The immunomodulating activity of trimodulin (polyvalent IgM, IgA, IgG solution): a post hoc analysis of the phase II CIGMA trial
Authors' conclusion
This post hoc pharmacodynamic analysis of a blinded phase II trial suggests that trimodulin compensates for, and more rapidly modifies, the dysregulated inflammatory response seen in sCAP patients.
Study context
- Population
- Patients with severe community-acquired pneumonia (sCAP)
- Participants
- 160 patients
- Comparison
- Trimodulin vs placebo
- Primary endpoint
- Pharmacodynamic effects on Ig replenishment, cellular (ANC, ALC, NLR) and soluble (PCT, CRP) markers of inflammation, and their impact on mortality
Methodological detailspharmacodynamic analysis, blinded, placebo-controlled
- Pharmacodynamic analysis
- Blinded
- Placebo-controlled
Primary result
As reported in the abstract
Pharmacodynamic markers
- Baseline IgM, IgG and ALC lower, ANC, NLR, PCT and C-reactive protein (CRP) higher in sCAP patients vs healthy subjects
- p < 0.0001
- More rapid normalization of ANC with trimodulin vs placebo
- ANOVA p = 0.016
- More rapid normalization of PCT with trimodulin vs placebo
- ANOVA p = 0.027
Further findings
28-day all-cause mortality (low baseline ALC subgroup)
P = 0.043
Mortality (low ALC, low IgM subgroup)
P = 0.006
Mortality (low ALC, high CRP subgroup)
P = 0.011
Ventilator-free days (low ALC, low IgM subgroup)
P = 0.009
Median
| Outcome | Trimodulin | Placebo | P value |
|---|---|---|---|
| Ventilator-free days (low baseline ALC subgroup) | 3.5 | 11 | P = 0.043 |
Original publication
The immunomodulating activity of trimodulin (polyvalent IgM, IgA, IgG solution): a post hoc analysis of the phase II CIGMA trial. Crit Care. Published 9 November 2023. doi:10.
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