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Subcutaneous Interferon-β-1a

New Formulation

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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.

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Notes

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

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Acknowledgements

The manuscript was reviewed by: B. M. Keegan, Department of Neurology, Mayo Clinic College of Medicine, Rochester, MN, USA; H. Panitch, University of Vermont College of Medicine, Burlington, VT, USA. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes based on any comments received were made on the basis of scientific and editorial merit.

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Authors and Affiliations

  1. Wolters Kluwer Health | Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754 Auckland, New Zealand

    Kate McKeage & Antona J. Wagstaff

  2. Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

    Kate McKeage & Antona J. Wagstaff

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  1. Kate McKeage
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  2. Antona J. Wagstaff
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Correspondence to Kate McKeage.

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McKeage, K., Wagstaff, A.J. Subcutaneous Interferon-β-1a. CNS Drugs 21, 871–876 (2007). https://doi.org/10.2165/00023210-200721100-00006

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