NEJM:诺华每月注射一次的奥法木单抗ofatumumab在多发性硬化症患者中展现优越疗效

2020-08-06 MedSci原创 MedSci原创

如果获批,ofatumumab将成为首个患者可以自行注射治疗的B细胞疗法,并且有可能成为复发型多发性硬化症的首选疗法。

诺华公司今天宣布《新英格兰医学杂志》(NEJM)发表了ASCLEPIOS I和II研究的阳性结果,这些研究评估了在复发型多发性硬化症(RMS)成年患者中,每月皮下注射一次奥法木单抗(ofatumumab,OMB157)与每天口服一次特立氟胺(Teriflunomide)相比的安全性和有效性。两项研究均达到主要终点,ofatumumab组患者的复发率显着降低。

Ofatumumab(OMB157)是全人源抗CD20单克隆抗体(mAb),可通过每月一次自行皮下注射给药。临床前研究证明,ofatumumab与CD20分子上独特的表位结合,诱导B细胞裂解和耗竭。

图片来源:https://www.slideshare.net/ESOSLIDES/2-stathis-10400840

ASCLEPIOS I和II研究招募了1882名18-55岁的MS患者,两项研究中Ofatumumab治疗组的年复发率(ARR)显着降低了51%(0.11对0.22)和58%(0.10对0.25),p<.001(实验的主要终点)。与特立氟胺相比,Ofatumumab在3个月将残疾加重(CDW)的相对危险度降低了34%(P = .002),在6个月将CDW的相对危险度降低了32%(P = .01)(实验的次要终点)。

Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med 2020;383:546-57. DOI: 10.1056/NEJMoa1917246

加州大学旧金山分校神经科学研究所主任Stephen L. Hauser说:“ ASCLEPIOS研究发现,ofatumumab可以显着减少新发炎症,并减少临床复发和进展事件。与特立氟胺相比,Ofatumumab对于RMS患者而言是一种潜在的新选择,具有可比的安全性,并且患者只需每月自行注射一次,非常灵活便利。”

2月,美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)分别接受了该公司的ofatumumab补充生物制剂许可申请(sBLA)和市场许可申请(MAA),用于治疗复发性多发性硬化症成年患者。如果获得批准,ofatumumab将是第一种可以在家中自行治疗的B细胞疗法,并且有可能成为RMS患者的首选疗法。

ofatumumab预计将于2020年9月在美国获得批准,到2021年第二季度将在欧洲获得批准。

原始出处:

https://www.firstwordpharma.com/node/1746854?tsid=4

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    2020-08-21 aweng

    神经科的堡垒正在一个个被攻克

    0

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    2020-12-12 snf701207
  6. [GetPortalCommentsPageByObjectIdResponse(id=1983125, encodeId=153d198312561, 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=37, 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=Thu May 20 12:49:13 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029961, encodeId=90ce2029961a7, content=<a href='/topic/show?id=d493e259c9' target=_blank style='color:#2F92EE;'>#fat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7259, encryptionId=d493e259c9, topicName=fat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Tue Nov 17 02:49:13 CST 2020, time=2020-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890143, encodeId=c8561890143ae, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Mon Apr 12 17:49:13 CST 2021, time=2021-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=811655, encodeId=0a9c811655aa, content=神经科的堡垒正在一个个被攻克, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTK2Cc3vDj2vOC1lhEK938ZDiaWPhkqXsH9j1RQXrNjZ4CzRias9MD5SSKTudxpLU6aAWXHrBm0YaWiaA/132, createdBy=57fa2297094, createdName=aweng, createdTime=Fri Aug 21 07:25:01 CST 2020, time=2020-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912421, encodeId=7f72191242138, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Dec 12 00:49:13 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282812, encodeId=23091282812ab, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sat Aug 08 08:49:13 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032605, encodeId=4b0e10326057d, 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=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Aug 06 20:49:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035374, encodeId=577c10353e445, 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=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Aug 06 20:49:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806601, encodeId=92fe80660157, content=好,不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200806/db94290124ad49009e7c09ddbf5766e8/92168638124c410b8d9628a01c24b855.jpg, createdBy=8da12551307, createdName=胃肠外科, createdTime=Thu Aug 06 18:43:33 CST 2020, time=2020-08-06, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1983125, encodeId=153d198312561, 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=37, 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=Thu May 20 12:49:13 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029961, encodeId=90ce2029961a7, content=<a href='/topic/show?id=d493e259c9' target=_blank style='color:#2F92EE;'>#fat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7259, encryptionId=d493e259c9, topicName=fat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Tue Nov 17 02:49:13 CST 2020, time=2020-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890143, encodeId=c8561890143ae, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Mon Apr 12 17:49:13 CST 2021, time=2021-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=811655, encodeId=0a9c811655aa, content=神经科的堡垒正在一个个被攻克, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTK2Cc3vDj2vOC1lhEK938ZDiaWPhkqXsH9j1RQXrNjZ4CzRias9MD5SSKTudxpLU6aAWXHrBm0YaWiaA/132, createdBy=57fa2297094, createdName=aweng, createdTime=Fri Aug 21 07:25:01 CST 2020, time=2020-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912421, encodeId=7f72191242138, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Dec 12 00:49:13 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282812, encodeId=23091282812ab, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sat Aug 08 08:49:13 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032605, encodeId=4b0e10326057d, 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=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Aug 06 20:49:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035374, encodeId=577c10353e445, 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=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Aug 06 20:49:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806601, encodeId=92fe80660157, content=好,不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200806/db94290124ad49009e7c09ddbf5766e8/92168638124c410b8d9628a01c24b855.jpg, createdBy=8da12551307, createdName=胃肠外科, createdTime=Thu Aug 06 18:43:33 CST 2020, time=2020-08-06, status=1, ipAttribution=)]
    2020-08-06 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2020-08-06 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

  9. [GetPortalCommentsPageByObjectIdResponse(id=1983125, encodeId=153d198312561, 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=37, 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=Thu May 20 12:49:13 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029961, encodeId=90ce2029961a7, content=<a href='/topic/show?id=d493e259c9' target=_blank style='color:#2F92EE;'>#fat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7259, encryptionId=d493e259c9, topicName=fat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Tue Nov 17 02:49:13 CST 2020, time=2020-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890143, encodeId=c8561890143ae, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Mon Apr 12 17:49:13 CST 2021, time=2021-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=811655, encodeId=0a9c811655aa, content=神经科的堡垒正在一个个被攻克, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTK2Cc3vDj2vOC1lhEK938ZDiaWPhkqXsH9j1RQXrNjZ4CzRias9MD5SSKTudxpLU6aAWXHrBm0YaWiaA/132, createdBy=57fa2297094, createdName=aweng, createdTime=Fri Aug 21 07:25:01 CST 2020, time=2020-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912421, encodeId=7f72191242138, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Dec 12 00:49:13 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282812, encodeId=23091282812ab, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sat Aug 08 08:49:13 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032605, encodeId=4b0e10326057d, 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=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Aug 06 20:49:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035374, encodeId=577c10353e445, 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=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Aug 06 20:49:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806601, encodeId=92fe80660157, content=好,不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200806/db94290124ad49009e7c09ddbf5766e8/92168638124c410b8d9628a01c24b855.jpg, createdBy=8da12551307, createdName=胃肠外科, createdTime=Thu Aug 06 18:43:33 CST 2020, time=2020-08-06, status=1, ipAttribution=)]
    2020-08-06 胃肠外科

    好,不错

    0

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