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Is Certolizumab Pegol Safe and Effective in the Treatment of Patients with Moderate to Severe Crohn’s Disease? A Meta-analysis of Controlled Clinical Trials

AUTHORS

Shekoufeh Nikfar 1 , 2 , Solmaz Ehteshami-Afshar 3 , 4 , Mohammad Abdollahi 1 , 4 , *

AUTHORS INFORMATION

1 Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, IR Iran

2 Food and Drug Organization, Ministry of Health and Medical Education, Tehran, IR Iran

3 Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran

4 Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, IR Iran

How to Cite: Nikfar S, Ehteshami-Afshar S, Abdollahi M. Is Certolizumab Pegol Safe and Effective in the Treatment of Patients with Moderate to Severe Crohn’s Disease? A Meta-analysis of Controlled Clinical Trials, Iran Red Crescent Med J. 2013 ; 15(8):e95980. doi: 10.5812/ircmj.11258.

ARTICLE INFORMATION

Iranian Red Crescent Medical Journal: 15 (8); e95980
Published Online: August 05, 2013
Article Type: Research Article
Received: July 03, 2019
Accepted: May 30, 2013
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Abstract

Background: Tumor necrosis factor-α (TNF-α) antibodies are currently used in patients with moderate to severe Crohn’s disease (CD) who are unresponsive to conventional therapies. Certolizumab pegol (Cp) is one of the anti-TNF-α agents introduced for the management of CD and rheumatoid arthritis.

Objectives: The aim of this meta-analysis is to assess the efficacy of Cp in inducing clinical response and remission in CD and the associated adverse events. The effect of Cp in terms of CD patients’ C-reactive protein (CRP) level was also studied.

Patients and Methods: Literature was searched for studies investigated the efficacy of Cp on inducing clinical response and maintaining remission in the patients with CD between 1966 and July 2012.

Results: Among 165 potentially relevant studies, six with a total of 1695 patients met the inclusion criteria and were meta-analyzed. In comparison to control groups, patients who received Cp had a relative risk (RR) of 1.38 with absolute risk reduction (ARR) = 0.12; 95% CI = 0.03 to 0.21), number needed for treatment (NNT) = 9; P < 0.0001 ) for clinical response and RR of 1.54 (ARR = 0.09; 95% CI = -0.0198 to 0.2), (NNT = 12; P < 0.0001) for maintenance of clinical remission and non-significant RR of 1.24 (P = 0.052) for induction of clinical remission. Baseline CRP did not significantly alter the magnitude or response. Adverse events were not significantly different among patients receiving Cp comparing to placebo.

Conclusions: Cp is effective for inducing clinical response and maintenance of clinical remission in patients with moderate to severe CD with similar side-effect profile as the control arms.

Keywords

Meta-analysis Certolizumab Pegol Crohn’s Disease

© 2013, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.

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