title: Subcutaneous interferon-beta-1a : new formulation.
abstract: The new formulation of subcutaneous interferon-beta-1a was developed without serum-derived components with the aim of improving immunogenicity and injection tolerability in patients with relapsing forms of multiple sclerosis (MS). In a prospectively defined interim analysis at 48 weeks of an ongoing, single-arm, phase IIIb trial, 13.9% of MS patients receiving the new formulation of subcutaneous interferon-beta-1a 44 microg three times weekly had developed neutralising antibodies (NAbs). In the EVIDENCE trial, which served as an historical control, 24.4% of patients receiving the same dosage of the current formulation had developed NAbs at 48 weeks. The new formulation demonstrated similar pharmacokinetic activity to that of the current formulation in a phase I, double-blind, placebo-controlled study in healthy volunteers. About two-thirds of patients with MS who received the new formulation of subcutaneous interferon-beta-1a were relapse free in the interim, 48-week analysis of the single-arm trial; this is similar to results for the current formulation from historical data. A comparison of results from the interim, 48-week analysis with historical-control data from the EVIDENCE trial indicates that the new formulation of interferon-beta-1a may be associated with a lower incidence of injection-site reactions and a higher incidence of influenza-like symptoms than the current formulation. Adverse events associated with the new formulation were mostly mild to moderate in severity
authors.affiliation: Wolters Kluwer Health, Adis, Auckland, New Zealand. demail@adis.co.nz
authors.forename: Kate
authors.initials: K
authors.lastname: McKeage
authors.forename: Antona J
authors.initials: AJ
authors.lastname: Wagstaff
mesh_terms: D006801:Humans; D007109:Immunity / Q000187:drug effects; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D016899:Interferon-beta; D000068556:Interferon beta-1a