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How to define responders in osteoarthritis

How to define responders in osteoarthritis
How to define responders in osteoarthritis
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.
0300-7995
719-729
Cooper, C.
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Adachi, J.D.
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Bardin, T.
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Berenbaum, F.
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Flamion, B.
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Jonsson, H,
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Kanis, J.A.
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Pelousse, F.
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Lems, W.F.
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Pelletier, J.P.
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Martel-Pelletier, J.
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Reiter, S.
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Reginster, J.Y.
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Rizzoli, R.
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Bruyere, O.
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Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Adachi, J.D.
fad23249-519e-4d11-ac21-f42742cd19fb
Bardin, T.
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Berenbaum, F.
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Flamion, B.
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Jonsson, H,
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Kanis, J.A.
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Pelousse, F.
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Lems, W.F.
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Pelletier, J.P.
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Martel-Pelletier, J.
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Reiter, S.
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Reginster, J.Y.
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Rizzoli, R.
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Bruyere, O.
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Cooper, C., Adachi, J.D. and Bardin, T. et al. (2013) How to define responders in osteoarthritis. Current Medical Research and Opinion, 29 (6), 719-729. (doi:10.1185/03007995.2013.792793). (PMID:23557069)

Record type: Article

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.

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Published date: June 2013
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 352423
URI: http://eprints.soton.ac.uk/id/eprint/352423
ISSN: 0300-7995
PURE UUID: d61c1b6b-bda1-4c28-ad64-32fe0da4f34d
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 14 May 2013 09:31
Last modified: 10 Dec 2019 01:53

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Contributors

Author: C. Cooper ORCID iD
Author: J.D. Adachi
Author: T. Bardin
Author: F. Berenbaum
Author: B. Flamion
Author: H, Jonsson
Author: J.A. Kanis
Author: F. Pelousse
Author: W.F. Lems
Author: J.P. Pelletier
Author: J. Martel-Pelletier
Author: S. Reiter
Author: J.Y. Reginster
Author: R. Rizzoli
Author: O. Bruyere

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