Clin Exp Rheumatol:赛妥珠单抗治疗类风湿性关节炎的疗效和安全性

2019-04-28 xiangting MedSci原创

快速降低疾病活动性和躯体机能改善一直持续至第104周。

这项研究旨在报道常规临床实践中,赛妥珠单抗(CZP)治疗活动性类风湿性关节炎(RA)患者的耐受性和疗效。

FαsT(NCT01069419)是一项非介入性、观察性的104周研究,在德国的163个地点进行。RA患者根据主治医师的判断进行治疗。在第104周达到临床缓解(DAS28-CRP<2.6)是该研究的主要终点。还评估了基于ESR(DAS28-ESR<2.6)的缓解数据。次要终点包括CZP治疗对疼痛、躯体功能和疾病活动性的影响。收集所有研究随诊的安全性数据。

1,117名患者参加了FαsT研究(78%为女性,平均年龄:55岁)。在第6周观察到快速反应(分别有18.7%和12.9%的患者DAS28-CRP和DAS28-ESR缓解),并且改善持续2年(分别有20.0%和13.9%的患者在第104周达到DAS28-CRP和DAS28-ESR缓解)。抗TNF初治患者比曾使用抗TNF治疗的患者改善更大(在第104周对于≥2、1和无抗TNFs的患者,平均DAS28-ESR从基线的变化[CfB]分别为-1.3、-1.5和-1.7)。所有次要终点指标均有改善。研究期间,1,111名患者使用CZP总共1,538患者年。745名患者(67.1%)报告了2,000次治疗相关不良事件(TEAEs);9名患者(0.8%)经历了致命结局的TEAEs。

CZP证明了在试验环境中观察到的疗效和安全性结局。快速降低疾病活动性和躯体机能改善一直持续至第104周。

原始出处:

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    2019-04-30 lmm397
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    2019-04-28 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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