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.

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.

• Authors: Shekoufeh Nikfar, Solmaz Ehteshami-Afshar, Mohammad Abdollahi
• Journal: Iranian Red Crescent medical journal (Iran Red Crescent Med J) Vol. 15 Issue 8 Pg. 668-75 (Aug 2013) ISSN: 2074-1804 [Print] Estonia
• PMID: 24578833 (Publication Type: Journal Article)