medwireNews: Tofacitinib is not associated with a higher risk for cardiovascular (CV) outcomes than tumor necrosis factor (TNF) inhibitors in the overall population of people with rheumatoid arthritis (RA), suggest findings from a US database study presented at the ACR Convergence 2021 virtual meeting.
However, “an increased risk of CV outcomes with tofacitinib cannot be ruled out” in people with CV risk factors or a history of CV disease (CVD), said Farzin Khosrow-Khavar (Brigham and Women's Hospital, Boston, Massachusetts, USA).
The STAR-RA study drew on three US databases, and included a total of 102,263 RA patients treated in routine care who initiated tofacitinib (n=12,852) or a TNF inhibitor between 2012 and 2020. The average age in the three databases ranged from 53 to 72 years, and the majority (77–79%) of patients were women.
Khosrow-Khavar reported that in the overall study population, people treated with tofacitinib and those on TNF inhibitors had a similar risk for the primary composite outcome of hospitalization for myocardial infarction or stroke, with a nonsignificant hazard ratio (HR) of 1.01 after adjustment for a range of confounding factors.
Similar findings were seen for the secondary outcomes of myocardial infarction, stroke, heart failure, and coronary revascularization in the overall study population, with the nonsignificant HRs ranging from 0.93 to 1.07.
The presenter explained that the analysis was also carried out in a subpopulation of people at high CV risk, with the same inclusion criteria as those applied in the ORAL Surveillance randomized controlled trial (RCT): at least one prescription of methotrexate; 65 years of age or older; and at least one additional CV risk factor.
In this “RCT duplicate” population, tofacitinib users had a numerically higher risk for the primary composite outcome relative to those on a TNF inhibitor, albeit without reaching statistical significance (HR=1.24).
In addition, among people from the main study population who had prior CVD (10–31% across the three databases), tofacitinib was associated with a higher risk for the primary outcome than TNF inhibitors, with a nonsignificant HR of 1.27.
“Overall, the results of this study point to potential heterogeneity” in the CV risk associated with tofacitinib, with no observed increased risk in the overall RA population, but “a potential increased risk […] in patients who have risk factors for cardiovascular disease,” concluded Khosrow-Khavar.
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