title: Neutralizing antibodies to interferon beta-1b are not associated with disease worsening in multiple sclerosis.
abstract: The clinical impact of neutralizing antibodies (NAbs) on interferon beta (IFNbeta) efficacy was studied in three large patient cohorts comprising 6698 multiple sclerosis (MS) patients receiving IFNbeta-1b across North America, Europe, and Australia. In North America and Europe, NAb testing was generally undertaken because of a poor clinical response; in Australia, it was mandatory for every patient. Of the 6697 patients tested, 28.9% had at least one NAb titre > or = 20 neutralizing units (NU)/ml, 14.4% had NAb titres > or = 100 NU/ml and 7.7% had NAb titres > or = 400 NU/ml. The NAb-positive rate of 37.0% in Australia was significantly greater than those in North America (21.3%) and Europe (27.6%), and this was observed at every NAb titre level. Our results suggest that NAbs are not responsible for poor clinical responses and that NAb status is of little clinical value. These findings will need to be confirmed in a large independent study.
authors.affiliation: Department of Neurology, University of California, San Francisco 94143-0114, USA. douglas.goodin@ucsf.edu
authors.forename: D S
authors.initials: DS
authors.lastname: Goodin
authors.forename: B
authors.initials: B
authors.lastname: Hurwitz
authors.forename: A
authors.initials: A
authors.lastname: Noronha
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000276:immunology* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000276:immunology*; D009500:Neutralization Tests; D016896:Treatment Outcome
chemical_list: D000068576:Interferon beta-1b; D016899:Interferon-beta