Exposure to disease modifying drugs reduces disability progression in pediatric-, adult- and late-onset relapsing multiple sclerosis: real world data from the Early Multiple Sclerosis Italian Cohort (E-MUSIC)
ECTRIMS Online Library. Fonderico M. 09/13/19; 279562; 303
Mattia Fonderico
Mattia Fonderico

Abstract: 303

Type: Scientific Session

Abstract Category: Therapy - Others

M.P. Amato1,2, M. Fonderico1, L. Pastò1, L. Razzolini1, E. Prestipino1, A. Bellinvia1, G. Comi3, F. Patti4, G. De Luca5, V. Brescia Morra6, E. Cocco7, C. Pozzilli8, P. Sola9, R. Bergamaschi10, G. Salemi11, M. Inglese12,13, E. Millefiorini14, S. Galgani15, M. Zaffaroni16, A. Ghezzi16, M. Salvetti17,18, G. Lus19, C. Florio20, R. Totaro21, F. Granella22, M. Vianello23, M. Gatto24, G. Di Battista25, U. Aguglia26, F.O. Logullo27, G. Lucisano28, P. Iaffaldano29, M. Trojano29, on behalf of the Italian Multiple Sclerosis Register Centers Group

1NEUROFARBA Department, University of Florence, 2IRCCS Fondazione Don Carlo Gnocchi, Florence, 3San Raffaele Hospital - INSPE; Vita-Salute San Raffaele University, Milan, 4Dipartimento di Scienze Mediche e Chirurgiche e Tecnologie Avanzate, GF Ingrassia, Sez. Neuroscienze, Centro Sclerosi Multipla, University of Catania, Catania, 5Clinica Neurologica, Policlinico SS Annunziata, Università G. D'Annunzio, Chieti, 6Department of Neuroscience, Reproductive and Odontostomatological Sciences, Federico II University, Napoli, 7Centro Sclerosi Multipla, ASSL Cagliari (ATS Sardegna); Dipartimento di Scienze Mediche e Sanità Pubblica, University of Cagliari, Cagliari, 8Multiple Sclerosis Center, S. Andrea Hospital, Dept. of Neurology and Psychiatry, S. Andrea Hospital/Sapienza University, Rome, 9Centro Malattie Demielinizzanti - Dipartimento di Neuroscienze, Azienda Ospedaliero-Universitaria/OCSAE, UO Neurologia, University of Modena and Reggio Emilia, Modena, 10IRCCS Foundation C. Mondino National Neurological Institute, University of Pavia, Pavia, 11Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, 12DINOGMI, University of Genoa, Genoa, 13IRCCS Ospedale Policlinico, San Martino, Genoa, 14Multiple Sclerosis Center, Policlinico Umberto I, Sapienza University, 15MS Centre, Department of Neurosciences, S. Camillo - Forlanini Hospital, Rome, 16ASST della Valle Olona, Multiple Sclerosis Center, S. Antonio Abate Hospital of Gallarate, Gallarate, 17Department of Neuroscience, Mental Health and Sensory Organs, Faculty of Medicine and Psychology, Centre for Experimental Neurological Therapies, S. Andrea Hospital/Sapienza University, 18IRCCS Istituto Neurologico Mediterraneo (INM) Neuromed, Rome, 19Università della Campania Luigi Vanvitelli, Naples, 20Multiple Sclerosis Center, Cardarelli Hospital, Naples, 21Demyelinating Diseases Center, Department of Neurology, San Salvatore Hospital, L'Aquila, 22Centro Sclerosi Multipla - Azienda Ospedaliero-Universitaria di Parma, University of Parma, Parma, 23Centro Sclerosi Multipla - Ospedale Regionale 'Ca' Foncello', Neurology Unit, Treviso, 24Ospedale Generale Regionale 'F. Miulli', Neurology Unit, Acquaviva delle Fonti (BA), 25Centro Sclerosi Multipla PO, ASL Roma 1, S. Filippo Neri Hospital, Rome, 26Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Neurology Unit, Catanzaro, 27Centro Sclerosi Multipla - UOC Neurologia - Ospedale di Macerata, Macerata, 28Center for Outcomes Research and Clinical Epidemiology, Pescara, 29Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari 'Aldo Moro' Policlinico, Bari, Italy

Introduction: Natural history studies have identified factors that predict evolution to Multiple Sclerosis (MS) or risk of disability accumulation over time in patients with a first Demyelinating Event (DE) suggestive of MS. Age at onset plays an important prognostic role, not completely understood, that may modify the impact of these factors and influence the therapeutic choice.
Objectives: To evaluate how the traditional prognostic predictors vary in three subgroups of relapsing MS patients defined by age at onset: Pediatric Onset Multiple Sclerosis (POMS ≤ 18 years), Adult Onset Multiple Sclerosis (AOMS 18 - 49 years) and Late Onset Multiple Sclerosis (LOMS ≥ 50 years).
Aims: To assess, in different age subgroups, the prognostic role of symptoms at onset, clinical relapses, presence of cerebrospinal fluid (CSF) oligoclonal bands, T2-lesion load at Magnetic Resonance Imaging (MRI) and exposure time to Disease Modifying therapies (DMTs) in patients with a first DE.
Methods: Patients with ≥5 years follow-up, ≥3 Expanded Disability Status Scale (EDSS) evaluations and a first neurological evaluation within 3 years from the first DE were selected from the Italian MS Registry. The clinical outcomes assessed were the risk of a second DE and risk of Confirmed Disability Progression (CDP) at three and 12 months. The risk of reaching a CDP was assessed using Cox regression models stratified by classes of age at onset.
Results: Three cohorts of 646 POMS, 8.473 AOMS and 448 LOMS were included in the analysis. DMTs reduced the risk for CDP in all the cohorts. This appeared to be related to the cumulative exposure to DMTs in a dose-dependent manner, with a progressive risk reduction in different quartiles of exposure (HRs for CDP at 3 months in non-exposed versus exposed >62% of the time: POMS 8.1, AOMS 6.7, LOMS 7.5, p< 0.0001). Results were consistent for CDP at 12 months in POMS and AOMS. Relapses - considered as time dependent covariate - were a risk factor for three and 12 months CDP in POMS [HR=2.5, p 0.002] and AOMS [HR=1.3, p< 0.0001] but not in LOMS [HR = 0.98]. MRI and CSF data analyses are ongoing.
Conclusions: Real-world data from the Italian MS Registry suggests that prognostic predictors can vary according to the patient age at onset. However, continuous DMTs exposure reduces the risk of CDP regardless of the patient age at the first DE.
Disclosure: MPA served on scientific advisory boards for and has received speaker honoraria and research support from Biogen Idec, Merck Serono, Bayer Schering Pharma, and Sanofi Aventis, and serves on the odilorial board of BMC Neurology.
LP received research support from Novartis, Biogen and speaker´s honoraria from Teva.
LR received research support from Novartis.
MF,EP,AB have nothing to disclose.
GC has received personal compensation, outside this work, for participating in scientific advisory boards and for speaking activities from Novartis, Teva, Sanofi Genzyme, Biogen, Roche, Almirall, Celgene, Forward Pharma, MedDay and Excemed.
FP received personal compensation for advisory board and speaking activities from Almirall, Biogen, Cilgane, Merck, Novartis, Roche, Sanofi and Teva.
DLG serves on scientific advisory boards and received honoraria and travel grants from Biogen, Merck Serono, Novartis, Roche.
VBM received personal fees for public speaking on consultancy from Merck, Novartis, Biogen, Genzyme, Teva and Alrmirall.
EC received research grants and honoraria as a speaker and member of advisory boards by: Almirall, Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi Genzyme, Teva, Roche.
CP has served on scientific advisory boards for Actelion, Biogen, Genzyme, Hofmann La Roche Ltd, Merck, Novartis, Sanofi and Teva and has received consulting and/or speaking fees, research support and travel grants from Allergan, Almirall, Biogen, Genzyme, Hofmann La Roche Ltd., Novartis, Sanofi and Teva.
PS has received speaker and advisory boards honoraria and travel grants from TEVA, Merck Serono, Sanofi-Genzyme, Novartis, and Biogen.
BR received funding for congress/travel/accommodation expenses for scientific meetings and honoraria for speaking from Almirall, Bayer Schering, Biogen, Merck Serono, Novartis, Sanofi-Genzyme, Teva; he served on scientific Advisory Boards for Almirall, Biogen, Merck Serono, Novartis, Sanofi-Genzyme, Teva; he received research grants for his Department by Biogen, Merck Serono, Sanofi-Genzyme, Teva.
GS received grants and honoraria by Biogen-Dompè, Sanofi-Aventis, Novartis, Teva, Merck-Serono, Almirall, and Roche.
IM has received research grants from NIH, NMSS, FISM, Teva Neuroscience and honoraria from Genzyme, Roche and Merck.
EM has received research grants from Roche, Merck, Biogen, Sanofi, Novartis.
SG has received speaker fees or travel expenses for attending meetings from Biogen, Merck-Serono, Teva Almirall, Sanofi-Aventis, Novartis, Genzyme.
AG has served on scientific advisory boards for Merck Serono, Biogen Idec and Teva Pharmaceutical Industries Ltd; has received speaker honoraria from Merck Serono, Biogen ldec, Bayer Schering Pharma, Novartis, and Serono Symposium International; served as a consultant for Novartis; and receives research support from SanofiAventis, Biogen Idec and Merck Serono.
MZ received honoraria for consultancy and participation in advisory boards or travel grants from Genzyme, Biogen Idec, Merck Serono, Sanofi-Aventis, Teva, and Novartis.
MS has received consulting fees and/or honoraria for speaking and/or research grants from Biogen, Genzyme, Merck Serono, Novartis, Roche, and Teva.
GL received research grants and honoraria as a speaker and member of advisory boards by: Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi Genzyme, Teva, Almirall, Allergan, Merz, Ipsen, Roche.
CF received personal compensation from Merck Serono, Biogen, and TEVA for public speaking and advisory boards.
RT has served on advisory boards and/or received honoraria for speaking or consultation fees from Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme, Teva, and Roche. Principal investigator in clinical trials for Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, Teva.
FG received research grant for his institution from Biogen and Genzyme Sanofi, served on scientific advisory boards for Biogen, Novartis, Merck, Genzyme Sanofi and Roche and received funding for travel and speaker honoraria from Biogen, Merck, Genzyme Sanofi, and Roche.
VM: nothing to disclose.
GDB received speaker honoraria and travel grants from Teva, Sanofi Genzyme, Biogen Serono and Novartis.
MG: no relevant or material financial interests that relate to the research described in this abstract.
UA reports a grant from Biogen. No disclosures relevant to this Abstract.
LFO has no disclosures relevant to this Abstract.
GL has no disclosures relevant to this Abstract.
PI has served on scientific advisory boards for Biogen Idec, Bayer Teva, Roche, Merck Serono, Novartis and Genzyme and has received funding for travel and/or Speaker honoraria from Sanofi Aventis, Genzyme, Biogen Idec, Teva, Merck, Serono and Novartis.
MT reported receiving speaker honoraria and research grants to her institution from and serving on advisory boards of Biogen, Merck Serono, and Novartis.

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