Coronary disease & ACSRandomised controlled trial

Anti-inflammatory therapy with low-dose IL-2 in acute coronary syndromes: a randomized phase 2 trial

Nat MedPublished

  • Randomised controlled trial
  • double-blind
  • placebo-controlled
  • phase 2

Authors' conclusion

In conclusion, in patients with ACSs, low-dose IL-2 safely increases Treg cell levels and reduces arterial inflammation.

Study context

Population
Patients with ACS and high-sensitivity C-reactive protein >2 mg l-1
Participants
31 vs 29
Comparison
Low-dose IL-2 vs placebo
  • Low-dose IL-2n = 31
  • Placebon = 29reference
Primary endpoint
Difference in arterial inflammation in the index vessel (highest average maximum target-to-background ratio pre-treatment) on [18F]FDG PET-CT
Follow-up
End of treatment (8 weeks)

Primary result

Arterial inflammation, index vessel · end of treatment

Difference

−0.171

95% CI −0.308 to −0.034

P = 0.015

Low-dose IL-2 vs Placebo
difference −0.171 (95% CI −0.308 to −0.034); P = 0.015

As reported in the abstract

Secondary outcomes

OutcomedifferenceP value
Arterial inflammation in more inflamed segments−8.3%P = 0.009

Treg cell levels

Low-dose IL-2 increased Treg cell levels vs placebo
P < 0.0001

Safety

events

OutcomeLow-dose IL-2Placebo
MACE · 2-year follow-up03

Original publication

Anti-inflammatory therapy with low-dose IL-2 in acute coronary syndromes: a randomized phase 2 trial. Nat Med. Published 8 January 2026. doi:10.1038/s41591-025-04090-y

Summarised from the published abstract; every number is checked against it