Feasibility assessment of radiolabeled FAPI-04 for diagnostic and therapeutic use in rheumatoid arthritis

Biomed Pharmacother. 2025 Jun:187:118048. doi: 10.1016/j.biopha.2025.118048. Epub 2025 Apr 16.

Abstract

Objective: Fibroblast activation protein alpha (FAPα) plays a key role in cartilage degradation, inflammation, and bone erosion, particularly in rheumatoid arthritis (RA) where fibroblast-like synoviocytes in synovial tissue show elevated FAPα expression. This study explored radiolabeled FAP inhibitors for arthritis diagnosis and therapy.

Design: We used the radiotracer 68Ga-FAPI-04 for PET/CT imaging to predict collagen-induced arthritis (CIA) onset. Weekly scans quantified tracer uptake via SUV values, correlating results with disease scores and incidence. For therapeutic evaluation, 177Lu-FAPI-04 targeted FAPα-expressing cells, and arthritis scores of treated CIA mice were compared with untreated controls using one-way ANOVA.

Results: CIA mice with elevated SUV one week post-booster immunization had a 94.6 % arthritis incidence. SUV correlated with arthritis severity, reflecting increased FAPα expression. Treatment with 177Lu-FAPI-04 reduced arthritis scores by 64 % compared to controls (p < 0.005).

Conclusion: Radiotracer 68Ga-FAPI-04 effectively targets FAPα, enabling PET imaging to identify CIA severity and onset sites in mice. Additionally, 177Lu-FAPI-04 demonstrated therapeutic potential by mitigating disease activity, suggesting its promise for RA treatment.

Keywords: Fibroblast activation protein α; Fibroblast-like synoviocytes; Rheumatoid arthritis.

MeSH terms

  • Animals
  • Arthritis, Experimental* / diagnostic imaging
  • Arthritis, Experimental* / drug therapy
  • Arthritis, Rheumatoid* / diagnosis
  • Arthritis, Rheumatoid* / diagnostic imaging
  • Arthritis, Rheumatoid* / drug therapy
  • Arthritis, Rheumatoid* / metabolism
  • Endopeptidases
  • Feasibility Studies
  • Fibroblast Activation Protein Alpha
  • Gallium Radioisotopes
  • Gelatinases* / antagonists & inhibitors
  • Gelatinases* / metabolism
  • Lutetium
  • Male
  • Membrane Proteins* / antagonists & inhibitors
  • Membrane Proteins* / metabolism
  • Mice
  • Mice, Inbred DBA
  • Positron Emission Tomography Computed Tomography / methods
  • Radioisotopes
  • Radiopharmaceuticals* / pharmacology
  • Serine Endopeptidases* / metabolism

Substances

  • Gallium Radioisotopes
  • Membrane Proteins
  • Serine Endopeptidases
  • Radiopharmaceuticals
  • Gelatinases
  • Lutetium
  • Endopeptidases
  • Radioisotopes
  • Fibroblast Activation Protein Alpha
  • Lutetium-177