Spondyloarthritis & psoriatic arthritis
Extracellular matrix turnover biomarkers reflect pharmacodynamic effects and treatment response of adalimumab in patients with axial spondyloarthritis—results from two randomized controlled trials
Authors' conclusion
ECM metabolites showed a pharmacodynamic effect and were associated with ASDAS response during TNF-α inhibitor treatment in patients with axSpA.
Study context
- Population
- Patients with axial spondyloarthritis (axSpA) in two RCTs (DANISH n = 52; ASIM n = 49)DANISH n = 52
- Comparison
- Adalimumab 40 mg every other week vs placebo for 12 (DANISH) or 6 (ASIM) weeks, thereafter adalimumab to week 48
- Primary endpoint
- Pharmacodynamic effect of ADA on serum extracellular matrix (ECM) turnover biomarkers
- Follow-up
- Weeks 6 or 12
Methodological detailsDANISH and ASIM, double-blind, placebo-controlled, biomarker analysis, linear mixed models
- DANISH and ASIM
- Double-blind
- Placebo-controlled
- Biomarker analysis
- Linear mixed models
Primary result
As reported in the abstract
Serum ECM biomarker levels, ADA vs placebo · 6 or 12 weeks
- C1M, C3M, C4M, C6M, CRP, PRO-C4 and CPa9-HNE levels declined with ADA compared to placebo
- all p < 0.05
Further findings
Baseline biomarkers by ASDAS-CRP response
- Patients with ASDAS-CRP major and/or clinically important improvement had significantly higher baseline C1M, C3M, C4M, C6M and PRO-C4 than those with no/low improvement
- all p < 0.05
Correlation of baseline biomarkers with ASDAS and structural damage scores
- Weak to moderate correlations
Original publication
Extracellular matrix turnover biomarkers reflect pharmacodynamic effects and treatment response of adalimumab in patients with axial spondyloarthritis—results from two randomized controlled trials. Arthritis Res Ther. Published 25 August 2023. doi:10.
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