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

الملخص EN

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.

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.