Canakinumab is a selective human monoclonal antibody against interleukin-1β, a pro-inflammatory cytokine that has been implicated in the development of atherothrombotic plaques. Increased interleukin-1β activity leads to elevated levels of high-sensitivity C-reactive protein, or CRP, a biomarker associated with an increased risk of coronary heart disease. Previous trials have demonstrated greater cardiovascular benefits from statins in those with elevated levels of high sensitivity CRP before treatment and when lower levels of high sensitivity CRP are achieved with treatment. However, it remains unclear whether reducing inflammation without lowering cholesterol would prevent cardiovascular events.
Investigators tested this hypothesis in the large double-blind CANTOS trial, which enrolled patients with a history of myocardial infarction and high sensitivity CRP levels of more than two milligrams per liter. 10,061 patients were randomized to four groups: subcutaneous injections every three months of 50 milligrams of canakinumab, 150 milligrams of canakinumab, 300 milligrams of canakinumab, or placebo. At baseline the median LDL cholesterol level was 82 milligrams per deciliter. Throughout the trial patients in the canakinumab groups had significantly lower high sensitivity CRP levels than those in the placebo group. LDL cholesterol levels were not reduced with canakinumab. The primary endpoint included non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death.
The median follow-up was 3.7 years. After adjustment from multiple testing, the 150 milligram dose of canakinumab, but not the other two doses, significantly reduced the rate of the primary endpoint. Rates of neutropenia, thrombocytopenia, and fatal infection or sepsis were increased with canakinumab treatment. The authors conclude that targeting interleukin-1β with canakinumab at one of three doses every three months reduced atherothrombotic events independent of lipid lowering. Full trial results are available at NEJM.org.
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