Abstract
Background:
In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment ( BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions.
Objective:
To examine detailed MRI findings from the first 2 years of this trial.
Design:
Double-blind, placebo-controlled, randomized, parallel-group, multicenter, phase 3 study.Setting: Ninety-eight centers worldwide.
Patients:
A total of 404 individuals with a first demyelinating event suggestive of multiple sclerosis.
Interventions:
Patients were randomized to receive interferon beta-1b, 250 mu g subcutaneously every other day, or placebo. After 24 months of treatment or on conversion to clinically definite multiple sclerosis, open-label interferon beta-1b treatment was offered.
Main Outcome Measures:
Reported MRI data from patients completing 2 years of follow-up.
Results:
Data were analyzed from 248 patients taking interferon beta-1b and 156 taking placebo. Across 2 years the cumulative number of newly active lesions was lower in patients receiving interferon beta-1b vs placebo ( median, 2.0 vs 5.0 [ reduction of 60%]; P < .001). This corresponded to lower cumulative numbers of new T2 lesions ( median, 1.0 vs 3.0 [ reduction of 66%]; P < .001) and new gadolinium- enhancing lesions (median, 0.0 vs 1.0; P < .001) in patients receiving interferon beta-1b vs placebo. From screening to month 24, T2 lesion volume decreased and was more pronounced in patients receiving interferon beta-1b (P= .02).
Conclusions:
Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group.
In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment ( BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions.
Objective:
To examine detailed MRI findings from the first 2 years of this trial.
Design:
Double-blind, placebo-controlled, randomized, parallel-group, multicenter, phase 3 study.Setting: Ninety-eight centers worldwide.
Patients:
A total of 404 individuals with a first demyelinating event suggestive of multiple sclerosis.
Interventions:
Patients were randomized to receive interferon beta-1b, 250 mu g subcutaneously every other day, or placebo. After 24 months of treatment or on conversion to clinically definite multiple sclerosis, open-label interferon beta-1b treatment was offered.
Main Outcome Measures:
Reported MRI data from patients completing 2 years of follow-up.
Results:
Data were analyzed from 248 patients taking interferon beta-1b and 156 taking placebo. Across 2 years the cumulative number of newly active lesions was lower in patients receiving interferon beta-1b vs placebo ( median, 2.0 vs 5.0 [ reduction of 60%]; P < .001). This corresponded to lower cumulative numbers of new T2 lesions ( median, 1.0 vs 3.0 [ reduction of 66%]; P < .001) and new gadolinium- enhancing lesions (median, 0.0 vs 1.0; P < .001) in patients receiving interferon beta-1b vs placebo. From screening to month 24, T2 lesion volume decreased and was more pronounced in patients receiving interferon beta-1b (P= .02).
Conclusions:
Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group.
| Original language | English |
|---|---|
| Pages (from-to) | 1292-1298 |
| Number of pages | 7 |
| Journal | Archives of Neurology |
| Volume | 64 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Sept 2007 |
Keywords
- Placebo-controlled trial
- Multiple-sclerosis lesions
- Double-blind
- Diagnostic-criteria
- Mri
- Multicenter
- Disability
- Guidelines
- Conversion
- Definite