At the American Heart Association (AHA) Scientific Sessions, Novartis announced new findings from the Phase 3 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) trial evaluating canakinumab in the prevention of recurrent cardiovascular events. The findings were also published in The Lancet.
Initial data from the randomized, double-blind, placebo-controlled, event-driven study showed a statistically significant 15% reduction in major adverse cardiovascular events (MACE) in patients with a prior heart attack and inflammatory atherosclerosis. The new analysis showed patients with a prior heart attack who achieved high-sensitivity C-reactive protein (hsCRP) levels <2mg/L at 3 months post-canakinumab dose had a 25% reduction in MACE compared to placebo (adjusted hazard ratio HRadj 0.75, 95% CI: 0.66–0.85; P<0.0001). This patient subgroup also experienced a significant 31% reduction in the rate of CV 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).
The authors noted no significant reduction in these endpoints for canakinumab-treated patients who achieved hsCRP ≥2mg/L. The estimated number of patients needed to treat (NNT) of the subgroup of patients was 16; the NNT for the whole CANTOS cohort was 24.
With regard to safety, the overall rates of adverse events (AEs), serious AEs, and discontinuations due to AEs in CANTOS were comparable to placebo for all canakinumab doses. No relationship was seen between on-treatment hsCRP and adverse events.
In general, the findings support on-treatment hsCRP testing as an efficient way to identify patients most likely to achieve the greatest benefits from long-term canakinumab treatment. Moreover, it showed that treating inflammation and lowering cholesterol may significantly cut the risk of recurrent CV events.
Canakinumab is an investigational, selective, high-affinity, fully human monoclonal antibody that inhibits IL-1β. It works by inhibiting inflammation that is caused by overproduction of IL-1β.
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