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How to define responders in osteoarthritis
Cooper, Cyrus Adachi, Jonathan D. Bardin, Thomas Berenbaum, Francis Flamion, Bruno Jonsson, Helgi Kanis, John A. Pelousse, Franz Lems, Willem F. Pelletier, Jean-Pierre
Cooper, Cyrus
Adachi, Jonathan D.
Bardin, Thomas
Berenbaum, Francis
Flamion, Bruno
Jonsson, Helgi
Kanis, John A.
Pelousse, Franz
Lems, Willem F.
Pelletier, Jean-Pierre
Abstract
Background: Osteoarthritis is a clinical syndrome of failure of the joint accompanied by varying degrees of joint pain, functional limitation, and reduced quality of life due to deterioration of articular cartilage and involvement of other joint structures. Scope: Regulatory agencies require relevant clinical benefit on symptoms and structure modification for registration of a new therapy as a disease-modifying osteoarthritis drug (DMOAD). An international Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and International Osteoporosis Foundation was convened to explore the current burden of osteoarthritis, review current regulatory guidelines for the conduct of clinical trials, and examine the concept of responder analyses for improving drug evaluation in osteoarthritis. Findings: The ESCEO considers that the major challenges in DMOAD development are the absence of a precise definition of the disease, particularly in the early stages, and the lack of consensus on how to detect structural changes and link them to clinically meaningful endpoints. Responder criteria should help identify progression of disease and be clinically meaningful. The ideal criterion should be sensitive to change over time and should predict disease progression and outcomes such as joint replacement. Conclusion: The ESCEO considers that, for knee osteoarthritis, clinical trial data indicate that radiographic joint space narrowing > 0.5 mm over 2 or 3 years might be a reliable surrogate measure for total joint replacement. On-going research using techniques such as magnetic resonance imaging and biochemical markers may allow the identification of these patients earlier in the disease process.
Keywords
magnetic resonance imaging, osteoarthritis, pain, responder, structure-modifying drug, X-ray
Date
2013
Type
Journal article
Journal
Current Medical Research and Opinion
Book
Volume
29
Issue
6
Page Range
719-729
Article Number
ACU Department
Mary MacKillop Institute for Health Research
Faculty of Health Sciences
Faculty of Health Sciences
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Event URL
Open Access Status
License
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Controlled