Paper Information

Journal:   IRANIAN RED CRESCENT MEDICAL JOURNAL (IRCMJ)   AUGUST 2013 , Volume 15 , Number 8; Page(s) 668 To 675.
 
Paper: 

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

 
 
Author(s):  NIKFAR SHEKOUFEH, EHTESHAMI AFSHAR SOLMAZ, ABDOLLAHI MOHAMMAD*
 
* FACULTY OF PHARMACY, AND PHARMACEUTICAL SCIENCES RESEARCH CENTER, TEHRAN UNIVERSITY OF MEDICAL SCIENCES, TEHRAN, IR IRAN
 
Abstract: 

Background: Tumor necrosis factor-? (TNF-?) 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-? 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.

 
Keyword(s): META-ANALYSIS, CERTOLIZUMAB PEGOL, CROHN’S DISEASE
 
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