STEROID-RELATED ADVERSE EVENTS OF CHRONIC BUDESONIDE USE IN PATIENTS AGE 60 AND OLDER WITH INFLAMMATORY BOWEL DISEASE AND MICROSCOPIC COLITIS

Abstract INTRODUCTION Budesonide is commonly used to treat older adults with inflammatory bowel disease (IBD) and microscopic colitis (MC). While budesonide has been established to have a favorable short-term safety profile in unselected cohorts, long term steroid-related adverse events in a large population of patients ≥60 years has not been well elucidated. METHODS In this multicenter retrospective study, we identified individuals with a diagnosis of Crohn’s disease (CD), ulcerative colitis (UC), or microscopic colitis (MC) who were started on long term budesonide (≥ 2 budesonide prescriptions within 360 days) at age ≥ 60 years. Rates of adverse events were compared to mesalamine and prednisone users. New diagnoses of hyperglycemia, infection, fracture, fall, glaucoma, cataract, osteopenia, and osteoporosis that occurred within 6 months after prescription were noted. Concurrent advanced therapies were accounted for. Multivariable logistic regression adjusting for sex, age of medication initiation, disease type, and history of falls was performed. RESULTS We identified 970 budesonide users, 2384 mesalamine users, and 2616 prednisone users. 66.2% of budesonide users were female, 45.6% had CD, 33.8% had UC, and 20.6% had MC, with a mean age of medication initiation of 72 years. Compared to prednisone users, budesonide users were less likely to develop hyperglycemia (5% vs 16%, p < 0.001), delirium (0.2% vs 2.6%, p < 0.001), and agitation (0% vs 0.9%, p < 0.001). Adverse events that were more common in budesonide than prednisone user were fall (24% vs 8%, p < 0.001), even after adjusting for prior history of falls (adjusted odds ratio [aOR]: 2.5, 95% confidence interval [CI]:1.96, 3.07), and osteoporosis (6% vs 3%, p < 0.001). Budesonide and prednisone users had similar rates in osteopenia, glaucoma, and cataracts after adjustment. They also had similar likelihood of infection (19% vs 19%, p = 0.07), though severe infection requiring hospitalization or urgent care were less likely in budesonide than in prednisone (6% vs 11%, p < 0.001), including after adjustment (aOR 0.5, CI:0.38, 0.70). DISCUSSION Budesonide had lower risks of psychiatric adverse events, hyperglycemia, and severe infection compared to prednisone. However, certain adverse events such as falls and osteoporosis were more likely in budesonide users, while other adverse events such as osteopenia, glaucoma, cataracts were similarly likely. Some of these findings may be confounded by indication, which cannot be ruled out. More studies on long term safety of budesonide are needed. It is important to adopt steroid-sparing strategies to long-term budesonide users.