NEJM:anifrolumab用于治疗系统性红斑狼疮

2019-12-19 MedSci MedSci原创

研究认为,对于系统性红斑狼疮患者, anifrolumab治疗后应答率高于安慰剂,在减少糖皮质激素剂量,改善皮肤病严重程度方面有显著效果

Aniforlumab是一种抗I型干扰素受体亚单位1单克隆抗体,用于治疗系统性红斑狼疮(SLE),在之前的III期临床试验中未达到主要终点,近日研究人员公布了该研究的次要终点结果。

SLE患者,在48周内每4周接受一次静脉注射anifrolumab(300毫克)或安慰剂。本试验的主要终点是第52周的反应,定义为BICLA评估的中到重度疾病活动减少,以及9个器官系统中无系统恶化,系统性红斑狼疮疾病活动指数无恶化,医生疾病活动的整体评估得分不增加0.3分或更高(从0[无疾病活动]至3[严重疾病])。次要终点包括基线时干扰素基因特异性患者的BICLA反应、糖皮质激素剂量减少、皮肤疾病严重程度降低、关节肿胀和软化计数减少以及年化耀斑率减少。

362名患者参与研究:180名患者接受了anifrolumab,182名患者接受了安慰剂。有BICLA反应的患者比例,anifrolumab组为47.8%,安慰剂组为31.5%(差异16.3%)。在具有高干扰素基因特征的患者中,anifrolumab组和安慰剂组的应答率分别为48.0%和30.7%;在具有低干扰素基因特征的患者中,应答率分别为46.7%和35.5%。次要终点中,糖皮质激素剂量和皮肤病的严重程度显著改善,但关节肿胀、软化和年化耀斑率差异不显著。接受anifrolumab治疗的患者中,带状疱疹和支气管炎的发生率分别为7.2%和12.2%。anifrolumab组有1例患者死于肺炎。

研究认为,对于系统性红斑狼疮患者, anifrolumab治疗后应答率高于安慰剂,在减少糖皮质激素剂量,改善皮肤病严重程度方面有显著效果。

原始出处:

Eric F. Morand et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med, December 18, 2019.

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    2020-08-25 huangshifeng
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    2020-01-27 snf701207
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    2019-12-21 zhouqu_8
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  7. [GetPortalCommentsPageByObjectIdResponse(id=2036500, encodeId=458720365000e, content=<a href='/topic/show?id=20059469f6' target=_blank style='color:#2F92EE;'>#IFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9469, encryptionId=20059469f6, topicName=IFR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b30d401, createdName=huangshifeng, createdTime=Tue Aug 25 06:53:00 CST 2020, time=2020-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2017194, encodeId=73e0201e194fb, content=<a href='/topic/show?id=9760e69058c' target=_blank style='color:#2F92EE;'>#系统性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76905, encryptionId=9760e69058c, topicName=系统性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2b9b368, createdName=qingrejiedu, createdTime=Fri May 15 13:53:00 CST 2020, time=2020-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912274, encodeId=14fd19122e434, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Jan 27 22:53:00 CST 2020, time=2020-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387380, encodeId=a4dd138e380a4, content=<a href='/topic/show?id=8a3a6814425' target=_blank style='color:#2F92EE;'>#狼疮#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68144, encryptionId=8a3a6814425, topicName=狼疮)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6e2500005, createdName=sunrural_42825357, createdTime=Sat Dec 21 08:53:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1436239, encodeId=ade7143623993, content=<a href='/topic/show?id=22f8e71238d' target=_blank style='color:#2F92EE;'>#红斑#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77123, encryptionId=22f8e71238d, topicName=红斑)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Sat Dec 21 08:53:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530180, encodeId=37f61530180d6, content=<a href='/topic/show?id=acdc25317a' target=_blank style='color:#2F92EE;'>#anifrolumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2531, encryptionId=acdc25317a, topicName=anifrolumab)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d8af12034197, createdName=lancelotzzl, createdTime=Sat Dec 21 08:53:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035053, encodeId=3eb81035053d0, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Dec 19 20:53:00 CST 2019, time=2019-12-19, status=1, ipAttribution=)]
    2019-12-19 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

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