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Clinical benefits of interferon beta-1a in relapsing–remitting MS: a phase IV study

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Fernández O, Arbizu T, Izquierdo G, Martínez-Yélamos A, Gata JM, Luque G, de Ramón E. Clinical benefits of interferon beta-1a in relapsing–remitting MS: a phase IV study.

Acta Neurol Scand 2003: 107: 7–11. © Blackwell Munksgaard 2003.

Objective– To evaluate the efficacy and safety of IFNβ-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 IFNβ-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– IFNβ-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. IFNβ-1a treatment was well tolerated. Conclusion– This study confirms and extends the beneficial clinical profile for IFNβ-1a in relapsing MS.

Keywords: IFNβ-1a; clinical trial; multiple sclerosis; phase IV study

Document Type: Research Article


Affiliations: 1: Department of Neurology, Hospital Regional Universitario Carlos Haya, Málaga, Spain; 2: Department of Neurology, Hospital Universitario de Bellvitge, Barcelona, Spain; 3: Department of Neurology, Hospital Universitario Virgen Macarena, Sevilla, Spain

Publication date: January 1, 2003


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