New study shows promise regarding enrichment in DMOAD trials based on imaging

Several imaging and biochemical markers have been shown to have prognostic validity for measuring the progression of knee osteoarthritis. The present study published in the July issue of Arthritis Care & Research (DOI 10.1002/acr.24557) was based within the Foundation of the National Institutes of Health OA Biomarkers Consortium, a sample comparable to a clinical trial population. Authors evaluated biomarkers from all biomarker domains (i.e., magnetic resonance imaging, radiographic imaging, and biochemical analysis) in multivariable models and demonstrated which biomarkers had prognostic value for knee OA progression. BICL leaders Drs. Guermazi and Roemer who are coauthors were the primary image analysts for the MRI grading. Among baseline biomarkers, the number of locations affected by osteophytes (MRI semiquantitative), quantitative central medial femoral and central lateral femoral cartilage thickness (MRI quantitative), and MRI semiquantitative synovitis predicted OA progression in most models. In addition and in most models, 24-month changes in semiquantitative MRI markers, quantitative central medial femoral cartilage thickness, quantitative medial tibial cartilage volume, and quantitative lateral patellofemoral bone area predicted progression.

The present study highlights the combination of biomarkers with potential prognostic utility in OA disease-modifying trials with imaging measures among the best predictors. These biomarkers could be used to enrich future trials with participants likely to experience progression of knee OA. The phase II of the OA Biomarkers Consortium is currently underway to externally validate the present findings and enable the submission of these biomarkers for regulatory review and formal qualification for use as prognostic biomarkers in disease-modifying OA trials.

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Summary of FDA/Arthritis Foundation osteoarthritis drug development workshop published in Seminars in Arthritis and Rheumatism

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New landmark imaging research highlights role of thigh muscle size and quality for OA progression