Infliximab for induction and maintenance therapy for ulcerative colitis
Infliximab for induction and maintenance therapy for ulcerative colitis
复制标题
DOI：
10.1056/nejmoa050516
复制
发表时间：
2005-12-08
影响因子：
158.5
通讯作者：
Colombel, JF
中科院分区：
文献类型：
--
作者：
Rutgeerts, P;Sandborn, WJ;Colombel, JF
背景：英夫利昔单抗，一种嵌合单克隆抗体，直接针对肿瘤坏死因子（α），是一种既定的治疗克罗恩病，但不是溃疡性colis.METHODS：两个随机，双盲，安慰剂对照研究-活动性溃疡性结肠炎试验1和2（ACT 1和ACT 2，分别）-评估的疗效英夫利昔单抗诱导和维持治疗成人溃疡性结肠炎。在每项研究中，364例中重度活动性溃疡性结肠炎患者尽管接受了合并药物治疗，但在第0、2和6周静脉注射安慰剂或英夫利西单抗（5 mg或10 mg/kg体重），然后每8周一次，直至第46周（ACT 1）或第22周（ACT 2）。ACT 1组随访54周，ACT 2组随访30周。结果：在ACT 1组中，69%接受5 mg英夫利昔单抗治疗的患者和61%接受10 mg英夫利昔单抗治疗的患者在第8周时有临床应答，而接受安慰剂治疗的患者中有37%有临床应答（P
BACKGROUND:Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor (alpha), is an established treatment for Crohn's disease but not ulcerative colitis.METHODS:Two randomized, double-blind, placebo-controlled studies -- the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively) -- evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2.RESULTS:In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P