IL-6受体单抗Kevzara,治疗新冠病毒COVID-19的III期临床失败

2020-07-03 MedSci原创 MedSci原创

赛诺菲和再生元宣布,在需要机械通气的新冠病毒COVID-19患者中,其风湿性关节炎药物Kevzara的III期试验失败。

赛诺菲(Sanofi)和再生元(Regeneron)宣布,在需要机械通气的新冠病毒COVID-19患者中,其风湿性关节炎药物Kevzara(sarilumab)400 mg的III期试验未能达到其主要和次要终点。根据结果​​,临床实验已停止,包括第二批接受更高800毫克剂量的患者。

See the source image

Kevzara是靶向白细胞介素-6(IL-6)受体的单抗药物。

Sanofi和Regeneron表示,在接受400 mg剂量组中观察到“较小的积极趋势”,但未达到统计学意义,并且在未插管的危重患者中被“阴性趋势抵消”。此外,80%的Kevzara患者和77%的安慰剂患者经历了不良事件。在接受Kevzara治疗的患者中,发生频率更高的严重不良事件包括多器官功能不全综合征(Kevzara发生率为6%,安慰剂为5%)以及低血压(发生率分别为4%和3%)。

Sanofi和Regeneron解释说,Kevzara试验是在中国进行的一项小型单臂研究后设计的,该研究在中国大部分重度发热住院的COVID-19患者中发现IL-6水平升高,并且使用罗氏的抗IL-6受体单抗Actemra/RoActemra(tocilizumab)可迅速减少发烧并改善氧合作用。

3月,罗氏在重度COVID-19肺炎住院患者中进行了III 期临床试验,以评估Actemra/RoActemra联合标准护理的治疗潜力。随后,该公司宣布与Gilead Sciences合作,评估Actemra/RoActemra与remdesivir的联合治疗潜力。

原始出处:

https://www.firstwordpharma.com/node/1737554?tsid=28&region_id=6

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encryptionId=acc0104634b, topicName=Kevzara)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=393b8160783, createdName=lifestar, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524832, encodeId=7054152483266, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594762, encodeId=68de1594e6214, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1028246, encodeId=9b5510282462a, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Fri Jul 03 09:38:10 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=801014, encodeId=49f88010140a, content=临床观察有多么不靠谱!<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/02/28/889a1910ded7780f3c049b354f1648b7.jpg, createdBy=2a791737770, createdName=mswert122, createdTime=Fri Jul 03 08:22:20 CST 2020, time=2020-07-03, status=1, ipAttribution=)]
    2020-08-12 1def5843m65(暂无匿称)

    没有多只有更!

    0

  5. 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createdBy=f00658, createdName=yyanpro@21cn.c, createdTime=Mon Dec 07 14:38:10 CST 2020, time=2020-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916293, encodeId=06811916293f8, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Fri Jan 08 12:38:10 CST 2021, time=2021-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=808185, encodeId=24688081857f, content=没有多只有更!, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7ced1734358, 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encryptionId=acc0104634b, topicName=Kevzara)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=393b8160783, createdName=lifestar, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524832, encodeId=7054152483266, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594762, encodeId=68de1594e6214, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1028246, encodeId=9b5510282462a, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Fri Jul 03 09:38:10 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=801014, encodeId=49f88010140a, content=临床观察有多么不靠谱!<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/02/28/889a1910ded7780f3c049b354f1648b7.jpg, createdBy=2a791737770, createdName=mswert122, createdTime=Fri Jul 03 08:22:20 CST 2020, time=2020-07-03, status=1, ipAttribution=)]
    2020-07-04 kzlchina
  6. 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encryptionId=acc0104634b, topicName=Kevzara)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=393b8160783, createdName=lifestar, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524832, encodeId=7054152483266, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sat Jul 04 21:38:10 CST 2020, time=2020-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594762, encodeId=68de1594e6214, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, 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channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/02/28/889a1910ded7780f3c049b354f1648b7.jpg, createdBy=2a791737770, createdName=mswert122, createdTime=Fri Jul 03 08:22:20 CST 2020, time=2020-07-03, status=1, ipAttribution=)]
    2020-07-04 lifestar
  7. 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  8. 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  9. 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    2020-07-03 公卫新人

    新冠肺炎,疫情何时才能消失

    0

  10. 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    2020-07-03 mswert122

    临床观察有多么不靠谱!#新冠肺炎#

    0

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