Tofacitinib not linked to increased risk of cardiovascular outcomes in patients with RA
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In the real-world setting, tofacitinib was not found to significantly increase risk of cardiovascular outcomes in patients with rheumatoid arthritis compared with TNF inhibitors, according to an abstract presented at ACR Convergence 2021.
“Recent reports from a post-marketing safety trial, ORAL Surveillance, indicated an increased risk of cardiovascular outcomes in RA patients treated with tofacitinib,” Farzin Khosrow-Khavar, MSc, PhD, a postdoctoral fellow at the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, and colleagues wrote. “Thus, the aim of this study was to examine the risk of CV outcomes associated with tofacitinib, compared with tumor necrosis factor inhibitors (TNFi), in patients with RA.”
Khosrow-Khavar and colleagues created two study cohorts of patients with RA beginning tofacitinib (Xeljanz, Pfizer) or TNF inhibitor treatment using U.S. claims data from Optum Clinformatics (2012 to 2020), IBM MarketScan (2012 to 2018), and Medicare parts A, B and D (2012 to 2017). One cohort mimicked the inclusion and exclusion criteria of the ORAL Surveillance trial and was defined as a restrictive randomized control trial (RCT)-duplicate cohort, while the second cohort included a representative population from routine care and was defined as a broader “real-world evidence” cohort. Researchers followed patients from treatment initiation until treatment discontinuation or switch, insurance disenrollment, end of study period or death. Inpatient claims for myocardial infarction or stroke were used to define the primary composite cardiovascular outcome.
Overall, the real-world evidence cohort included 102,263 patients, with 28,568, 34,083 and 39,612 patients identified from Optum, MarketScan and Medicare, respectively. Of these patients, 13.2% from Optum, 15.6% from MarketScan and 9.5% from Medicare initiated tofacitinib treatment. Within the same cohort, researchers found a history of cardiovascular disease in 13% of patients in Optum, 10% in MarketScan and 31% in Medicare.
Per 100 person-years, the crude incidence rates of the primary cardiovascular endpoint for real-world patients using tofacitinib and TNF inhibitors were 0.73 (95% CI, 0.47-1.09) and 0.61 (95% CI, 0.51-0.72) in Optum, 0.75 (95% CI, 0.52-1.05) and 0.52 (95% CI, 0.44-0.61) in MarketScan and 2.14 (95% CI, 1.66-2.70) and 1.86 (95% CI, 1.71-2.02) in Medicare respectively. Overall, in the real-world evidence cohort, the pooled HR for CV outcomes comparing tofacitinib with TNF inhibitors was 1.01 (95% CI, 0.83-1.23). However, for patients with baseline cardiovascular disease, the pooled HR was 1.27 (95% CI, 0.95-1.70).
Results from the RCT-duplicate cohort comparing tofacitinib with TNF inhibitors were found to be similar with reports from the ORAL Surveillance trial (HR = 1.24; 95% CI, 0.90-1.69; HR = 1.33; 95% CI, 0.91-1.94, respectively).
“This multi-database large population-based study did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib, in comparison with TNFI, in the overall RA patient population treated in the real-world setting," the researchers concluded. “However, similar to the reported results from ORAL Surveillance trial, tofacitinib, in comparison with TNFI, was associated with an increased, but statistically non-significant, risk of cardiovascular outcomes in RA patients with cardiovascular risk factors or a history of cardiovascular disease.”
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Khosrow-Khavar F, et al. Abstract #1939. Presented at: ACR Convergence 2021; November 3-10, 2021 (virtual meeting).
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