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NEJM:利格珠单抗治疗慢性自发性荨麻疹的疗效分析

2019-10-03 xing.T MedSci原创

由此可见,与使用奥马珠单抗或安慰剂相比,慢性自发性荨麻疹患者使用72 mg或240 mg的利格珠单抗治疗的症状完全控制率更高。

在大多数慢性自发性荨麻疹患者中,绝大部分当前可用的疗法并不能完全控制症状。利格珠单抗是下一代高亲和力的人源化单克隆抗IgE抗体。对于在批准剂量或增加剂量的H1-抗组胺药治疗后症状未充分控制的中度至重度慢性自发性荨麻疹患者中,关于利格珠单抗的剂量反应关系以及利格珠单抗与奥马珠单抗和安慰剂相比的疗效和安全性数据十分有限。

近日,顶级医学期刊NEJM上发表了一篇研究文章,在2b期剂量寻找试验中,研究人员随机分配患者接受每4周皮下注射24 mg、72 mg或240 mg利格珠单抗、300 mg剂量奥马珠单抗或安慰剂,持续治疗20周,或单剂量120毫克利格珠单抗治疗。荨麻疹、瘙痒和血管性水肿的疾病症状通过每周活动评分进行监测。该研究的主要目的是确定完全控制荨麻疹的剂量-反应关系(以每周一次的荨麻疹严重程度评分,从0到21,得分越高表明严重程度越高);该反应的主要终点在第12周进行评估。每周一次的荨麻疹活动评分为0表明了症状的完全控制(从0到42,评分越高,表明严重程度越高)。在整个试验过程中对安全性进行了分析。

该研究共有382名患者接受了随机分组。在第12周,接受24 mg、72 mg和240 mg利格珠单抗治疗的患者中分别有30%、51%和42%的患者完全控制了荨麻疹,而相比之下,奥马珠单抗组只有26%的患者,安慰剂组无患者完全控制了荨麻疹。研究人员明确了剂量反应关系。在第12周时,接受24 mg、72 mg和240 mg的利格珠单抗治疗的患者分别有30%、44%和40%的患者完全控制了症状,相比之下,奥马珠单抗组只有26%的患者,安慰剂组无患者完全控制了症状。在这项小型且简短的试验中,没有出现关于利格珠单抗或奥马珠单抗的安全性问题。

由此可见,与使用奥马珠单抗或安慰剂相比,慢性自发性荨麻疹患者使用72 mg或240 mg的利格珠单抗治疗的症状完全控制率更高。 

原始出处:

Marcus Maurer,et al.Ligelizumab for Chronic Spontaneous Urticaria.NEJM.2019.https://www.nejm.org/doi/full/10.1056/NEJMoa1900408

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    2019-10-05 zhaojie88
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  5. [GetPortalCommentsPageByObjectIdResponse(id=2028867, encodeId=1df9202886e6f, content=<a href='/topic/show?id=67573230860' target=_blank style='color:#2F92EE;'>#利格珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32308, encryptionId=67573230860, topicName=利格珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a5712500001, createdName=晓辰, createdTime=Tue Apr 14 22:52:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1647254, encodeId=a672164e25457, content=<a href='/topic/show?id=e9bae04003f' target=_blank style='color:#2F92EE;'>#疗效分析#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70400, encryptionId=e9bae04003f, topicName=疗效分析)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=219323401160, createdName=rebeccajiejie, createdTime=Thu Aug 06 21:52:00 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355581, encodeId=4dc7135558175, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378790, encodeId=e53413e87903d, content=<a href='/topic/show?id=f263536e74f' target=_blank style='color:#2F92EE;'>#慢性自发性荨麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53677, encryptionId=f263536e74f, topicName=慢性自发性荨麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5319428, createdName=jjjiang0199, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530602, encodeId=7e861530602d2, content=<a href='/topic/show?id=ed4a860e872' target=_blank style='color:#2F92EE;'>#自发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86078, encryptionId=ed4a860e872, topicName=自发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=584a12117168, createdName=sodoo, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032298, encodeId=4774103229811, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Oct 03 15:52:00 CST 2019, time=2019-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1034970, encodeId=823a10349e068, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Oct 03 15:52:00 CST 2019, time=2019-10-03, status=1, ipAttribution=)]
    2019-10-05 sodoo
  6. [GetPortalCommentsPageByObjectIdResponse(id=2028867, encodeId=1df9202886e6f, content=<a href='/topic/show?id=67573230860' target=_blank style='color:#2F92EE;'>#利格珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32308, encryptionId=67573230860, topicName=利格珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a5712500001, createdName=晓辰, createdTime=Tue Apr 14 22:52:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1647254, encodeId=a672164e25457, content=<a href='/topic/show?id=e9bae04003f' target=_blank style='color:#2F92EE;'>#疗效分析#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70400, encryptionId=e9bae04003f, topicName=疗效分析)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=219323401160, createdName=rebeccajiejie, createdTime=Thu Aug 06 21:52:00 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355581, encodeId=4dc7135558175, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378790, encodeId=e53413e87903d, content=<a href='/topic/show?id=f263536e74f' target=_blank style='color:#2F92EE;'>#慢性自发性荨麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53677, encryptionId=f263536e74f, topicName=慢性自发性荨麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5319428, createdName=jjjiang0199, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530602, encodeId=7e861530602d2, content=<a href='/topic/show?id=ed4a860e872' target=_blank style='color:#2F92EE;'>#自发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86078, encryptionId=ed4a860e872, topicName=自发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=584a12117168, createdName=sodoo, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032298, encodeId=4774103229811, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Oct 03 15:52:00 CST 2019, time=2019-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1034970, encodeId=823a10349e068, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Oct 03 15:52:00 CST 2019, time=2019-10-03, status=1, ipAttribution=)]
    2019-10-03 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=2028867, encodeId=1df9202886e6f, content=<a href='/topic/show?id=67573230860' target=_blank style='color:#2F92EE;'>#利格珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32308, encryptionId=67573230860, topicName=利格珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a5712500001, createdName=晓辰, createdTime=Tue Apr 14 22:52:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1647254, encodeId=a672164e25457, content=<a href='/topic/show?id=e9bae04003f' target=_blank style='color:#2F92EE;'>#疗效分析#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70400, encryptionId=e9bae04003f, topicName=疗效分析)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=219323401160, createdName=rebeccajiejie, createdTime=Thu Aug 06 21:52:00 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355581, encodeId=4dc7135558175, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378790, encodeId=e53413e87903d, content=<a href='/topic/show?id=f263536e74f' target=_blank style='color:#2F92EE;'>#慢性自发性荨麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53677, encryptionId=f263536e74f, topicName=慢性自发性荨麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5319428, createdName=jjjiang0199, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530602, encodeId=7e861530602d2, content=<a href='/topic/show?id=ed4a860e872' target=_blank style='color:#2F92EE;'>#自发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86078, encryptionId=ed4a860e872, topicName=自发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=584a12117168, createdName=sodoo, createdTime=Sat Oct 05 03:52:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032298, encodeId=4774103229811, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Oct 03 15:52:00 CST 2019, time=2019-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1034970, encodeId=823a10349e068, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Oct 03 15:52:00 CST 2019, time=2019-10-03, status=1, ipAttribution=)]
    2019-10-03 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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