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JNNP:意大利多发性硬化患者中不同剂量那他珠单抗间隔给药方案的临床疗效

2020-10-17 MedSci原创 MedSci原创

那他珠单抗(NTZ;Tysabri)是一种人源性抗α4整合素单克隆抗体,可阻断淋巴细胞与内皮细胞的粘附,从而阻止其迁移到中枢神经系统(CNS)并减少炎症。NTZ在复发-缓解多发性硬化症研究

那他珠单抗(NTZ;Tysabri)是一种人源性抗α4整合素单克隆抗体,可阻断淋巴细胞与内皮细胞的粘附,从而阻止其迁移到中枢神经系统(CNS)并减少炎症。NTZ在复发-缓解多发性硬化症研究中的安全性和有效性研究显示,与安慰剂相比,NTZ能够将年化复发率(ARR)降低68%,新发或扩大的高强度病变的累积减少83%,12周持续残疾进展42%,24周持续残疾进展54%。那他珠单抗(NTZ)是治疗多发性硬化症(MS)最有效的治疗方案之一。作者的研究旨在与标准的4周给药策略相比。评估NTZ在意大利多发性硬化症人群中的有效性,

材料和方法:这项回顾性多中心研究包括2012年6月1日至2018年5月15日期间接受NTZ治疗的复发缓解型多发性硬化症(RR-MS)患者,随后进行“意大利MS登记”。所有MS患者根据NTZ给药时间表分为两组:标准间隔给药(SID)患者(平均28-32天)和延长间隔给药(EID),包括33-49天(中位数43)的患者。在基线检查时(开始使用NTZ前)、治疗12个月(T1)和24个月(T2)后评估临床数据。

结果:5231例RR-MS患者中,有2092例(平均年龄43.2±12.0,女性占60.6%)接受了NTZ治疗。根据SID,共有1254人(59.9%)接受了NTZ治疗,根据EID,共有838人(40.1%)接受了NTZ治疗。在12个月和24个月时,两组之间的年复发率和残疾状况没有差异。两组的进展指数和确诊的残疾恶化情况相似。

治疗多发性硬化症患者的医生一直试图平衡这种高效药物的风险和益处。EID患者的高数量已经反映出意大利临床医生倾向于偏离每月SID,并根据不同患者情况延迟NTZ给药。

 

与SID相比,使用延长间隔时间的NTZ显示出类似的效果。EID计划的临床疗效不变可能会引起在耐受性和安全性方面可能有优势的问题。

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    2021-05-31 jml2009
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1689100, encodeId=4427168910067, content=<a href='/topic/show?id=7e88952e86f' target=_blank style='color:#2F92EE;'>#那他珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95278, encryptionId=7e88952e86f, topicName=那他珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1dc28724374, createdName=ms9474365431325850, createdTime=Mon Jul 26 17:09:46 CST 2021, time=2021-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907205, encodeId=677f190e205d4, content=<a href='/topic/show?id=acc02289e40' target=_blank style='color:#2F92EE;'>#临床疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22897, encryptionId=acc02289e40, topicName=临床疗效)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8346212, createdName=respect, createdTime=Mon May 10 20:09:46 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890171, encodeId=607f18901e152, 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=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon May 31 19:09:46 CST 2021, time=2021-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805813, encodeId=7e2d180581370, content=<a href='/topic/show?id=e976e885830' target=_blank style='color:#2F92EE;'>#给药方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78858, encryptionId=e976e885830, topicName=给药方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Mon Aug 02 15:09:46 CST 2021, time=2021-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893126, encodeId=e6e68931269f, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Mon Oct 19 18:26:20 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1385473, encodeId=96cf13854e393, content=<a href='/topic/show?id=c31c5322844' target=_blank style='color:#2F92EE;'>#意大利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53228, encryptionId=c31c5322844, topicName=意大利)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ae503, createdName=pps20019, createdTime=Mon Oct 19 14:09:46 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892747, encodeId=972f892e4737, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Sun Oct 18 06:50:18 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032688, encodeId=9c6310326881a, 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=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun Oct 18 02:09:46 CST 2020, time=2020-10-18, status=1, ipAttribution=)]
    2020-10-19 1244c0ebm28暂无昵称

    学习学习

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1689100, encodeId=4427168910067, content=<a href='/topic/show?id=7e88952e86f' target=_blank style='color:#2F92EE;'>#那他珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95278, encryptionId=7e88952e86f, topicName=那他珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1dc28724374, createdName=ms9474365431325850, createdTime=Mon Jul 26 17:09:46 CST 2021, time=2021-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907205, encodeId=677f190e205d4, content=<a href='/topic/show?id=acc02289e40' target=_blank style='color:#2F92EE;'>#临床疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22897, encryptionId=acc02289e40, topicName=临床疗效)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8346212, createdName=respect, createdTime=Mon May 10 20:09:46 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890171, encodeId=607f18901e152, 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=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon May 31 19:09:46 CST 2021, time=2021-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805813, encodeId=7e2d180581370, content=<a href='/topic/show?id=e976e885830' target=_blank style='color:#2F92EE;'>#给药方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78858, encryptionId=e976e885830, topicName=给药方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Mon Aug 02 15:09:46 CST 2021, time=2021-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893126, encodeId=e6e68931269f, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Mon Oct 19 18:26:20 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1385473, encodeId=96cf13854e393, content=<a href='/topic/show?id=c31c5322844' target=_blank style='color:#2F92EE;'>#意大利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53228, encryptionId=c31c5322844, topicName=意大利)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ae503, createdName=pps20019, createdTime=Mon Oct 19 14:09:46 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892747, encodeId=972f892e4737, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Sun Oct 18 06:50:18 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032688, encodeId=9c6310326881a, 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=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun Oct 18 02:09:46 CST 2020, time=2020-10-18, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1689100, encodeId=4427168910067, content=<a href='/topic/show?id=7e88952e86f' target=_blank style='color:#2F92EE;'>#那他珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95278, encryptionId=7e88952e86f, topicName=那他珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1dc28724374, createdName=ms9474365431325850, createdTime=Mon Jul 26 17:09:46 CST 2021, time=2021-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907205, encodeId=677f190e205d4, content=<a href='/topic/show?id=acc02289e40' target=_blank style='color:#2F92EE;'>#临床疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22897, encryptionId=acc02289e40, topicName=临床疗效)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8346212, createdName=respect, createdTime=Mon May 10 20:09:46 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890171, encodeId=607f18901e152, 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=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon May 31 19:09:46 CST 2021, time=2021-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805813, encodeId=7e2d180581370, content=<a href='/topic/show?id=e976e885830' target=_blank style='color:#2F92EE;'>#给药方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78858, encryptionId=e976e885830, topicName=给药方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Mon Aug 02 15:09:46 CST 2021, time=2021-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893126, encodeId=e6e68931269f, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Mon Oct 19 18:26:20 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1385473, encodeId=96cf13854e393, content=<a href='/topic/show?id=c31c5322844' target=_blank style='color:#2F92EE;'>#意大利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53228, encryptionId=c31c5322844, topicName=意大利)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ae503, createdName=pps20019, createdTime=Mon Oct 19 14:09:46 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892747, encodeId=972f892e4737, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Sun Oct 18 06:50:18 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032688, encodeId=9c6310326881a, 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=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun Oct 18 02:09:46 CST 2020, time=2020-10-18, status=1, ipAttribution=)]
    2020-10-18 易水河

    学习学习

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1689100, encodeId=4427168910067, content=<a href='/topic/show?id=7e88952e86f' target=_blank style='color:#2F92EE;'>#那他珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95278, encryptionId=7e88952e86f, topicName=那他珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1dc28724374, createdName=ms9474365431325850, createdTime=Mon Jul 26 17:09:46 CST 2021, time=2021-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907205, encodeId=677f190e205d4, content=<a href='/topic/show?id=acc02289e40' target=_blank style='color:#2F92EE;'>#临床疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22897, encryptionId=acc02289e40, topicName=临床疗效)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8346212, createdName=respect, createdTime=Mon May 10 20:09:46 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890171, encodeId=607f18901e152, 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=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon May 31 19:09:46 CST 2021, time=2021-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805813, encodeId=7e2d180581370, content=<a href='/topic/show?id=e976e885830' target=_blank style='color:#2F92EE;'>#给药方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78858, encryptionId=e976e885830, topicName=给药方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b632500090, createdName=h.y200607_23674418, createdTime=Mon Aug 02 15:09:46 CST 2021, time=2021-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893126, encodeId=e6e68931269f, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Mon Oct 19 18:26:20 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1385473, encodeId=96cf13854e393, content=<a href='/topic/show?id=c31c5322844' target=_blank style='color:#2F92EE;'>#意大利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53228, encryptionId=c31c5322844, topicName=意大利)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ae503, createdName=pps20019, createdTime=Mon Oct 19 14:09:46 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892747, encodeId=972f892e4737, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Sun Oct 18 06:50:18 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032688, encodeId=9c6310326881a, 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=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun Oct 18 02:09:46 CST 2020, time=2020-10-18, status=1, ipAttribution=)]
    2020-10-18 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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近日Nature杂志子刊Nat. Rev. Neurol 新闻与观点一栏,就法国尼斯大学Cohen 博士等学者于2014年4月发表在JAMA Neurol 杂志上的多发性硬化(MS)转换疗法——那他珠单抗转换为芬戈莫德治疗一文,进行了评价与讨论。具体内容如下:那他珠单抗被批准用于多发性硬化症的治疗,开启了高效免疫调节新时代。遗憾的是,并非所有患者对那他珠单抗治疗均反应良好,并且它的益处也被进展性多

Lancet Neurol:那他珠单抗对延缓继发性多发性硬化患者疾病进展效果不佳

总体上,那他珠单抗对改善继发性多发性硬化患者疾病进展的效果不显著,但对可改善患者上肢运动能力有一定积极作用

Neurology:那他珠单抗治疗的多发性硬化症妇女妊娠决策-胎儿风险!

由此可见,该研究结果显示,妊娠12周以后暴露于那他珠单抗与SA风险增加有关,尽管处于一般人群的预期范围内,而CA的风险需要进一步研究。考虑到那他珠单抗混悬液引起疾病复发的高风险,可以计划继续使用那他珠单抗治疗,同时严格监测受孕情况。

Neurology:芬戈莫德治疗导致的进行性多灶性白质脑病风险极低

研究认为,对于未接受过那他珠单抗治疗的患者,接受芬戈莫德导致的进行性多灶性白质脑病风险极低,每1000患者的发病率为0.069,每100000患者年发病3.12例

Neurology:那他珠单抗治疗的多发性硬化症妇女妊娠决策-产妇风险!

总体而言,该研究结果表明从产妇风险的角度来看,避免那他珠单抗清除和分娩后早期恢复DMD的联合治疗是最佳的治疗选择。这种方法必须考虑到可能的胎儿风险,需要与产妇一并讨论,并需要进一步调查。

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