氨甲蝶呤联合英夫利西单抗的效果不优于英夫利西单抗单药治疗克罗恩病

Methotrexate in Combination with Infliximab is no More Effective than Infliximab Alone in Patients with Crohn’s Disease
期刊: GASTROENTEROLOGY2013年11月期卷

 

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 to infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15 to 40 mg/day) within the preceding 6 weeks. Patients were randomly assigned 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, 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 lack of prednisone-free remission (CD Activity Index <150) at week 14 or failure to maintain remission through week 50.

 

RESULTS: Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P = .63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Pre-specified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated.

 

CONCLUSIONS: The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone.

 

结论:对于克罗恩病患者,氨甲蝶呤联合英夫利西单抗的疗法安全性良好,但疗效并不优于英夫利西单抗单药治疗。
 
 

学科代码:消化病学   关键词:Methotrexate; Infliximab
来源: 爱思唯尔
爱思唯尔介绍:全球最大的科技医学出版商――爱思唯尔以出版发行高品质的、前沿的科学、技术和医学信息,并保证其满足全世界科技和医学工作者对于信息的需求而著称。现在,公司建立起全球的学术体系,拥有7,000名期刊编辑、70,000名编辑委员会成员、200,000专家审稿人以及500,000名作者,每年出版2,000本期刊和2,200种新书,并拥有17,000种在库图书。 马上访问爱思唯尔网站http://www.elseviermed.cn
顶一下(0
您可能感兴趣的文章
    发表评论网友评论(0)
      发表评论
      登录后方可发表评论,点击此处登录