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Nyboe Andersen N, Pasternak B, Andersson M, Nielsen NM, Jess T. Risk of Demyelinating Diseases in the Central Nervous System in Patients With Inflammatory Bowel Disease Treated With Tumor Necrosis Factor Inhibitors. JAMA Intern Med. 2015;175(12):1990–1992. doi:https://doi.org/10.1001/jamainternmed.2015.5396
An association between usage of tumor necrosis factor inhibitors (anti-TNF) in patients with inflammatory bowel disease (IBD) and other immune-mediated diseases and demyelinating diseases in the central nervous system has been suggested by case reports.1,2 However, it remains uncertain whether these cases are directly related to anti-TNF therapy because there is evidence of an underlying association between demyelinating disease and IBD.3 In a nationwide population-based cohort, we compared rates of central demyelinating diseases among patients with IBD exposed and unexposed to anti-TNF.
The general study design and data sources used have been described in detail elsewhere.4,5 Briefly, using the Danish Civil Registration System, we identified a source population of 4 million people living in Denmark from January 1, 1999, to December 31, 2012. Unique personal identifiers permitted linkage to data from health registries on IBD diagnoses, anti-TNF exposure, and outcomes. After the date of first anti-TNF dose, the patient was categorized as ever exposed. The outcome was defined as a diagnosis of a central demyelinating disease, including multiple sclerosis, optic neuritis, transverse myelitis, and other central demyelinating diseases. Patients with a history of central demyelinating disease and those with use of anti-TNF prior to 1999 or prior to IBD diagnosis were excluded. The study was approved by the Danish Data Protection Agency. Ethics approval is not required for registry-based research in Denmark.
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