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Secondary CANTOS Analysis IDs Canakinumab Responders

High-sensitivity C-reactive protein (hs-CRP) testing after a single dose of canakinumab appears to identify patients with atherosclerotic cardiovascular disease most likely to benefit from treatment, according to results of a secondary CANTOS analysis.

But treatment with the orphan drug is costly, associated with a small but significant increase in fatal infections, and delivered what some regarded as an underwhelming 15% reduction in major adverse coronary events (MACE) in the entire CANTOS population.

A secondary analysis was reported at the American Heart Association 2017 Scientific Sessions and simultaneously published in the Lancet.  When the investigators looked at biologic responses to the drug, patients who achieved hs-CRP <2 mg/L at 3 months had an adjusted 25% relative risk reduction in MACE (hazard ratio [HR] 0.75, P<0.0001) and 31% risk reduction in CV death (HR 0.69, P=0.0004) and all-cause mortality (HR 0.69, P<0.0001).

For those with an hs-CRP above this threshold, canakinumab had minimal effects on MACE (HR 0.90, P=0.11), CV death (HR 0.99, P=0.95), or all-cause mortality (HR 1.05, P=0.56).

"We believe these observations have clinical importance not only for the pathophysiology of inflammation and future drug development, but also for patient selection, cost-effectiveness, and personalized medicine," said primary investigator Dr Paul Ridker (Brigham and Women"s Hospital, Boston, MA).

"The tradition inside cardiovascular medicine until fairly recently has been to treat everybody with everything," Ridker said in an interview. "I think the oncology world got to this issue of personalized medicine more quickly because the drugs they give are highly toxic, so you want to make sure they"re targeting the tumor; and they"re highly expensive, so you need to identify who benefits to justify the expense.

"I think the introduction of monoclonal antibodies into cardiovascular medicine—the two examples in the last 12 months obviously being the PCSK9 inhibitors and canakinumab—are for the first time pushing us in that direction," he said.

  2. Lancet 2017; DOI:10.1016/S0140-6736(17)32865-9.