Osteoarthritis: Current Molecular Biomarkers and the Way Forward.
Journal Article (Journal Article;Review)
The ultimate hope of researchers and patients is a pathway to development of treatments for osteoarthritis to modify the disease process in addition to the symptoms. However, development of disease modifying drugs requires objective endpoints such as measures of joint structure, joint tissue homeostasis and/or joint survival-measures such as provided by imaging biomarkers, molecular biomarkers and joint replacement frequency, respectively. Although biomarkers supporting investigational drug use and drug approval include surrogate endpoints that may not necessarily reflect or directly correlate with the clinical outcome of interest, a formal biomarker qualification process currently exists that is a rigorous three stage process that yields biomarker approvals (or denials) for specific contexts of use. From a cost perspective, biochemical biomarkers are the 'ones to beat'; however, even well-validated biomarkers may not cross the translation gaps for eventual use in healthcare unless they offer an advantage in terms of cost per quality adjusted life year. This review summarizes the case FOR and AGAINST biomarkers in drug development and highlights the current data for a subset of biomarkers in the osteoarthritis research field informing on cartilage homeostasis, joint inflammation and altered subchondral bone remodeling.
Full Text
Duke Authors
Cited Authors
- Kraus, VB; Karsdal, MA
Published Date
- September 2021
Published In
Volume / Issue
- 109 / 3
Start / End Page
- 329 - 338
PubMed ID
- 32367210
Electronic International Standard Serial Number (EISSN)
- 1432-0827
Digital Object Identifier (DOI)
- 10.1007/s00223-020-00701-7
Language
- eng
Conference Location
- United States