Regulatory T cells (Treg cells) represent the immunosuppressive arm of the immune system, naturally controlling unwanted inflammatory responses and actively suppressing effector T cells. Anti-inflammatory therapies for acute coronary syndrome (ACS) that target innate immunity, such as canakinumab and colchicine, have yielded modest efficacy and result in substantial side effects. These considerations inspired Mallat and colleagues to investigate the potential of low-dose IL-2 in patients with ACS. The rationale of using low-dose IL-2 is to selectively expand Treg cells, which are known to be decreased in patients with ACS. Treg cell expansion would allow effective reduction of inflammation in a more precise manner while preserving an active immune system capable of preventing opportunistic infections.
Mallat and colleagues recently published in Nature Medicine the results of the IVORY trial, a double-blind, placebo-controlled phase 2 study of low-dose IL-2 for the reduction of vascular inflammation in ACS. In this trial, patients with ACS received low-dose IL-2 for 8 weeks to reduce vascular inflammation and major adverse cardiovascular events (MACE). IVORY builds on prior work by Mallat’s group demonstrating the protective role of Treg cells in atherosclerosis and on findings from the LILACS trial (of low-dose IL-2 in patients with stable ischemic heart disease and ACS), which identified a dosing regimen that selectively and significantly expands Treg cells in coronary artery disease.
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