S1662 Long-Term Safety of Biologics Compared to Steroids and Aminosalicylates in Inflammatory Bowel Disease: A 5-Year Cohort Study

Introduction: Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, requires effective long-term therapy to optimize outcomes. Biologics, steroids, and aminosalicylates are commonly used treatments, but concerns remain about their long-term safety, particularly regarding cancer, infections, thromboembolism, and hospitalizations. This study evaluates and compares the long-term safety profiles of biologics vs steroids and aminosalicylates over 5 years using real-world data. Methods: We conducted a retrospective cohort study using the TriNetX Research Network, including IBD patients aged ≥18 years treated with biologics or steroids and aminosalicylates from 2015 to 2020. Propensity score matching balanced demographic and clinical characteristics between cohorts (n = 19,610 each). Incidence of cancer, infections, thromboembolism, and hospitalizations was assessed at 6 months, 1 year, 3 years, and 5 years. Risk estimates were compared, and Kaplan-Meier analysis with hazard ratios (HR) evaluated event-free probabilities. Results: Biologic therapies consistently demonstrated superior safety compared to steroids and aminosalicylates across all time points. Cancer-free survival at 5 years was significantly higher in the biologic group (99.32% vs 98.43%), as were infection-free (86.30% vs 68.42%), thromboembolism-free (97.55% vs 92.61%), and hospitalization-free probabilities (92.16% vs 77.30%; P < 0.001 for all). Incidence rates were lower in the biologic group for cancer (0.3% vs 0.9%), infections (7.6% vs 19.1%), thromboembolism (1.5% vs 4.5%), and hospitalizations (4.7% vs 16.5%; P < 0.001 for all). Conclusion: Biologic therapies significantly outperformed steroids and aminosalicylates in long-term safety, reducing the risks of cancer, infections, thromboembolism, and hospitalizations over 5 years. These findings support biologics as the preferred treatment strategy in IBD management, particularly for patients at higher risk of severe complications. By clarifying the safety profiles of these therapies, these results reinforce the role of biologics in evidence-based clinical practice. Future prospective studies should validate these findings and investigate underlying mechanisms to optimize patient outcomes and guide individualized treatment.