Safety of Prescription Nonsteroidal Anti-inflammatory Drugs in Adults With Inflammatory Bowel Disease: Data From a Large Administrative Claims Cohort.

Abstract

The concern that nonsteroidal anti-inflammatory drugs (NSAIDs) may precipitate flares of inflammatory bowel disease (IBD) has limited their use in managing musculoskeletal symptoms in those with IBD, but safety data are mixed. This retrospective cohort study included patients with IBD aged at least 18 years from Optum's deidentified Clinformatics Data Mart Database (2000-2022). Patients with a new NSAID prescription fill were matched to those without an NSAID fill during the study period. The index date for exposed patients was the date of first NSAID fill, with a matched date for unexposed. Propensity score-based inverse probability of treatment-weighted Cox proportional hazards models evaluated the association between NSAID exposure and time to IBD-related hospitalization across IBD subtypes. A hazard ratio (HR) of 1.2 was prespecified as the non-inferiority margin. Among 348,095 patients with IBD, 23.2% were NSAID-exposed. NSAID exposure was associated with a small increase in IBD-related hospitalization in the overall cohort but demonstrated non-inferiority (HR 1.07, 95% confidence interval [CI] 1.04-1.10). Non-inferiority was met with no significantly increased risk of IBD-related hospitalization in patients with ulcerative colitis (HR 0.97, 95% CI 0.93-1.02). In contrast, non-inferiority was not met in the Crohn disease subgroup (HR 1.16, 95% CI 1.12-1.21). Patients with ulcerative colitis did not have a significantly increased risk of IBD-related hospitalization associated with NSAID exposure and met non-inferiority, whereas non-inferiority could not be established for those with Crohn disease. These results suggest that NSAID use may be acceptable for select patients with IBD who have significant musculoskeletal symptoms, especially those with ulcerative colitis.