Luca Prosperini1, Matteo Lucchini2, Shalom Haggiag2, Paolo Bellantonio2, Assunta Bianco2, Maria Chiara Buscarinu2, Fabio Buttari2, Diego Centonze2, Antonio Cortese2, Laura De Giglio2, Roberta Fantozzi2, Elisabetta Ferraro2, Arianna Fornasiero2, Ada Francia2, Simonetta Galgani2, Claudio Gasperini2, Girolama Alessandra Marfia2, Enrico Millefiorini2, Viviana Nociti2, Simona Pontecorvo2, Carlo Pozzilli2, Serena Ruggieri2, Marco Salvetti2, Eleonora Sgarlata2, Massimiliano Mirabella2. 1. 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. luca.prosperini@gmail.com. 2. 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.
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.
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 sclerosisoutpatient 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.
Authors: Gabrielle Simoneau; Fabio Pellegrini; Thomas Pa Debray; Julie Rouette; Johanna Muñoz; Robert W Platt; John Petkau; Justin Bohn; Changyu Shen; Carl de Moor; Mohammad Ehsanul Karim Journal: Mult Scler Date: 2022-04-06 Impact factor: 5.855
Authors: Paulus S Rommer; Ron Milo; May H Han; Sammita Satyanarayan; Johann Sellner; Larissa Hauer; Zsolt Illes; Clemens Warnke; Sarah Laurent; Martin S Weber; Yinan Zhang; Olaf Stuve Journal: Front Immunol Date: 2019-07-11 Impact factor: 7.561
Authors: Lara Diem; Ariadne Daponte; Oliver Findling; Andrei Miclea; Myriam Briner; Anke Salmen; Ralf Gold; Constantinos Kilidireas; Andrew Chan; Maria Elftheria Evangelopoulos; Robert Hoepner Journal: Neurol Neuroimmunol Neuroinflamm Date: 2020-01-14
Authors: Amber Salter; Samantha Lancia; Gary Cutter; Ruth Ann Marrie; Jason P Mendoza; James B Lewin; Robert J Fox Mellen Journal: Ther Adv Neurol Disord Date: 2021-06-30 Impact factor: 6.570