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Neurology:Occrelizumab在不同类型的多发性硬化症患者中的安全性

2021-09-08 Nebula MedSci原创

Ocrelizumab 在复发性或原发性进行性多发性硬化症患者中长期使用的安全性良好

Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。CD20阳性B细胞被认为是导致髓鞘和轴突损伤的关键因素,这种神经损伤可导致多发性硬化症(MS)患者残疾。

目前,Ocrelizumab 已获得了FDA批准用于治疗多发性硬化症。本文报告了 Ocrelizumab 用于复发性多发性硬化症(RMS)和原发性进行性多发性硬化症患者长达7年的安全性

安全性分析是基于11项临床试验(包括2期、3期和3b期试验)中接受 Ocrelizumab 治疗的所有患者的综合临床和实验室数据。对于选定的不良事件(AEs),使用额外的上市后数据。使用多种流行病学资料对严重感染 (SI) 和恶性肿瘤的发病率进行分析。

严重感染的年发生率

截止2020年1月时,共有5680位多发性硬化症患者接受了 Ocrelizumab 治疗(共暴露了18218个患者·年[PY])。在接受 Ocrelizumab 治疗的患者中,不良事件(AE)的发生率为 248 例/100 患者·年(范围 246-251),严重 AE、输液相关反应和感染的发生率分别是 7.3(7.0-7.7)、25.9(25.1-26.6)和 76.2(74.9-77.4)/100 患者·年;在3期试验治疗过程中,Ocrelizumab组的不良事件发生率与对照组的相近最常见的严重 AE(包括 SI 和恶性肿瘤)的发生率与流行病学数据报告的范围一致

综上,无论是在临床试验中持续使用长达 7 年,还是在现实世界中广泛使用超过 3 年,Ocrelizumab 在复发性或原发性进行性多发性硬化症患者中的安全性均良好。

原始出处:

Hauser Stephen L,Kappos Ludwig,Montalban Xavier et al. Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis.[J] .Neurology, 2021, https://doi.org/10.1212/WNL.0000000000012700

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    2021-11-02 yinhl1978
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    2022-04-23 jml2009
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  5. 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encodeId=e2d41015892bb, content=Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd984965877, createdName=1453df99m58暂无昵称, createdTime=Wed Sep 08 23:19:41 CST 2021, time=2021-09-08, status=1, ipAttribution=)]
    2022-04-22 snf701207
  6. 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encodeId=e2d41015892bb, content=Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd984965877, createdName=1453df99m58暂无昵称, createdTime=Wed Sep 08 23:19:41 CST 2021, time=2021-09-08, status=1, ipAttribution=)]
    2021-09-10 zhaojie88
  7. 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encodeId=e2d41015892bb, content=Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd984965877, createdName=1453df99m58暂无昵称, createdTime=Wed Sep 08 23:19:41 CST 2021, time=2021-09-08, status=1, ipAttribution=)]
    2021-09-10 HinsMax
  8. [GetPortalCommentsPageByObjectIdResponse(id=1983185, encodeId=098b1983185ec, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Sun Jan 30 11:17:38 CST 2022, time=2022-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2001468, encodeId=6dbd200146868, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, 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encodeId=e2d41015892bb, content=Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd984965877, createdName=1453df99m58暂无昵称, createdTime=Wed Sep 08 23:19:41 CST 2021, time=2021-09-08, status=1, ipAttribution=)]
    2021-09-09 查查佳佳

    哦靠天咯是咯矿咯啊伏特加

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1983185, encodeId=098b1983185ec, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Sun Jan 30 11:17:38 CST 2022, time=2022-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2001468, encodeId=6dbd200146868, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, 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encodeId=e2d41015892bb, content=Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd984965877, createdName=1453df99m58暂无昵称, createdTime=Wed Sep 08 23:19:41 CST 2021, time=2021-09-08, status=1, ipAttribution=)]
    2021-09-09 与狼共舞

    学习学习

    0

  10. 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encodeId=e2d41015892bb, content=Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd984965877, createdName=1453df99m58暂无昵称, createdTime=Wed Sep 08 23:19:41 CST 2021, time=2021-09-08, status=1, ipAttribution=)]
    2021-09-08 1453df99m58暂无昵称

    Ocrelizumab(OCR)是一种人源化的抗CD20 单克隆抗体,可选择性地靶向CD20阳性B细胞。

    0

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