Lancet respirat med:托珠单抗治疗系统性硬化症的3期临床试验结果

2020-09-03 MedSci原创 MedSci原创

托珠单抗(tocilizumab)是一种抗白介素6受体抗体,已有的2期试验提示其在系统性硬化症中具有一定疗效。本研究进一步开展了一项随机对照3期试验,以评估托珠单抗系统性硬化症的疗效和安全性。

托珠单抗(tocilizumab)是一种抗白介素6受体抗体,已有的2期试验提示其在系统性硬化症中具有一定疗效。本研究进一步开展了一项多中心、随机、双盲、安慰剂为对照的3期试验,以评估托珠单抗系统性硬化症的疗效和安全性。

2015年11月20日-2017年2月14日,在20个国家的75处共招募了210位患有弥漫性皮肤系统性硬化不超过60个月、且校正的Rodnan皮肤评分(mRSS)在10-35分的患者,按1:1随机分至托珠单抗组(104位;162 mg,皮下注射,1/周,共48周)或安慰剂组(106位)。主要指标是48周时mRSS的变化。次要指标有48周时的预计用力肺活量的百分比(FVC%预测值)、治疗失败的时间、患者汇报和医生汇报的预后。

在意向治疗人群中,48周时,托珠单抗组mRSS较基线时的变化的最小乘方均值(LSM)为-6.14,而安慰剂组为-4.41(校正差值 -1.73,95% CI -3.78~0.32,p=0.10)。托珠单抗组48周时的预测FVC%也有明显改善,LSM差值 4.2(95% CI 2.0-6.4,p=0.0002),治疗失败时间也提示托珠单抗有较好疗效(风险比 0.63[95% CI 0.37-1.06],p=0.08)。与基线相比,48周时两组健康评估问卷-残疾指数和患者-全局和医师-全局视觉模拟量表评估的变化无明显差异。最常见的不良反应为感染(托珠单抗组 52%、安慰剂组 50%)。托珠单抗组和安慰剂组分别有13位和18位受试者发生重度不良反应:原发感染(3例 vs 8例)和血管事件(2例 vs 7例)。

皮肤纤维化的主要终点未达到。FVC%预计值的次要终点结果提示,托珠单抗治疗或可保护患者的肺功能。安全性问题如既往报道。

原始出处:

Dinesh Khanna, et al. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Respiratory Medicine. August 28, 2020.

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    期待更多的研究。

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createdName=howi, createdTime=Sat Oct 31 04:12:21 CST 2020, time=2020-10-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983135, encodeId=47c419831352c, 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=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Apr 14 10:12:21 CST 2021, time=2021-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1595517, encodeId=b8c4159551e28, content=<a href='/topic/show?id=371912932d' target=_blank style='color:#2F92EE;'>#3期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1293, encryptionId=371912932d, topicName=3期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=79cd18252620, createdName=slcumt, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610685, encodeId=c5711610685e6, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627387, encodeId=6a5e162e387f4, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033958, encodeId=ef8b1033958cc, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Sep 03 21:12:21 CST 2020, time=2020-09-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=882522, encodeId=dc9988252261, content=真, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200903/79d0f015e6084e5ca462828ca002414e/27d5d6b264cb4eeebf7092dc1fb8eae8.jpg, createdBy=22155415237, createdName=ms7000000139248197, createdTime=Thu Sep 03 18:21:25 CST 2020, time=2020-09-03, status=1, ipAttribution=)]
    2020-10-31 howi
  5. [GetPortalCommentsPageByObjectIdResponse(id=1056053, encodeId=e9a810560539e, content=期待更多的研究。, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfc84293490, createdName=13f0c37dm61暂无昵称, createdTime=Wed Sep 29 12:55:48 CST 2021, time=2021-09-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911255, encodeId=a1a31911255b9, content=<a href='/topic/show?id=18171289d6' target=_blank style='color:#2F92EE;'>#3期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1289, encryptionId=18171289d6, topicName=3期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d275294, createdName=andy2087, createdTime=Tue Jun 15 10:12:21 CST 2021, time=2021-06-15, status=1, ipAttribution=), 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topicName=3期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=79cd18252620, createdName=slcumt, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610685, encodeId=c5711610685e6, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627387, encodeId=6a5e162e387f4, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033958, encodeId=ef8b1033958cc, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Sep 03 21:12:21 CST 2020, time=2020-09-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=882522, encodeId=dc9988252261, content=真, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200903/79d0f015e6084e5ca462828ca002414e/27d5d6b264cb4eeebf7092dc1fb8eae8.jpg, createdBy=22155415237, createdName=ms7000000139248197, createdTime=Thu Sep 03 18:21:25 CST 2020, time=2020-09-03, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1056053, encodeId=e9a810560539e, content=期待更多的研究。, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfc84293490, createdName=13f0c37dm61暂无昵称, createdTime=Wed Sep 29 12:55:48 CST 2021, time=2021-09-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911255, encodeId=a1a31911255b9, content=<a href='/topic/show?id=18171289d6' target=_blank style='color:#2F92EE;'>#3期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1289, encryptionId=18171289d6, topicName=3期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d275294, createdName=andy2087, createdTime=Tue Jun 15 10:12:21 CST 2021, time=2021-06-15, status=1, ipAttribution=), 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topicName=3期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=79cd18252620, createdName=slcumt, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610685, encodeId=c5711610685e6, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627387, encodeId=6a5e162e387f4, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033958, encodeId=ef8b1033958cc, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Sep 03 21:12:21 CST 2020, time=2020-09-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=882522, encodeId=dc9988252261, content=真, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200903/79d0f015e6084e5ca462828ca002414e/27d5d6b264cb4eeebf7092dc1fb8eae8.jpg, createdBy=22155415237, createdName=ms7000000139248197, createdTime=Thu Sep 03 18:21:25 CST 2020, time=2020-09-03, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1056053, encodeId=e9a810560539e, content=期待更多的研究。, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfc84293490, createdName=13f0c37dm61暂无昵称, createdTime=Wed Sep 29 12:55:48 CST 2021, time=2021-09-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911255, encodeId=a1a31911255b9, content=<a href='/topic/show?id=18171289d6' target=_blank style='color:#2F92EE;'>#3期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1289, encryptionId=18171289d6, topicName=3期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d275294, createdName=andy2087, createdTime=Tue Jun 15 10:12:21 CST 2021, time=2021-06-15, status=1, ipAttribution=), 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topicName=3期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=79cd18252620, createdName=slcumt, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610685, encodeId=c5711610685e6, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627387, encodeId=6a5e162e387f4, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Sat Sep 05 09:12:21 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033958, encodeId=ef8b1033958cc, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Sep 03 21:12:21 CST 2020, time=2020-09-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=882522, encodeId=dc9988252261, content=真, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200903/79d0f015e6084e5ca462828ca002414e/27d5d6b264cb4eeebf7092dc1fb8eae8.jpg, createdBy=22155415237, createdName=ms7000000139248197, createdTime=Thu Sep 03 18:21:25 CST 2020, time=2020-09-03, status=1, ipAttribution=)]
  8. 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  9. 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    2020-09-03 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

  10. 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    2020-09-03 ms7000000139248197

    0

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