Strategic application of imaging in DMOAD clinical trials: focus on eligibility, drug delivery, and semiquantitative assessment of structural progression.

Despite decades of research efforts and multiple clinical trials aimed at discovering efficacious disease-modifying osteoarthritis (OA) drugs (DMOAD), we still do not have a drug that shows convincing scientific evidence to be approved as an effective DMOAD. It has been suggested these DMOAD clinical trials were in part unsuccessful since eligibility criteria and imaging-based outcome evaluation were solely based on conventional radiography. The OA research community has been aware of the limitations of conventional radiography being used as a primary imaging modality for eligibility and efficacy assessment in DMOAD trials. An imaging modality for DMOAD trials should be able to depict soft tissue and osseous pathologies that are relevant to OA disease progression and clinical manifestations of OA. Magnetic resonance imaging (MRI) fulfills these criteria and advances in technology and increasing knowledge regarding imaging outcomes likely should play a more prominent role in DMOAD clinical trials. In this perspective article, we will describe MRI-based tools and analytic methods that can be applied to DMOAD clinical trials with a particular emphasis on knee OA. MRI should be the modality of choice for eligibility screening and outcome assessment. Optimal MRI pulse sequences must be chosen to visualize specific features of OA.

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© The Author(s), 2023.

Déclaration de conflit d'intérêts

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AG: received consultancy fees from Pfizer, Novartis, MerckSerono, TissueGene, AstraZeneca, and Regeneron. He is a shareholder of Boston Imaging Core Lab., LLC. FWR: Consultant to Calibr and Grünenthal. He is a shareholder to of Boston Imaging Core Lab., LLC. MDC: He is a shareholder to of Boston Imaging Core Lab., LLC. AM: received consultancy fees from Pfizer, Novartis AG, Kolon TissueGene, Sanofi, GSK, Haleon, Laboratoires Expanscience, CSC Pharma, Orion Corporation, Pacira Biosciences, and Aptissen SA. He serves on the Scientific Advisory Board of Kolon TissueGene, ResearchSquare and Aptissen SA. DH: received publication royalties from Wolters Kluwer. All other authors have no competing interests.