Effects of pentosan polysulfate sodium on synovial fluid biomarkers in moderate to severe knee osteoarthritis: an exploratory, phase 2, randomized, double-blind, placebo-controlled trial
Authors' conclusion
Changes in synovial fluid ARGS, serum CTX-I, and serum C2C suggest potential mechanisms for iPPS in knee osteoarthritis.
Study context
- Population
- Participants with knee OA pain (moderate to severe knee OA)randomised 1:1:1
- Participants
- 61 participants
- Comparison
- Subcutaneous injectable pentosan polysulfate sodium (iPPS) vs placebo for 39 days
- Primary endpoint
- Change from baseline in synovial fluid biomarkers
- Follow-up
- Day 56
Methodological detailsexploratory, phase 2, double-blind, placebo-controlled
- Exploratory
- Phase 2
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Synovial fluid biomarkers, adjusted change from baseline, LS mean difference
Each group vs placeboEstimate (CI)P value
iPPS
LS mean difference (COMP) −23.60 %(−62.60 to 15.40)
iPPS
LS mean difference (ARGS) −56.60 %(−106.59 to −6.62)
P = 0.028iPPS
LS mean difference (TIMP-1) 10.55 %(−35.35 to 56.45)
- Inflammation biomarker TNF-α decreased
- −110.15% (−270.57, 50.27)
- Pain modulator βNGF decreased
- −36.05% (−97.86, 25.77)
Secondary outcomes
Serum and urinary biomarkers · Day 56
- Serum COMP decreased
- −10.64% (−21.82, 0.55)
- Serum C2C decreased
- −7.30% (−17.48, 2.88)
- Serum CTX-I increased
- 35.74% (5.46, 66.01; p = 0.022)
- Urinary CTX-II decreased
- −53.27% (−157.40, 50.86)
Synovial fluid biomarkers · Day 168
- Synovial fluid ARGS remained significantly decreased
- −74.01% (−137.57, −10.45; p = 0.024)
- Synovial COMP remained decreased
- −24.40% (−68.99, 20.20)
Serum and urinary biomarkers · Day 168
- Serum CTX-I remained significantly increased
- 65.52% (8.73, 122.31; p = 0.025)
- Serum COMP remained decreased
- −10.85% (−26.03, 4.33)
- Serum ARGS decreased
- −7.79% (−16.22, 0.63)
- Serum C2C further decreased vs placebo
- −29.25% (−54.45, −4.04; p = 0.024)
- Urinary CTX-II decreased
- −8.03% (−38.00, 21.94)
Safety
Adverse events
- iPPS well tolerated with no serious related AEs or AEs of special interest
Original publication
Effects of pentosan polysulfate sodium on synovial fluid biomarkers in moderate to severe knee osteoarthritis: an exploratory, phase 2, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. Published 26 January 2026. doi:10.
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