Lancet子刊:依匹单抗用于预防偏头痛的安全性和有效性研究

2022-06-29 MedSci原创 MedSci原创

该研究表明伊匹单抗可能是预防偏头痛患者疾病发作的有效治疗选择。

靶向CGRP的单克隆抗体依匹单抗在3期试验中显示了从输液后第二天即可预防的偏头痛以及可接受的安全性和耐受性,但对以前预防治疗失败的患者亚群的益处没有进行研究。为此,来自lancet neurology旨在研究依匹单抗在成人偏头痛患者中预防偏头痛的安全性和有效性,以及此前2-4次预防治疗失败的情况。

DELIVER是一项多中心、多臂的3b期试验,包括24周的双盲、安慰剂对照期和48周的剂量盲法扩展研究。从欧洲(n=93)和美国(n=3)的96个研究地点招募了患有发作性或慢性偏头痛的成人,每月至少有4个偏头痛日,并有证据表明在过去10年内曾有2-4次预防性治疗失败的记录。

患者通过一个集中的随机系统被随机分配(1:1:1),按基线月度头痛天数和国家分层,分配依匹单抗100mg、300mg或安慰剂。主要疗效终点是第1-12周平均每月偏头痛天数较从基线开始的变化。

在2020年6月1日至2021年10月7日期间,891人被随机分配并接受了至少一个剂量的研究药物(依匹单抗100mg n=299[34%],依匹单抗300mg n=294[33%],安慰剂n=298[33%])。865名患者完成了安慰剂对照期。从基线到第1-12周,平均每月偏头痛天数的变化是:依匹单抗100mg -4.8,依匹单抗300mg -5.3,安慰剂-2.1。

与安慰剂相比,与基线相比,每月平均偏头痛天数的变化,伊匹单抗100毫克 -2.7; 伊匹单抗300毫克-3.2,差异显著。伊匹单抗100毫克组42%的患者发生了治疗突发的不良事件, 300毫克组为41%,安慰剂组为40%。

综上,该研究表明伊匹单抗可能是预防偏头痛患者疾病发作的有效治疗选择。

 

参考文献:

Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial

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    2022-11-22 howi
  4. [GetPortalCommentsPageByObjectIdResponse(id=2066706, encodeId=a5762066e06e4, content=<a href='/topic/show?id=1d3d45e090e' target=_blank style='color:#2F92EE;'>#安全性和有效性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45709, encryptionId=1d3d45e090e, topicName=安全性和有效性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/E33DC517C2EC449E463E3D01D81745BA/100, createdBy=75e12500157, createdName=ms1756883563247400, createdTime=Sat Feb 04 22:14:41 CST 2023, time=2023-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1820084, encodeId=71661820084b6, content=<a href='/topic/show?id=fa3a10028630' target=_blank style='color:#2F92EE;'>#预防偏头痛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100286, encryptionId=fa3a10028630, topicName=预防偏头痛)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c737344, createdName=lg.zhao, createdTime=Tue Jan 03 08:14:41 CST 2023, time=2023-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831597, encodeId=64d7183159e30, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Tue Nov 22 04:14:41 CST 2022, time=2022-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1244028, encodeId=b48212440289e, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Thu Jun 23 01:14:41 CST 2022, time=2022-06-23, status=1, ipAttribution=)]
    2022-06-23 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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