total of 110 patients were randomized (placebo, 28; baricitinib 1-mg, 28; 2-mg, 27; 4-mg, 27). The baricitinib 1-mg dose was dropped after the first interim analysis based on lower SALT30 response rate. At week 36, the proportion of patients achieving a SALT score of ≤20 was significantly greater in baricitinib 2-mg (33.3%, P = .016) and 4-mg (51.9%, P = .001) groups versus placebo (3.6%). Baricitinib was well tolerated with no new safety findings.
LIMITATIONS: Small sample size limits generalizability of results.
CONCLUSION: These results support the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss.
Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
PMID 34090959 J Am Acad Dermatol. 2021 Oct;85(4):847-853. doi: 10.1016/j.jaad.2021.05.050. Epub 2021 Jun 16.
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