PMID- 24578833 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140228 LR - 20211021 IS - 2074-1804 (Print) IS - 2074-1812 (Electronic) IS - 2074-1804 (Linking) VI - 15 IP - 8 DP - 2013 Aug TI - 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. PG - 668-75 LID - 10.5812/ircmj.11258 [doi] AB - BACKGROUND: Tumor necrosis factor-alpha (TNF-alpha) 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-alpha 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. FAU - Nikfar, Shekoufeh AU - Nikfar S AD - Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, IR Iran ; Food and Drug Organization, Ministry of Health and Medical Education, Tehran, IR Iran. FAU - Ehteshami-Afshar, Solmaz AU - Ehteshami-Afshar S AD - Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran ; Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, IR Iran. FAU - Abdollahi, Mohammad AU - Abdollahi M AD - Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, IR Iran ; Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, IR Iran. LA - eng PT - Journal Article DEP - 20130805 PL - Estonia TA - Iran Red Crescent Med J JT - Iranian Red Crescent medical journal JID - 101319850 PMC - PMC3918190 OTO - NOTNLM OT - Certolizumab Pegol OT - Crohn's Disease OT - Meta-analysis EDAT- 2014/03/01 06:00 MHDA- 2014/03/01 06:01 PMCR- 2013/08/01 CRDT- 2014/03/01 06:00 PHST- 2013/03/18 00:00 [received] PHST- 2013/05/30 00:00 [accepted] PHST- 2014/03/01 06:00 [entrez] PHST- 2014/03/01 06:00 [pubmed] PHST- 2014/03/01 06:01 [medline] PHST- 2013/08/01 00:00 [pmc-release] AID - 10.5812/ircmj.11258 [doi] PST - ppublish SO - Iran Red Crescent Med J. 2013 Aug;15(8):668-75. doi: 10.5812/ircmj.11258. Epub 2013 Aug 5.