Tofacitinib Does Not Increase VTE Risk More Than TNF Inhibitors

By Kaitlyn D’Onofrio - Last Updated: August 30, 2023

The risk of venous thromboembolism (VTE) is not statistically different for rheumatoid arthritis (RA) patients treated with tofacitinib compared to patients using a tumor necrosis factor (TNF) inhibitor, according to a study presented at the annual meeting of the American College of Rheumatology. 

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Researchers collected data from the Truven Marketscan (2012-2016) and Medicare (parts A, B, and D, 2012-2015) databases for RA patients aged ≥ 18 years. There were 34,074 RA patients from the Truven database (mean age, 50 years), of whom 5.6% were tofacitinib initiators, and 17,086 Medicare patients (mean age, 71 years), of whom 5.8% were tofacitinib initiators. Tofacitinib initiators were more likely to have used at least three non-biologic disease modifying agents and glucocorticoids at the start of the study, meaning this group had “more active or longer duration [of] RA.” The primary outcome was VTE, which study authors defined as “a composite of pulmonary embolism or deep vein thrombosis diagnosis in inpatient claims, on as treated basis.” 

Incidence rates/100 person-years for the Truven cohort in tofacitinib and TNF-inhibitor patients were 0.60 and 0.34, respectively, and in the Medicare cohort were 1.12 and 0.92, respectively. In propensity score-adjusted analyses, there was no significant differences in risk of VTE for tofacitinib and TNF-inhibitor patients for both groups. 

While tofacitinib patients had a numerically higher VTE risk than TNF-inhibitor patients, researchers said the difference did not have statistical significance.  

“Although residual confounding is possible and the precision of estimates was limited due to a small event count, these results are helpful in ruling out the possibility of a large increase in the risk of VTE with tofacitinib and provide preliminary evidence regarding the safety of this JAK inhibitor agent with respect to VTE risk,” the researchers wrote. 

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Source: American College of Rheumatology

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