Off-label prescriptions of drugs used for the treatment of Crohn's disease or ulcerative colitis

Melek Simsek*, Birgit I. Lissenberg-Witte, Milou L. M. van Riswijk, Sander Verschuren, Frank Hoentjen, Bas Oldenburg, Cyriel Y. Ponsioen, C. Janneke van der Woude, Andrea E. van der Meulen, Marieke Pierik, Gerard Dijkstra, Nanne K. H. de Boer, Parelsnoer Institute (PSI), Dutch Initiative on Crohn's and Colitis (ICC)

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


BackgroundOff-label prescribing is encountered across various fields of medicine and creates alternative treatment options, but is associated with unknown safety risks. The use of off-label drugs for the treatment of patients with inflammatory bowel diseases (IBD) has not been characterised before.

AimTo assess the proportion and characteristics of off-label prescribing for IBD in tertiary care centres in the Netherlands.

MethodsA 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-label if they were unlicensed for Crohn's disease and/or ulcerative colitis by the Medicines Evaluation Board. Uni- and multivariable analyses were used to identify patient-specific characteristics predictive of increased off-label use.

ResultsFor the induction and/or maintenance treatment of 4583 IBD patients, 12651 historical and current drug records were available in the database. Of these, 2374 (19%) were considered off-label prescriptions. Out of 4583 IBD patients, 1477 (32%) were exposed to off-label drugs. Commonly prescribed off-label IBD drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%). Non-thiopurine/methotrexate off-label drugs were prescribed in 243 patients (6%), including biological agents or tofacitinib in 47 IBD patients (1%). Off-label prescriptions were more common in ulcerative colitis than Crohn's disease (37% vs 29%, P

ConclusionAbout one-fifth of prescriptions for IBD were off-label and one-third of IBD patients, especially ulcerative colitis patients, were exposed to off-label drugs.

Original languageEnglish
Pages (from-to)1293-1300
Number of pages8
JournalAlimentary Pharmacology & Therapeutics
Issue number10
Publication statusPublished - May 2019


  • Crohn's disease
  • drugs
  • inflammatory bowel disease
  • off-label
  • prescriptions
  • therapeutic care
  • ulcerative colitis

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