title: A safety assessment of anti-tumor necrosis factor alpha therapy for treatment of Crohn's disease.
abstract: BACKGROUND
  Anti-tumor necrosis factor-alpha (TNF-α) therapy has revolutionized the medical treatment of Crohn's disease (CD). Nevertheless, anti-TNF-α therapy has been associated with serious adverse events (SAE) raising safety concerns. This review focuses on the safety profile of anti-TNF-α agents in CD.
  
  
  METHODS
  We performed a literature search until August 2015 to collect safety data on infliximab, adalimumab and certolizumab pegol monotherapy or combined with immunomodulators (IMM). We have mainly focused on infections and malignancies. Safety in pregnancy, the elderly and children are also presented.
  
  
  CONCLUSIONS
  Available data in CD suggest that anti-TNF-α monotherapy or in combination with IMM is relatively safe, although it may be associated with an elevated risk of serious infections, skin cancer and lymphoma. However, as this data derive mainly from cohort studies, post-marketing registries, and meta-analyses of RCTs, often characterized by inherited methodological weaknesses that may hinder their validity, data from large, statistically powered, prospective studies of sufficient follow up are required to define the actual risk of SAE during anti-TNF-α therapy in IBD. The role of therapeutic drug monitoring in predicting and preventing SAE awaits confirmation.
authors.affiliation: a Evaggelismos Hospital , Department of Gastroenterology , Athens , Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Papamichael
authors.affiliation: a Evaggelismos Hospital , Department of Gastroenterology , Athens , Greece.
authors.forename: Gerassimos J
authors.initials: GJ
authors.lastname: Mantzaris
authors.affiliation: b Inserm U954, and Department of Gastroenterology , Nancy University Hospital, Université de Lorraine , Nancy , France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D015331:Cohort Studies; D003424:Crohn Disease / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D015201:Meta-Analysis as Topic; D011247:Pregnancy; D012449:Safety; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; D014409:Tumor Necrosis Factor-alpha
keywords: Anti-TNF-α therapy; Crohn’s disease; adalimumab; certolizumab pegol; infection; inflammatory bowel disease; infliximab; malignancy; mortality; safety