人抗肿瘤坏死因子单克隆抗体(阿达木单抗)在克罗恩病中的研究:标准一级试验  

Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: The CLASSIC-I trial

作　　者：Hanauer S. B. Sandborn W. J. Rutgeerts P. 赵天智(译) 张欣(校) 

机构地区：[1]Division of Gastroenterology, University of Chicago Medical Center, 5841 South Maryland Avenue, Chicago, IL 60637, United States [2]不详

出　　处：《世界核心医学期刊文摘（胃肠病学分册）》2006年第8期23-24,共2页Core Journals in Gastroenterology

摘　　要：Background& Aims: Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn’s disease (CD). Adalimumab is a human immunoglobulin G1 (IgG1)- monoclonal antibody targeting tumor necrosis factor (TNF). A randomized, double-blind, placebo-contro-lled, dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD. Methods: A total of 299 patients with moderate to severe CD naive to anti-TNF therapy were randomized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or placebo. The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 (defined as a Crohn’s Disease Activity Index score < 150 points) among the 80 mg/40 mg, 160 mg/80 mg, and placebo groups. Results: The rates of remission at week 4 in the adalimumab 40 mg/20 mg, 80 mg/40 mg, and 160 mg/80 mg groups were 18% (P = .36), 24% (P = .06), and 36% (P = .001), respectively, and 12% in the placebo group. Adverse events occurred at similar frequencies in all 4 treatment groups except injection site reactions, which were more common in adalimumab-treated patients. Conclusions: Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn’s disease naive to anti-TNF therapy. The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2. Adalimumab was well tolerated.Background ＆ Aims： Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn＇s disease （CD）. Adalimumab is a human immunoglobulin G1 （IgG1） - monoclonal antibody targeting tumor necrosis factor （TNF）. A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD. Methods： A total of 299 patients with moderate to severe CD naive to anti-TNF therapy were randomized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or placebo. The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 （defined as a Crohn＇s Disease Activity Index score 〈 150 points） among the 80 mg/40 mg, 160 mg/80 mg, and placebo groups. Results： The rates of remission at week 4 in the adalimumab 40 mg/20 mg, 80 mg/40 mg, and 160 mg/80 mg groups were 18% （P = . 36）, 24% （P = . 06）, and 36% （P = .001）, respectively, and 12% in the placebo group. Adverse events occurred at similar frequencies in all 4 treatment groups except injection site reactions, which were more common in adalimumab-treated patients. Conclusions： Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn＇s disease naive to anti-TNF therapy. The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2. Adalimumab was well tolerated.

关 键 词：抗肿瘤坏死因子单克隆抗体 阿达木单抗 克罗恩病 肿瘤坏死因子(TNF) 试验 安慰剂对照 抗-TNF治疗 标准 人免疫球蛋白 阻断治疗 

分 类 号：R392.11[医药卫生—免疫学] R971.1[医药卫生—基础医学]