1. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis
- Author
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Cohen, J, Barkhof, F, Comi, G, Hartung, H, Khatri, B, Montalban, X, Pelletier, J, Capra, R, Gallo, P, Izquierdo, G, Tiel Wilck, K, de Vera, A, Jin, J, Stites, T, Wu, S, Aradhye, S, Kappos, L, TRANSFORMS Study Group, Contributor, Centonze, D, Cohen, Ja, Barkhof, F, Comi, Giancarlo, Hartung, Hp, Khatri, Bo, Montalban, X, Pelletier, J, Capra, R, Gallo, P, Izquierdo, G, TIEL WILCK, K, DE VERA, A, Jin, J, Stites, T, Wu, S, Aradhye, S, KAPPOS L., TRANSFORM STUDY GROUP, Cohen, J. A., Barkhof, F., Comi, G., Hartung, H., Khatri, B. O., Montalban, X., Pelletier, J., Capra, R., Gallo, P., Izquierdo, G., Tiel-Wilck, K., Vera, A. d., Jin, J., Stites, T., Wu, S., Aradhye, S., Kappos, L., Brescia Morra, V., Altri, 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 Stite, Stacy Wu, Shreeram Aradhye, Ludwig Kappo, for the TRANSFORMS Study Group, Alessandra Lugaresi, Centre de résonance magnétique biologique et médicale (CRMBM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Radiology and nuclear medicine, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases, and Ben Dahan, David
- Subjects
Male ,Medizin ,Administration, Oral ,Arrhythmias ,Relapsing-Remitting ,drug therapy/pathology ,Disability Evaluation ,chemistry.chemical_compound ,0302 clinical medicine ,Sphingosine ,Teriflunomide ,Propylene Glycols/adverse effects/*therapeutic use ,Interferon-beta/adverse effects/*therapeutic use ,Intramuscular ,0303 health sciences ,Statistics ,Brain ,General Medicine ,Middle Aged ,Magnetic Resonance Imaging ,Fingolimod ,Intention to Treat Analysis ,3. Good health ,adverse effects/therapeutic use ,Administration ,chemically induced ,Disease Progression ,intramuscular interferon ,Settore MED/26 - Neurologia ,Female ,Young Adult ,Double-Blind Method ,Humans ,Injections, Intramuscular ,Interferon-beta ,Multiple Sclerosis, Relapsing-Remitting ,Immunosuppressive Agents ,Adult ,Propylene Glycols ,Adolescent ,Statistics, Nonparametric ,Arrhythmias, Cardiac ,Cardiac ,medicine.drug ,Oral ,medicine.medical_specialty ,Multiple Sclerosis ,Injections ,adverse effects/analogs /&/ derivatives/therapeutic use ,03 medical and health sciences ,Relapsing-Remitting/*drug therapy/pathology ,Internal medicine ,Fingolimod Hydrochloride ,medicine ,Brain/pathology ,Nonparametric ,fingolimod ,Cardiac/chemically induced ,030304 developmental biology ,business.industry ,Multiple sclerosis ,fingolimod, multiple sclerosis, therapy ,Interferon beta-1a ,relapsing multiple sclerosis ,Management of multiple sclerosis ,medicine.disease ,Immunosuppressive Agents/adverse effects/*therapeutic use ,Oral, Adolescent, Adult, Arrhythmias ,chemically induced, Brain ,pathology, Disability Evaluation, Disease Progression, Double-Blind Method, Female, Humans, Immunosuppressive Agents ,adverse effects/therapeutic use, Injections ,Intramuscular, Intention to Treat Analysis, Interferon-beta ,adverse effects/therapeutic use, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis ,drug therapy/pathology, Propylene Glycols ,adverse effects/therapeutic use, Sphingosine ,adverse effects/analogs /&/ derivatives/therapeutic use, Statistics ,Nonparametric, Young Adult ,Surgery ,Siponimod ,chemistry ,Ponesimod ,Sphingosine/adverse effects/*analogs & derivatives/therapeutic use ,pathology ,business ,030217 neurology & neurosurgery - Abstract
1533-4406 (Electronic) 0028-4793 (Linking) Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't; 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: A total of 1153 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod--0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95% CI, 0.12 to 0.21) in the 0.5-mg group--than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P
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- 2010
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