Neutralizing antibodies in multiple sclerosis patients on weekly intramuscular Avonex and biosimilar interferon beta-1a (CinnoVex): Comparing results of measurements in two different laboratories

Journal of Immunological Methods

Volumn 388, Issue 1-2, 2013, Pages 46-48

  Shahkarami, Mohammad Amir ^a   Vaziri, Behrouz ^b   Salami, Shiva ^c   Harandi, Ali Amini ^d   Oger, Joel ^e  

^a ISFAHAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b PASTEUR INSTITUTE OF IRAN   (Iran)

^c CinnoVex Collaborating Research Group   (Iran)

^d SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^e UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Cytopathic effect; Interferon beta; Luciferase; Multiple sclerosis; Neutralizing antibody

Indexed keywords

BETA1A INTERFERON; CINNOVEX; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG;

ANTIBODY TITER; ARTICLE; BLOOD VOLUME; CANADA; COMPARATIVE STUDY; CONTROLLED STUDY; CYTOPATHOGENIC EFFECT; DOUBLE BLIND PROCEDURE; HUMAN; MAJOR CLINICAL STUDY; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ANTIBODIES, NEUTRALIZING; BIOSIMILAR PHARMACEUTICALS; BRITISH COLUMBIA; DOUBLE-BLIND METHOD; HUMANS; INTERFERON-BETA; IRAN; LUCIFERASES; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; STATISTICS, NONPARAMETRIC;

EID: 84872614677     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2012.11.013     Document Type: Article

References (13)

1. Antonelli G., Bagnato F., Pozzilli C., Simeoni E., Bastianelli S., Currenti M., De Pisa F., Fieschi C., Gasperini C., Salvetti M., Dianzani F. Development of neutralizing antibodies in patients with relapsing-remitting multiple sclerosis treated with IFN-beta1a. J. Interferon Cytokine Res. 1998, 18:345.
2. Boz C., Oger J., Gibbs E., Grossberg S.E. Reduced effectiveness of longterm interferon-ß treatment on relapses in neutralizing antibody positive multiple sclerosis patients: a Canadian multiple sclerosis clinic-based study. Mult. Scler. 2007, 13:1127.
3. Clanet M., Radue E.W., Kappos L., Hartung H.P., Hohlfeld R., Sandberg-Wollheim M., Kooijmans-Coutinho M.F., Tsao E.C., Sandrock A.W. A randomized, double-blind, dose-comparison study of weekly interferon beta-1a in relapsing MS. Neurology 2002, 59:1507. European IFNbeta-1a (Avonex) Dose-Comparison Study Investigators.
4. Cohen J.A., Cutter G.R., Fischer J.S., Goodman A.D., Heidenreich F.R., Kooijmans M.F., Sandrock A.W., Rudick R.A., Simon J.H., Simonian N.A., Tsao E.C., Whitaker J.N. Benefit of interferon beta-1a on MSFC progression in secondary progressive MS. Neurology 2002, 59:679. IMPACT Investigators.
5. Compston A., Coles A. Multiple sclerosis. Lancet 2002, 359:1221.
6. Files J.G., Gray J.L., Do L.T., Foley W.P., Gabe J.D., Nestaas E., Pungor E. A novel sensitive and selective bioassay for human type I interferons. J. Interferon Cytokine Res. 1998, 18:1019.
7. 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.
8. 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., Priore R.L., Pullicino P.M., Scherokman B.J., Whitham R.H., et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis: the Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. 1996, 39:285.
9. Jacobs L.D., Beck R.W., Simon J.H., Kinkel R.P., Brownscheidle C.M., Murray T.J., Simonian N.A., Slasor P.J., Sandrock A.W. N. Engl. J. Med. 2000, 343:898.
10. Lam R., Farrell R., Aziz T., Gibbs E., Giovannoni G., Grossberg S., Oger J. Validating parameters of a luciferase reporter gene assay to measure neutralizingantibodies to IFN beta in multiple sclerosis patients. J. Immunol. Methods 2008, 336:113.
11. Pungor E., 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.
12. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat. Rev. Drug. Discov. 2002, 1:457.
13. Uzé G., Di Marco S., Mouchel-Vielh E., Monneron D., Bandu M.T., Horisberger M.A., Dorques A., Lutfalla G., Mogensen K.E. Domains of interaction between alpha interferon and its receptor components. J. Mol. Biol. 1994, 243:245.