Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.

Autor:	Iaffaldano P; 1 Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari 'Aldo Moro', Piazza G. Cesare 11, 70124, Bari, Italy., Lucisano G; 1 Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari 'Aldo Moro', Piazza G. Cesare 11, 70124, Bari, Italy 2 Department of Clinical Pharmacology and Epidemiology, Mario Negri Sud Foundation, Via Nazionale per Lanciano 8, 66030, Santa Maria Imbaro (CH), Italy., Pozzilli C; 3 Multiple Sclerosis Center, S.Andrea Hospital, Dept. of Neurology and Psychiatry, La Sapienza University, Via di Grottarossa, 1035, 00189, Rome, Italy., Brescia Morra V; 4 Department of Neurosciences, Reproductive and Odontostomatological Sciences, University 'Federico II', Via Pansini 5, 80131 Napoli, Italy., Ghezzi A; 5 Multiple Sclerosis Center, S.Antonio Abate Hospital, Via Pastori 4, 21013 Gallarate (VA), Italy., Millefiorini E; 6 Multiple Sclerosis Center, Policlinico Umberto I, La Sapienza University, Viale dell'Università 30, 00185, Rome, Italy., Patti F; 7 Dipartimento di Scienze Mediche e Chirurgiche e Tecnologie Avanzate, GF Ingrassia, Sez. Neuroscienze, Centro Sclerosi Multipla, Università di Catania, Via Santa Sofia 78, 95123 Catania, Italy., Lugaresi A; 8 Department of Neuroscience, Imaging and Clinical Sciences, Multiple Sclerosis Center, 'SS. Annunziata' Hospital, University 'G. D'Annunzio', Via dei Vestini snc, 66100, Chieti, Italy., Zimatore GB; 9 Operative Unit of Neurology, 'Dimiccoli' General Hospital, Viale Ippocrate 15, 76121, Barletta, Italy., Marrosu MG; 10 Multiple Sclerosis Center, University of Cagliari, Via Is Guadazzonis 2, 09126, Cagliari, Italy., Amato MP; 11 Department of NEUROFARBA, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy., Bertolotto A; 12 Neurologia 2, CRESM (Centro Riferimento Regionale Sclerosi Multipla), AOU S. Luigi, Regione Gonzole 10, 10043 Orbassano (TO), Italy., Bergamaschi R; 13 Inter-department Multiple Sclerosis Research Centre, C. Mondino National Institute of Neurology Foundation, Via Mondino 2, 27100, Pavia, Italy., Granella F; 14 Department of Neurosciences, University of Parma, Via Volturno 39, 43125, Parma, Italy., Coniglio G; 15 Neurology Unit, 'Madonna delle Grazie' Hospital, Contrada Cattedra Ambulante snc, 75100, Matera, Italy., Tedeschi G; 16 Division of Neurology, Second University of Naples, Via Costantinopoli 104, 80138, Naples, Italy., Sola P; 17 Department of Neurosciences, Neurology Unit, University of Modena and Reggio Emilia, Nuovo Ospedale Civile S. Agostino/Estense, Via Giardini 1355, 41126, Modena, Italy., Lus G; 18 Multiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine, Second University of Naples, Via Luciano Armanni 5, 80138, Napoli, Italy., Ferrò MT; 19 Neurological Department, 'Maggiore' Hospital, Largo Dossena 2, 26013, Crema, Italy., Iuliano G; 20 Department of Neurosciences, 'S.Giovanni di Dio' Hospital, Largo Città di Ippocrate, 84131, Salerno, Italy., Corea F; 21 Neurology Unit, 'S.Giovanni Battista' Hospital, Via Arcamone, 06124, Foligno, Italy., Protti A; 22 Multiple Sclerosis Center, Neurological Department, 'Niguarda Ca' Granda' Hospital, Piazza Ospedale Maggiore 3, 20162, Milan, Italy., Cavalla P; 23 Multiple Sclerosis Center, Department of Neuroscience, University of Turin & City of Health and Science University Hospital of Turin, Via Verdi 8, 10124, Turin, Italy., Guareschi A; 24 Multiple Sclerosis Center, Medicine Department, Fidenza Hospital, Via Don Enrico Tincati 5, 43125 Fidenza, Italy., Rodegher M; 25 Department of Neurology, Vita-Salute San Raffaele University, San Raffaele Scientific Institute, Via Olgettina, 48 20132, Milan, Italy., Paolicelli D; 1 Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari 'Aldo Moro', Piazza G. Cesare 11, 70124, Bari, Italy., Tortorella C; 1 Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari 'Aldo Moro', Piazza G. Cesare 11, 70124, Bari, Italy., Lepore V; 2 Department of Clinical Pharmacology and Epidemiology, Mario Negri Sud Foundation, Via Nazionale per Lanciano 8, 66030, Santa Maria Imbaro (CH), Italy., Prosperini L; 3 Multiple Sclerosis Center, S.Andrea Hospital, Dept. of Neurology and Psychiatry, La Sapienza University, Via di Grottarossa, 1035, 00189, Rome, Italy., Saccà F; 4 Department of Neurosciences, Reproductive and Odontostomatological Sciences, University 'Federico II', Via Pansini 5, 80131 Napoli, Italy., Baroncini D; 5 Multiple Sclerosis Center, S.Antonio Abate Hospital, Via Pastori 4, 21013 Gallarate (VA), Italy., Comi G; 25 Department of Neurology, Vita-Salute San Raffaele University, San Raffaele Scientific Institute, Via Olgettina, 48 20132, Milan, Italy., Trojano M
Jazyk:	angličtina
Zdroj:	Brain : a journal of neurology [Brain] 2015 Nov; Vol. 138 (Pt 11), pp. 3275-86. Date of Electronic Publication: 2015 Sep 11.
DOI:	10.1093/brain/awv260
Abstrakt:	The comparative effectiveness of fingolimod versus interferon beta/glatiramer acetate was assessed in a multicentre, observational, prospectively acquired cohort study including 613 patients with relapsing multiple sclerosis discontinuing natalizumab in the Italian iMedWeb registry. First, after natalizumab suspension, the relapse risk during the untreated wash-out period and during the course of switch therapies was estimated through Poisson regression analyses in separated models. During the wash-out period an increased risk of relapses was found in patients with a higher number of relapses before natalizumab treatment (incidence rate ratio = 1.31, P = 0.0014) and in patients discontinuing natalizumab due to lack of efficacy (incidence rate ratio = 2.33, P = 0.0288), patient's choice (incidence rate ratio = 2.18, P = 0.0064) and adverse events (incidence rate ratio = 2.09, P = 0.0084). The strongest independent factors influencing the relapse risk after the start of switch therapies were a wash-out duration longer than 3 months (incidence rate ratio = 1.78, P < 0.0001), the number of relapses experienced during and before natalizumab treatment (incidence rate ratio = 1.61, P < 0.0001; incidence rate ratio = 1.13, P = 0.0118, respectively) and the presence of comorbidities (incidence rate ratio = 1.4, P = 0.0097). Switching to fingolimod was associated with a 64% reduction of the adjusted-risk for relapse in comparison with switching to interferon beta/glatiramer acetate (incidence rate ratio = 0.36, P < 0.0001). Secondly, patients who switched to fingolimod or to interferon beta/glatiramer acetate were propensity score-matched on a 1-to-1 basis at the switching date. In the propensity score-matched sample a Poisson model showed a significant lower incidence of relapses in patients treated with fingolimod in comparison with those treated with interferon beta/glatiramer acetate (incidence rate ratio = 0.52, P = 0.0003) during a 12-month follow-up. The cumulative probability of a first relapse after the treatment switch was significantly lower in patients receiving fingolimod than in those receiving interferon beta/glatiramer acetate (P = 0.028). The robustness of this result was also confirmed by sensitivity analyses in subgroups with different wash-out durations (less or more than 3 months). Time to 3-month confirmed disability progression was not significantly different between the two groups (Hazard ratio = 0.58; P = 0.1931). Our results indicate a superiority of fingolimod in comparison to interferon beta/glatiramer acetate in controlling disease reactivation after natalizumab discontinuation in the real life setting. (© The Author (2015). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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