Summary of FDA/Arthritis Foundation osteoarthritis drug development workshop published in Seminars in Arthritis and Rheumatism
The summary of last year’s FDA/Arthritis Foundation osteoarthritis drug development workshop has been published in Seminars in Arthritis and Rheumatism. Dr. Roemer of BICL’s management team was an invited participant of this event presenting on the role of imaging in DMOAD trials. Aim of the workshop was to discuss the current state of science in the disease of OA, identify the knowledge gaps, and examine the developmental and regulatory challenges in bringing these products to market.
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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In preparation for the workshop, a series of planning committee teleconferences and patient perspective sessions were facilitated by the FDA and Arthritis Foundation, with the participation of important organizations including National Institutes of Health (NIH), Osteoarthritis Research Society International (OARSI), and Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). The virtual workshop brought various stakeholders together to discuss the current state of drug development in OA, insights from promising research, considerations on the assessment of clinical benefit, and the regulatory challenges.
Dr. Roemer clearly stated that MRI has promise as an enrichment tool due to superior structural disease characterization and potential to identifying the subset of the patient population for whom an intervention would have a clinically meaningful benefit-risk profile. MRI is able to stratify patient populations into different structural endo- or phenotypes such as inflammatory, subchondral bone, atrophic or cartilage /meniscus considering the mode of action of a given pharmacologic compound.
Like biochemical markers, the mode of action of the product must be considered when using MRI markers. For instance, with an anabolic compound, knees without cartilage loss should be excluded and knees with cartilage damage need to be included to show re-growth of cartilage. With an anti-catabolic compound, widespread full-thickness cartilage loss should be excluded to be able to monitor slowing of cartilage loss or preservation of cartilage tissue. Technical advances in the field of MRI research allow image acquisition in a very short time of 3–5 min which supports the use of MRI to be used as a screening instrument due to feasibility that was not available until recently.