巴瑞替尼治疗斑秃的研究综述。

Review of Baricitinib in the Treatment of Alopecia Areata.

出版信息

J Drugs Dermatol. 2023 Sep 1;22(9):935-940. doi: 10.36849/JDD.7357.

Abstract

BACKGROUND

Alopecia areata (AA) is a debilitating autoimmune disease that results in non-scarring hair loss. Baricitinib is the Food and Drug Administration (FDA) approved treatment for AA. Objective: Review the mechanism of action, pharmacokinetics, pharmacodynamics, efficacy, and safety of baricitinib in the treatment of AA. Methods: A literature review was conducted using the MEDLINE (PubMed) and EMBASE databases for articles published between January 2010 to November 2022. Articles in English discussing baricitinib's efficacy and safety in AA, pharmacodynamic, and pharmacokinetic profiles were included.

RESULTS

Two identical phase III trials (BRAVE-AA1 and BRAVE-AA2) were evaluated. A greater percentage of subjects receiving baricitinib 4 mg or 2 mg dose achieved a Severity of Alopecia Tool score equal to or less than 20 vs placebo. In BRAVE-AA1, for 4 mg, 2 mg, and placebo, respectively, these values were 38.8%, 22.8%, and 6.2%; in BRAVE-AA2, these values were 35.9%, 19.4%, and 3.3% (P<0.001).

DISCUSSION

Baricitinib is the first FDA-approved treatment for AA. Other treatments for AA are used off-label with variable efficacy. Baricitinib is associated with black-box warnings due to adverse effects (AEs) associated with other Janus Kinase (JAK) inhibitors or use in other diseases. In the two large AA trials, AEs were considered mild or moderate; those reported more often with baricitinib than placebo included acne, elevations of low- and high-density lipoprotein cholesterol, and elevation of creatinine kinase. Baricitinib is a relatively tolerable and safe therapeutic alternative for severe AA, although additional study is needed to assess its long-term efficacy and safety. Citation: Singh R, Driscoll MS. Review of baricitinib in the treatment of alopecia areata. J Drugs Dermatol. 2023;22(9):935-939. doi:10.36849/JDD.7357.

摘要

背景

斑秃是一种使人虚弱的自身免疫性疾病，可导致非瘢痕性脱发。巴瑞替尼是食品和药物管理局（FDA）批准的斑秃治疗药物。目的：综述巴瑞替尼治疗斑秃的作用机制、药代动力学、药效学、疗效和安全性。方法：使用 MEDLINE（PubMed）和 EMBASE 数据库对 2010 年 1 月至 2022 年 11 月期间发表的文章进行文献回顾。纳入讨论巴瑞替尼治疗斑秃的疗效和安全性、药效学和药代动力学特征的英文文章。结果：评估了两项相同的 III 期试验（BRAVE-AA1 和 BRAVE-AA2）。与安慰剂相比，接受巴瑞替尼 4mg 或 2mg 剂量治疗的患者中有更大比例达到严重程度脱发评估工具评分等于或小于 20。在 BRAVE-AA1 中，4mg、2mg 和安慰剂组分别为 38.8%、22.8%和 6.2%；在 BRAVE-AA2 中，这些数值分别为 35.9%、19.4%和 3.3%（P<0.001）。讨论：巴瑞替尼是 FDA 批准的第一种斑秃治疗药物。其他斑秃治疗药物是在没有明确疗效的情况下用于治疗其他疾病的。巴瑞替尼因与其他 Janus 激酶（JAK）抑制剂相关的不良反应（AE）或在其他疾病中的应用而被贴上黑框警告标签。在这两项大型斑秃试验中，AE 被认为是轻度或中度的；与巴瑞替尼相关的比安慰剂更常见的报告 AE 包括痤疮、低和高密度脂蛋白胆固醇升高以及肌酸激酶升高。巴瑞替尼是一种相对可耐受和安全的治疗严重斑秃的替代药物，尽管需要进一步研究来评估其长期疗效和安全性。参考文献：Singh R, Driscoll MS. Review of baricitinib in the treatment of alopecia areata. J Drugs Dermatol. 2023;22(9):935-939. doi:10.36849/JDD.7357.