Impact of Fingolimod Therapy on Magnetic Resonance Imaging Outcomes in Patients With Multiple Sclerosis
In: Archives of neurology (Chicago), Jg. 69 (2012), Heft 10, S. 1259-1269
academicJournal
- print, 39 ref
Zugriff:
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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Impact of Fingolimod Therapy on Magnetic Resonance Imaging Outcomes in Patients With Multiple Sclerosis
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Autor/in / Beteiligte Person: | RADUE, Ernst-Wilhelm ; O'CONNOR, Paul ; ZHANG-AUBERSON, Lixin ; FRANCIS, Gordon ; BURTIN, Pascale ; KAPPOS, Ludwig ; POLMAN, Chris H ; HOHLFELD, Reinhard ; CALABRESI, Peter ; SELMAJ, Krystof ; MUELLER-LENKE, Nicole ; AGOROPOULOU, Catherine ; HOLDBROOK, Frederick ; DE VERA, Ana ; FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) Study Group |
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Zeitschrift: | Archives of neurology (Chicago), Jg. 69 (2012), Heft 10, S. 1259-1269 |
Veröffentlichung: | Chicago, IL: American Medical Association, 2012 |
Medientyp: | academicJournal |
Umfang: | print, 39 ref |
ISSN: | 0003-9942 (print) |
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