Low-dose interleukin-2 missed its main survival goal; a biomarker subgroup did better
- Study published
- Added to this website
MIROCALS tested whether low doses of interleukin-2, a drug that boosts regulatory immune cells, could improve survival when added to riluzole. 220 people were randomly assigned to the drug or a placebo for 18 months.
The main, unadjusted analysis was not statistically significant: risk of death was 19% lower with the drug, but this could be chance (hazard ratio 0.81, p = 0.33). An analysis adjusted for pre-set prognostic factors did show a significant benefit.
In the 70% of participants with lower spinal-fluid neurofilament (pNfH) levels at the start, risk of death was 48% lower with the drug. No difference was seen in those with high levels. The treatment was safe and raised regulatory immune cells as intended.
What this does not show
The trial missed its primary endpoint. Subgroup results generate hypotheses and need confirmation in a new trial. Several authors hold patents or licences related to the drug.
Source
Efficacy and safety of low-dose IL-2 as an add-on therapy to riluzole (MIROCALS): a phase 2b, double-blind, randomised, placebo-controlled trial
This summary explains a single study. It is not medical advice and does not say what applies to any one person. Talk to your ALS care team before making decisions about treatment or trials.