NEJM:巴瑞替尼治疗斑秃,40%患者头发覆盖能达到80%!(BRAVE-AA研究)

2022-03-27 MedSci原创 MedSci原创

斑秃

斑秃是一种自身免疫性疾病,其特点是头发、眉毛和睫毛脱落,且治疗有限。可发生于任何年龄,但以青壮年多见,两性发病率无明显差异。约 5%~10% 的斑秃可渐进性发展或迅速发展成全秃或普秃,全球范围内大约有 1.47 亿成人重度斑秃患者,中国大约有 400 万。

而Baricitinib 是一种每日口服一次的选择性、可逆性JAK1/2抑制剂,可以中断与斑秃发病机制有关的细胞因子传导信号。最初由 Incyte 公司开发,2009年12月,礼来与Incyte达成了Baricitinib的全球独家合作开发协议。迄今为止,该产品已在70多个国家获得批准,治疗中重度活动性类风湿性关节炎。2020年3月,FDA 授予Baricitinib用于治疗成人重度斑秃的突破性疗法认定。2022年2 月,美国 FDA 授予 Baricitinib治疗成人重度斑秃的优先审查权。去年的研究结果显示JAK抑制剂巴瑞替尼可恢复80%头发生长,可能是斑秃的良药!随着随访时间延长,疗效进一步提升。

Baricitinib(商品名:Olumiant,艾乐明)已经在全球70多个国家获批上市,用于治疗中重度活动性类风湿性关节炎。在欧盟和日本,还获批治疗接受过全身系统性治疗的中重度特应性皮炎成年患者。此前,Baricitinib已获得美国FDA授予的突破性疗法认定,用于治疗斑秃。

近日,《新英格兰医学杂志》也发表了文章“Two Phase 3 Trials of Baricitinib for Alopecia Areata”,介绍了Baricitinib 治疗斑秃的两项 III期试验结果。

图片

来源:《新英格兰医学杂志》

研究人员进行了两项随机、安慰剂对照的 3 期试验(BRAVE-AA1 和 BRAVE-AA2),在 BRAVE-AA1 试验中招募了 654 名患者,在 BRAVE-AA2 试验中招募了 546 名患者,共1200名患者完成了为期52周的治疗。两项研究均包含重度斑秃成年患者,定义为SALT评分≥50(头皮脱发面积大于等于50%)。基线时,受试者的平均SALT得分为85.5(85.5%头皮脱发)。‍患者随机接受 Baricitinib 4mg/日、Baricitinib 2mg/日与安慰剂。

BRAVE-AA1结果表明,在治疗36周后,4 mg巴瑞替尼,2 mg巴瑞替尼和安慰剂的SALT评分<=20(头皮脱发面积小于等于20%)分别为38.8%,22.8%和6.2%。BRAVE-AA2结果表明,在治疗36周后,4 mg巴瑞替尼,2 mg巴瑞替尼和安慰剂的SALT评分<=20分别为35.9%,19.4%和3.3%,结果是相似的。在BRAVE-AA1中,4mg巴瑞替尼与安慰剂的差异为32.6%(95%CI为25.6-39.5),2mg巴瑞替尼与安慰剂的差异为16.6%(95% CI, 9.5 to 23.8),均P<0.001。在BRAVE-AA2试验中相应的值分别为32.6(95% CI, 25.6 to 39.6)和16.1%(95% CI, 9.1 to 23.2),均P<0.001。

主要终点显示,在36 周时,口服4mg的Baricitinib效果优于2mg的Baricitinib,同时,口服Baricitinib的头皮毛发再生方面优于安慰剂。但是还需要更多的试验来评估Baricitinib治疗斑秃的疗效和安全性。

在最近几天召开的AAD年会上,礼来官网发布对斑秃患者进行为期52周的Baricitinib治疗效果的新闻。在52周时,近 75% 对 4mg的Baricitinib有反应并且头皮毛发覆盖率达到 90%。试验数据如下:

基线时,患者平均SALT为85.5。第52周时,接受4mg巴瑞替尼的患者中,39.0%的患者至少有80%的头发覆盖,其中74.1%有超过90%覆盖。

在服用4mg的Baricitinib的患者中,2/5的患者(39.0%,n=201/515)头发及毛发显著再生。3/4患者(74.1%,n=149/201)在 52 周时也达到了 SALT 评分≤10 或 90% 的头发覆盖率。另外,超过2/5 临床医生报告的结果 (ClinRO) 评分≥2 分的患者(眉毛:44.1%,n=154/349;睫毛:45.3%,n=139/307),眉毛和睫毛间隙出现小头发,实现毛发再生。

而服用2mg的Baricitinib的患者中,超过1/5的患者(22.6%,n=77/340)在52周时头发显著再生,其中2/3的患者在 52 周(67.5%,n=52/77)实现了头发覆盖率达到 90 % 甚至更多。另外,分别有超过1/5和1/4的患者(眉毛:22.9%,n=55/240;睫毛:25.5%,n=51/200)眉毛和睫毛间隙出现小头发,出现完全再生或再生。

不管是试验36周,还是52周(中位暴露时间为 56 周),服用Baricitinib发生的副作用一致,主要包括:上呼吸道道感染、头痛、痤疮、尿路感染和肌肉相关血液标志物增加等。

总而言之,Baricitinib的长期疗效数据显示它对头发、睫毛和眉毛有着显著再生效果。

2019年6月Baricitinib已在中国上市,用于治疗对甲氨蝶呤响应不足的中重度类风湿关节炎。而斑秃适应症在中国目前还处于III期临床研究阶段,期待它早日造福中国的斑秃患者。

关于艾乐明® (巴瑞替尼片)

巴瑞替尼是一款每天一次口服给药的JAK抑制剂,在全球超过70个国家和地区获批用于治疗中重度活动性类风湿关节炎(RA)成年患者。在中国获批的适应症为适用于对一种或多种改善病情抗风湿药(DMARD)疗效不佳或不耐受的中重度活动性类风湿关节炎成年患者。巴瑞替尼可以与甲氨蝶呤或其他非生物改善病情抗风湿药联合使用。

2009年12月,礼来制药与因赛特医疗宣布了针对巴瑞替尼研发、商业化以及相关后续化合物针对炎症性疾病、自身免疫性疾病的全球独占专利和合作协议。

参考资料:

King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata.N Engl J Med. 2022 Mar 26. doi: 10.1056/NEJMoa2110343

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    2022-10-05 ms7000001959689395

    剩下百分之60的恢复如何啊?

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    2023-06-04 ms7000001959689395 来自辽宁省

    剩下百分之60的患者恢复如何

    0

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    2022-05-17 赛华佗
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    2022-03-29 qindq
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    2022-03-27 12047943m00暂无昵称

    斑秃者**

    0

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