Abstract | BACKGROUND:
Fingolimod ( FTY720), a sphingosine-1-phosphate-receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis. METHODS: In this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 microg. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T(2)-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months. RESULTS: CONCLUSIONS: This trial showed the superior efficacy of oral fingolimod with respect to relapse rates and MRI outcomes in patients with multiple sclerosis, as compared with intramuscular interferon beta-1a. Longer studies are needed to assess the safety and efficacy of treatment beyond 1 year. (ClinicalTrials.gov number, NCT00340834.)
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Authors | Jeffrey A Cohen, Frederik Barkhof, Giancarlo Comi, Hans-Peter Hartung, Bhupendra O Khatri, Xavier Montalban, Jean Pelletier, Ruggero Capra, Paolo Gallo, Guillermo Izquierdo, Klaus Tiel-Wilck, Ana de Vera, James Jin, Tracy Stites, Stacy Wu, Shreeram Aradhye, Ludwig Kappos, TRANSFORMS Study Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 362
Issue 5
Pg. 402-15
(Feb 04 2010)
ISSN: 1533-4406 [Electronic] United States |
PMID | 20089954
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | 2010 Massachusetts Medical Society |
Chemical References |
- Immunosuppressive Agents
- Propylene Glycols
- Interferon-beta
- Fingolimod Hydrochloride
- Sphingosine
- Interferon beta-1a
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Arrhythmias, Cardiac
(chemically induced)
- Brain
(pathology)
- Disability Evaluation
- Disease Progression
- Double-Blind Method
- Female
- Fingolimod Hydrochloride
- Humans
- Immunosuppressive Agents
(adverse effects, therapeutic use)
- Injections, Intramuscular
- Intention to Treat Analysis
- Interferon beta-1a
- Interferon-beta
(adverse effects, therapeutic use)
- Magnetic Resonance Imaging
- Male
- Middle Aged
- Multiple Sclerosis, Relapsing-Remitting
(drug therapy, pathology)
- Propylene Glycols
(adverse effects, therapeutic use)
- Sphingosine
(adverse effects, analogs & derivatives, therapeutic use)
- Statistics, Nonparametric
- Young Adult
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