BASEL (dpa-AFX) - Novartis (NVS) announced results from a new analysis of the Phase III CANTOS study. The pre-planned secondary analysis of an exploratory endpoint showed that people with a prior heart attack who achieved hsCRP levels below 2mg/L at three months after the first dose of canakinumab had a 25% reduction in major adverse cardiovascular events (MACE) versus placebo (HR(adj)=0.75, 95% CI 0.66-0.85, p<0.0001).
These patients also had a significant reduction of 31% in the rate of cardiovascular (CV) death (HR(adj)=0.69, 95% CI 0.56-0.85, p=0.0004) and all-cause death (HR(adj)=0.69, 95% CI 0.58-0.81, p<0.0001).
There was no significant reduction in these endpoints observed among those treated with canakinumab who achieved hsCRP levels equal to or above 2mg/L.
The analysis indicated that on-treatment hsCRP testing may offer a quick and reliable way to identify the patients most likely to achieve the greatest benefits from long-term canakinumab treatment.
It also demonstrates that treating inflammation in addition to lowering cholesterol may significantly reduce the risk of recurrent CV events.
Canakinumab has been shown to have major effects on inflammation, which is associated with atherothrombosis, the main cause of acute coronary syndromes and CV death. People with elevated inflammatory biomarkers, such as hsCRP (high-sensitivity C-reactive protein), are at an increased risk of CV events. The hsCRP test is a simple, inexpensive and widely available blood biomarker test that may also be used for residual inflammatory risk.
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