Natalizumab for the treatment of active Crohn's disease: Results of the ENCORE trial
Natalizumab for the treatment of active Crohn's disease: Results of the ENCORE trial
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DOI：
10.1053/j.gastro.2007.03.024
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发表时间：
2007-05-01
期刊：
影响因子：
29.4
通讯作者：
Sandborn, William J.
中科院分区：
文献类型：
--
作者：
Targan, Stephan R.;Feagan, Brian G.;Sandborn, William J.
背景与目的：一项随机安慰剂对照试验评估了natalizumab诱导治疗克罗恩病患者的疗效。方法：以c反应蛋白浓度升高为特征的中度至重度活动性克罗恩病和活动性炎症患者（N = 509）随机（1:1）在第0、4和8周静脉注射natalizumab 300mg或安慰剂。主要终点是诱导反应（从第8周到第12周，克罗恩病活动指数评分从基线下降70点）。其他疗效终点包括持续缓解（克罗恩病活动指数评分< 150分）和随时间缓解或缓解的患者比例。结果：在第8周至第12周，48%的natalizumab治疗患者和32%的安慰剂治疗患者出现了缓解（P < 0.001）。接受纳塔利珠单抗治疗的患者中有26%持续缓解，接受安慰剂治疗的患者中有16%持续缓解（P = 0.002）。natalizumab第4周的缓解率为51%，安慰剂为37% （P = 0.001）。在随后的评估中，接受natalizumab治疗的患者的反应仍然明显更高（P < 0.001）。natalizumab治疗的患者在第4周、第8周和第12周的缓解率也显著提高(P
Background & Aims: A randomized placebo-controlled trial evaluated the efficacy of natalizumab induction therapy in patients with Crohn's disease. Methods: Patients (N = 509) with moderately to severely active Crohn's disease and active inflammation characterized by elevated C-reactive protein concentrations were randomized (1:1) to receive natalizumab 300 mg or placebo intravenously at Weeks 0, 4, and 8. The primary end point was induction of response (>= 70-point decrease from baseline in the Crohn's Disease Activity Index score at Week 8 sustained through Week 12). Additional efficacy end points included the proportion of patients with sustained remission (Crohn's Disease Activity Index score < 150 points) and response or remission over time. Results: Response at Week 8 sustained through Week 12 occurred in 48% of natalizumab-treated patients and 32% of patients receiving placebo (P < .001). Sustained remission occurred in 26% of natalizumab-treated patients and 16% of patients receiving placebo (P = .002). Week 4 response rates were 51% for natalizumab and 37% for placebo (P = .001). Responses remained significantly higher at subsequent assessments (P < .001) in natalizumab-treated patients. Natalizumab-treated patients also had significandy higher remission rates at Weeks 4, 8, and 12 (P