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Published on: December 9, 2015
Randomized study of once-weekly interferon beta-1la therapy in relapsing multiple sclerosis: three-year data from the
M S Freedman1, G S Francis, E A C M Sanders
1Ottawa Hospital - General Campus, Ottawa, Ontario, Canada. mfreedman@ottawahospital.on.ca
Background:
Once weekly interferon beta-1a for multiple sclerosis (OWIMS) demonstrated modest, but significant, magnetic resonance imaging (MRI) benefit of once-weekly (qw) interferon (IFN) beta-1a at 48 weeks, but no significant effect on relapses.
Objective:
An OWIMS extension permitted assessment of longer-term efficacy/safety of qw IFN beta-1a in relapsing-remitting multiple sclerosis (RRMS).
Methods:
Placebo patients were rerandomized to IFN beta-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 beta-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 beta-1a compared with placebo, this study confirms the lack of meaningful clinical benefit with once-weekly dosing.
Insights
Once weekly interferon beta-1a showed MRI benefits but no significant relapse reduction in multiple sclerosis patients over three years. This dosing regimen lacks meaningful clinical benefit compared to other interferon beta-1a treatments.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- The Once Weekly Interferon beta-1a for Multiple Sclerosis (OWIMS) study initially showed modest MRI benefits but no relapse reduction with once-weekly interferon (IFN) beta-1a.
- An extension study aimed to assess the long-term efficacy and safety of this dosing regimen in relapsing-remitting multiple sclerosis (RRMS).
Purpose of the Study:
- To evaluate the longer-term efficacy and safety of once-weekly interferon beta-1a in RRMS patients.
- To assess magnetic resonance imaging (MRI) lesion activity and relapse rates over an extended treatment period.
Main Methods:
- Patients initially on placebo were rerandomized to receive either 22 or 44 mcg of IFN beta-1a once weekly for two additional 48-week periods.
- The primary outcome was MRI lesion activity, with relapse rates and other MRI measures as secondary outcomes.
Main Results:
- After three years, no significant differences in median T2 lesion counts were observed between the 44 mcg, 22 mcg, and placebo groups.
- Annualized relapse rates were similar across all groups, with the lowest rate in the 44 mcg group (0.77) but not statistically significant.
- While neutralizing antibodies did not impact relapse rates, MRI active lesions increased in antibody-positive patients on 44 mcg compared to antibody-negative patients.
Conclusions:
- Once weekly interferon beta-1a, particularly at 44 mcg, demonstrated a significant MRI effect but not a significant relapse effect compared to placebo in RRMS.
- No significant dose-dependent effect was observed.
- The study concluded that once-weekly dosing of interferon beta-1a does not provide meaningful clinical benefit in RRMS, unlike three-times-weekly subcutaneous administration.
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