title: Natalizumab treatment in multiple sclerosis patients: a multicenter experience in clinical practice in Italy.
abstract: We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in 12 multiple sclerosis (MS) Italian centers enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity. At the end of follow-up, the cumulative proportion of patients free from relapses was 68&#x0025;; the proportion of patients free from Expanded Disability Status Scale (EDSS) progression was 93&#x0025;; the proportion of patients free from combined clinical activity was 65&#x0025;; the proportion of patients free from MRI activity was 77&#x0025;; and the proportion of patients free from any disease activity was 53&#x0025;. Natalizumab was effective in reducing clinical and neuroradiological disease activity. Its effectiveness in clinical practice is higher than that reported in pivotal trials and was maintained over time.
authors.affiliation: Department of Neurology, University of LAquila, LAquila, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Totaro
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, University G. DAnnunzio, Chieti, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Lugaresi
authors.affiliation: Department of Neurology, IRCCS NEUROMED, Pozzilli, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Bellantonio
authors.affiliation: Department of Neurology, Azienda Ospedali Riuniti, Ancona, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Danni
authors.affiliation: Department of Neurology, Ospedali Riuniti, Foggia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Costantino
authors.affiliation: Department of Neurosciences, Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gasperini
authors.affiliation: Department of Neurology, Ospedale Caldarelli, Napoli, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Florio
authors.affiliation: Department of Neurology, ASUR Marche AV3, Macerata, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Pucci
authors.affiliation: Department of Neurology, Ospedale Renzetti, Lanciano, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Maddestra
authors.affiliation: Department of Neurology, AORN San Giuseppe Moscati, Avellino, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Spitaleri
authors.affiliation: Department of Neurology, Second University of Napoli, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Lus
authors.affiliation: Department of Neurology, Ospedale Miulli, Acquaviva delle Fonti, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Ardito
authors.affiliation: Department of Neurology, Ospedale Miulli, Acquaviva delle Fonti, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Farina
authors.affiliation: Department of Neurology, University of LAquila, LAquila, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Rossi
authors.affiliation: Department of Neurology, University of LAquila, LAquila, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Di Carmine
authors.affiliation: Department of Life, Health and Environmental Sciences, University of LAquila, LAquila, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Altobelli
authors.affiliation: Department of Neurology, University of LAquila, LAquila, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Maccarone
authors.affiliation: Department of Neurology, University of LAquila, LAquila, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Casalena
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, University G. DAnnunzio, Chieti, Italy.
authors.forename: G
authors.initials: G
authors.lastname: De Luca
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, University G. DAnnunzio, Chieti, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Travaglini
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, University G. DAnnunzio, Chieti, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Di Ioia
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, University G. DAnnunzio, Chieti, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Di Tommaso
authors.affiliation: Department of Neurology, IRCCS NEUROMED, Pozzilli, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Fantozzi
authors.affiliation: Department of Neurology, IRCCS NEUROMED, Pozzilli, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Ruggieri
authors.affiliation: Department of Neurology, Azienda Ospedali Riuniti, Ancona, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Provinciali
authors.affiliation: Department of Neurology, Azienda Ospedali Riuniti, Ancona, Italy.
authors.forename: S
authors.initials: S
authors.lastname: De Riso
authors.affiliation: Department of Neurology, Ospedali Riuniti, Foggia, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Mundi
authors.affiliation: Department of Neurology, Ospedali Riuniti, Foggia, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Fuiani
authors.affiliation: Department of Neurosciences, Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Galgani
authors.affiliation: Sapienza University, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Ruggieri
authors.affiliation: Department of Neurology, Ospedale Caldarelli, Napoli, Italy.
authors.forename: G T
authors.initials: GT
authors.lastname: Maniscalco
authors.affiliation: Department of Neurology, ASUR Marche AV3, Macerata, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Giuliani
authors.affiliation: Department of Neurology, ASUR Marche AV3, Macerata, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Cartechini
authors.affiliation: Department of Neurology, AORN San Giuseppe Moscati, Avellino, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Petretta
authors.affiliation: Department of Neurology, Second University of Napoli, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Fratta
authors.affiliation: Department of Neurology, Second University of Napoli, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Alfieri
authors.affiliation: Department of Neurology, Ospedale Miulli, Acquaviva delle Fonti, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Gatto
authors.affiliation: Department of Neurology, University of LAquila, LAquila, Italy, on behalf of Natalizumab Long-Term Treatment Study group (NALTET).
authors.forename: A
authors.initials: A
authors.lastname: Carolei
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D004185:Disability Evaluation; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy*; D000069442:Natalizumab; D011358:Product Surveillance, Postmarketing; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069442:Natalizumab