NEJM:Vedolizumab vs 阿达木单抗治疗中重度溃疡性结肠炎

2019-09-26 MedSci MedSci原创

研究认为,对于中重度活动性溃疡性结肠炎患者,Vedolizumab在取得临床缓解和内镜改善方面优于阿达木单抗

生物疗法在溃疡性结肠炎患者中得到了广泛的应用。

近日研究人员开展3b期临床研究,比较了Vedolizumab和阿达木单抗对中重度活动期溃疡性结肠炎成人的疗效。有25%的患者曾接触过阿达木单抗以外的肿瘤坏死因子抑制剂。患者随机在第1天和第2、6、14、22、30、38和46周接受300毫克vedolizumab或皮下注射40毫克阿达木单抗,第1周总剂量为160毫克,第2周为80毫克,第2周为每2周40毫克,直到第50周。研究的主要终点是在52周临床缓解(Mayo评分≤2)。

共有769例患者参与研究,并至少接受一剂vedolizumab (383例)或阿达木单抗 (386例)。在第52周,与阿达木单抗组相比,vedolizumab组的临床缓解率更高(31.3% vs 22.5%;差异:8.8%),内窥镜改善率也更高(39.7% vs 27.7%;差异,11.9%)。无糖皮质类固醇临床缓解率:vedolizumab组为12.6%,阿达木单抗组为21.8%(差异,-9.3%)。Vedolizumab和阿达木单抗暴露后的感染率分别为每100例患者23.4例和34.6例,而严重感染的发生率为每100例患者每年1.6例和2.2例。

研究认为,对于中重度活动性溃疡性结肠炎患者,Vedolizumab在取得临床缓解和内镜改善方面优于阿达木单抗。

原始出处:

Bruce E. Sands et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med, September 26, 2019.

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    2020-06-29 snf701207
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    2019-10-09 nymo
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    2019-09-26 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

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