Biomarker guided immunomodulatory precision medicine to improve prognostic, predictive and adaptive enrichment strategies in sepsis trials

Expert Rev Mol Diagn. 2025 Jul;25(7):357-369. doi: 10.1080/14737159.2025.2505537. Epub 2025 May 17.

Abstract

Introduction: The aim of this review is to summarize the advances of the last 5 years in the field of biomarker-guided therapeutic approach in sepsis through prognostic, predictive, and adaptive enrichment strategies.

Areas covered: A thorough search of the literature was done based on the existing biomarkers for which clinical trials of integration in the inclusion criteria are available. The authors reviewed the accessible completed and ongoing studies, which use IL-6, ferritin, IL-7, sTREM-1, IL-15, HLA-DR, DPP-3 and/or bioADM for diagnosis of sepsis or septic shock, prognosis of outcome of interest or/and personalized treatment tailored to each patient's endotype classification.

Expert opinion: Inconclusive sepsis trial outcomes highlight the need for strategic protocol design, patient stratification, and biomarker-guided immunomodulatory therapies. Future advancements should focus on real-time biomarker monitoring, personalized treatment, and point-of-care diagnostics to optimize therapeutic efficacy and patient outcomes.

Keywords: Adaptive enrichment; biomarker; endotype; immunomodulation; predictive enrichment; prognostic enrichment; sepsis; septic shock.

Publication types

  • Review

MeSH terms

  • Biomarkers*
  • Clinical Trials as Topic
  • Humans
  • Immunomodulation*
  • Precision Medicine* / methods
  • Prognosis
  • Sepsis* / diagnosis
  • Sepsis* / etiology
  • Sepsis* / immunology
  • Sepsis* / therapy

Substances

  • Biomarkers