title: 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.
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.
  
  
  OBJECTIVE
  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.
  
  
  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.
authors.affiliation: 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.
authors.forename: Shekoufeh
authors.initials: S
authors.lastname: Nikfar
authors.affiliation: 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.
authors.forename: Solmaz
authors.initials: S
authors.lastname: Ehteshami-Afshar
authors.affiliation: 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.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Abdollahi
keywords: Certolizumab Pegol; Crohn’s Disease; Meta-analysis