Precision Immunotherapy to Improve Sepsis Outcomes: The ImmunoSep Randomized Clinical Trial
Primary result · SOFA decrease ≥1.4 pointsResult — go to the resultDifference 17.2% 95% CI 6.8%–27.2%Authors' conclusion
Among patients with sepsis, precision immunotherapy targeting macrophage activation-like syndrome and sepsis-induced immunoparalysis improved organ dysfunction by day 9 compared with placebo.
Study context
- Population
- Adults with sepsis (Sepsis-3) due to community- or hospital-acquired pneumonia, ventilator-associated pneumonia or bacteremia, with macrophage activation-like syndrome (ferritin >4420 ng/mL) or sepsis-induced immunoparalysis (ferritin ≤4420 ng/mL and <5000 HLA-DR receptors on CD45/CD14 monocytes)276 analysed
- Participants
- 281 adults
- Comparison
- Standard care + precision immunotherapy vs standard care + placebo
- Precision immunotherapyn = 131
- Placebon = 145reference
- Primary endpoint
- Decrease of ≥1.4 points in mean Sequential Organ Failure Assessment (SOFA) score from baseline
- Follow-up
- Day 9
Methodological detailsdouble-blind, double-dummy, placebo-controlled, multinational (6 countries), Enrolment August 5, 2021; last follow-up April 29, 2024
- Double-blind
- Double-dummy
- Placebo-controlled
- Multinational (6 countries)
- Enrolment August 5, 2021; last follow-up April 29, 2024
Primary result
SOFA decrease ≥1.4 points
Difference
17.2%
95% CI 6.8%–27.2%
P = 0.002
Events by treatment group
Precision immunotherapy vs Placebo
difference 17.2% (95% CI 6.8%–27.2%); P = 0.002
As reported in the abstract
Secondary outcomes
28-day mortality
- Not statistically significantly different between groups
Safety
- Serious treatment-emergent adverse events, total
- 1069 (88.8%)
- Increased incidence of anemia in the anakinra group
- Increased incidence of hemorrhage in the recombinant human interferon gamma group
Original publication
Precision Immunotherapy to Improve Sepsis Outcomes: The ImmunoSep Randomized Clinical Trial. JAMA. Published 3 March 2026. doi:10.
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