Abstract |
The efficacy of interferon (IFN) beta has been shown in several placebo-controlled, parallel-group studies in relapsing-remitting multiple sclerosis (RRMS). PRISMS, the largest such study to date, clearly demonstrated the efficacy of IFN beta-1a on all outcome measures over 2 years during the placebo-controlled, parallel-group phase. However, this study's placebo-crossover design also provided us with a unique opportunity to conduct a prospective within-group assessment, eliminating the impact of inter-patient variability. At the start of year 3, patients receiving placebo during years 1-2 were re-randomized in a dose-blinded fashion to receive IFN beta-1a, 22 or 44 mcg subcutaneously three times weekly, during years 3 and 4. Clinic visits occurred 3-6 monthly and T2 MRI scans were obtained after 1 and 2 years on therapy. Comparison of the mean relapse count per patient over 2 years (the primary outcome measure) during time on placebo (years 1 and 2) with that during active treatment (years 3 and 4) revealed a decrease from 2.6 to 1.2 in both dose groups (54% relative reduction; p<0.001). Disability progression, T2 MRI lesion activity and accumulation of T2 lesion burden were also significantly improved with therapy (p<0.01). No new safety issues were noted. These data provide further support for IFN beta-1a's efficacy in RRMS. The ability to detect significant treatment effects with reduced patient numbers in this type of before/after analysis, may be due to the reduction in inter-patient variability.
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Authors | J Oger, G Francis, P Chang, PRISMS Study Group |
Journal | Journal of the neurological sciences
(J Neurol Sci)
Vol. 237
Issue 1-2
Pg. 45-52
(Oct 15 2005)
ISSN: 0022-510X [Print] Netherlands |
PMID | 16026803
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Interferon Type I
- Recombinant Proteins
- Interferon-beta
- Interferon beta-1a
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Topics |
- Adult
- Cross-Over Studies
- Disability Evaluation
- Disease Progression
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Interferon Type I
(administration & dosage, adverse effects, therapeutic use)
- Interferon beta-1a
- Interferon-beta
(administration & dosage, adverse effects, therapeutic use)
- Magnetic Resonance Imaging
- Male
- Multiple Sclerosis, Relapsing-Remitting
(drug therapy)
- Prospective Studies
- Recombinant Proteins
- Recurrence
- Research Design
- Treatment Outcome
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