Tofacitinib and Cardiovascular Events

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Rheumatoid arthritis patients taking tofacitinib could face some increased risks for significant cardiovascular events, depending upon their underlying characteristics, according to the results of a new study.

In an article published in a recent Arthritis & Rheumatology issue, researchers investigated the impact 24 weeks of tofacitinib treatment had on patients’ risks of major adverse cardiovascular events. The results were inconsistent.

“In pooled analyses of tofacitinib-treated patients, traditional cardiovascular risk factors at baseline appeared to be associated with an increased risk of future major adverse cardiovascular events, while no apparent association was observed between future risk and baseline disease activity or inflammation,” said study author Koshika Soma, M.D., a clinician with Pfizer Pharmaceuticals.

To determine whether an association between tofacitinib and cardiovascular problems exists, researchers evaluated data on 4,076 patients enrolled in six phase III studies and two long-term extension studies over seven years. The studies analyzed 5 mg and 10 mg twice daily tofacitinib monotherapy and in combination with csDMARDs.

According to study results, 52 patients experienced major adverse cardiovascular events. Twelve patients died, 19 had non-fatal heart attacks, and 23 had non-fatal strokes. Two individuals had more than one event occur. Cardiovascular problems occurred more often in older individuals who had higher body mass index, were more likely to have a history of diabetes or high blood pressure, and were more likely to take statins. Affected patients also had longer disease duration, slightly higher total cholesterol, higher LDL, and slightly lower HDL levels.

After 24 weeks of tofacitinib treatment, investigators discovered increased HDL and decreased total cholesterol were associated with a reduced risk of future major cardiac events, but higher total cholesterol and lower LDL levels weren’t. Conversely, accelerated red blood cell sedimentation rates in tofacitinib patients, which indicated increased inflammation, may be associated with future risk.

Ultimately, investigators said, additional research is needed to determine tofacitinib’s cardiovascular safety compared other medications for rheumatoid arthritis, such as adalimumab or etanercept.

REFERENCE

Charles-Schliemann C, DeMasi R, Valdez H, Soma K, Hwang LJ, Boy M, Biswas P, McInnes I, Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long-Term Extension Studies of Tofacitinib in Patients with Rheumatoid Arthritis. Arthritis & Rheumatology (2019), doi: 10.1002/art.40911