Efficacy and Safety of Certolizumab Pegol for Crohn's Disease: A Systematic Review and Meta-Analysis

被引:17
作者
Da, Wei [1 ]
Zhu, Jinshui [1 ]
Wang, Long [1 ]
Lu, Yunmin [1 ]
机构
[1] Shanghai Jiao Tong Univ, Peoples Hosp 6, Dept Gastroenterol, Shanghai 200233, Peoples R China
关键词
Certolizumab pegol; Crohn's disease; Gastroenterology; Meta-analysis; Remission rate; Response rate; CLINICAL-TRIALS; UNITED-STATES; MANAGEMENT; CDP870; INDEX;
D O I
10.1007/s12325-013-0026-3
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The authors performed a systematic review and meta-analysis of data from randomized controlled trials (RCTs) to evaluate the efficacy and safety of certolizumab pegol. The authors searched PubMed, MEDLINE via Medscape, BioMed Central, Google Scholar, China National Knowledge Infrastructure (CNKI), the Cochrane library, and the Directory of Open Access Journals. The outcomes of interest were response and remission rates and the treatment-related toxicity rate. A total of five RCTs, involving 1,891 participants, were included. The meta-analysis revealed that certolizumab significantly increased the overall (induction + maintenance therapy) response [odds ratio (OR) 1.565, 95% CI 1.056-2.321, P = 0.026] and remission rates (OR 1.626, 95% CI 1.297-2.038, P < 0.001) compared with placebo. Certolizumab significantly increased the response and remission rates when given as maintenance therapy (OR 2.171, 95% CI 1.644-2.866, P < 0.001 and OR 1.888, 95% CI 1.390-2.565, P < 0.001), but not as induction therapy (OR 1.234, 95% CI 0.912-1.671, P = 0.173 and OR 1.361, 95% CI 0.974-1.901, P = 0.071). Certolizumab (induction + maintenance therapy) did not significantly increase the treatment-related toxicity rate compared with placebo (OR 0.985, 95% CI 0.799-1.214, P = 0.887). Certolizumab may be an efficacious treatment for Crohn's disease as maintenance therapy and appears to have a favorable safety profile.
引用
收藏
页码:541 / 553
页数:13
相关论文
共 22 条
[1]   Tumor necrosis factor-alpha antibody for maintenace of remission in Crohn's disease [J].
Behm, B. W. ;
Bickston, S. J. .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2008, (01)
[2]  
BEST WR, 1976, GASTROENTEROLOGY, V70, P439
[3]   Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone [J].
Dahabreh, Issa J. ;
Economopoulos, K. .
CLINICAL TRIALS, 2008, 5 (02) :116-120
[4]   METAANALYSIS IN CLINICAL-TRIALS [J].
DERSIMONIAN, R ;
LAIRD, N .
CONTROLLED CLINICAL TRIALS, 1986, 7 (03) :177-188
[5]   Bias in meta-analysis detected by a simple, graphical test [J].
Egger, M ;
Smith, GD ;
Schneider, M ;
Minder, C .
BMJ-BRITISH MEDICAL JOURNAL, 1997, 315 (7109) :629-634
[6]   Efficacy of Biological Therapies in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis [J].
Ford, Alexander C. ;
Sandborn, William J. ;
Khan, Khurram J. ;
Hanauer, Stephen B. ;
Talley, Nicholas J. ;
Moayyedi, Paul .
AMERICAN JOURNAL OF GASTROENTEROLOGY, 2011, 106 (04) :644-659
[7]  
HARVEY RF, 1980, LANCET, V1, P514
[8]   Assessing the quality of reports of randomized clinical trials: Is blinding necessary? [J].
Jadad, AR ;
Moore, RA ;
Carroll, D ;
Jenkinson, C ;
Reynolds, DJM ;
Gavaghan, DJ ;
McQuay, HJ .
CONTROLLED CLINICAL TRIALS, 1996, 17 (01) :1-12
[9]   The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States [J].
Kappelman, Michael D. ;
Rifas-Shiman, Sheryl L. ;
Kleinman, Ken ;
Ollendorf, Dan ;
Bousvaros, Athos ;
Grand, Richard J. ;
Finkelstein, Jonathan A. .
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2007, 5 (12) :1424-1429
[10]   Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: Meta-analysis of placebo-controlled trials [J].
Peyrin-Biroulet, Laurent ;
Deltenre, Pierre ;
De Suray, Nicolas ;
Branche, Julien ;
Sandborn, William J. ;
Colombel, Jean-Frederic .
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2008, 6 (06) :644-653