Ann Rheum Dis:托法替尼治疗强直性脊柱炎的III期试验结果

2021-07-20 xiangting MedSci原创

在活动性 AS 成年患者中,托法替尼的疗效更好。

这项研究评估了托法替尼对强直性脊柱炎(AS)成年患者的疗效和安全性。

                                       

这是一项 III 期、随机、双盲、安慰剂对照研究,纳入年龄≥18岁的活动性 AS患者,这些患者符合改良的纽约标准,并且2 种以上的非甾体类药物疗效不佳。按 1:1比例将患者随机分配接受托法替尼 5mg每天两次或安慰剂治疗,共 16 周。第 16 周后,所有患者均接受开放标签托法替尼治疗直至第 48 周。主要和次要终点分别是第 16 周国际脊柱关节炎学会改善≥20%(ASAS20) 和改善≥40% (ASAS40) 的应答率。同时评估了安全性。

 

结果如下:269 名患者被随机分组:托法替尼组,n=133;安慰剂组,n=136。第 16 周时,托法替尼组的 ASAS20 应答率(56.4%,75人)明显高于安慰剂组(29.4%,40人)(p<0.0001),托法替尼组ASAS40 应答率(40.6%,54人)也明显高于安慰剂组(12.5%,17 人)(p<0.0001)。第 16 周时,托法替尼组和安慰剂组分别有 73 名患者 (54.9%) 和  70 名患者 (51.5%) 出现不良事件; 2 名患者(1.5%)和 1 名患者(0.7%)有严重不良事件。第 48 周时,托法替尼组的133 名患者中有 3 名 (2.3%) 出现肝脏事件, 3 名患者 (2.3%) 出现不严重的带状疱疹, 1 名 患者(0.8%) 出现重症感染;安慰剂组2 名患者 (1.5%) 患者出现不严重的带状疱疹。没有死亡、恶性肿瘤、主要不良血管事件血栓栓塞或机会性感染发生。

                                            图:48周内托法替尼与安慰剂的疗效比较

由此可见,在活动性 AS 成年患者中,托法替尼的疗效更好。没有发现新的安全隐患。

 

原始出处:

Atul Deodhar. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study . Ann Rheum Dis. August  2021.

 

 

 

 

 

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    2022-03-07 医者仁者

    国内翻译为#托法替布#的更多

    0

  3. 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    2021-07-20 谦逊

    托法替尼和托法替布是一个药吧

    1

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  4. 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createdName=1249898am16暂无昵称, createdTime=Thu Jul 22 03:06:26 CST 2021, time=2021-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594910, encodeId=5cae159491071, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu Jul 22 03:06:26 CST 2021, time=2021-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1001113, encodeId=e5bf10011131d, content=好文章,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Jul 20 12:17:28 CST 2021, time=2021-07-20, status=1, ipAttribution=)]
    2021-12-15 zywlvao
  5. [GetPortalCommentsPageByObjectIdResponse(id=2013658, encodeId=0c75201365825, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Mon Mar 28 10:06:26 CST 2022, time=2022-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1200145, encodeId=229512001452c, content=国内翻译为<a href='/topic/show?id=d15b546e9f7' target=_blank style='color:#2F92EE;'>#托法替布#</a>的更多, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54679, encryptionId=d15b546e9f7, topicName=托法替布)], attachment=null, authenticateStatus=null, 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createdName=1249898am16暂无昵称, createdTime=Thu Jul 22 03:06:26 CST 2021, time=2021-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594910, encodeId=5cae159491071, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu Jul 22 03:06:26 CST 2021, time=2021-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1001113, encodeId=e5bf10011131d, content=好文章,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Jul 20 12:17:28 CST 2021, time=2021-07-20, status=1, ipAttribution=)]
    2021-12-27 juliusluan78
  6. [GetPortalCommentsPageByObjectIdResponse(id=2013658, encodeId=0c75201365825, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Mon Mar 28 10:06:26 CST 2022, time=2022-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1200145, encodeId=229512001452c, content=国内翻译为<a href='/topic/show?id=d15b546e9f7' target=_blank style='color:#2F92EE;'>#托法替布#</a>的更多, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54679, encryptionId=d15b546e9f7, topicName=托法替布)], attachment=null, authenticateStatus=null, 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createdName=1249898am16暂无昵称, createdTime=Thu Jul 22 03:06:26 CST 2021, time=2021-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594910, encodeId=5cae159491071, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu Jul 22 03:06:26 CST 2021, time=2021-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1001113, encodeId=e5bf10011131d, content=好文章,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Jul 20 12:17:28 CST 2021, time=2021-07-20, status=1, ipAttribution=)]
  7. 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  8. 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  9. 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    2021-07-20 yangchou

    好文章,谢谢分享

    0

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