Natalizumab induction and maintenance therapy for Crohn's disease
Natalizumab induction and maintenance therapy for Crohn's disease
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DOI：
10.1056/nejmoa043335
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发表时间：
2005-11-03
影响因子：
158.5
通讯作者：
Rutgeerts, P
中科院分区：
文献类型：
--
作者：
Sandborn, WJ;Colombel, JF;Rutgeerts, P
背景：那他珠单抗是一种针对α（4）整联蛋白的人源化单克隆抗体，可抑制白细胞粘附和迁移到炎症组织中。方法：我们进行了两项对照试验来评估那他珠单抗作为活动性克罗恩病患者的诱导和维持治疗。在第一项试验中，905名患者被随机分配在第0、4和8周接受300 mg那他珠单抗或安慰剂。主要结局是缓解，定义为第10周克罗恩病活动指数（CDAI）评分降低至少70分。在第二项试验中，339名在第一项试验中对那他珠单抗有反应的患者被随机重新分配，每四周接受300 mg那他珠单抗或安慰剂，直至第56周。主要结局是持续缓解至第36周。两项试验的次要结果是疾病缓解（CDAI评分小于150）。结果：在第一项试验中，那他珠单抗组和安慰剂组在10周时的应答率（分别为56%和49%; P=0.05）和缓解率（分别为37%和30%; P=0.12）相似。在第二项试验中，继续使用那他珠单抗导致了更高的持续应答率（61%对28%，P
BACKGROUND:Natalizumab, a humanized monoclonal antibody against alpha(4) integrin, inhibits leukocyte adhesion and migration into inflamed tissue.METHODS:We conducted two controlled trials to evaluate natalizumab as induction and maintenance therapy in patients with active Crohn's disease. In the first trial, 905 patients were randomly assigned to receive 300 mg of natalizumab or placebo at weeks 0, 4, and 8. The primary outcome was response, defined by a decrease in the Crohn's Disease Activity Index (CDAI) score of at least 70 points, at week 10. In the second trial, 339 patients who had a response to natalizumab in the first trial were randomly reassigned to receive 300 mg of natalizumab or placebo every four weeks through week 56. The primary outcome was a sustained response through week 36. A secondary outcome in both trials was disease remission (a CDAI score of less than 150).RESULTS:In the first trial, the natalizumab and placebo groups had similar rates of response (56 percent and 49 percent, respectively; P=0.05) and remission (37 percent and 30 percent, respectively; P=0.12) at 10 weeks. Continuing natalizumab in the second trial resulted in higher rates of sustained response (61 percent vs. 28 percent, P