人肿瘤坏死因子α单克隆抗体(CDP571)治疗中重度克罗恩病:一项随机双盲安慰剂对照试验

作     者：Sandborn W.J. Feagan B.G. Radford-Smith G. 翟惠虹 

作者机构：Mayo Cl inic 200 First Street SW Rochester MN 55905 United StatesDr. 

出 版 物：《世界核心医学期刊文摘（胃肠病学分册）》 (Core Journals in Gastroenterology)

年 卷 期：2005年第1卷第2期

页      面：35-36页

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

主　　题：克罗恩病 CDP571 肿瘤坏死因子α 随机双盲 安慰剂对照 短期疗效 统计学结果 临床因素 活动指数 基线水平 

摘      要：Background: Targeting tumour necrosis factor α(TNF-α) has demonstrated effi cacy in Crohn’s disease. Aim: To evaluate CDP571, a humanised antibody to TNF- α, for treating active Crohn’s disease. Patients: A total of 396 patients with moderate to severe Crohn’s disease. Methods: In a 28 week, randomised, double blind, placebo controlled trial, patients received intravenous CDP571 (10 mg/kg) or placebo every eight weeks to week 24. The primary outcome measure was clinic al response (a decrease in the Crohn’s disease activity index (CDAI) to ≥100 p oints or remission (CDAI score ≤150 points)) at week 28. A secondary outcome me asure was clinical response (using the same definition) at week 2. Results: Clin ical response occurred at week 28 in 80/263 (30.4%) CDP571 patients and 31/132 (23.5%) placebo patients (p = 0.102). Clinical response at week 2 occurred in 9 0/263 (34.2%) CDP571 patients and 28/132 (21.2%) placebo patients (p = 0.011). Post hoc exploratory subgroup analysis of 159 patients with baseline C reactive protein (CRP) ≥10 mg/l demonstrated significant differences between CDP571 and placebo in clinical response rates at weeks 2 (CDP571, 50/101 (49.5%); placebo , 9/58 (15.5%); p0.001) and 28 (CDP571, 29/101 (28.7%); placebo, 7/58 (12.1% ); p = 0.018). Adverse events occurred at similar frequencies in both treatment groups. Conclusions: CDP571 is modestly effective for short but not long term tr eatment of unselected patients with moderate to severe Crohn’s disease. The cli nical relevance of this short term effect is unclear. Post hoc analysis suggests both short and long term efficacy of CDP571 in patients with elevated baseline CRP (≥10 mg/l). CDP571 is well tolerated.