{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T12:40:58Z","timestamp":1773060058130,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,3,25]],"date-time":"2019-03-25T00:00:00Z","timestamp":1553472000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Off\u2010label prescribing is encountered across various fields of medicine and creates alternative treatment options, but is associated with unknown safety risks. The use of off\u2010label drugs for the treatment of patients with inflammatory bowel diseases (IBD) has not been characterised before.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the proportion and characteristics of off\u2010label prescribing for IBD in tertiary care centres in the Netherlands.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A prospective database of IBD patients from all Dutch university hospitals was used to collect data on drug prescriptions for IBD and demographics. Drugs were classified as off\u2010label if they were unlicensed for Crohn's disease and\/or ulcerative colitis by the Medicines Evaluation Board. Uni\u2010 and multivariable analyses were used to identify patient\u2010specific characteristics predictive of increased off\u2010label use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For the induction and\/or maintenance treatment of 4583 IBD patients, 12\u00a0651 historical and current drug records were available in the database. Of these, 2374 (19%) were considered off\u2010label prescriptions. Out of 4583 IBD patients, 1477 (32%) were exposed to off\u2010label drugs. Commonly prescribed off\u2010label IBD drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%). Non\u2010thiopurine\/methotrexate off\u2010label drugs were prescribed in 243 patients (6%), including biological agents or tofacitinib in 47 IBD patients (1%). Off\u2010label prescriptions were more common in ulcerative colitis than Crohn's disease (37% vs 29%, <jats:italic>P\u00a0&lt;\u00a0<\/jats:italic>0.001). Smokers and patients that received \u22655 drug types during their disease course were more likely to be exposed to off\u2010label drugs (smoking 33% vs 27% and multiple drug use 66% vs 22%, both <jats:italic>P\u00a0&lt;\u00a0<\/jats:italic>0.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>About one\u2010fifth of prescriptions for IBD were off\u2010label and one\u2010third of IBD patients, especially ulcerative colitis patients, were exposed to off\u2010label drugs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.15229","type":"journal-article","created":{"date-parts":[[2019,3,25]],"date-time":"2019-03-25T20:07:43Z","timestamp":1553544463000},"page":"1293-1300","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Off\u2010label prescriptions of drugs used for the treatment of Crohn\u2019s disease or ulcerative colitis"],"prefix":"10.1111","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8827-955X","authenticated-orcid":false,"given":"Melek","family":"Simsek","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology Amsterdam UMC, Vrije Universiteit Amsterdam, AG&amp;M research institute Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit I.","family":"Lissenberg\u2010Witte","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics Amsterdam UMC, Vrije Universiteit Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Milou L. M.","family":"van Riswijk","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Amsterdam UMC, Vrije Universiteit Amsterdam, AG&amp;M research institute Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sander","family":"Verschuren","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Amsterdam UMC, Vrije Universiteit Amsterdam, AG&amp;M research institute Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Hoentjen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Radboud University Medical Centre Nijmegen The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bas","family":"Oldenburg","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology University Medical Centre Utrecht Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cyriel Y.","family":"Ponsioen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Amsterdam UMC, Academical Medical Centre Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. Janneke","family":"van der Woude","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Erasmus University Medical Centre Rotterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea E.","family":"van der Meulen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Leiden University Medical Centre Leiden The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marieke","family":"Pierik","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Maastricht University Medical Centre Maastricht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerard","family":"Dijkstra","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology University Medical Centre Groningen and University of Groningen Groningen The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nanne K. 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