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CNS Drugs

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01.10.2007 | Adis Drug Profile

Subcutaneous Interferon-β-1a

New Formulation

verfasst von: Kate McKeage, Antona J. Wagstaff

Erschienen in: CNS Drugs | Ausgabe 10/2007

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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.

The use of trade names is for product identification purposes only and does not imply endorsement.

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Titel: Subcutaneous Interferon-β-1a
New Formulation
verfasst von: Kate McKeage
Antona J. Wagstaff
Publikationsdatum: 01.10.2007
Verlag: Springer International Publishing
Erschienen in: CNS Drugs / Ausgabe 10/2007
Print ISSN: 1172-7047
Elektronische ISSN: 1179-1934
DOI: https://doi.org/10.2165/00023210-200721100-00006

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