Validation of a novel multi-biomarker test to assess rheumatoid arthritis disease activity.

Curtis JR, van der Helm-van Mil AH, Knevel R, Huizinga TW, Haney DJ, Shen Y, Ramanujan S, Cavet G, Centola M, Hesterberg LK, Chernoff D, Ford K, Shadick NA, Hamburger M, Fleischmann R, Keystone E, Weinblatt ME.
Journal   Arthritis Care Res.
Species  
Analytes Measured   CRP , EGF , IL-6 , Leptin , MMP-1 , MMP-3 total , Resistin , SAA , TNF-RI , VCAM-1 , Flt-1 VEGFR1
Matrix Tested   Serum
Year   2012
Volume  
Page Numbers  
Application   Cytokines and Chemokines
Abstract
OBJECTIVE.: Quantitative assessment of disease activity in rheumatoid arthritis (RA) is important for patient management, and additional objective information may aid rheumatologists in clinical decision-making. We validated a recently-developed multi-biomarker disease activity (MBDA) test relative to clinical disease activity in diverse RA cohorts. METHODS.: Serum samples were obtained from the InFoRM, BRASS, and Leiden Early Arthritis Clinic cohorts. Levels of 12 biomarkers were measured and combined according to a pre-specified algorithm to generate the composite MBDA score. The relationship of the MBDA score to clinical disease activity was characterized separately in seropositive and seronegative patients using Pearson correlations and area under the receiver operator characteristic curve (AUROC) to discriminate between patients with low and moderate/high disease activity. Associations between changes in MBDA score and clinical responses 6-12 weeks after initiation of anti-TNF or methotrexate treatment were evaluated by AUROC. RESULTS.: The MBDA score was significantly associated with DAS28-CRP in both seropositive (AUROC=0.77; P<0.001) and seronegative patients (AUROC=0.70; P<0.001). In subgroups based on age, sex, body-mass index, and treatment, the MBDA score was associated with DAS28-CRP (P<0.05) in all seropositive and most seronegative subgroups. Changes in MBDA score at 6-12 weeks could discriminate both ACR50 responses (P=0.03) and DAS28-CRP improvement (P=0.002). Changes in MBDA score at 2 weeks were also associated with subsequent DAS28-CRP response (P=0.02). CONCLUSION.: Our findings establish the criterion and discriminant validity of a novel multi-biomarker test as an objective measure of RA disease activity to aid in the management of RA patients.

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Singleplex
U-PLEX Custom Metabolic Group 1 (human) 384-well Assays
BAFF, BDNF, β-NGF, C-Peptide, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, EPO, FGF-21, FGF-23, FLT3L, Fractalkine, FSH, G-CSF, Ghrelin (active), Ghrelin (total), GIP (active), GIP (inactive), GIP (total), GLP-1 (active), GLP-1 (inactive), GLP-1 (total), Glucagon, GM-CSF, GRO-α, I-309, IFN-α2a, IFN-β, IFN-γ, IL-1α, IL-1β, IL-1RA, IL-2, IL-2Rα, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17C, IL-17D, IL-17E/IL-25, IL-17F, IL-18, IL-21, IL-22, IL-23, IL-27, IL-29/IFN-λ1, IL-31, IL-33, Insulin, IP-10, Leptin, Luteinizing Hormone (LH), MCP-1, MCP-2, MCP-4, M-CSF, MDC, MIF, MIP-1α, MIP-5, PP, Proinsulin, PYY (total), SDF-1α, TARC, TNF-α, TNF-β, TPO, TRAIL, TSLP, VEGF-A, YKL-40 | Human
Multiplex
U-PLEX Custom Biomarker Group 1 (human) 384-well Assays
CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, EPO, FLT3L, Fractalkine, G-CSF, GM-CSF, GRO-α, I-309, IFN-α2a, IFN-β, IFN-γ, IL-1α, IL-1β, IL-1RA, IL-2, IL-2Rα, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-17E/IL-25, IL-17F, IL-18, IL-21, IL-22, IL-23, IL-27, IL-29/IFN-λ1, IL-31, IL-33, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, M-CSF, MDC, MIF, MIP-1α, MIP-1β, MIP-3α, MIP-3β, MIP-5, SDF-1α, TARC, TNF-α, TNF-β, TPO, TRAIL, TSLP, VEGF-A, YKL-40 | Human
Multiplex
U-PLEX Human CRP Antibody Set
CRP | Human
U-PLEX Human VCAM-1 Antibody Set
VCAM-1 | Human
U-PLEX Human SAA Antibody Set
SAA | Human
U-PLEX Human CRP Assay
CRP | Human
Singleplex
U-PLEX Human SAA Assay
SAA | Human
Singleplex
U-PLEX Human VCAM-1 Assay
VCAM-1 | Human
Singleplex
S-PLEX NHP IL-6 Kit
IL-6 | Non-human primate
Singleplex
S-PLEX Human IL-6 Kit
IL-6 | Human
Singleplex
R-PLEX Mouse CRP Antibody Set
CRP | Mouse
R-PLEX Mouse SAA Antibody Set
SAA | Mouse
Human Leptin Antibody
Leptin | Human
V-PLEX Metabolic Panel 1 Human Kit
C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, Leptin, PP | Human
Multiplex
V-PLEX Human Leptin Kit
Leptin | Human
Singleplex
V-PLEX Plus Metabolic Panel 1 Human Kit
C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, Leptin, PP | Human
Multiplex
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