TY - JOUR
T1 - 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
AU - Syversen, Silje W
AU - Landewe, Robert
AU - van der Heijde, Désirée
AU - Bathon, Joan M
AU - Boers, Maarten
AU - Bykerk, Vivian P
AU - Fitzgerald, Oliver
AU - Gladman, Dafna D
AU - Garnero, Patrick
AU - Geusens, Piet
AU - El-Gabalawy, Hani
AU - Inman, Robert D
AU - Kraus, Virginia
AU - Kvien, Tore K
AU - Mease, Philip J
AU - Ostergaard, Mikkel
AU - Ritchlin, Christopher J
AU - Tak, Paul-Peter
AU - Taylor, William J
AU - Maksymowych, Walter P
PY - 2009
Y1 - 2009
N2 - 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 II 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 111 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.
AB - 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 II 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 111 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.
KW - Arthritis, Rheumatoid
KW - Biological Markers
KW - Consensus Development Conferences as Topic
KW - Humans
KW - Joints
KW - Predictive Value of Tests
KW - Reproducibility of Results
U2 - 10.3899/jrheum.090262
DO - 10.3899/jrheum.090262
M3 - Journal article
C2 - 19671812
SN - 0315-162X
VL - 36
SP - 1769
EP - 1784
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 8
ER -