title: The London position statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organisation: safety.
abstract: This paper in the series from the World Congress of Gastroenterology addresses the safety and immunogenicity of biological therapy. The safety profile in randomized controlled studies of all biological agents in Crohn's disease (CD) and ulcerative colitis has been generally favorable, but a small percentage of patients experience severe side effects on biological therapy, including pneumonia, tuberculosis, lymphoma, demyelination, drug-induced lupus, or hepatotoxicity. Although there is unequivocal evidence of an increased risk of serious infection among patients with rheumatoid arthritis treated with anti-tumor necrosis factor therapy, the evidence is less clear in CD. The risk of infection may be increased by combination therapy with steroids and/or immunomodulators. There is a specific risk of the rare γ δ hepatosplenic lymphoma that appears to have a predeliction for young males on combination therapy. The α4 integrin antagonist natalizumab also carries a specific risk of progressive multifocal leucoencephalopathy and reactivation of JC virus infection. The immunogenicity of biological therapy is complex: all agents are potentially immunogenic and this can be reduced by combination with immunomodulators. This may enhance both therapeutic efficacy and the risk of infection or malignancy, so the balance of risk and benefit must be judged for individual patients.
authors.affiliation: Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium. gert.vanassche@uz.kuleuven.be
authors.forename: Gert
authors.initials: G
authors.lastname: Van Assche
authors.forename: James D
authors.initials: JD
authors.lastname: Lewis
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: Edward V
authors.initials: EV
authors.lastname: Loftus
authors.forename: Qin
authors.initials: Q
authors.lastname: Ouyang
authors.forename: Julian
authors.initials: J
authors.lastname: Panes
authors.forename: Corey A
authors.initials: CA
authors.lastname: Siegel
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Simon P L
authors.initials: SP
authors.lastname: Travis
authors.forename: Jean-Frederic
authors.initials: JF
authors.lastname: Colombel
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D009369:Neoplasms / Q000139:chemically induced*; D009894:Opportunistic Infections / Q000139:chemically induced* / Q000382:microbiology; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha