title: Safety of infliximab for the treatment of inflammatory bowel disease: current understanding of the potential for serious adverse events.
abstract: BACKGROUND
  Infliximab , a chimeric monoclonal antibody directed towards TNF-α, has revolutionized the treatment of inflammatory bowel disease (IBD). Since this therapy suppresses the immune system by neutralizing the immunological activity of TNF, concerns exist regarding the potential for infection, malignancy and immune disorders.
  
  
  METHODS
  Comprehensive data from randomized controlled trials, meta-analyses and cohort studies have defined the risk of infection and malignancy with infliximab. Additional data regarding associations with immune disorders, such as drug-induced lupus, demyelinating syndromes and psoriaform skin disease have emerged, primarily from case reports. We report evidence from the most robust data sources that have examined these adverse events.
  
  
  CONCLUSIONS
  A modest increase in the incidence of serious infection with infliximab and TNF-antagonists has been observed in methodologically rigorous studies. Combination therapy with an immunosuppressant does not confer a higher risk of serious infection than infliximab monotherapy. TNF-antagonist therapy alone with an immunosuppressant is not associated with higher rates of malignancy. Additional data are required to define causality, the magnitude and determinants of risk for other immune-related complications. Available data suggest the therapeutic index of infliximab is favorable for treatment of moderate-to-severe IBD.
authors.affiliation: University of Western Ontario, Robarts Research Institute, Department of Medicine , London , Canada.
authors.forename: Reena
authors.initials: R
authors.lastname: Khanna
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
mesh_terms: D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007154:Immune System Diseases / Q000139:chemically induced; D007239:Infections / Q000139:chemically induced; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D009369:Neoplasms / Q000139:chemically induced; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: Crohn’s disease; adverse events; inflammatory bowel disease; infliximab; monoclonal antibodies; safety; treatment; ulcerative colitis