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Heart Happy: CV Safety of TNFi Etanercept vs IL-6i Tocilizumab
November 15 2016 4:00 PM ET — via RheumReports
An RCT evaluating the safety of Actemra vs. Enbrel (which apparently cost $300 million pUSD) showed no difference in cardiovascular events in patients with active RA and at least one CV risk who were age >50 years (Giles J et al. #3L). There were more than 1500 patients per arm and this event-driven trial, i.e. when enough CV events occurred, the trial was stopped. The combined rate of CV events was 78 in the etanercept arm and 83 for tocilizumab, with an non-significant hazard ratio of 1.05 (CI: 0.77-1.43). All of the specific events such as CV death, fatal and non-fatal MI and mortality, were also not significantly different between the two groups. This is a confirmation of the CV safety for TCZ. One aspect not addressed by this study was determination of efficacy. The trial had no outcomes to determine relative benefits between these two agents.
A separate study (Kim SC et al. #2611) compared TNFi and tocilizumab in 3 large claims databases. This study involved 870 patients after a prior biologic or tofacitinib who started TCZ, who were matched to TNFi starters. There was no difference between the groups for CV signal.
So if TNFi's reduce CV risk (either by controlling inflammation or by a direct effect on the vasculature or both) and the risk of TCZ for CV events is not different than that for TNFi's, the logic to me is that TCZ reduces CV risk in active RA patients. Of course, neither study had a placebo or treatment-free control group for ethical reasons, but the logic is likely true.
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About the Author
Dr. Janet Pope
Dr. Janet Pope is Professor of Medicine at Western University and Division Head of Rheumatology. Dr. Pope's research interests include epidemiologic studies in scleroderma, classification criteria in systemic sclerosis, systemic lupus erythematosus and rheumatoid arthritis.
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