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P702 Off-label drug use in patients with inflammatory bowel disease: a national survey among tertiary care centres

M. Simsek*1, F. Hoentjen2, B. Oldenburg3, C. Y. Ponsioen4, J. van der Woude5, A. E. van der Meulen6, M. Pierik7, G. Dijkstra8, N. K. de Boer1

1Amsterdam UMC, VU Medical Center, Gastroenterology and Hepatology, Amsterdam, The Netherlands, 2Radboud University Medical Center, Gastroenterology and Hepatology, Nijmegen, The Netherlands, 3University Medical Center Utrecht, Gastroenterology and Hepatology, Utrecht, The Netherlands, 4Amsterdam UMC, Academical Medical Center, Gastroenterology and Hepatology, Amsterdam, The Netherlands, 5Erasmus University Medical Center, Gastroenterology and Hepatology, Rotterdam, The Netherlands, 6Leiden University Medical Center, Gastroenterology and Hepatology, Leiden, The Netherlands, 7Maastricht University Medical Center, Gastroenterology and Hepatology, Maastricht, The Netherlands, 8University Medical Center Groningen and University of Groningen, Gastroenterology and Hepatology, Groningen, The Netherlands

Background

In daily clinical practice, drugs are commonly prescribed outside the terms of product license, also known as off-label prescribing. Off-label drugs create alternative treatment options, but are associated with unknown safety risks since they are under-evaluated for unlicensed indications. The use of off-label drugs for the treatment of inflammatory bowel diseases (IBD) has not been characterised. We aimed to assess the proportion and characteristics of off-label prescribing for IBD in tertiary care in the Netherlands.

Methods

A prospective database of IBD patients from all university hospitals in The Netherlands was used to collect data on (historical) drug prescriptions for IBD and demographics. Drugs were classified as off-label if they were unlicensed for Crohn’s disease and/or ulcerative colitis. Uni- and multi-variate analyses were used to identify patient-specific characteristics predictive of increased off-label use.

Results

A total of 12 651 historical and current drug records for the induction and/or maintenance treatment of 4583 IBD patients (59% female and 62% Crohn’s disease) were available in the database. Of these, 2374 (19%) were considered off-label drug 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%). Off-label prescriptions were more common in ulcerative colitis than Crohn’s disease (37% vs. 29%, p < 0.001). Smokers and patients exposed to multiple ( ≥5) types of drugs during their disease course were more likely to be exposed to off-label drugs (smoking 33% vs. 27% and multiple (≥5) drug use 66% vs. 22%, both p < 0.001).

Conclusion

About 19% of prescriptions for IBD were off-label and one-third of IBD patients, especially patients with ulcerative colitis, were exposed to off-label drugs. Future studies are needed to evaluate the consequences of off-label prescriptions for the treatment of IBD.