Validation of a novel multibiomarker test to assess rheumatoid arthritis disease activity |
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| Authors: | Jeffrey R. Curtis Annette H. van der Helm‐van Mil Rachel Knevel Michael E. Weinblatt |
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| Affiliation: | 1. University of Alabama at BirminghamDr. Curtis has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Pfizer, BMS, Crescendo Bioscience, and Abbott and (more than $10,000 each) from Roche/Genentech, UCB, Centocor, Amgen, and the Consortium of Rheumatology Researchers of North America (CORRONA), and has received research support from Amgen, UCB, CORRONA, Genentech, Centocor, Pfizer, and Crescendo Bioscience.;2. Leiden University Medical Center, Leiden, The Netherlands |
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| 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 multibiomarker disease activity (MBDA) test relative to clinical disease activity in diverse RA cohorts. Methods Serum samples were obtained from the Index for Rheumatoid Arthritis Measurement, Brigham and Women's Hospital Rheumatoid Arthritis Sequential Study, and Leiden Early Arthritis Clinic cohorts. Levels of 12 biomarkers were measured and combined according to a prespecified 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's correlations and the area under the receiver operating 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–tumor necrosis factor or methotrexate treatment were evaluated by the AUROC. Results The MBDA score was significantly associated with the Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP) in both seropositive (AUROC 0.77, P < 0.001) and seronegative (AUROC 0.70, P < 0.001) patients. In subgroups based on age, sex, body mass index, and treatment, the MBDA score was associated with the DAS28‐CRP (P < 0.05) in all seropositive and most seronegative subgroups. Changes in the MBDA score at 6–12 weeks could discriminate both American College of Rheumatology criteria for 50% improvement responses (P = 0.03) and DAS28‐CRP improvement (P = 0.002). Changes in the 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 multibiomarker test as an objective measure of RA disease activity to aid in the management of RA in patients with this condition. |
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