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The ENTRACTE trial examined the risk for major adverse cardiovascular events (MACE) in RA patients and found no increased risk of MACE in patients treated with tocilizumab (TCZ) versus etanercept (ETN).
The trial was undertaken to examine the CV consequences of the hyperlipidemia seen in up to 20% of patientstreated with IL-6 inhibitors.
The study enrolled 3080 active seropositive RA, who had inadequate responses to conventional synthetic disease‐modifying antirheumatic drugs, and at least one cardiovascular risk factor. Patients were randomlized to open‐label TCZ 8 mg/kg/month or ETN 50 mg/week and followed up for an average of 3.2 years. The primary end point was comparison of time‐to‐first MACE.
When compared to patients treated with ETN, levels of LDL, HDL, and triglycerides were 11.1%, 5.7%, and 13.6% higher, respectively, by week 4 (P<.001).
There were a totall of 161 MACE (83 TCZ; 78 ETN) and the hazard ratio of MACE with tocilizumab (vs. ETN) was 1.05 (95% CI 0.77, 1.43). Similarly the HR for secondary endpoints (non-fatal MI, stroke, cardiovascular death and all causes of death) were not significantly different.
Adverse events were higher with TCZ, but not significantly higer, including serious infection (4.5 vs. 3.2/100PYs) and gastrointestinal perforation (8 vs. 1). Rates of malignancy, hypersensitivity events, serious bleeding events, serious hepatic events and deaths (39 vs. 34) were not different between groups.
This study demonstrates an equivalent, low cardiovascular risk in RA patients treated with tocilizumab, despite changes in lipid levels.