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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/9906

Title: Testing of the OMERACT 8 Draft Validation Criteria for a Soluble Biomarker Reflecting Structural Damage in Rheumatoid Arthritis: A Systematic Literature Search on 5 Candidate Biomarkers
Authors: Syversen, Silje W.
Landewe, Robert
van der Heijde, D.
Bathon, Joan M.
Boers, Maarten
Bykerk, Vivian P.
Fitzgerald, Oliver
Gladman, Dafna D.
Garnero, Patrick
GEUSENS, Piet
El-Gabalawy, Hani
Inman, Robert D.
Kraus, Virginia
Kvien, Tore K.
Mease, Philip J.
Ostergaard, Mikkel
Ritchlin, Christopher J.
Tak, Paul-Peter
Taylor, William J.
Maksymowych, Walter P.
Issue Date: 2009
Publisher: J RHEUMATOL PUBL CO
Citation: JOURNAL OF RHEUMATOLOGY, 36(8). p. 1769-1784
Abstract: Objective. To test the OMERACT 8 draft validation criteria for Soluble biomarkers by assessing the strength of literature evidence in support of 5 candidate biomarkers. Methods. A systematic literature search was conducted on the 5 soluble biomarkers RANKL, osteoprotegerin (OPG), matrix metalloprotease (MMP-3), urine C-telopeptide of types I and 11 collagen (U-CTX-I and U CTX-II), focusing on the 14 OMERACT 8 criteria. Two electronic voting exercises were conducted to address: (1) strength of evidence for each biomarker as reflecting structural damage according to each individual criterion and the importance of each individual criterion; (2) overall strength of evidence in support of each of the 5 candidate biomarkers as reflecting, structural damage endpoints in rheumatoid arthritis (RA) and identification of omissions to the criteria set. Results. The search identified I I I articles. The strength of evidence in support of these biomarkers reflecting structural damage was low for all biomarkers and was rated highest for U-CTX-II [score of 6.5 (numerical rating scale 0-10)]. The lowest scores for retention of specific criteria in the draft set went to criteria that refer to the importance of animal Studies, correlations with other biomarkers reflecting damage, and an understanding of the metabolism of the biomarker. Conclusion. Evidence in support of any of the 5 tested biomarkers (MMP-3, CTX-I, CTX-II, OPG, RANKL) was inadequate to allow their substitution for radiographic endpoints in RA. Three of the criteria in the draft criteria set might not be required, but few omissions were identified. (J Rheumatol 2009;36:1769-84; doi: 10.3899/jrheum.090262)
Notes: [Syversen, Silje W.] Univ Oslo, Diakonhjemmet Hosp, Dept Rheumatol, Oslo, Norway. [Landewe, Robert] Univ Hosp Maastricht, Maastricht, Netherlands. [van der Heijde, Desiree] Leiden Univ, Med Ctr, Leiden, Netherlands. [Bathon, Joan M.] Johns Hopkins Univ, Sch Med, Dept Med, Div Rheumatol, Baltimore, MD 21205 USA. [Boers, Maarten] Vrije Univ Amsterdam, Med Ctr, Dept Clin Epidemiol & Biostat, Amsterdam, Netherlands. [Bykerk, Vivian P.] Univ Toronto, Mt Sinai Hosp, Univ Hlth Network, Rebecca MacDonald Ctr Arthrit & Autoimmune Dis, Toronto, ON M5G 1X5, Canada. [Fitzgerald, Oliver] St Vincents Univ Hosp, Dublin 4, Ireland. [Gladman, Dafna D.] Toronto Western Res Inst, Univ Hlth Network, Toronto, ON, Canada. [Garnero, Patrick] INSERM, Res Unit 664, F-69008 Lyon, France. [Garnero, Patrick] CCBR SYNARC, Lyon, France. [Geusens, Piet] Maastricht Univ, Med Ctr, Maastricht, Netherlands. Univ Hasselt, Biomed Res Ctr, Hasselt, Belgium. [El-Gabalawy, Hani] Univ Manitoba, Winnipeg, MB, Canada. [Kraus, Virginia] Duke Univ, Med Ctr, Durham, NC USA. [Mease, Philip J.] Swedish Med Ctr, Seattle, WA USA. [Ostergaard, Mikkel] Copenhagen Univ Hosp, Dept Rheumatol, Copenhagen, Denmark. [Ostergaard, Mikkel] Copenhagen Univ Hosp, Dept Rheumatol, Herlev, Denmark. [Ostergaard, Mikkel] Copenhagen Univ Hosp, Dept Rheumatol, Hvidovre, Denmark. [Ritchlin, Christopher J.] Univ Rochester, Med Ctr, Rochester, NY 14642 USA. [Tak, Paul-Peter] Univ Amsterdam, Acad Med Ctr, Div Clin Immunol & Rheumatol, NL-1105 AZ Amsterdam, Netherlands. [Taylor, William J.] Univ Otago, Rehabil Teaching & Res Unit, Wellington, New Zealand. [Maksymowych, Walter P.] Univ Alberta, Dept Med, Edmonton, AB T6G 2S2, Canada.
URI: http://hdl.handle.net/1942/9906
DOI: 10.3899/jrheum.090262
ISI #: 000269164700038
ISSN: 0315-162X
Category: A1
Type: Journal Contribution
Validation: ecoom, 2010
Appears in Collections: Research publications

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