S503 Tofacitinib vs Vedolizumab: A 36-Month Journey in Ulcerative Proctitis Management With Insights on Efficacy and Safety: Propensity-Matched Cohort Analysis Using TriNetX Database

Introduction: Tofacitinib, a Janus kinase inhibitor, and vedolizumab, an integrin antagonist, are therapeutic options for ulcerative colitis, including ulcerative proctitis (UP). This study aims to compare the efficacy and safety of tofacitinib versus vedolizumab in patients with UP over 36 months. Methods: Utilizing TriNetX Network Database, a retrospective cohort study was conducted comparing patients with UP treated with tofacitinib (n = 567) versus vedolizumab (n = 567). Propensity score matching was employed to balance baseline characteristics and minimize confounding. Outcomes included oral and intravenous corticosteroid use, hospitalization, proctectomy rates, venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and opportunistic infections at 6, 12, 24, and 36 months. Results: At 6 months, the use of IV corticosteroids was significantly lower in the tofacitinib group compared to the vedolizumab group (odds ratio [OR] = 0.47, 95% confidence interval [CI]: 0.337–0.648). Similarly, the use of intravenous (IV) or oral corticosteroids was reduced in the tofacitinib group (OR = 0.766, 95% CI: 0.597–0.983). However, hospitalization rates were higher in the tofacitinib group (OR = 1.45, 95% CI: 1.088–1.932). At 12 months, IV corticosteroid use remained lower in the tofacitinib group (OR = 0.506, 95% CI: 0.374–0.684), but hospitalization rates were again higher (OR = 1.328, 95% CI: 1.018–1.733). At 24 months, the tofacitinib group showed significantly reduced use of IV corticosteroids (OR = 0.488, 95% CI: 0.367–0.648) and IV or oral corticosteroids (OR = 0.727, 95% CI: 0.573–0.921). Additionally, the incidence of venous thromboembolism (VTE) was lower in the tofacitinib group (OR = 0.445, 95% CI: 0.209–0.948). By 36 months, the trend continued, with reduced use of IV corticosteroids (OR = 0.508, 95% CI: 0.386–0.669) and IV or oral corticosteroids (OR = 0.74, 95% CI: 0.585–0.936) in the tofacitinib group, alongside a lower risk of VTE (OR = 0.469, 95% CI: 0.233–0.942). Other outcomes, including proctectomy rates, MACE, and opportunistic infections, showed no significant differences between groups across all time points. Conclusion: In patients with UP, tofacitinib may reduce corticosteroid dependence compared to vedolizumab over 36 months. However, it may be associated with higher hospitalization rates in the early treatment phase. Further studies are needed to evaluate the long-term safety and efficacy of both treatments.