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The role of radiography and MRI for eligibility assessment in DMOAD trials of knee OA

Abstract

Currently, no disease-modifying osteoarthritis drugs (DMOADs) have been approved. Past clinical trials have failed for several reasons, including the commonly applied definition of eligibility based on radiographic assessment of joint structure. In the context of precision medicine, finding the appropriate patient for a specific treatment approach will be of increasing relevance. Phenotypic stratification by use of imaging at the time of determining eligibility for clinical trials will be paramount and cannot be achieved using radiography alone. Furthermore, identification of joints at high risk of rapid progression of osteoarthritis is needed in order to enable a more efficient DMOAD trial design. In addition, joints at high risk of collapse need to be excluded at screening. The use of MRI might offer advantages over radiography in this context. Technological advances and simplified image assessment address many of the commonly perceived barriers to the application of MRI to assessment of eligibility for DMOAD clinical trials.

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Author information

F.W.R. researched data for the article. F.W.R. and A.G. wrote the article. All authors made a substantial contribution to discussions of the content and reviewed and/or edited the manuscript before submission.

Competing interests

F.W.R. declares that he holds shares in Boston Imaging Core Lab, LLC. C.K.K. declares that he has received research grants from Abbvie and EMD Serono and has acted as a consultant for Astellas, EMD Serono, Fidia and Thusane. A.G. declares that he holds shares in and is president of Boston Imaging Core Lab, LLC and that he has acted as a consultant for Astra Zeneca, General Electric, Merck Serono, OrthoTrophix, Pfizer, Tissue Gene, and Sanofi. D.H. and D.T.F. declare no competing interests.

Correspondence to Frank W. Roemer.

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Fig. 1: Radiographically normal knees are frequently not structurally normal on MRI.
Fig. 2: Influence of knee positioning on radiographic imaging of joint space width.
Fig. 3: Identifying the underlying pathology leading to knee pain in osteoarthritis by MRI.
Fig. 4: Structural phenotypes of osteoarthritis as defined by MRI.
Fig. 5: Joint space narrowing on radiographs could be a result of cartilage damage, meniscal damage or meniscal extrusion or a combination of these features.
Fig. 6: Exclusionary findings in screening for eligibility for clinical trials of potential DMOADs.