Risk of serious infection, myocardial infarction, stroke, and thromboembolic events in patients in the United States with ulcerative colitis treated with tofacitinib compared with biologic treatments

BACKGROUND: This analysis of insurer-complete administrative data and claims from a United States database (Komodo Health) assessed the risk of serious infections, myocardial infarction (MI), stroke, and venous thromboembolism (VTE) among patients with ulcerative colitis (UC) initiating tofacitinib or biologic treatments. METHODS: Patients with UC initiating treatment with tofacitinib, ustekinumab, vedolizumab, or tumor necrosis factor inhibitors (TNFis) from May 31, 2018, to September 30, 2022, were included. Stabilized inverse probability treatment weights (sIPTWs) were calculated and Cox proportional hazards models with sIPTWs were used to calculate hazard ratios; bootstrapping was used to calculate 95% CIs. RESULTS: In total, 5171, 10 424, 17 129, and 29 872 patients initiated tofacitinib, ustekinumab, vedolizumab, and TNFis, respectively. The mean patient age at index was 43.1 years and the mean follow-up was 359.2 days. At baseline, a greater proportion of patients initiating tofacitinib vs biologics had used ≥ 2 prior biologics (46.3% vs 7.5%-33.7%, respectively). Incidence rates (IRs)/100 patient-years (PY) of serious infections were 2.62, 2.73, 2.45, and 3.25 for tofacitinib, ustekinumab, vedolizumab, and TNFi, respectively. For MI/stroke and VTE the IRs/100 PY were, respectively, 0.13 and 0.17 for tofacitinib, 0.17 and 0.16 for ustekinumab, 0.17 and 0.23 for vedolizumab, and 0.19 and 0.33 for TNFi. There were no significant differences in the risk of developing serious infections, MI/stroke, or VTE between treatments. CONCLUSIONS: No significant risk differences were observed among patients with UC initiating tofacitinib compared with biologics in a large US claims database. These findings add to evaluations of treatment risks vs benefits in patients with UC. EUROPEAN UNION POST-AUTHORIZATION STUDY (PAS) REGISTER NUMBER: EUPAS103443.