Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study
Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study
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DOI：
10.1016/j.jaad.2021.05.050
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发表时间：
2021-09-08
影响因子：
13.8
通讯作者：
Dutronc, Yves
中科院分区：
文献类型：
--
作者：
King, Brett;Ko, Justin;Dutronc, Yves
背景：美国食品和药物管理局尚未批准治疗斑秃的治疗方法。目的：在成人斑秃的 2 期研究 (BRAVE-AA1) 中，评估巴瑞替尼对头皮脱发≥50% 的患者的疗效和安全性。方法：患者按 1:1:1:1 随机分配接受安慰剂或巴瑞替尼 1 mg、2 mg 或 4 mg，每日一次。所有患者完成第 12 周和第 36 周或在这些时间点之前停止治疗后，进行了两次连续的中期分析。主要终点是达到脱发严重程度工具 (SALT) 评分的患者比例
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