The drug also resulted in a 31% reduction in rates of cardiovascular death.
A new analysis of the phase 3 CANTOS trial has shown that a subgroup of patients had a 25% reduction in major adverse cardiovascular events when treated with canakinumab (ACZ885, Novartis).
Pending final regulatory discussions, Novartis plans to file CANTOS CV data for regulatory approval before 2018.
The pre-planned secondary analysis of an exploratory endpoint showed that people with a prior myocardial infarction who achieved hsCRP levels below 2mg/L at 3 months after the first dose of canakinumab experienced a 25% reduction in major adverse cardiovascular events versus placebo (HRadj=0.75, 95% CI 0.66-0.85, p<0.0001), according to a Novartis statement.
The hsCRP test is a simple, inexpensive and widely available blood biomarker test that may also be used for residual inflammatory risk.
Patients in the new analysis also had a 31% reduction in the rate of cardiovascular death (HRadj=0.69, 95% CI 0.56-0.85, p=0.0004) and all-cause death (HRadj=0.69, 95% CI 0.58-0.81, p<0.0001). Moreover, there was no significant reduction in these endpoints observed among those treated with canakinumab who achieved hsCRP levels equal to or above 2mg/L.
According to the statement, the new analysis shows that on-treatment hsCRP testing could offer a reliable way to identify patients who are most likely to achieve the greatest benefits from long-term treatment with canakinumab, and also demonstrates that treating inflammation and lowering cholesterol could significantly reduce the risk of recurrent cardiovascular events.
"This CANTOS analysis suggests that the initial biologic response to canakinumab may provide a simple method to identify which patients are most likely to obtain long-term benefits," said Dr. Paul Ridker, MD, CANTOS study chairman and director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital. "Importantly, these data also support the value of targeting inflammation when treating patients who have had a heart attack in the past, reinforcing that 'lower is better' when it comes to levels of inflammation."
The new analysis also evaluated the number of patients needed to treat (NNT) — an epidemiological measure used to communicate the effectiveness of a health-care intervention where lower NNT signifies a more effective intervention. The estimated NNT of the subgroup of patients was 16, indicating that 16 patients treated with canakinumab whose hsCRP values dropped below 2mg/L would need to be treated for 5 years to prevent one death, heart attack, stroke or coronary revascularization. The NNT for the entire CANTOS cohort was 24.
CANTOS was one of the largest and longest-running clinical trials Novartis has ever conducted, with more than 10,000 patients enrolled over a 6-year period. Initial data from the CANTOs study showed that quarterly treatment with 150mg canakinumab resulted in a statsitcally significant 15% reduction in major adverse cardiovascular events — a composite of CV death, non-fatal myocardial infarction and stroke – in people with priopir heart attacka and inflammatory atherosclerosis.
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