VTE Risk in RA Not Significantly Higher With Tofacitinib vs TNF Inhibitors

VTE Thrombosis Thrombus
VTE Thrombosis Thrombus
Although the incidence rate of venous thromboembolism was numerically higher in patients treated with tofacitinib vs TNF inhibitors, the risk was not statistically significant.
The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .

CHICAGO — Although the risk for venous thromboembolism (VTE) is numerically higher in patients with rheumatoid arthritis (RA) treated with tofacitinib vs tumor necrosis factor inhibitors (TNFis), this risk is statistically not significant, according to data presented at the 2018 ACR/ARHP Annual Meeting, held October 19-24, in Chicago, Illinois.

In the premarketing trials of baricitinib, a Janus kinase inhibitor, there was a noted possible increased risk for VTE. Consequently, the US Food and Drug Administration restricted the approval to the low dose of baricitinib only (2 mg) for RA treatment. Researchers sought to determine whether tofacitinib may also have an increased risk for VTE risk. Therefore, they conducted a new-user cohort study using administrative claims data from Truven Marketscan and Medicare databases to evaluate the VTE risk in tofacitinib compared with TNFIs.

The researchers identified 34,074 and 17,086 patients with RA from Truven and Medicare, respectively, with mean ages of 50 and 71 years. A total of 5.6% and 5.8% of patients were tofacitinib initiators. At baseline, patients who were tofacitinib initiators had used ≥3 nonbiologic disease-modifying medications and glucocorticoids, which indicated a longer duration or more active disease in this group.

Patients were followed for VTE, which was defined as a composite of pulmonary embolism or deep vein thrombosis diagnosis.

In the Truven database, the incidence rates of VTE per 100 person-years were 0.60 (95% CI, 0.26-1.19) and 0.34 (95% CI, 0.27-0.41) for tofacitinib initiators and TNFi users, respectively, while the incidence rates in the Medicare patients were 1.12 and 0.92 for tofacitinib initiators and TNFi users, respectively.

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Propensity score adjusted hazard ratios demonstrated no significant differences in VTE risk between tofacitinib and TNF inhibitors in either database (pooled hazard ratio, 1.33; 95% CI, 0.78-2.24).

Although there was a numerically higher risk for VTE in patients treated with tofacitinib vs TNF inhibitors, it was statistically nonsignificant. In addition, the absolute rates of VTE were low and comparable with those observed in the premarketing trials of baricitinib and tofacitinib.

“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 [Janus kinase inhibitor] agent with respect to VTE risk,” the researchers noted.

Disclosures: Dr Weinblatt reports financial support from Amgen, Bristol Myers Squibb, Crescendo Bioscience, and Sanofi/Regeneron, among others. Dr Kim reports financial support from Bristol Myers Squibb, Pfizer, and Roche.

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Desai RJ, Pawar A, Weinblatt ME, Kim SC. Comparative risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors: a cohort study of rheumatoid arthritis patients. Presented at: ACR/ARHP 2018 Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract L09.

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