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Clinical benefits of interferon beta‐1a in relapsing–remitting MS: a phase IV study
Author(s) -
Fernández O.,
Arbizu T.,
Izquierdo G.,
MartínezYélamos A.,
Gata J. M.,
Luque G.,
De Ramón E.
Publication year - 2003
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1034/j.1600-0404.2003.01350.x
Subject(s) - medicine , exacerbation , relapsing remitting , multiple sclerosis , expanded disability status scale , interferon beta 1a , clinical trial , interferon beta , immunology
Objective– To evaluate the efficacy and safety of IFN β ‐1a (Avonex ® , Biogen, Inc., Cambridge, MA, USA) in patients with relapsing–remitting multiple sclerosis (MS). Methods – In this multicenter, open‐label, prospective clinical trial, 96 patients with relapsing–remitting MS received IFN β ‐1a 30 mcg intramuscularly once weekly for 2 years. Outcome variables included: change from baseline in mean number of exacerbations, proportion of exacerbation‐free patients, and mean Expanded Disability Status Scale (EDSS) scores at Years 1 and 2. Results – IFN β ‐1a significantly ( P < 0.0001) reduced exacerbation rate at Years 1 and 2 of treatment. The percentage of exacerbation‐free patients was 53% during Year 1 and 33% during Year 2. Mean EDSS scores were 2.96 ± 1.26 at baseline, 2.89 ± 1.42 at Year 1, and 3.00 ± 1.62 at Year 2 ( P = 0.116). EDSS scores improved in 35.4%, remained stable in 28.1%, and worsened in 36.5% of patients. IFN β ‐1a treatment was well tolerated. Conclusion – This study confirms and extends the beneficial clinical profile for IFN β ‐1a in relapsing MS.