Methotrexate in Combination With Infliximab Is No More Effective Than Infliximab Alone in Patients With Crohn's Disease
Methotrexate in Combination With Infliximab Is No More Effective Than Infliximab Alone in Patients With Crohn's Disease
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DOI：
10.1053/j.gastro.2013.11.024
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发表时间：
2014-03-01
期刊：
影响因子：
29.4
通讯作者：
Greenberg, Gordon R.
中科院分区：
文献类型：
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作者：
Feagan, Brian G.;McDonald, John W. D.;Greenberg, Gordon R.
背景与目的：甲氨蝶呤和英夫利昔单抗是治疗克罗恩病（CD）的有效药物。在甲氨蝶呤-英夫利昔单抗联合维持试验中，我们评估了联合治疗比英夫利昔单抗单独治疗的潜在优势。方法：在一项为期50周的双盲安慰剂对照试验中，我们比较了126例在前6周内开始强的松诱导治疗（15-40 mg/天）的CD患者的甲氨蝶呤和英夫利昔单抗与英夫利昔单抗。患者被随机分配到甲氨蝶呤组，初始每周剂量为10mg，逐渐增加到25mg /周（n = 63），或安慰剂组（n = 63）。两组均在第1、3、7和14周给予英夫利昔单抗（5 mg/kg体重），此后每8周给予一次。泼尼松从第1周开始逐渐减量，不迟于第14周停用。主要终点是治疗失败的时间，定义为缺乏无泼尼松缓解(CD活性指数，
BACKGROUND & AIMS: Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. METHODS: In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index,