Nat Commun:Tofacitinib治疗系统性红斑狼疮的1期临床试验结果

2021-06-08 haibei MedSci原创

30名受试者以2:1的区间随机接受tofacitinib(5毫克,每天两次)或安慰剂治疗。这项研究的主要结果是tofacitinib的安全性和耐受性。次要结果包括临床反应和机制研究。

系统性红斑狼疮(SLE)的发病机制涉及多种先天和适应性免疫途径的失调。先天免疫系统的作用,特别是I型干扰素、低密度中性粒细胞和中性粒细胞胞外陷阱(NETs),现在被认为是系统性红斑狼疮发病机制及其相关血管损伤的重要潜在参与者。

已有的研究显示,心血管疾病(CVD)和过早动脉硬化的风险在系统性红斑狼疮中明显增加,特别是在年轻女性中。遗憾的是,至今为止,人们在调节系统性红斑狼疮血管病变、动脉粥样硬化的发展和进展上付出的努力一直不成功。

系统性红斑狼疮的免疫失调特点被认为在推动过早的动脉粥样硬化方面起着突出的作用。具体来说,I型干扰素(IFN)途径和被称为低密度粒细胞(LDG)的独特中性粒细胞亚群显示出增强的形成中性粒细胞胞外陷阱(NETs)的能力,已被直接牵涉到血管损伤、动脉粥样硬化斑块形成和CVD的进展中。

Janus激酶/信号转导者和转录激活者(JAK/STAT)途径是一个基本的信号级联,被细胞用来应对各种细胞因子和生长因子的影响。

已有的研究显示,在狼疮动物模型中,Janus激酶(JAK)抑制剂tofacitinib可改善临床疾病特征、免疫失调和血管功能障碍。最近,研究人员在系统性红斑狼疮受试者中进行了一项随机、双盲、安慰剂对照的tofacitinib临床试验(ClinicalTrials.gov NCT02535689)。

在这项研究中,30名受试者以2:1的区间随机接受tofacitinib(5毫克,每天两次)或安慰剂治疗。这项研究的主要结果是tofacitinib的安全性和耐受性。次要结果包括临床反应和机制研究

疾病活动和病人报告的结果量表

结果显示,tofacitinib在治疗系统性红斑狼疮的过程中是安全的,符合研究的主要终点。该研究结果还显示,tofacitinib能善与系统性红斑狼疮过早发生动脉硬化有关的心脏代谢和免疫学参数。tofacitinib可改善高密度脂蛋白胆固醇水平(p = 0.0006,CI 95%:4.12,13.32)和颗粒数(p = 0.0008,CI 95%:1.58,5.33);卵磷脂:胆固醇酰基转移酶浓度(p = 0.024,CI 95%:1.1,-26. 5),胆固醇外流能力(p = 0.08,CI 95%:-0.01,0.24),改善动脉僵硬度和内皮依赖性血管舒张,以及减少I型IFN基因特征、低密度粒细胞和循环NETs。其中一些改善在有STAT4风险等位基因的受试者中更为有力

 

原始出处:

Sarfaraz A. Hasni et al. Phase 1 double-blind randomized safety trial of the Janus kinase inhibitor tofacitinib in systemic lupus erythematosus. Nature Communications (2021). 

 

 

 

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    2021-12-19 liuli5079
  4. 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  5. [GetPortalCommentsPageByObjectIdResponse(id=2017282, encodeId=6677201e28214, 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=32, 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=Wed Nov 24 21:20:12 CST 2021, time=2021-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738603, encodeId=32af1e3860304, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, 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  6. 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    2021-12-05 daviiliu
  7. 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createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Wed Jun 09 22:20:12 CST 2021, time=2021-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=971729, encodeId=64539e1729aa, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6db85516334, createdName=155****8898, createdTime=Tue Jun 08 09:23:03 CST 2021, time=2021-06-08, status=1, ipAttribution=)]
    2022-01-13 liye789132251
  8. 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  9. 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    2021-06-09 zhouqu_8
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    2021-06-08 155****8898

    学习

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