Neutralizing and binding antibodies to interferon beta in patients with multiple sclerosis: A comparison of assay results from three Italian centres

Journal of Immunoassay and Immunochemistry

Volumn 30, Issue 1, 2009, Pages 40-50

  Bellomi, Francesca ^a   Bramanti, Placido ^b   Trojano, Maria ^c   Scagnolari, Carolina ^a   Muto, Antonella ^a   Sessa, Edoardo ^b   Volpe, Vito La ^c   Russo, Pierluigi ^d   Antonelli, Guido ^a,d  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

^b IRCCS CENTRO NEUROLESI BONINO PULEJO   (Italy)

^c UNIVERSITY OF BARI   (Italy)

^d SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

Antibodies to interferon; Interferon beta; Multiple sclerosis

Indexed keywords

ANTIBODY; BETA INTERFERON; BETA1A INTERFERON; BINDING ANTIBODY; INTERFERON BETA SERINE; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG;

ANTIBODY DETECTION; ANTIBODY TITER; ANTIGEN BINDING; ARTICLE; CONTROLLED STUDY; CYTOPATHOGENIC EFFECT; DATA ANALYSIS; DIAGNOSTIC ACCURACY; DISEASE ASSOCIATION; HUMAN; IMMUNOASSAY; ITALY; LABORATORY DIAGNOSIS; MAJOR CLINICAL STUDY; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; REPRODUCIBILITY;

ANTIBODIES; HUMANS; INTERFERON-BETA; MULTIPLE SCLEROSIS; NEUTRALIZATION TESTS; REAGENT KITS, DIAGNOSTIC; RECOMBINANT PROTEINS;

EID: 58149149644     PISSN: 15321819     EISSN: 15324230     Source Type: Journal    
DOI: 10.1080/15321810802569857     Document Type: Article

References (33)

1. Foster, G.R. Interferons in host defense. Semin. Liver. Dis. 1997, 17, 287-295.
2. Fernandez, O. Interferons in relapsing-remitting multiple sclerosis: are there benefits from long-term use? C.N.S. Drugs 2004, 18, 1057-1070.
3. Goodin, D.S. Treatment of multiple sclerosis with human beta interferon. Int. M.S. J. 2005, 12, 96-108.
4. PRISMS (Prevention or Relapses and Disability by Interferon-beta-1a Subcutaneously in Multiple Sclerosis) Study Group; the University of British Columbia MS/MRI Analysis Group: PRISMS-4. Long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 2001, 56, 1628-1636.
5. Jacobs, L.D.; Cookfair, D.L.; Rudick, R.A.; Herndon, R.M.; Richert, J.R.; Salazar, A.M.; Fischer, J.S.; Goodkin, D.E.; Granger, C.V.; Simon, J.H.; Alam, J.J.; Bartoszak, D.M.; Bourdette, D.N.; Braiman, J.; Brownscheidle, C.M.; Coats, M.E.; Cohan, S.L.; Dougherty, D.S.; Kinkel, R.P.; Mass, M.K.; Munschauer, F.E. 3rd; Priore, R.L.; Pullicino, P.M.; Scherokman, B.J.; Whitham, R.H.; The Multiple Sclerosis Collaborative Research Group. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann. Neurol. 1996, 39, 285-294.
6. Simon, J.H.; Jacobs, L.D.; Campion, M.; Wende, K.; Simonian, N.; Cookfair, D.L.; Rudick, R.A.; Herndon, R.M.; Richert, J.R.; Salazar, A.M.; Alam, J.J.; Fischer, J.S.; Goodkin, D.E.; Granger, C.V.; Lajaunie, M.; Martens-Davidson, A.L.; Meyer, M.; Sheeder, J.; Choi, K.; Scherzinger, A.L.; Bartoszak, D.M.; Bourdette, D.N.; Braiman, J.; Brownscheidle, C.M.; Whitham, R.H.; The Multiple Sclerosis Collaborative Research Group. Magnetic resonance studies of intramuscular interferon beta-1a for relapsing multiple sclerosis. Ann. Neurol. 1998, 43, 79-87.
7. The Once Weekly Interferon for MS Study Group. Evidence of interferon beta-1a dose response in relapsing-remitting MS: the OWIMS Study. Neurology 1999, 53, 679-686.
8. Arnason, B.G. Long-term experience with interferon beta-1b (Betaferon) in multiple sclerosis. J. Neurol. 2005, 252 (Suppl 3), iii28-iii33.
9. Murdoch, D.; Lyseng-Williamson, K.A. Subcutaneous recombinant interferon-beta-1a (Rebif): a review of its use in relapsing-remitting multiple sclerosis. Drugs 2005, 65, 1295-1312.
10. Wingerchuk, D.M. Multiple sclerosis disease-modifying therapies: adverse effect surveillance and management. Expert Rev. Neurother. 2006, 6, 333-346.
11. Markowitz, C. Development of interferon-beta as a therapy for multiple sclerosis. Expert Opin. Emerg. Drugs 2004, 9, 363-374.
12. Goodin, D.S.; Frohman, E.M.; Garmany, G.P. Jr.; Halper, J.; Likosky, W.H.; Lublin, F.D.; Silberberg, D.H.; Stuart, W.H.; van den Noort, S. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002, 58, 169-178.
13. Durelli, L.; Ricci, A. Anti-interferon antibodies in multiple sclerosis. molecular basis and their impact on clinical efficacy. Front. Biosci. 2004, 9, 2192-2204.
14. Antonelli, G. Development of neutralizing and binding antibodies to interferon (IFN) in patients undergoing IFN therapy. Antiviral Res. 1994, 24, 235-244.
15. Schellekens, H.; Casadevall, N. Immunogenicity of recombinant human proteins: causes and consequences. J. Neurol. 2004, 251 (Suppl. 2), II4-II9.
16. Bellomi, F.; Scagnolari, C.; Tomassini, V.; Gasperini, C.; Paolillo, A.; Pozzilli, C.; Antonelli, G. Fate of neutralizing and binding antibodies to IFN beta in MS patients treated with IFN beta for 6 years. J. Neurol. Sci. 2003, 215, 3-8.
17. Schellekens, H. The immunogenicity of biopharmaceuticals. Neurology 2003, 61 (Suppl. 5), S11-S12.
18. Antonelli, G.; Bagnato, F.; Dianzani, F. Considerations on the development of serum antibodies to interferon-beta. New Microbiol. 2005, 28, 183-192.
19. Sorensen, P.S.; Deisenhammer, F.; Duda, P.; Hohlfeld, R.; Myhr, K.M.; Palace, J.; Polman, C.; Pozzilli, C.; Ross, C. Guidelines on use of anti-IFN-beta antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-beta antibodies in multiple sclerosis. Eur. J. Neurol. 2005, 12, 817-827.
20. Runkel, L.; De Dios, C.; Karpusas, M.; Baker, D.; Li, Z.; Zafari, M.; Betzenhauser, M.; Muldowney, C.; Miller, S.; Redlich, P.N.; Grossberg, S.E.; Whitty, A.; Hochman, P.S. Mapping of IFN-beta epitopes important for receptor binding and biologic activation: comparison of results achieved using antibody-based methods and alanine substitution mutagenesis. J. Interferon Cytokine Res. 2001, 21, 931-941.
21. Deisenhammer, F.; Reindl, M.; Harvey, J.; Gasse, T.; Dilitz, E.; Berger, T. Bioavailability of interferon beta 1b in MS patients with and without neutralizing antibodies. Neurology 1999, 52, 1239-1243.
22. Francis, G.S.; Rice, G.P.; Alsop, J.C. Interferon beta-1a in MS: results following development of neutralizing antibodies in PRISMS. Neurology 2005, 65, 48-55.
23. Durelli, L.; Verdun, E.; Barbero, P.; Bergui, M.; Versino, E.; Ghezzi, A.; Montanari, E.; Zaffaroni, M. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002, 359, 1453-1460.
24. Giovannoni, G.; Goodman, A. Neutralizing anti-IFN-beta antibodies: how much more evidence do we need to use them in practice? Neurology 2005, 65, 6-8.
25. Perini, P.; Facchinetti, A.; Bulian, P.; Massaro, A.R.; Pascalis, D.D.; Bertolotto, A.; Biasi, G.; Gallo, P. Interferon-beta (IFN-beta) antibodies in interferon-beta1a- and interferon-beta1b-treated multiple sclerosis patients. Prevalence, kinetics, cross-reactivity, and factors enhancing interferon-beta immunogenicity in vivo. Eur. Cytokine Netw. 2001, 12, 56-61.
26. Bertolotto, A.; Deisenhammer, F.; Gallo, P.; Solberg Sorensen, P. Immunogenicity of interferon beta: differences among products. J. Neurol. 2004, 251 (Suppl. 2), II15-II24.
27. WHO Expert Committee on Biological Standardization. Thirty-fifth report. World Health Organ. Tech. Rep. Ser. 1985, 725, 1-140.
28. Grossberg, S.E.; Kawade, Y. The expression of potency of neutralizing antibodies for interferons and other cytokines. Biotherapy 1997, 10, 93-98.
29. Grossberg, S.E.; Kawade, Y.; Kohase, M.; Yokoyama, H.; Finter, N. The neutralization of interferons by antibody. I. Quantitative and theoretical analyses of the neutralization reaction in different bioassay systems. J. Interferon Cytokine Res. 2001, 21, 729-742.
30. Kawade, Y. Quantitation of neutralization of interferon by antibody. Meth. Enzymol. 1986, 119, 558-573.
31. Grossberg, S.E.; Kawade, Y.; Kohase, M.; Klein, J.P. The neutralization of interferons by antibody. II. Neutralizing antibody unitage and its relationship to bioassay sensitivity: the tenfold reduction unit. J. Interferon Cytokine Res. 2001, 21, 743-755.
32. Pungor, E., Jr.; Files, J.G.; Gabe, J.D.; Do, L.T.; Foley, W.P.; Gray, J.L.; Nelson, J.W.; Nestaas, E.; Taylor, J.L.; Grossberg, S.E. A novel bioassay for the determination of neutralizing antibodies to IFN-beta1b. J. Interferon Cytokine Res. 1998, 18, 1025-1030.
33. Deisenhammer, F.; Schellekens, H.; Bertolotto, A. Measurement of neutralizing antibodies to interferon beta in patients with multiple sclerosis. J. Neurol. 2004, 251 (Suppl. 2), II31-II39.