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Published on: June 15, 2019
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Precision Immunotherapy to Improve Sepsis Outcomes: The ImmunoSep Randomized Clinical Trial
Evangelos J Giamarellos-Bourboulis1,2, Antigone Kotsaki1,2, Ioanna Kotsamidi3
1Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Greece.
JAMA
|December 8, 2025
Summary
Precision immunotherapy targeting macrophage activation-like syndrome or sepsis-induced immunoparalysis improved organ dysfunction in sepsis patients by day 9. This tailored approach demonstrated significant benefits compared to placebo in a recent clinical trial.
Area of Science:
- Critical Care Medicine
- Immunology
- Translational Medicine
Background:
- Sepsis presents a significant challenge due to its heterogeneous nature.
- Optimal immunotherapy strategies for sepsis remain uncertain, necessitating personalized approaches.
Purpose of the Study:
- To evaluate if precision immunotherapy, tailored to macrophage activation-like syndrome or sepsis-induced immunoparalysis, improves organ dysfunction by day 9.
- To assess the efficacy of targeted immunomodulatory agents in sepsis management.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 276 sepsis patients across 6 countries.
- Patients were stratified based on macrophage activation-like syndrome or sepsis-induced immunoparalysis biomarkers.
- Interventions included anakinra or recombinant human interferon gamma for precision immunotherapy versus placebo.
Main Results:
- Precision immunotherapy significantly improved Sequential Organ Failure Assessment (SOFA) scores by day 9 compared to placebo (35.1% vs 17.9%).
- The difference in SOFA score reduction was statistically significant (17.2%; P=.002).
- No significant difference in 28-day mortality was observed; however, specific adverse events were noted.
Conclusions:
- Precision immunotherapy targeting distinct immune profiles in sepsis effectively improves organ dysfunction.
- This study highlights the potential of biomarker-guided therapy in sepsis management.
- Further research is warranted to optimize safety and efficacy of these targeted treatments.
