Isotretinoin Does Not Increase the Risk of Inflammatory Bowel Disease: A TriNetX Retrospective Cohort Analysis

Background: The increasing use of long-term, low-dose isotretinoin for acne has raised concerns about a potential association with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.

To evaluate the association between isotretinoin therapy and the risk of IBD using a large real-world database.

We conducted a retrospective cohort study utilizing the TriNetX network. Patients with acne who received isotretinoin were compared to acne patients who were not exposed to isotretinoin. Propensity score matching (1:1) was performed to balance baseline characteristics. Patients were followed for 6 to 10 years post-exposure. Primary outcomes included incidence of IBD, Crohn's disease, and ulcerative colitis. Secondary outcomes included irritable bowel syndrome (IBS), fecal calprotectin elevation, and elevated lipid levels. Hazard ratios (HRs) were calculated using Cox proportional hazards models.

Among 81,641 isotretinoin-exposed and 1,876,038 unexposed patients, 61,894 matched pairs were analyzed. Isotretinoin use was not associated with increased risk of IBD (HR: 0.88, 95% CI: 0.49–1.57) or ulcerative colitis (HR: 1.05, 95% CI: 0.78–1.41), and was associated with decreased risk of Crohn's disease (HR: 0.69, 95% CI: 0.51–0.94). IBS and fecal calprotectin elevation were not significantly different between groups. Lipid levels in the isotretinoin group were transiently elevated.

Long-term isotretinoin therapy does not increase the risk of IBD in acne patients.  .