title: Incidence of antibodies to interferon-beta in patients treated with recombinant human interferon-beta 1a from mammalian cells.
abstract: Patients receiving recombinant human interferon-beta 1a (IFN-beta 1a) produced in Chinese hamster ovary (CHO) cells were tested for the formation of neutralizing antibodies (NABs) to IFN-beta. Samples were tested in an enzyme-linked immunosorbent assay (ELISA), and if positive were then tested for neutralization of antiviral activity in an IFN-beta bioassay. A total of 793 patients with viral diseases, premalignant and malignant diseases, and multiple sclerosis received IFN-beta 1a in clinical studies. Long-term studies included 56 patients with cancer treated for 6 or 12 months and 334 patients with multiple sclerosis (MS) at the end of one year of treatment. All of the NAB-positive patients were found in the latter. Positivity in a single specimen was found in 14.4% of the MS patients. The incidence of sustained neutralizing antibody titres (i.e. positive in two tests at least 6 months apart) was 6.9% in this group. Comparison with results from other studies suggests that CHO-derived IFN-beta 1a induces less neutralizing antibody than IFN-beta 1b produced in E. coli.
authors.affiliation: Ares-Serono SA Geneva, Switzerland.
authors.forename: A K
authors.initials: AK
authors.lastname: Abdul-Ahad
authors.forename: A R
authors.initials: AR
authors.lastname: Galazka
authors.forename: M
authors.initials: M
authors.lastname: Revel
authors.forename: M
authors.initials: M
authors.lastname: Biffoni
authors.forename: E C
authors.initials: EC
authors.lastname: Borden
mesh_terms: D000818:Animals; D000917:Antibody Formation; D016466:CHO Cells; D002985:Clinical Protocols; D006224:Cricetinae; D003429:Cross Reactions; D004311:Double-Blind Method; D004926:Escherichia coli / Q000235:genetics / Q000276:immunology; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000009:adverse effects* / Q000096:biosynthesis / Q000276:immunology; D008297:Male; D009500:Neutralization Tests; D011994:Recombinant Proteins / Q000009:adverse effects / Q000096:biosynthesis / Q000276:immunology
chemical_list: D011994:Recombinant Proteins; D016899:Interferon-beta