Journal
ARCHIVES OF NEUROLOGY
Volume 69, Issue 10, Pages 1259-1269Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/archneurol.2012.1051
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Funding
- Actelion
- Basilea Pharmaceutica Ltd
- Biogen Idec
- Merck Serono
- Novartis
- Novartis Pharma AG
- Bayer Schering
- GlaxoSmithKline
- Roche
- Teva
- UCB
- Bayer Schering Pharma
- sanofi-aventis
- Abbott
- Bayer
- EMD-Serono
- Genentech
- Vertex
- Genzyme
- ONO Pharmaceuticals
- Swiss MS Society
- Swiss National Research Foundation
- European Union
- Gianni Rubatto Foundation
- Roche Research Foundation
- Novartis Pharma AG, Basel, Switzerland
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Objective: To assess the impact of fingolimod (FTY720) therapy on magnetic resonance imaging measures of inflammatory activity and tissue damage in patients participating in a 2-year, placebo-controlled, phase 3 study. Design: Patients with active relapsing-remitting multiple sclerosis were randomized to receive fingolimod, 0.5 mg; fingolimod, 1.25 mg; or placebo for 2 years. Standardized magnetic resonance imaging scans were obtained at months 0, 6, 12, and 24 and centrally evaluated for number and volume of T1 gadolinium-enhancing, T2 hyperintense, and T1 hypointense lesions and for percentage of brain volume change. Findings were compared across subgroups by treatment and baseline characteristics. Setting: Worldwide, multicenter clinical trial. Patients: Patients were part of the fingolimod FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) clinical trial for relapsing-remitting multiple sclerosis (N=1272). Main Outcome Measures: We measured the effect of therapy on acute inflammatory activity, burden of disease, and irreversible loss of brain volume. Results: Fingolimod therapy resulted in rapid and sustained reductions in inflammatory lesion activity as assessed by gadolinium-enhancing and new/newly enlarged T2 lesions after 6, 12, and 24 months of therapy (P<.001, all comparisons vs placebo). Changes in T2 hyperintense and T1 hypointense lesion volume also significantly favored fingolimod (P<.05, all comparisons). Fingolimod, 0.5 mg (licensed dose), significantly reduced brain volume loss during months 0 to 6, 0 to 12, 12 to 24, and 0 to 24 (P<.05, all comparisons) vs placebo, and subgroup analyses confirmed these effects over 2 years irrespective of the presence/absence of gadolinium-enhancing lesions, T2 lesion load, previous treatment status, or level of disability. Conclusion: These results, coupled with the significant reductions in relapse rates and disability progression reported previously, support the positive impact on long-term disease evolution.
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