Assessing the Risk of MI, Stroke, Thromboembolic Events in Patients With UC Treated With Tofacitinib, Biologics

Patients with ulcerative colitis (UC) taking tofacitinib or biologics do not have an increased risk of myocardial infarction or stroke (MI-S) or thromboembolic events (TE), according to a study presented at ACG 2024.

“There is limited information on safety events observed for tofacitinib using real-world data that includes an active comparator,” the investigators noted.

Researchers analyzed UC patients initiating with: 5,171 tofacitinib; n=10,424 ustekinumab; n=17,129 vedolizumab; n=29,872 TNFi. They calculated stabilized inverse probability treatment weights (sIPTW)  using 17 covariates to assess the risk of MI-S and TE, and an additional 53 in a sensitivity analysis to control for additional comorbidities, UC-related measures, and health care utilization variables.

The findings based on a total of 113 MI-S and 166 TE events showed that the the incidence rates of MI-S and TE per 100 person-years were 0.13 (95% CI 0.05, 0.28) and 0.17 (95% CI 0.07, 0.34) for tofacitinib; 0.17 (95% CI 0.10, 0.27) and 0.16 (95% CI 0.09, 0.26) for ustekinumab; 0.17 (95% CI 0.12, 0.24) and 0.23 (95% CI 0.17, 0.31) for vedolizumab; and 0.19 (95% CI 0.15, 0.25) and 0.33 (95% CI 0.27, 0.40) for TNFi. Overall, the researchers noted that there were no appreciable differences in the risk of developing MI-S or TE between treatment groups.

“In this large US-based claims analysis adjusting for many covariates, there were no significant differences in risk of developing MI-S or TE among pts with UC initiating tofacitinib compared to biologics. These findings are important for the consideration of treatment options and discussions of risks/benefits for UC patients,” the researchers concluded.

Reference

Rubin D, Schreiber S, Danese S, et al. Risk of Myocardial Infarction, Stroke, and Thromboembolic Events in Patients With Ulcerative Colitis Treated With Tofacitinib Compared to Biologic Treatments in the United States Abstract #P0827. Presented at the American College of Gastroenterology 2024 Annual Scientific Meeting & Postgraduate Course; October 25-30, Philadelphia, Pennsylvania.