Ann Rheum Dis:苏金单抗改善活动性银屑病关节炎的症状并抑制影像学进展

2018-03-18 xiangting MedSci原创

24周时与安慰剂比较,Sc苏金单抗300mg和150mg伴和不伴LD显著改善PsA患者的临床症状,并抑制影像学结构进展。

这项研究旨在评估一种白介素-17A抑制剂,皮下(sc)苏金单抗对银屑病关节炎(PsA)患者的临床症状和影像学进展的影响。

将活动性PsA的成人患者(n = 996)按照2:2:2:3随机分配为sc苏金单抗300 mg或150 mg伴负荷剂量(LD)组,150 mg不伴LD组或安慰剂组。所有组在基线,第1,2和3周接受苏金单抗或安慰剂,然后从第4周开始每4周用药。主要终点是在第16周达到美国风湿病学会20(ACR20)应答的患者比例。

第16周时,苏金单抗300mg伴LD组(62.6%),150mg伴LD(55.5%)或150mg不伴LD(59.5%)达到ACR20应答的患者显著多于安慰剂组(27.4%)(p均<0.0001;非应答者归因)。第24周时,所有苏金单抗组vs.安慰剂组通过van der Heijde改良Sharp总评分衡量的影像学进展被显著抑制(300mg伴LD组、150mg不伴LD组p< 0.01;150mg伴LD组p<0.05,线性外推法)。不同治疗组间第24周不良事件发生率相似:63.1%(300mg伴LD组),62.7%(150mg伴LD组),61.1%(150mg不伴LD组)和62.0%(安慰剂组)。没有死亡或新的安全信号报道。

24周时与安慰剂比较,Sc苏金单抗300mg和150mg伴和不伴LD显著改善PsA患者的临床症状,并抑制影像学结构进展。

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    2018-03-20 lmm397
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    2018-03-18 1ddf0692m34(暂无匿称)

    学习了.长知识

    0

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