250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 microg or 500 microg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis. Between November, 2003, and June, 2005, 2...

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Bibliographic Details
Published in:Lancet neurology 2009-10, Vol.8 (10), p.889-897
Main Authors: O'Connor, Paul, Filippi, Massimo, Arnason, Barry, Comi, Giancarlo, Cook, Stuart, Goodin, Douglas, Hartung, Hans-Peter, Jeffery, Douglas, Kappos, Ludwig, Boateng, Francis, Filippov, Vitali, Groth, Maria, Knappertz, Volker, Kraus, Christian, Sandbrink, Rupert, Pohl, Christoph, Bogumil, Timon, O'Connor, P, Filippi, M, Arnason, B, Cook, S, Goodin, D, Hartung, H-P, Harung, H-P, Kappos, L, Jeffery, D, Comi, G
Format: Article
Language:English
Subjects:
Adolescent
Adult
Brain - drug effects
Brain - pathology
Dose-Response Relationship, Drug
Double-Blind Method
Female
Glatiramer Acetate
Humans
Immunologic Factors - therapeutic use
Interferon beta-1b
Interferon-beta - administration & dosage
Magnetic Resonance Imaging
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Multiple Sclerosis, Relapsing-Remitting - pathology
Peptides - therapeutic use
Young Adult
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Summary:The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 microg or 500 microg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis. Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 microg or 500 microg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502. We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p
ISSN:1474-4465
DOI:10.1016/S1474-4422(09)70226-1