Thromboembolic Risk in Ulcerative Colitis Patients on Advanced Therapy

Introduction: Patients with ulcerative colitis (UC) have an increased risk of thromboembolic events. While advanced therapies (ADTs) have improved treatment outcomes, their comparative thromboembolic risks remain unclear.
Methods: This retrospective cohort study utilized the Japanese Medical Data Vision claims database to assess patients with UC initiating treatment with tumour necrosis factor (TNF) inhibitors, vedolizumab, or tofacitinib. We evaluated the risk of venous thrombotic events (VTEs), cardiovascular events (CVEs), and major adverse cardiovascular events (MACEs).
Results: A total of 8,125 TNF inhibitor users, 1,218 tofacitinib users, and 2,469 vedolizumab users were included in this study. Compared with TNF inhibitors, vedolizumab was associated with a significantly lower risk of VTE (HR: 0.48, 95% confidence interval [CI]: 0.29-0.78; P < 0.01) and CVE (HR: 0.46, 95% CI: 0.27-0.80; P < 0.01), with no significant difference observed for MACE. Tofacitinib 5 mg twice daily (BID) did not significantly increase VTE, CVE, or MACE, whereas tofacitinib 10 mg BID showed elevated HRs for MACE, albeit with wide CIs. Concomitant use of 5-aminosalicylic acid was associated with a lower incidence of VTE and CVE.
Conclusions: Vedolizumab may reduce thrombotic and cardiovascular risks compared to TNF inhibitors. Tofacitinib 5 mg BID demonstrates comparable safety profile, while higher doses require careful patient evaluation.