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International Journal of Pharmacology
Year: 2011  |  Volume: 7  |  Issue: 3  |  Page No.: 325 - 332

A Systematic Review and Meta-analysis of the Efficacy and Adverse Events of Infliximab in Comparison to Corticosteroids and Placebo in Active Ulcerative Colitis

Shekoufeh Nikfar, Solmaz Ehteshami-Afshar and Mohammad Abdollahi    

Abstract: The proinflammatory cytokine tumor necrosis factor alpha (TNF-α) plays a major role in severity of Ulcerative Colitis (UC) and thus inhibition of TNF-α is used to control severe cases of UC. The present meta-analysis was performed to collect and review all the clinical trials that investigated the efficacy and tolerability of infliximab in order to determine whether infliximab is more effective than placebo or corticosteroids in inducing response and remission in UC. All bibliographic databases such as PubMed, Scopus, Web of Science and Cochrane Central Register of Controlled Trials were searched for studies investigated the efficacy of infliximab for the management of UC. Data were collected from 1966 to September 2010. Three trials represented 57 patients with UC who were randomized to receive infliximab or corticosteroids and 5 trials represented 827 patients with UC who were randomized to receive infliximab or placebo were included in the analysis. The summary Relative Risk (RR) for clinical remission in comparison of infliximab with placebo was 1.93 with a 95% Confidence Interval (CI) of 1.62-2.3 and a significant RR (p<0.0001). Summary RR for adverse events of infliximab comparing to placebo was 1.07 with a 95% CI of 0.99-1.14, a non-significant RR (p = 0.0725). The summary RR for serious adverse events of infliximab comparing to placebo was 0.83 with a 95% CI of 0.44-1.54 as a non-significant RR (p = 0.5472). The summary RR for clinical remission of infliximab comparing to corticosteroids was 1.07 with a 95% CI of 0.87-1.31 as a non-significant RR (p = 0.5353). Patients receiving infliximab were 1.93 and 1.07 times more likely to go to the remission as compared to those receiving placebo and corticosteroids, respectively. Meanwhile, the risk of adverse events in the patients receiving infliximab was 1.07 times more than placebo group. The risk of opportunistic infection was high in patients who have failed steroids and cyclosporine and were using infliximab. Although infliximab is more effective than corticosteroids in inducing clinical remission, we believe further trials are still needed to judge stronger in this respect.

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