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July 10, 2018; 91 (2) Article

Fingolimod vs dimethyl fumarate in multiple sclerosis

A real-world propensity score-matched study

Luca Prosperini, Matteo Lucchini, Shalom Haggiag, Paolo Bellantonio, Assunta Bianco, Maria Chiara Buscarinu, Fabio Buttari, Diego Centonze, Antonio Cortese, Laura De Giglio, Roberta Fantozzi, Elisabetta Ferraro, Arianna Fornasiero, Ada Francia, Simonetta Galgani, Claudio Gasperini, Girolama Alessandra Marfia, Enrico Millefiorini, Viviana Nociti, Simona Pontecorvo, Carlo Pozzilli, Serena Ruggieri, Marco Salvetti, Eleonora Sgarlata, Massimiliano Mirabella
First published June 6, 2018, DOI: https://doi.org/10.1212/WNL.0000000000005772
Luca Prosperini
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Matteo Lucchini
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Shalom Haggiag
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Paolo Bellantonio
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Assunta Bianco
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Maria Chiara Buscarinu
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Fabio Buttari
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Diego Centonze
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Antonio Cortese
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Laura De Giglio
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Roberta Fantozzi
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Elisabetta Ferraro
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Arianna Fornasiero
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Ada Francia
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Simonetta Galgani
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Claudio Gasperini
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Girolama Alessandra Marfia
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Enrico Millefiorini
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Viviana Nociti
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Simona Pontecorvo
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Carlo Pozzilli
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Serena Ruggieri
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Marco Salvetti
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Eleonora Sgarlata
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Massimiliano Mirabella
From the Department of Neurosciences (L.P., S.H., S.G., C.G., S.R.), S. Camillo-Forlanini Hospital; Department of Neurology and Psychiatry (A.C., L.D.G., A. Francia, E.M., S.P., C.P., S.R., E.S.), Sapienza University; Fondazione Policlinico Universitario IRCCS “A. Gemelli” (M.L., A.B., V.N., M.M.), Università Cattolica del Sacro Cuore, Rome; Unit of Neurology and of Neurorehabilitation (P.B., F.B., D.C., R.F., M.S.), IRCCS Neuromed, Pozzilli (IS); Center for Experimental Neurological Therapies (M.C.B., A. Fornasiero, M.S.), S. Andrea Hospital, Deptartment of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome; Department of Systems Medicine (F.B., D.C., G.A.M.), MS Clinical and Research Center, Tor Vergata University; Neurology Unit (E.F.), S. Filippo Neri Hospital, Rome; and Don Carlo Gnocchi Foundation Onlus (V.N.), Milan, Italy.
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Fingolimod vs dimethyl fumarate in multiple sclerosis
A real-world propensity score-matched study
Luca Prosperini, Matteo Lucchini, Shalom Haggiag, Paolo Bellantonio, Assunta Bianco, Maria Chiara Buscarinu, Fabio Buttari, Diego Centonze, Antonio Cortese, Laura De Giglio, Roberta Fantozzi, Elisabetta Ferraro, Arianna Fornasiero, Ada Francia, Simonetta Galgani, Claudio Gasperini, Girolama Alessandra Marfia, Enrico Millefiorini, Viviana Nociti, Simona Pontecorvo, Carlo Pozzilli, Serena Ruggieri, Marco Salvetti, Eleonora Sgarlata, Massimiliano Mirabella
Neurology Jul 2018, 91 (2) e153-e161; DOI: 10.1212/WNL.0000000000005772

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Abstract

Objective To directly compare fingolimod (FNG) and dimethyl fumarate (DMF) on no evident disease activity (NEDA) status in patients with relapsing-remitting multiple sclerosis (RRMS) from 7 multiple sclerosis outpatient clinics in Central Italy.

Methods We analyzed data of patients with RRMS who started an oral agent, namely DMF or FNG, either as first treatment (naives) or after switching from self-injectable drugs (switchers). We performed a propensity score (PS)–based nearest-neighbor matching within a caliper of 0.05 to select patients with homogeneous baseline characteristics. Pairwise censoring was adopted to adjust for difference in length of follow-up between the 2 treatment groups. Comparisons were then conducted in matched samples with Cox models (stratified by center) with NEDA-3 as the main outcome. NEDA-3 was defined as no relapses, no disability worsening, and no MRI activity.

Results Overall, 483 and 456 patients eligible for analysis started on FNG and DMF, respectively. The PS-matching procedure retained a total of 550 patients (275 per group). After a median on-study follow-up of 18 months, the proportions of patients with NEDA-3 were similar (FNG 73%, DMF 70%; hazard ratio [HR] 0.74, p = 0.078). Subgroup analyses showed a comparable effectiveness of the 2 drugs in naives (n = 170, HR 1.15, p = 0.689), whereas FNG was superior to DMF in the achievement of NEDA-3 status among switchers (n = 380, HR 0.57, p = 0.007).

Conclusion We found no significant difference between FNG and DMF on NEDA-3 status, while subgroup analyses suggest the superiority of FNG over DMF in patients switching from self-injectable drugs.

Classification of evidence This study provides Class IV evidence that for patients with RRMS, DMF and FNG have comparable efficacy in treatment-naive patients and that FNG is superior to DMF in patients switching from self-injectable drugs.

Glossary

CONFIRM=
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis;
DEFINE=
Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS;
DMF=
dimethyl fumarate;
EDSS=
Expanded Disability Status Scale;
FNG=
fingolimod;
FREEDOMS=
Fingolimod Research Evaluating Effects of Daily Oral Treatment in Multiple Sclerosis;
Gd=
gadolinium;
HR=
hazard ratio;
MS=
multiple sclerosis;
NEDA=
no evident disease activity;
PS=
propensity score;
RCT=
randomized clinical trial;
RRMS=
relapsing-remitting multiple sclerosis;
TRANSFORMS=
Trial Assessing Injectable Interferon Versus FTY720 Oral in Relapsing-Remitting Multiple Sclerosis

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Class of Evidence: NPub.org/coe

  • Received November 8, 2017.
  • Accepted in final form April 6, 2018.
  • © 2018 American Academy of Neurology
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