Detection and characterization of antibodies against recombinant human erythropoietin by RIPA, ELISA and neutralization assay in patients with renal anemia

Journal of Immunological Methods

Volumn 336, Issue 2, 2008, Pages 152-158

  Gross, Johann ^a   Moller, Renate ^a   Bischoff, Steffen ^b   Canaan Kühl, Sima ^a   Fromme, Manfred ^c   Henke, Wolfgang ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Dialysis Centre   (Germany)

^c Nephrology Center   (Germany)

Author keywords

Affinity; Antibodies; Erythropoietin; Neutralization

Indexed keywords

ERYTHROPOIETIN ANTIBODY; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; ANTIBODY DETECTION; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; COLONY FORMATION; CONTROLLED STUDY; DRUG INHIBITION; ENZYME LINKED IMMUNOSORBENT ASSAY; FOLLOW UP; HUMAN; KIDNEY TUBULE; PRIORITY JOURNAL; PROTEIN ANALYSIS; RADIOIMMUNOPRECIPITATION; SERODIAGNOSIS;

ADULT; AGED; AGED, 80 AND OVER; ANEMIA; ANTIBODIES; ANTIBODY AFFINITY; ENZYME-LINKED IMMUNOSORBENT ASSAY; ERYTHROPOIETIN, RECOMBINANT; FEMALE; HUMANS; KIDNEY DISEASES; KIDNEY FAILURE; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; RADIOIMMUNOPRECIPITATION ASSAY;

EID: 46149111432     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2008.04.009     Document Type: Article

References (24)

1. Bennett C.L., Luminari S., Nissenson A.R., Tallman M.S., Klinge S.A., McWilliams N., McKoy J.M., Kim B., Lyons E.A., Trifilio S.M., Raisch D.W., Evens A.M., Kuzel T.M., Schumock G.T., Belknap S.M., Locatelli F., Rossert J., and Casadevall N. Pure red-cell aplasia and epoetin therapy. N. Engl. J. Med. 351 (2004) 1403
2. Casadevall N., Nataf J., Viron B., Kolta A., Kiladjian J.J., Martin-Dupont P., Michaud P., Papo T., Ugo V., Teyssandier I., Varet B., and Mayeux P. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. 346 (2002) 469
3. Casadevall N., Cournoyer D., Marsh J., Messner H., Pallister C., Parker-Williams J., and Rossert J. Recommendations on haematological criteria for the diagnosis of epoetin-induced pure red cell aplasia. Eur. J. Haematol. 73 (2004) 389
4. Deisenhammer F., Schellekens H., and Bertolotto A. Measurement of neutralizing antibodies to interferon beta in patients with multiple sclerosis. J. Neurol. 251 Suppl 2 (2004) II31
5. Feldman L., Heinzerling R., Hillam R.P., Chern Y.E., Frazier J.G., Davis K.L., and Sytkowski A.J. Four unique monoclonal antibodies to the putative receptor binding domain of erythropoietin inhibit the biological function of the hormone. Exp. Hematol. 20 (1992) 64
6. Fibi M.R., Aslan M., Hintz-Obertreis P., Pauly J.U., Gerken M., Luben G., Lauffer L., Siebold B., Stuber W., and Nau G. Human erythropoietin-specific sites of monoclonal antibody-mediated neutralization. Blood 81 (1993) 670
7. Fisher J.W. Erythropoietin: physiologic and pharmacologic aspects. Proc. Soc. Exp. Biol. Med. 216 (1997) 358
8. Gross J., Moller R., Henke W., and Hoesel W. Detection of anti-EPO antibodies in human sera by a bridging ELISA is much more sensitive when coating biotinylated rhEPO to streptavidin rather than using direct coating of rhEPO. J. Immunol. Methods 313 (2006) 176
9. Gupta S., Indelicato S.R., Jethwa V., Kawabata T., Kelley M., Mire-Sluis A.R., Richards S.M., Rup B., Shores E., Swanson S.J., and Wakshull E. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J. Immunol. Methods 321 (2007) 1
10. Hoesel W., Gross J., Moller R., Kanne B., Wessner A., Muller G., Muller A., Gromnica-Ihle E., Fromme M., Bischoff S., and Haselbeck A. Development and evaluation of a new ELISA for the detection and quantification of antierythropoietin antibodies in human sera. J. Immunol. Methods 294 (2004) 101
11. Kawade Y., Finter N., and Grossberg S.E. Neutralization of the biological activity of cytokines and other protein effectors by antibody: theoretical formulation of antibody titration curves in relation to antibody affinity. J. Immunol. Methods 278 (2003) 127
12. Kelley M., Cooper C., Matticoli A., and Greway A. The detection of anti-erythropoietin antibodies in human serum and plasma Part II. Validation of a semi-quantitative (3)H-thymidine uptake assay for neutralizing antibodies. J. Immunol. Methods 300 (2005) 179
13. Kruger A., Schroer W., Rohrs F., and Vescio G. PRCA in a patient treated with epoetin beta. Nephrol. Dial. Transplant. 18 (2003) 1033
14. Schellekens H. Lesson learned from Eprex-associated pure red cell aplasia. Kidney Blood Press. Res. 30 Suppl 1 (2007) 9 Electronic publication@2007 Aug 27
15. Swanson S.J., Ferbas J., Mayeux P., and Casadevall N. Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin. Nephron Clin. Pract. 96 (2004) c88
16. Tacey R., Greway A., Smiell J., Power D., Kromminga A., Daha M., Casadevall N., and Kelley M. The detection of anti-erythropoietin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay. J. Immunol. Methods 283 (2003) 317
17. Thorpe R., and Swanson S.J. Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): an assessment of available procedures. Nephrol. Dial. Transplant. 20 Suppl 4 (2005) iv16
18. Thorpe R., and Swanson S.J. Current methods for detecting antibodies against erythropoietin and other recombinant proteins. Clin. Diagn. Lab. Immunol. 12 (2005) 28
19. Tolman C., Duja S., Richardson D., Rashid R., McVerry A., Mooney A., Baker R., and Will E. Four cases of pure red cell aplasia secondary to epoetin beta, with strong temporal relationships. Nephrol. Dial. Transplant. 19 (2004) 2133
20. Wadhwa M., Bird C., Dilger P., Gaines-Das R., and Thorpe R. Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals. J. Immunol. Methods 278 (2003) 1
21. Weber G., Gross J., Kromminga A., Loew H.H., and Eckardt K.U. Allergic skin and systemic reactions in a patient with pure red cell aplasia and anti-erythropoietin antibodies challenged with different epoetins. J. Am. Soc. Nephrol. 13 (2002) 2381
22. Wei X., Swanson S.J., and Gupta S. Development and validation of a cell-based bioassay for the detection of neutralizing antibodies against recombinant human erythropoietin in clinical studies. J. Immunol. Methods 293 (2004) 115
23. Wilson D.P., and McElwain D.L. A model of neutralization of Chlamydia trachomatis based on antibody and host cell aggregation on the elementary body surface. J. Theor. Biol. 226 (2004) 321
24. Wu G., Wadgymar A., Wong G., Ting R., Nathoo B., Mendelssohn D., Pandeya S., Sapir D., and Tam P. A cross-sectional immunosurveillance study of anti-EPO antibody levels in CRF patients receiving epoetin alfa in 5 Ontario Renal Centers. Am. J. Kidney Dis. 44 (2004) 264