BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time | 0.0027 | ||
| Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time | Hazard Ratio (HR) 0.663 | 0.488–0.902 | 0.0028 |
| Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time | Hazard Ratio (HR) 0.764 | 0.497–1.174 | 0.1604 |
| Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time | 0.1768 | ||
| Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60 | 0.3832 | ||
| Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60 | 0.8880 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
Results by group
Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time
up to 60 months after start of treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Initial IFNB-1b (Interferon Beta-1b) | 26.9 cum. percentage of particip. with CDMS | 292 | |
| Initial Placebo | 45.0 cum. percentage of particip. with CDMS | 176 | |
| Initial IFNB-1b (Interferon Beta-1b) | 36.7 cum. percentage of particip. with CDMS | 292 | |
| Initial Placebo | 51.2 cum. percentage of particip. with CDMS | 176 | |
| Initial IFNB-1b (Interferon Beta-1b) | 46.2 cum. percentage of particip. with CDMS | 292 | |
| Initial Placebo | 57.3 cum. percentage of particip. with CDMS | 176 |
p = 0.0027
Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time
up to 60 months after start of treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Initial IFNB-1b (Interferon Beta-1b) | 12.8 percentage of particip. with EDSS progr. | 292 | |
| Initial Placebo | 19.9 percentage of particip. with EDSS progr. | 176 | |
| Initial IFNB-1b (Interferon Beta-1b) | 16.8 percentage of particip. with EDSS progr. | 292 | |
| Initial Placebo | 25.3 percentage of particip. with EDSS progr. | 176 | |
| Initial IFNB-1b (Interferon Beta-1b) | 24.9 percentage of particip. with EDSS progr. | 292 | |
| Initial Placebo | 28.9 percentage of particip. with EDSS progr. | 176 |
p = 0.1768
Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60
60 months after start of treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Initial IFNB-1b (Interferon Beta-1b) | 125 units on a scale | 107–139 | 169 |
| Initial Placebo | 125 units on a scale | 104.83–140 | 91 |
Initial IFNB-1b (Interferon Beta-1b)
Initial Placebo
p = 0.8880
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Initial IFNB-1b (Interferon Beta-1b) | 292 | 61 (20.9%) | |
| Initial Placebo | 176 | 42 (23.9%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time
up to 60 months after start of treatment
Disability progressionRelapsesTime to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time
up to 60 months after start of treatment
Disability progressionFunctional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60
60 months after start of treatment
FatigueWalking and mobilityQuality of life (reported by participants)
Other measures (8)
Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria
up to 60 months after start of treatment
RelapsesMRI lesionsRelapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses
up to 60 months after start of treatment
RelapsesRelapse-based Efficacy Domain (Supportive): Annualized Relapse Rate
up to 60 months after start of treatment
RelapsesDisability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60
60 months after start of treatment
Disability progressionThinking and memoryWalking and mobilityMRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60
up to 60 months after start of treatment
MRI lesionsMRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60
60 months after start of treatment
MRI lesionsMRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60
60 months after start of treatment
MRI lesionsMRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60
60 months after start of treatment
MRI lesionsBrain volume loss
Who could take part
Early (CIS/RIS) · 18 to 48
Inclusion Criteria: * Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months Exclusion Criteria: * No participation in the initial BENEFIT study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study). Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.
Papers
Results
Vitamin D, smoking, EBV, and long-term cognitive performance in MS: 11-year follow-up of BENEFIT.Neurology · 2020
Results
Sodium intake and multiple sclerosis activity and progression in BENEFIT.Ann Neurol · 2017
Results
No association of multiple sclerosis activity and progression with EBV or tobacco use in BENEFIT.Neurology · 2015
Results
Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis.Mult Scler · 2012
Results
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.Lancet Neurol · 2009
Results
MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome.BMC Neurol · 2009
Results
Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study.Lancet · 2007
Results
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.Arch Neurol · 2007
Results
Hartung HP, Freedman MS, Polman CH, Edan G, Kappos L, Miller DH, Montalban X, Barkhof F, Petkau J, White R, Sahajpal V, Knappertz V, Beckmann K, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Interferon beta-1b-neutralizing antibodies 5 years after clinically isolated syndrome. Neurology. 2011 Aug 30;77(9):835-43. doi: 10.1212/WNL.0b013e31822c90d7. Epub 2011 Aug 17.Results
Freedman MS, Metzig C, Kappos L, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Yarden J, Spector L, Fire E, Dotan N, Schwenke S, Lanius V, Sandbrink R, Pohl C. Predictive nature of IgM anti-alpha-glucose serum biomarker for relapse activity and EDSS progression in CIS patients: a BENEFIT study analysis. Mult Scler. 2012 Jul;18(7):966-73. doi: 10.1177/1352458511432327. Epub 2011 Dec 19.
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History
Started
Aug 2002
Main results due
May 2008
Finished
May 2008
Results posted
Nov 2010
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