Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease
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DOI：
10.1056/nejmoa1215739
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发表时间：
2013-08-22
影响因子：
158.5
通讯作者：
Parikh, Asit
中科院分区：
文献类型：
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作者：
Sandborn, William J.;Feagan, Brian G.;Parikh, Asit
Vedolizumab是一种α（4）β（7）整联蛋白抗体，在克罗恩病中的疗效尚不清楚。方法在一项综合研究中，我们评估了活动性克罗恩病成人患者静脉注射Vedolizumab治疗（300 mg）的效果。在诱导试验中，368例患者在第0周和第2周（队列1）随机分配接受Vedolizumab或安慰剂治疗，747例患者在第0周和第2周（队列2）接受开放标签Vedolizumab治疗;在第6周评估疾病状态。在维持试验中，461例对Vedolizumab有应答的患者被随机分配接受安慰剂或Vedolizumab，每8或4周一次，直至第52周。在第6周，队列1中接受Vedolizumab治疗的患者中共有14.5%和接受安慰剂治疗的患者中有6.8%达到临床缓解（即，克罗恩病活动指数[CDAI]评分下降≥ 100分）（P = 0.23）。在队列1和队列2中诱导治疗有应答的患者中，Vedolizumab每8周一次和每4周一次组分别有39.0%和36.4%的患者在第52周达到临床缓解，而安慰剂组为21.6%（P
BACKGROUNDThe efficacy of vedolizumab, an alpha(4)beta(7) integrin antibody, in Crohn's disease is unknown.METHODSIn an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52.RESULTSAt week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of = 100-point decrease in the CDAI score) (P = 0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P