Meta-analysis: serious adverse events in Crohn's disease patients treated with TNF-alpha inhibitors.

Background/Aims: It remains a question whether anti-TNF-alpha treatment is associated with an increase of serious adverse events (SAE) in Crohn's Disease (CD) patients. This study aims to assess the risk of SAE of anti-TNF-alpha treatment in CD patients. Methodology: Literature search of EMBASE, PubMed, ScienceDirect, Cochrane Library and ClinicalTrials.gov until June 2012 was conducted. Eligible studies were randomized controlled trials (RCTs) of TNF-alpha inhibitors treated for at least 24 weeks in CD patients. Results: Thirteen RCTs, involving 4,257 patients with CD were included in analysis. SAE were reported in 364 patients (14.26%) in treatment groups and 263 patients (15.43%) in control groups. The proportion of patients with SAE was lower with TNF-alpha inhibitors than with placebo (OR, 0.80; 95% CI, 0.67-0.96; p=0.01). Compared with controls, the risks of malignancy and serious infection treated with TNF-alpha inhibitors showed no significant difference (p>0.05). Conclusions: In CD patients, anti-TNF-alpha treatment, especially for adalimumab, could decrease the incidence of SAE, without an increased risk of malignancy or serious infection. TNF-alpha inhibitors are safe in treatment of CD patients. To assess the risk of SAE, larger samples of randomized control trials with long term follow-up are needed