Tofacitinib Does Not Increase VTE Risk More Than TNF Inhibitors

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. 

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