Subcutaneous Interferon-β-1a: New Formulation

Authors: McKeage, Kate; Wagstaff, Antona J.

Source: CNS Drugs, Volume 21, Number 10, 2007 , pp. 871-876(6)

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Abstract:

▴ The new formulation of subcutaneous interferon-β-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-β-1a 44µg 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-β-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-β-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.

Keywords: Adis Drug Profiles; Immunomodulators; Interferon beta 1a; Multiple sclerosis

Document Type: Research article

Affiliations: 1: Wolters Kluwer Health | Adis, Auckland, New Zealand, an editorial office of Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

Publication date: 2007-01-01