TY - JOUR
T1 - Off-label prescriptions of drugs used for the treatment of Crohn's disease or ulcerative colitis
AU - Simsek, Melek
AU - Lissenberg-Witte, Birgit I.
AU - van Riswijk, Milou L. M.
AU - Verschuren, Sander
AU - Hoentjen, Frank
AU - Oldenburg, Bas
AU - Ponsioen, Cyriel Y.
AU - van der Woude, C. Janneke
AU - van der Meulen, Andrea E.
AU - Pierik, Marieke
AU - Dijkstra, Gerard
AU - de Boer, Nanne K. H.
AU - Parelsnoer Institute (PSI)
AU - Dutch Initiative on Crohn's and Colitis (ICC)
N1 - Funding Information:
Declaration of funding interests: Melek Simsek has received an unrestricted research Grant from TEVA Pharma. Birgit I. Lissenberg‐ Witte, Milou L. M. van Riswijk and Sander Verschuren have nothing to declare. Frank Hoentjen has served on advisory boards or as speaker for Abbvie, Janssen‐Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk and has served as consultant for Celgene. He has received unrestricted research Grants from Dr. Falk, Janssen‐Cilag and Abbvie. Bas Oldenburg has received unrestricted research Grants from Abbvie, Dr. Falk, MSD, Takeda, Pfizer, Ferring, Cablon and has participated in the advisory board of Pfizer, Jansen, Abbvie, Takeda and MSD. Cyriel Y. Ponsioen has served as speaker for Takeda, Tillotts and Abbvie and has received research Grants from Takeda. He has been a consultant for Takeda and Pliant. C. Janneke van der Woude has participated in the advisory board and/or received financial compensation from Pfizer, MSD, FALK Benelux, Tramedico, Abbott laboratories, Mundipharma Pharmaceuticals, Jans-sen, Takeda and Ferring. Andrea E. van der Meulen has served as a speaker for Janssen and Takeda. She has served as consultant for Takeda. She has received a research grant from Takeda. Marieke Pierik has served as a speaker for MSD and has received research Grants from European Union and Dr. Falk. Gerard Dijkstra has received unrestricted research Grants from AbbVie and Takeda. He has served as a member of the advisory board for Mundipharma and Pharmacosmos and has received speaker fees from Takeda, Pfizer and Janssen. Nanne K. H. de Boer has served as a speaker for Abb-Vie, Takeda and MSD. He has served as consultant and principal investigator for Takeda and TEVA Pharma B.V. He has received unrestricted research Grants from Dr. Falk and Takeda.
Publisher Copyright:
© 2019 The Authors. Alimentary Pharmacology & Therapeutics Published by John Wiley & Sons Ltd.
PY - 2019/5
Y1 - 2019/5
N2 - 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%, PConclusionAbout 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.
AB - 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%, PConclusionAbout 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.
KW - Crohn's disease
KW - drugs
KW - inflammatory bowel disease
KW - off-label
KW - prescriptions
KW - therapeutic care
KW - ulcerative colitis
U2 - 10.1111/apt.15229
DO - 10.1111/apt.15229
M3 - Article
C2 - 30908719
SN - 0269-2813
VL - 49
SP - 1293
EP - 1300
JO - Alimentary Pharmacology & Therapeutics
JF - Alimentary Pharmacology & Therapeutics
IS - 10
ER -