Table 1.

Immunotherapies proven to be effective in phase III clinical trials in cardiovascular disease

Trial (year)	Agent	Drug target	Trial design	Patient cohort	Primary end point	Main outcomes	Ref.
CANTOS (2017)	Canakinumab	Inhibition of the IL-1β pathway	Randomized, double-blind, placebo-controlled	10,061 patients with previous MI and elevated plasma CRP levels	Non-fatal MI, non-fatal stroke or death from cardiovascular causes	The 150-mg dose of canakinumab reduced cardiovascular events compared with placebo, independent of lipid level reductions	32
COLCOT (2019)	Colchicine	Broad cellular effects, including inhibition of tubulin polymerization, alteration of leukocyte responsiveness, and inhibition of inflammasome assembly and IL-1 release	Randomized, double-blind, placebo-controlled	4,745 patients with MI within 30 days before enrolment	Death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or hospitalization for angina leading to coronary revascularization	Colchicine decreased the risk of the composite end point compared with placebo	33
LoDoCo2 (2020)	Colchicine	Broad cellular effects, including inhibition of tubulin polymerization, alteration of leukocyte responsiveness, and inhibition of inflammasome assembly and IL-1 release	Randomized, double-blind, placebo-controlled	5,522 patients with chronic coronary artery disease	Death from cardiovascular causes, spontaneous MI, ischaemic stroke or ischaemia-driven coronary revascularization	Colchicine decreased the risk of the composite end point compared with placebo	34

CRP, C-reactive protein; MI, myocardial infarction.