Randomized study of once-weekly interferon β-1a therapy in relapsing multiple sclerosis: three-year data from the OWIMS study
Background: Once weekly interferon β-1a for multiple sclerosis (OWIMS) demonstrated modest, but significant, magnetic resonance imaging (MRI) benefit of once-weekly (qw) interferon (IFN) β-1a at 48 weeks, but no significant effect on relapses. Objective: An OWIMS extension permitted assessment of lo...
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| Vydáno v: | Multiple sclerosis Ročník 11; číslo 1; s. 41 - 45 |
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| Hlavní autoři: | , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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Thousand Oaks, CA
SAGE Publications
01.02.2005
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| ISSN: | 1352-4585, 1477-0970 |
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| Abstract | Background: Once weekly interferon β-1a for multiple sclerosis (OWIMS) demonstrated modest, but significant, magnetic resonance imaging (MRI) benefit of once-weekly (qw) interferon (IFN) β-1a at 48 weeks, but no significant effect on relapses. Objective: An OWIMS extension permitted assessment of longer-term efficacy/safety of qw IFN β-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: Placebo patients were rerandomized to IFN β-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 β-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 β-1a compared with placebo, this study confirms the lack of meaningful clinical benefit with once-weekly dosing. |
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| AbstractList | Background: Once weekly interferon β-1a for multiple sclerosis (OWIMS) demonstrated modest, but significant, magnetic resonance imaging (MRI) benefit of once-weekly (qw) interferon (IFN) β-1a at 48 weeks, but no significant effect on relapses. Objective: An OWIMS extension permitted assessment of longer-term efficacy/safety of qw IFN β-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: Placebo patients were rerandomized to IFN β-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 β-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 β-1a compared with placebo, this study confirms the lack of meaningful clinical benefit with once-weekly dosing. |
| Author | Duquette, P Freedman, M S Sanders, E ACM Murray, T J Rice, G PA Abramsky, O Metz, L Comi, G O'Brien, F Francis, G S Bouchard, J-P Pelletier, J O'Connor, P |
| Author_xml | – sequence: 1 givenname: M S surname: Freedman fullname: Freedman, M S email: mfreedman@ottawahospital.on.ca organization: Ottawa Hospital-General Campus, Ottawa, Ontario, Canada – sequence: 2 givenname: G S surname: Francis fullname: Francis, G S organization: Serono Inc., Rockland, MA, USA, Elan Pharmaceuticals – sequence: 3 givenname: E ACM surname: Sanders fullname: Sanders, E ACM organization: Ignatius Hospital, Breda, the Netherlands – sequence: 4 givenname: G PA surname: Rice fullname: Rice, G PA organization: Multiple Sclerosis Clinic, University Hospital, London, Ontario, Canada – sequence: 5 givenname: P surname: O'Connor fullname: O'Connor, P organization: St Michael Hospital, Toronto, Ontario, Canada – sequence: 6 givenname: G surname: Comi fullname: Comi, G organization: Centro Sclerosi Multipla, Ospedale San Raffaele, Milan, Italy – sequence: 7 givenname: P surname: Duquette fullname: Duquette, P organization: Hôpital Notre-Dame, Montréal, Québec, Canada – sequence: 8 givenname: L surname: Metz fullname: Metz, L organization: Foothills Hospital, Calgary, Alberta, Canada – sequence: 9 givenname: T J surname: Murray fullname: Murray, T J organization: Queen Elizabeth II Health Sciences Centre (Centre for Clinical Research), Halifax, Nova Scotia, Canada – sequence: 10 givenname: J-P surname: Bouchard fullname: Bouchard, J-P organization: Hôpital de l’Enfant Jésus, Quebec City, Québec, Canada – sequence: 11 givenname: O surname: Abramsky fullname: Abramsky, O organization: Hadassah Medical Centre, Jerusalem, Israel – sequence: 12 givenname: J surname: Pelletier fullname: Pelletier, J organization: Service de Neurologie, Centre Hospitalier Universitaire de Marseille, Marseille, France – sequence: 13 givenname: F surname: O'Brien fullname: O'Brien, F organization: Serono Inc., Rockland, MA, USA |
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| Cites_doi | 10.1212/01.WNL.0000034080.43681.DA 10.1002/ana.410390304 10.1016/S0140-6736(02)08430-1 10.1016/S0140-6736(98)03334-0 10.1212/WNL.56.12.1628 10.1056/NEJM200009283431301 10.1002/1531-8249(199908)46:2<197::AID-ANA9>3.0.CO;2-P 10.1097/00002371-199304000-00006 10.1212/WNL.43.4.655 10.1212/01.WNL.0000032256.35561.D6 10.1212/WNL.53.4.679 10.1212/WNL.51.3.738 10.1046/j.1468-1331.1998.520187.x 10.1016/S0140-6736(00)04725-5 |
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| Keywords | relapsing multiple sclerosis OWIMS study controlled clinical trial relapse-related outcomes MRI once-weekly dosing randomized interferon β-1a |
| Language | English |
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| References_xml | – volume: 5 start-page: 1 year: 1998 end-page: 7 article-title: Comparative bioavailability of recombinant human interferon beta-1a after intramuscular and subcutaneous administration publication-title: Eur J Neurol – volume: 59 start-page: 1507 year: 2002 end-page: 1517 article-title: A randomized, double-blind, dose-comparison study of weekly interferon beta-1a in relapsing MS publication-title: Neurology – volume: 357 start-page: 1576 year: 2001 end-page: 1582 article-title: Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study publication-title: Lancet – volume: 359 start-page: 1453 year: 2002 end-page: 1460 article-title: Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN) publication-title: Lancet – volume: 343 start-page: 898 year: 2000 end-page: 904 article-title: Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis publication-title: N Engl J Med – volume: 46 start-page: 197 year: 1999 end-page: 206 article-title: Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis publication-title: Ann Neurol – volume: 43 start-page: 655 year: 1993 end-page: 661 article-title: Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial publication-title: Neurology – volume: 51 start-page: 738 year: 1998 end-page: 742 article-title: Serum interferon beta-1a (Avonex) levels following intramuscular injection in relapsing-remitting MS patients publication-title: Neurology – volume: 39 start-page: 285 year: 1996 end-page: 294 article-title: Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis publication-title: Ann Neurol – volume: 53 start-page: 679 year: 1999 end-page: 686 article-title: Evidence of interferon beta-1a dose response in relapsing-remitting MS publication-title: Neurology – volume: 13 start-page: 191 year: 1993 end-page: 200 article-title: Pharmacodynamics of biological response in vivo after single and multiple doses of interferon-beta publication-title: J Immun-other – volume: 352 start-page: 1498 year: 1998 end-page: 1504 article-title: Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis publication-title: Lancet – volume: 56 start-page: 1628 year: 2001 end-page: 1636 article-title: PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS publication-title: Neurology – volume: 59 start-page: 1496 year: 2002 end-page: 1506 article-title: Randomized, comparative study of inter-feron beta-1a treatment regimens in MS. The EVIDENCE trial publication-title: Neurology – ident: atypb10 doi: 10.1212/01.WNL.0000034080.43681.DA – ident: atypb12 doi: 10.1002/ana.410390304 – ident: atypb11 doi: 10.1016/S0140-6736(02)08430-1 – volume-title: Summary basis for approval year: 1995 ident: atypb13 – ident: atypb5 doi: 10.1016/S0140-6736(98)03334-0 – ident: atypb7 doi: 10.1212/WNL.56.12.1628 – ident: atypb14 doi: 10.1056/NEJM200009283431301 – ident: atypb6 doi: 10.1002/1531-8249(199908)46:2<197::AID-ANA9>3.0.CO;2-P – ident: atypb2 doi: 10.1097/00002371-199304000-00006 – ident: atypb8 doi: 10.1212/WNL.43.4.655 – ident: atypb9 doi: 10.1212/01.WNL.0000032256.35561.D6 – ident: atypb4 doi: 10.1212/WNL.53.4.679 – ident: atypb3 doi: 10.1212/WNL.51.3.738 – ident: atypb1 doi: 10.1046/j.1468-1331.1998.520187.x – ident: atypb15 doi: 10.1016/S0140-6736(00)04725-5 |
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