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M2 macrophage activation in recurrent acute pancreatitis: an explorative analysis of a randomized controlled trial

Rasmus Hagn-Meincke1,2, Mathias E Cook1,2, Jens B Frøkjær2,3

  • 1Centre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.

Scandinavian Journal of Gastroenterology
|July 3, 2026
PubMed
Abstract

Insights

Naldemedine did not alter M2 macrophage activation markers in recurrent acute pancreatitis (RAP) patients. However, sCD163 levels correlated with disease activity, indicating macrophage activation plays a role in RAP.

Area of Science:

  • Immunology
  • Gastroenterology
  • Clinical Trials

Background:

  • M2 macrophage activation is implicated in pancreatitis, potentially driving progression from recurrent acute pancreatitis (RAP) to chronic disease.
  • Existing evidence is primarily preclinical or cross-sectional, necessitating prospective studies to understand M2 macrophage activation in RAP.

Purpose of the Study:

  • To prospectively investigate the effect of naldemedine on M2 macrophage activation biomarkers (sCD163 and sCD206) in patients with RAP.
  • To explore the association between changes in these biomarkers and clinical measures of disease activity.

Main Methods:

  • An exploratory analysis of a multicenter, randomized, placebo-controlled trial involving patients with RAP.
  • Patients received either naldemedine (0.2 mg daily) or placebo for 12 months.
  • Plasma levels of sCD163 and sCD206 were measured at baseline and trial end, analyzed using linear mixed-effects models and Spearman correlation.

Main Results:

  • Naldemedine treatment did not result in significant changes in mean sCD163 or sCD206 levels compared to placebo.
  • A numerical reduction in RAP frequency was observed with naldemedine, though not statistically significant (HR 0.49, p=0.076).
  • Changes in plasma sCD163 levels positively correlated with the frequency of RAP attacks (rho=0.348, p=0.009) and pain flares (rho=0.318, p=0.017).

Conclusions:

  • Naldemedine did not significantly modulate M2 macrophage activation biomarkers in this RAP cohort.
  • The correlation between sCD163 changes and clinical disease activity underscores the role of macrophage activation in RAP pathophysiology.
  • Further research is needed to clarify the immunomodulatory potential of naldemedine and the precise role of M2 macrophages in pancreatitis progression.
Keywords:
Recurrent acute pancreatitisbiomarkerimmunologymacrophagesrandomized controlled trial

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