Characterization of a multiplex, 12-biomarker test for rheumatoid arthritis

Journal of Pharmaceutical and Biomedical Analysis

Volumn 70, Issue , 2012, Pages 415-424

  Eastman, P Scott ^a   Manning, William C ^a   Qureshi, Ferhan ^a   Haney, Douglas ^a   Cavet, Guy ^a   Alexander, Claire ^a   Hesterberg, Lyndal K ^a  

^a Crescendo Bioscience Inc   (United States)

Author keywords

Analytical characterization; Biomarker profile; Disease activity; Multiplex immunoassay; Protein biomarker; Rheumatoid arthritis

Indexed keywords

ANALGESIC AGENT; ANTIBODY; BIOLOGICAL MARKER; C REACTIVE PROTEIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; EPIDERMAL GROWTH FACTOR; GLYCOPROTEIN GP 39; INTERLEUKIN 6; INTERSTITIAL COLLAGENASE; LEPTIN; NONSTEROID ANTIINFLAMMATORY AGENT; RESISTIN; RHEUMATOID FACTOR; SERUM AMYLOID A; STEROID; STROMELYSIN; TUMOR NECROSIS FACTOR ALPHA RECEPTOR; VASCULAR CELL ADHESION MOLECULE 1; VASCULOTROPIN A;

ACCURACY; ADULT; AGED; ARTICLE; CROSS REACTION; DRUG BLOOD LEVEL; FEMALE; HUMAN; IMMUNOASSAY; IMMUNOGLOBULIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS;

ADULT; AGED; AGED, 80 AND OVER; ALGORITHMS; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL MARKERS; BLOOD PROTEINS; CALIBRATION; FEMALE; HUMANS; IMMUNOASSAY; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PREDICTIVE VALUE OF TESTS; PROGNOSIS; PROTEIN DENATURATION; PROTEIN STABILITY; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84866243149     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2012.06.003     Document Type: Article

References (29)

1. Fransen J., Stucki G., van Riel P.L.C.M. Rheumatoid arthritis measures: Disease Activity Score (DAS), Disease Activity Score-28 (DAS28), Rapid Assessment of Disease Activity in Rheumatology (RADAR) and Rheumatoid Arthritis Disease Activity Index (RADAI). Arthritis Rheum. 2003, 49:S214-S224.
2. Prevoo M.L., van't Hof M.A., Kuper H.H., van Leeuwen M.A., van de Putte L.B., van Riel P. Modified disease activity scores that include twenty-eight-joint counts. Arthritis Rheum. 1995, 38:44-48.
3. Van der Heijde D., van 't Hof M.A., Van Riel P., Theunisse L.A., Lubberts E.W., van Leeuwen M.A., van Rijswijk M.H., de Putte L.B. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann. Rheum. Dis. 1990, 49:916-920.
4. Bombardier C., Tugwell P., Sinclair A., Dok C., Anderson G., Buchanan W.W. Preference for endpoint measures in clinical trials: results of structured workshops. J. Rheumatol. 1982, 9:798-801.
5. Pincus T. Limitations of a quantitative swollen and tender joint count to assess and monitor patients with rheumatoid arthritis. Bull. NYU Hosp. Joint Dis. 2008, 66:216-233.
6. Marhadour T., Jousse-Joulin S., Chales G., Grange L., Hacquard C., Loeuille D., Sellam J., Albert J.D., Bentin J., Chary Valckenaere I., d'Agostino M.A., Etchepare F., Gaudin P., Hudry C., Dougados M., Saraux A. Reproducibility of joint swelling assessments in long-lasting rheumatoid arthritis: influence on Disease Activity Score-28 values (SEA-Repro study part I). J. Rheumatol. 2010, 37:932-937.
7. Inoue E., Yamanaka H., Hara M., Tomatsu T., Kamatani N. Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28-C-reactive protein threshold values. Ann. Rheum. Dis. 2007, 66:407-409.
8. Syversen S.W., Haavardsholm E.A., Boyesen P., Goll G.L., Okkenhaug C., Gaarder P.I., van der Heijde D., Kvien T.K. Biomarkers in early rheumatoid arthritis: longitudinal associations with inflammation and joint destruction measured by magnetic resonance imaging and conventional radiographs. Ann. Rheum. Dis. 2010, 69:845-850.
9. Chandra P.E., Sokolove J., Hipp B.G., Lindstrom T.M., Elder J.T., Reveille J.D., Eberl H., Klause U., Robinson W.H. Novel multiplex technology for diagnostic characterization of rheumatoid arthritis. Arthritis Res. Ther. 2011, 13:R102.
10. Hueber W., Tomooka B.H., Zhao X., Kidd B.A., Drijfhout J.W., Fries J.F., van Venrooji W.J., Metzger A.L., Genovese M.C., Robinson W.H. Proteomic analysis of secreted proteins in early rheumatoid arthritis: anti-citrulline autoreactivity is associated with up regulation of proinflammatory cytokines. Ann. Rheum. Dis. 2007, 66:712-719.
11. van der Pouw Kraan T.C., van Gaalen F.A., Kasperkovitz P.V., Verbeet N.L., Smeets T.J., Kraan M.C., Fero M., Tak P.P., Huizinga T.W., Pieterman E., Breedveld F.C., Alizadeh A.A., Verweij C.L. Rheumatoid arthritis is a heterogeneous disease: evidence for differences in the activation of the STAT-1 pathway between rheumatoid tissues. Arthritis Rheum. 2003, 48:2132-2145.
12. Sagoo P., Perucha E., Sawitzki B., Tomiuk S., Stephens D.A., Miqueu P., Chapman S., Craciun L., Sergeant R., Brouard S., Rovis F., Jimenez E., Ballow A., Giral M., Rebollo-Mesa I., Le Moine A., Braudeau C., Hilton R., Gerstmayer B., Bourcier K., Sharif A., Krajewska M., Lord G.M., Roberts I., Goldman M., Wood K.J., Newell K., Seyfert-Margolis V., Warrens A.N., Janssen U., Volk H.D., Soulillou J.P., Hernandez-Fuentes M.P., Lechler R.I. Development of a cross-platform biomarker signature to detect renal transplant tolerance in humans. J. Clin. Invest. 2010, 120:1848-1861.
13. Tseng G.C., Cheng C., Yu Y.P., Nelson J., Michalopoulos G., Luo J.H. Investigating multi-cancer biomarkers and their cross-predictability in the expression profiles of multiple cancer types. Biomark Insights 2009, 4:57-79.
14. Wener M.H. Multiplex, megaplex, index, and complex: the present and future of laboratory diagnostics in rheumatology. Arthritis Res. Ther. 2011, 13:134.
15. Lee J.W., Weiner R.S., Sailstad J.M., Bowsher R.R., Knuth D.W., O'Brien P.J., Fourcroy J.L., Dixit R., Pandite L., Pietrusko R.G., Soares H.D., Quarmby V., Vesterqvist O.L., Potter D.M., Witliff J.L., Fritche H.A., O'Leary T., Perlee L., Kadam S., Wagner J.A. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm. Res. 2005, 22:499-511.
16. Cummings J., Raynaud F., Jones L., Sugar R., Dive C. Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs. Brit. J. Cancer 2010, 103:1313-1317.
17. Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., Wagner J.A. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 2006, 23:312-328.
18. Hueber W., Tomooka B.H., Batliwalla F., Li W., Monach P.A., Tibshirani R.J., Van Vollenhoven R.F., Lampa J., Saito K., Tanaka Y., Genovese M.C., Klareskog L., Gregersen P.K., Robinson W.H. Blood autoantibody and cytokine profiles predict response to anti-tumor necrosis factor therapy in rheumatoid arthritis. Arthritis Res. Ther. 2009, 11:R76.
19. Valentin M.A., Ma S., Zhao A., Legay F., Avrameas A. Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J. Pharm. Biomed. Anal. 2011, 55:869-877.
20. Fu Q., Zhu J., Van Eyk J.E. Comparison of multiplex immunoassay platforms. Clin. Chem. 2010, 56:314-318.
21. Liew M., Groll M., Thompson J., Call S., Moser J., Hoopes J., Voelkerding K., Wittwer C., Spendlove R. Validating a custom multiplex ELISA against individual commercial immunoassays using clinical samples. BioTechniques 2007, 42:327-333.
22. Ellington A.A., Kullo I.J., Bailey K.R., Klee G.G. Antibody-based protein multiplex platforms: technical and operational challenges. Clin. Chem. 2010, 56:186-193.
23. Zhao X., Qureshi F., Eastman P.S., Manning W.C., Alexander C., Robinson W.H., Hesterberg L.K. Pre-analytical effects of blood sampling and handling in quantitative immunoassays for rheumatoid arthritis. J. Immunol. Methods 2012, 378:72-80.
24. M.F. Bakker, G. Cavet, J.W. Jacobs, J.W. Bijlsma, D.J. Haney, Y. Shen, L.K. Hesterberg, D. Smith, M. Centola, J.A.G. Van Roon, F.P. Lafeber, P.M. Welsing, Performance of a multi-biomarker score measuring rheumatoid arthritis disease activity in the CAMERA Tight Control study, Arthritis Res. Ther., , in press. doi:10.1136/annrheumdis-2011-200963.
25. J.R. Curtis, A.H. van der Helm-van Mil, R. Knevel, T. Huizinga, D.J. Haney, Y. Shen, S. Ramanujan, G. Cavet, M. Centola, L.K. Hesterberg, D. Chernoff, K. Ford, N.A. Shadick, M. Hamburger, R. Fleischman, E. Keystone, M. Weinblatt, Validation of a novel multi-biomarker test to assess rheumatoid arthritis disease activity, Arthritis Care Res., in press.
26. Arnett F.C., Edworthy S.M., Bloch D.A., McShane D.J., Fries J.F., Cooper N.S., Healey L.A., Kaplan S.R., Liang M.H., Luthra H.S., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988, 31:315-324.
27. Debad J.D., Glezer E.N., Wohlstader J.N., Sigal G.B. Clinical and Biological Applications of ECL 2004, Marcel Dekker, New York.
28. Findlay J.W., Dillard R.F. Appropriate calibration curve fitting in ligand binding assays. AAPS J. 2007, 9:E260-E267.
29. Selby C. Interference in immunoassay. Ann. Clin. Biochem. 1999, 36:704-721.