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Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis
Author(s) -
Simsek Melek,
LissenbergWitte Birgit I.,
van Riswijk Milou L. M.,
Verschuren Sander,
Hoentjen Frank,
Oldenburg Bas,
Ponsioen Cyriel Y.,
van der Woude C. Janneke,
van der Meulen Andrea E.,
Pierik Marieke,
Dijkstra Gerard,
de Boer Nanne K. H.
Publication year - 2019
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.15229
Subject(s) - medicine , thiopurine methyltransferase , ulcerative colitis , medical prescription , off label use , inflammatory bowel disease , tofacitinib , drug , methotrexate , crohn's disease , allopurinol , disease , azathioprine , pharmacology , rheumatoid arthritis
Background Off‐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. Aim To assess the proportion and characteristics of off‐label prescribing for IBD in tertiary care centres in the Netherlands. Methods 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‐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. Results For the induction and/or maintenance treatment of 4583 IBD patients, 12 651 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 < 0.001). Smokers and patients that received ≥5 drug types during their disease course were more likely to be exposed to off‐label drugs (smoking 33% vs 27% and multiple drug use 66% vs 22%, both P < 0.001). Conclusion About 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.