Risk of venous thromboembolism higher with tofacitinib use in patients with RA
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In patients with rheumatoid arthritis, risk of venous thromboembolism was higher in those taking 10 mg of tofacitinib twice a day compared to 5 mg or TNF inhibitors, according to findings from the ORAL Surveillance study.
Rheumatologists recognize that RA increases the risk of venous thromboembolism (VTE) compared to the general population, as does treatment with tofacitinib (Xeljanz, Pfizer), Christina Charles-Schoeman, MD, MS, of the department of medicine at the University of California, Los Angeles, said in her presentation at ACR Convergence 2021.
“A 2019 review by the Tofacitinib Rheumatology Data Safety Monitoring Board noted a statistically and clinically important difference in the frequency of pulmonary embolism (PE) with tofacitinib 10 mg twice daily compared to the TNF inhibitor group in the ORAL Surveillance study,” Charles-Schoeman told Healio. “The current work evaluated the risk of venous thromboembolism (VTE), including deep venous thrombosis (DVT) and PE individually, across treatment arms in the complete ORAL Surveillance study.”
Patients with moderate-to-severe RA were randomized to receive either 5mg of tofacitinib twice daily, 10 mg twice daily or TNF inhibitors, and were at least 50 years of age, had at least one additional cardiovascular risk factor, had an inadequate response to methotrexate and had no current or prior malignancy.
Researchers reviewed 30 global studies conducted from March 2014 to July 2020, in which 1,455, 1,456 and 1,451 patients receiving methotrexate took tofacitinib 5 mg twice daily, 10 mg twice daily and TNF inhibitors, respectively. The data followed patients in the 10 mg group who switched to 5 mg due to a protocol change in February 2019, according to the presentation.
The 10 mg tofacitinib group had the highest incidence rates of VTE, DVT and PE, with statistically significant differences for VTE and PE compared with the 5 mg group and TNF inhibitor group. However, there were no significant differences between patients on 5 mg tofacitinib and TNF inhibitors, Charles-Schoeman said.
“These results are consistent with the findings of the ad hoc safety analysis done in 2019, which resulted in dose reduction from the 10 mg to 5 mg tofacitinib,” she said during the presentation.
Based on analysis of data in 6-month intervals, incidence rates in each group were similar over time, according to the presentation.
“Age, male sex, baseline BMI greater than or equal to 30 kg/m2, history of hypertension or VTE, and baseline use of oral contraceptives or [hormone replacement therapy], corticosteroids or antidepressants were identified as significant baseline risk factors for PE across all treatment groups in multivariate modeling,” Charles-Schoeman said.
Moreover, rates of VTE, DVT and PE were higher across all groups in patients with a history of VTE compared with those with no previous incidence of VTE.
“Understanding molecular mechanisms that drive venous thrombotic disease in patients with rheumatoid arthritis will be critical for the prevention of this serious comorbidity in the future,” Charles-Schoeman told Healio.
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Charles-Schoeman C. Abstract 1941. Presented at: ACR Convergence 2021; November 3-10, 2021 (virtual meeting).
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