Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials

Maksymowych, Walter P. ; Landewe, Robert ; Boers, Maarten ; Garnero, Patrick ; Geusens, Piet ; El-Gabalawy, Hani ; Heinegård, Dick LU ; Krause, Virginia ; Lohmander, Stefan LU orcid and Matyas, John , et al. (2007) In Journal of Rheumatology 34(3). p.634-640
Abstract
Objective. Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. Methods. A special interest group was established... (More)
Objective. Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. Methods. A special interest group was established comprising investigators with expertise in soluble biomarker assay development as well as in outcomes research. This project was initiated by means of a Delphi consensus exercise. A list of draft criteria was first generated following a review of a US National Institutes of Health (NIH) 2000 white paper (available at: http://www.niams.nih.gov/ne/oi/ oabiomarwhipap.htm) that focused on biomarkers in OA, and these were organized under subject headings relevant to the OMERACT filter: truth, discrimination, and feasibility. Additional criteria were solicited from the working group. This was followed by 3 rounds of voting. Results. A list of 31 criteria was generated prior to voting. The first 2 rounds of voting resulted in cumulative agreement that 19 criteria be retained and 4 discarded, while discrepancies were recorded for 8 criteria. In the third round of voting, cumulative agreement was achieved to retain 5 of the 8 discrepant criteria, so that the final list included 24 criteria. Conclusion. A draft set of criteria for validation of a soluble biomarker to be regarded as reflecting radiological damage endpoints in clinical trials has been proposed on the basis of consensus. (Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
criteria, validation, spondyloarthritis, biomarker, rheumatoid arthritis, OMERACT, structural damage
in
Journal of Rheumatology
volume
34
issue
3
pages
634 - 640
publisher
Journal of Rheumatology Publishing Company Limited
external identifiers
  • wos:000244613800030
  • scopus:33847619751
ISSN
0315-162X
language
English
LU publication?
yes
additional info
The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Connective Tissue Biology (013230151), Department of Orthopaedics (Lund) (013028000)
id
89ab42af-7c5e-4e3e-8ccb-08cf5d26c831 (old id 672581)
date added to LUP
2016-04-01 12:33:05
date last changed
2023-03-10 06:26:26
@article{89ab42af-7c5e-4e3e-8ccb-08cf5d26c831,
  abstract     = {{Objective. Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. Methods. A special interest group was established comprising investigators with expertise in soluble biomarker assay development as well as in outcomes research. This project was initiated by means of a Delphi consensus exercise. A list of draft criteria was first generated following a review of a US National Institutes of Health (NIH) 2000 white paper (available at: http://www.niams.nih.gov/ne/oi/ oabiomarwhipap.htm) that focused on biomarkers in OA, and these were organized under subject headings relevant to the OMERACT filter: truth, discrimination, and feasibility. Additional criteria were solicited from the working group. This was followed by 3 rounds of voting. Results. A list of 31 criteria was generated prior to voting. The first 2 rounds of voting resulted in cumulative agreement that 19 criteria be retained and 4 discarded, while discrepancies were recorded for 8 criteria. In the third round of voting, cumulative agreement was achieved to retain 5 of the 8 discrepant criteria, so that the final list included 24 criteria. Conclusion. A draft set of criteria for validation of a soluble biomarker to be regarded as reflecting radiological damage endpoints in clinical trials has been proposed on the basis of consensus.}},
  author       = {{Maksymowych, Walter P. and Landewe, Robert and Boers, Maarten and Garnero, Patrick and Geusens, Piet and El-Gabalawy, Hani and Heinegård, Dick and Krause, Virginia and Lohmander, Stefan and Matyas, John and Saxne, Tore and van der Heijde, Desiree}},
  issn         = {{0315-162X}},
  keywords     = {{criteria; validation; spondyloarthritis; biomarker; rheumatoid arthritis; OMERACT; structural damage}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{634--640}},
  publisher    = {{Journal of Rheumatology Publishing Company Limited}},
  series       = {{Journal of Rheumatology}},
  title        = {{Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials}},
  volume       = {{34}},
  year         = {{2007}},
}