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1-in-3 patients with IBD prescribed treatments off-label
Roughly one-fifth of all prescriptions for inflammatory bowel disease are considered “off-label” with one-third of all patients receiving drugs with off-label prescriptions, according to research published in Alimentary Pharmacology & Therapeutics.
Melek Simsek, of the department of gastroenterology and hepatology at Amsterdam UMC in the Netherlands, and colleagues wrote that off-label prescribing is common across many specialties with previous studies estimating their use as high as 21% of all prescriptions.
“In the treatment of [IBD], off-label drugs are prescribed as well, especially in patients who failed standard treatment regimens,” they wrote. “The overall magnitude of off-label prescribing for Crohn's disease and ulcerative colitis is unknown.”
Researchers built a prospective database comprising all patients with IBD at every university Hospital in the Netherlands. They collected data on prescriptions and demographics, and classified drugs as “off-label” if they were unlicensed for Crohn’s disease or ulcerative colitis by the Dutch Medicines Evaluation Board.
Investigators identified 12,651 historical and current drug records from 4,583 patients. Of these, 2,374 were considered off-label prescriptions (19%), and 1,477 patients were exposed to off-label drugs (32%). The most common off-label drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%).
In their analysis, Simsek and colleagues found that off-label prescriptions were more common among patients with UC (37%) compared with CD (29%; P < .001). Off-label prescriptions were also more common in patients who smoked (33% vs. 27%) and patients who took at least five different drug types (66% vs. 22%).
Simsek and colleagues wrote that they were not able to explore the reasons for initiation or withdrawal from off-label drugs.
“Future research is needed to evaluate the considerations for, and knowledge about, off-label prescriptions and its safety and consequences for the treatment of IBD,” they concluded. “Another interesting issue would be the impact of costs of off-label prescriptions, as compared to novel costly pharmaceutical agents, on the treatment of IBD.” – by Alex Young
Disclosures: The authors report no relevant financial disclosures.