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Randomized study of once-weekly interferon ß-1a therapy in relapsing multiple sclerosis: three-year data from the OWIMS study

Ottawa Hospital-General Campus, Ottawa, Ontario, Canada, mfreedman{at}ottawahospital.on.ca

G S Francis

Serono Inc., Rockland, MA, USA, Elan Pharmaceuticals

E ACM Sanders

Ignatius Hospital, Breda, the Netherlands

G PA Rice

Multiple Sclerosis Clinic, University Hospital, London, Ontario, Canada

P O'Connor

St Michael Hospital, Toronto, Ontario, Canada

G Comi

Centro Sclerosi Multipla, Ospedale San Raffaele, Milan, Italy

P Duquette

Hôpital Notre-Dame, Montréal, Québec, Canada

L Metz

Foothills Hospital, Calgary, Alberta, Canada

T J Murray

Queen Elizabeth II Health Sciences Centre (Centre for Clinical Research), Halifax, Nova Scotia, Canada

J-P Bouchard

Hôpital de l’Enfant Jésus, Quebec City, Québec, Canada

O Abramsky

Hadassah Medical Centre, Jerusalem, Israel

J Pelletier

Service de Neurologie, Centre Hospitalier Universitaire de Marseille, Marseille, France

F O'Brien

Serono Inc., Rockland, MA, USA

OWIMS Study Group

University of British Columbia MS/MRI Research Group

Background: Once weekly interferon ß-1a for multiple sclerosis (OWIMS) demonstrated modest, but significant, magnetic resonance imaging (MRI) benefit of once-weekly (qw) interferon (IFN) ß-1a at 48 weeks, but no significant effect on relapses. Objective: An OWIMS extension permitted assessment of longer-term efficacy/safety of qw IFN ß-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: Placebo patients were rerandomized to IFN ß-1a, 22 or 44 mcg qw, for two additional 48-week intervals. Primary outcome was MRI lesion activity. Relapse rate and other MRI measures were secondary outcomes. Results: After three years, median (mean) T2 lesion count/patient/scan was 1.3 (2.6) for 44 mcg, 1.7 (3.3) for 22 mcg, 1.7 (3.4) for placebo/22 mcg, 2.0 (3.6) for placebo/44 mcg (all differences not significant). Annualized relapse rates were lowest for 44 mcg (0.77) versus other groups (0.83-0.86, not significant). Persistent neutralizing antibodies did not affect relapse rates, but MRI active lesions were increased in antibody-positive patients receiving 44 mcg compared to antibody negative patients. Conclusions: In RRMS, once weekly IFN ß-1a, particularly 44 mcg, can induce a significant MRI, but not relapse, effect, compared with placebo. No significant dose effect was seen. In contrast to the significant effect observed with three-times-weekly dosing of subcutaneous IFN ß-1a compared with placebo, this study confirms the lack of meaningful clinical benefit with once-weekly dosing.

Key Words: controlled clinical trial • interferon ß-1a • MRI • once-weekly dosing • OWIMS study • randomized • relapse-related outcomes • relapsing multiple sclerosis

Multiple Sclerosis, Vol. 11, No. 1, 41-45 (2005)
DOI: 10.1191/1352458505ms1126oa


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