Uday N Shivaji1,2, Caroline L Sharratt3,4, Tom Thomas5, Samuel C L Smith6, Marietta Iacucci1,2,6, Gordon W Moran3,4, Subrata Ghosh1,2,6, Neeraj Bhala5,7. 1. National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Birmingham, UK. 2. Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK. 3. National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK. 4. Nottingham Digestive Diseases Centre, Nottingham University Hospitals, Nottingham, UK. 5. Department of Gastroenterology, University Hospitals Birmingham, Birmingham, UK. 6. Institute of Translational Medicine, Edgbaston, UK. 7. University of Birmingham, Birmingham, UK.
Abstract
BACKGROUND: Biological therapy is currently widely used to treat IBD. Infliximab, adalimumab and golimumab are currently licensed anti-TNF therapies. Biosimilar anti-TNF monoclonal antibodies are increasingly used. Anti-TNF therapies are widely used and their adverse effects are well characterised, and may cause significant morbidity and mortality in a small proportion of exposed patients. Gastroenterologists need to understand the mechanisms for these effects, recognise these swiftly and manage such events appropriately. AIM: To cover the range of potential adverse reactions as a result of biologic therapy and specifically management of these events. METHODS: A Medline and Pubmed search was undertaken. Search terms included were "anti-TNF," "infliximab" or "adalimumab" or "golimumab" combined with the keywords "ulcerative colitis" or "Crohn's disease" or "inflammatory bowel disease" and then narrowed to articles containing the keywords "complications," "side effects" or "adverse events" or "safety profile." International guidelines were also reviewed where relevant. RESULTS: Adverse events discussed in this review include infusion reactions, blood disorders and infections (including bacterial, viral, fungal and opportunistic infections) as well as autoimmune, dermatological disorders, cardiac and neurological conditions. Malignancies including solid organ, haematological and those linked to viral disease are discussed. CONCLUSIONS: Anti-TNF therapy has wide-ranging effects on the immune system resulting in a spectrum of potential adverse events in a small proportion of patients. Research advances are improving the understanding, recognition and management of these adverse events.
BACKGROUND: Biological therapy is currently widely used to treat IBD. Infliximab, adalimumab and golimumab are currently licensed anti-TNF therapies. Biosimilar anti-TNF monoclonal antibodies are increasingly used. Anti-TNF therapies are widely used and their adverse effects are well characterised, and may cause significant morbidity and mortality in a small proportion of exposed patients. Gastroenterologists need to understand the mechanisms for these effects, recognise these swiftly and manage such events appropriately. AIM: To cover the range of potential adverse reactions as a result of biologic therapy and specifically management of these events. METHODS: A Medline and Pubmed search was undertaken. Search terms included were "anti-TNF," "infliximab" or "adalimumab" or "golimumab" combined with the keywords "ulcerative colitis" or "Crohn's disease" or "inflammatory bowel disease" and then narrowed to articles containing the keywords "complications," "side effects" or "adverse events" or "safety profile." International guidelines were also reviewed where relevant. RESULTS: Adverse events discussed in this review include infusion reactions, blood disorders and infections (including bacterial, viral, fungal and opportunistic infections) as well as autoimmune, dermatological disorders, cardiac and neurological conditions. Malignancies including solid organ, haematological and those linked to viral disease are discussed. CONCLUSIONS: Anti-TNF therapy has wide-ranging effects on the immune system resulting in a spectrum of potential adverse events in a small proportion of patients. Research advances are improving the understanding, recognition and management of these adverse events.
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