title: Meta-analysis: serious adverse events in Crohn's disease patients treated with TNF-alpha inhibitors.
abstract: OBJECTIVE
  It remains a question whether anti-TNF-a 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-a treatment in CD patients.
  
  
  METHODS
  Literature search of EMBASE, PubMed, ScienceDirect, Cochrane Library and ClinicalTrials.gov until June 2012 was conducted. Eligible studies were randomized controlled trials (RCTs) ofTNF-a 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-a 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-a inhibitors showed no significant difference (p>0.05).
  
  
  CONCLUSIONS
  In CD patients, anti-TNF-a treatment, especially for adalimumab, could decrease the incidence of SAE, without an increased risk of malignancy or serious infection. TNF-a 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.
authors: Di
authors: D
authors: Zhang
authors: Bin
authors: B
authors: Xiong
authors: Xiaogai
authors: X
authors: Li
authors: Tangpeng
authors: T
authors: Xu
authors: Mingxia
authors: M
authors: Yu
mesh_terms: D000068879:Adalimumab; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects; D003424:Crohn Disease / Q000188:drug therapy*; D006801:Humans; D007239:Infections / Q000139:chemically induced; D000069285:Infliximab; D008223:Lymphoma / Q000139:chemically induced; D016032:Randomized Controlled Trials as Topic; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab