title: A novel bioassay for the determination of neutralizing antibodies to IFN-beta1b.
abstract: We have adapted the new MxA gene-induction bioassay to measure neutralizing antibodies to interferon-beta1b (IFN-beta1b, the active ingredient in Betaseron) in sera from patients treated with Betaseron. This antibody assay has been validated to quantify neutralizing titers of 1:20 and above, with a precision of +/- 0.20 in log10. We have used this MxA gene-induction antibody assay to reinvestigate serum samples from multiple sclerosis (MS) patients treated with Betaseron. The titers measured were closely comparable to those obtained in antiviral assays. Data obtained by both methods show that neutralizing antibodies may appear and subsequently disappear over time in the sera of some patients treated with Betaseron. Sera from some patients contain binding antibodies to IFN-beta1b. It was shown that binding antibody titers do not correlate quantitatively or qualitatively with neutralizing antibody titers, and indeed, a number of patients develop high levels of binding antibodies but never form measurable levels of neutralizing antibodies.
authors.affiliation: Berlex Laboratories, Inc., Richmond, CA 94804-0099, USA. erno_pungor@Berlex.com
authors.forename: E
authors.initials: E
authors.lastname: Pungor
authors.forename: J G
authors.initials: JG
authors.lastname: Files
authors.forename: J D
authors.initials: JD
authors.lastname: Gabe
authors.forename: L T
authors.initials: LT
authors.lastname: Do
authors.forename: W P
authors.initials: WP
authors.lastname: Foley
authors.forename: J L
authors.initials: JL
authors.lastname: Gray
authors.forename: J W
authors.initials: JW
authors.lastname: Nelson
authors.forename: E
authors.initials: E
authors.lastname: Nestaas
authors.forename: J L
authors.initials: JL
authors.lastname: Taylor
authors.forename: S E
authors.initials: SE
authors.lastname: Grossberg
mesh_terms: D000937:Antigen-Antibody Reactions; D000998:Antiviral Agents / Q000276:immunology; D001681:Biological Assay; D019204:GTP-Binding Proteins; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology*; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000276:immunology*; D064547:Myxovirus Resistance Proteins; D011506:Proteins / Q000276:immunology; D011994:Recombinant Proteins / Q000276:immunology; D016037:Single-Blind Method
chemical_list: D000998:Antiviral Agents; D007074:Immunoglobulin G; C579071:MX1 protein, human; D064547:Myxovirus Resistance Proteins; D011506:Proteins; D011994:Recombinant Proteins; D000068576:Interferon beta-1b; D016899:Interferon-beta; D019204:GTP-Binding Proteins; D000068556:Interferon beta-1a