罗氏的白细胞介素6受体单抗Satralizumab治疗视神经脊髓炎谱系障碍的临床试验成功

2019-12-03 不详 MedSci原创

罗氏(Roche)宣布了其SAkuraSky研究的数据,该研究中评估了靶向白细胞介素6(IL-6)受体单抗satralizumab(SA237)用于治疗视神经脊髓炎谱系障碍(NMOSD)的安全性和疗效。NMOSD是一种中枢神经系统炎症。

罗氏(Roche)宣布了其SAkuraSky研究的数据,该研究评估了靶向白细胞介素6(IL-6)受体单抗satralizumab(SA237)用于治疗视神经脊髓炎谱系障碍(NMOSD)的安全性和疗效。NMOSD是一种中枢神经系统炎症。

试验结果显示,接受satralizumab联合基线免疫抑制剂治疗的41名患者中只有8名(20%)经历了方案中定义的复发(PDR),相比之下,接受安慰剂治疗的42名患者中有18名(43%)。

在第48、96和144周时,接受satralizumab联合基线治疗的患者中89%,78%和74%的患者无复发,而使用安慰剂联合基线治疗的患者分别为66%,59%和49% 。

在AQP4-IgG血清反应阳性亚组的分析显示,接受satralizumab治疗的27例AQP4-IgG血清学阳性患者中有3例(11%)经历了PDR,而接受安慰剂的28例患者中有12例(43%)。

satralizumab和安慰剂组之间发生严重不良事件的患者比例相似,与安慰剂组相比,用该药物治疗的患者感染率(包括严重感染)更低。

satralizumab在第零、第二和第四周进行皮下给药,然后每隔四周给药一次。该药物用于治疗NMOSD已在美国、欧洲和日本指定为孤儿药,并于2018年12月被FDA授予突破性疗法称号。

NMOSD患者经历不可预测的严重复发,直接导致累积的、永久的、神经系统的损害和残疾。该病常被误诊为多发性硬化症。

原始出处:


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style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Sun May 10 16:32:00 CST 2020, time=2020-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1666997, encodeId=f8e6166699e1b, content=<a href='/topic/show?id=5fda90e061e' target=_blank style='color:#2F92EE;'>#视神经#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90706, encryptionId=5fda90e061e, topicName=视神经)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=14db26078051, createdName=gj0740, createdTime=Sun Aug 16 19:32:00 CST 2020, time=2020-08-16, status=1, ipAttribution=), 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encryptionId=0240e17398f, topicName=白细胞介素6受体单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Wed May 27 03:32:00 CST 2020, time=2020-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483182, encodeId=4da41483182b3, content=<a href='/topic/show?id=abcd90e22c3' target=_blank style='color:#2F92EE;'>#视神经脊髓炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90722, encryptionId=abcd90e22c3, topicName=视神经脊髓炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a587885671, createdName=ms8538335253054589, createdTime=Thu Dec 05 00:32:00 CST 2019, time=2019-12-05, status=1, ipAttribution=)]
    2020-05-10 bsmagic9140
  5. 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encryptionId=0240e17398f, topicName=白细胞介素6受体单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Wed May 27 03:32:00 CST 2020, time=2020-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483182, encodeId=4da41483182b3, content=<a href='/topic/show?id=abcd90e22c3' target=_blank style='color:#2F92EE;'>#视神经脊髓炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90722, encryptionId=abcd90e22c3, topicName=视神经脊髓炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a587885671, createdName=ms8538335253054589, createdTime=Thu Dec 05 00:32:00 CST 2019, time=2019-12-05, status=1, ipAttribution=)]
    2020-08-16 gj0740
  6. 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  7. 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style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Sun May 10 16:32:00 CST 2020, time=2020-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1666997, encodeId=f8e6166699e1b, content=<a href='/topic/show?id=5fda90e061e' target=_blank style='color:#2F92EE;'>#视神经#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90706, encryptionId=5fda90e061e, topicName=视神经)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=14db26078051, createdName=gj0740, createdTime=Sun Aug 16 19:32:00 CST 2020, time=2020-08-16, status=1, ipAttribution=), 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encryptionId=0240e17398f, topicName=白细胞介素6受体单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Wed May 27 03:32:00 CST 2020, time=2020-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483182, encodeId=4da41483182b3, content=<a href='/topic/show?id=abcd90e22c3' target=_blank style='color:#2F92EE;'>#视神经脊髓炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90722, encryptionId=abcd90e22c3, topicName=视神经脊髓炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a587885671, createdName=ms8538335253054589, createdTime=Thu Dec 05 00:32:00 CST 2019, time=2019-12-05, status=1, ipAttribution=)]
  8. 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encryptionId=0240e17398f, topicName=白细胞介素6受体单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Wed May 27 03:32:00 CST 2020, time=2020-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483182, encodeId=4da41483182b3, content=<a href='/topic/show?id=abcd90e22c3' target=_blank style='color:#2F92EE;'>#视神经脊髓炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90722, encryptionId=abcd90e22c3, topicName=视神经脊髓炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a587885671, createdName=ms8538335253054589, createdTime=Thu Dec 05 00:32:00 CST 2019, time=2019-12-05, status=1, ipAttribution=)]
    2020-03-01 xlysu
  9. 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  10. 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