The safety of anti-tumor necrosis factor-alpha agents used for the treatment of inflammatory bowel disease: a systematic review and meta-analysis

Abstract

Background. Anti-tumor necrosis factor alpha (anti-TNF-α) therapy is used to treat inflammatory bowel disease. Infrequent but serious adverse events related to these medications have occurred. -- Objective. The aim of this meta-analysis is to evaluate the safety of anti-TNF-α agents in patients with inflammatory bowel disease (IBD). -- Methods. Randomized trials that evaluated an anti-TNF-α agent (infliximab, adalimumab, certolizumab, etanercept, COP 571 and onercept) for the treatment of IBD were included. The studies had to report on safety and tolerability. Trials were identified by searching electronic databases and the data were analyzed using the Cochrane review manager (RevMan 5.1) software. -- Results. Twenty four studies were included in the meta-analysis. There was no statistical difference in the frequency of withdrawal due to adverse events, serious infections, death, malignancies or tuberculosis between anti-TNF-α and placebo groups. Placebo patients were more likely to experience a serious adverse event than patients treated with an anti-TNF-α agent. Patients treated with anti-TNF-α agents were more likely to develop pneumonia or experience an infusion reaction than placebo patients. There were no reports of opportunistic infections, congestive heart failure, or demyelinating disease, for any of the agents studied. However, post marketing surveillance has shown that patients are at an increased risk of opportunistic infections. Adverse events with anti-TNF-α agents were noted to occur irrespective of the indication. -- Conclusion. Overall, the results of this meta-analysis demonstrate that the use of anti-TNF-α agents is safe for patients with IBD.