Retrospective study to evaluate the long-term impact of different treatment strategies on disability outcomes in patients with Relapsing Multiple Sclerosis. Italian IMedWeb MS Registry. RE.LO.DI.MS Study
SYNOPSIS AND RESULTS
The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies. To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS ‘real-world’ settings. The multicentre, observational, retrospectively acquired cohort study evaluate the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register.
Data start
Data end
2017-05-08
2019-12-15
PARTICIPATING CENTERS
Carlo Avolio, Dipartimento Scienze Mediche e Chirurgiche, Università degli Studi di Foggia, Foggia Simona Bonavita, Giacomo Lus, Centro SM, Università della Campania "L. Vanvitelli", Napoli Vincenzo Brescia Morra, Centro Sclerosi Multipla, Dipartimento di Neuroscienze, Scienze della Riproduzione e Odontostomatologia, Università Federico II, Napoli Marco Capobianco, Centro Regionale di riferimento per la SM, Unità Neurologica, Ospedale Universitario San Luigi, Orbassano, TO Eleonora Cocco, Dipartimento di Scienze Mediche e Salute Pubblica, Università di Cagliari, Centro SM, Cagliari Antonella Conte, Dipartimento di Neuroscienze Umane, Sapienza Università di Roma, Roma Giovanna De Luca, Università degli Studi Gabriele D'annunzio, Clinica Neurologica, Dipartimento di Neuroscienze e Imaging Università "G. D'Annunzio", Chieti, Pescara Francesca De Robertis, Ospedale Vito Fazzi, Lecce Claudio Gasperini, Dipartimento di Neuroscienze, Azienda Ospedaliera San Camillo-Forlanini, Roma Maurizia Gatto, Neurologia e Stroke Unit, Ente Ecclesiastico, Ospedale Generale Regionale Mulli, Acquaviva delle Fonti (BA) Paola Gazzola, Centro Sclerosi Multipla, ASL3 Genovese, Ospedale P.A. Micone, Genova Antonio Iaffaldano, Ospedale Antonio Perrino, Università degli studi di Bari, Bari Alessia Manni, Pietro Iaffaldano, Maria Trojano, Dipartimento di scienze mediche di base, Neuroscienze ed organi di senso, Università degli Studi di Bari, Bari Giuseppe Lucisano, Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara; Dipartimento di scienze mediche di base, Neuroscienze ed organi di senso, Università degli Studi di Bari, Bari Davide Maimone, Centro SM, Neurologia, Azienda Ospedaliera Garibaldi, Catania Giulia Mallucci Dipartimento di Neurologia, IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia Giorgia Teresa Maniscalco, Neurologia, Ospedale Cardarelli, Centro Regionale per la Sclerosi Multipla, Napoli Girolama Alessandra Marfia, Clinica Neurologica, Dipartimento di Neuroscienze, Policlinico Tor Vergata, Roma Francesco Patti, Centro SM, Azienda Ospedaliera-Universitaria, Policlinico Vittorio Emanuele, Università degli Studi di Catania, Catania Ilaria Pesci, Centro SM, UO Neurologia, Ospedale Fidenza, Fidenza Carlo Pozzilli, Centro SM, Ospedale S. Andrea, Sapienza Università di Roma, Roma Marco Rovaris, Fondazione Don Carlo Gnocchi, Milano Giuseppe Salemi, Dipartimento di Biomedicina, Neuroscienze e Diagnostica Avanzata, Università degli Studi di Palermo, Palermo Marco Salvetti, CENTERS Centro Neurologico Terapie Sperimentali, Sapienza Università di Roma, Azienda Ospedaliera S. Andrea, Roma Daniele Spitaleri, Dipartimento di Neurologia, Azienda Ospedaliera S. G. Moscati, Avellino Rocco Totaro, Centro Malattie Demielinizzanti presso la Clinica Neurologica, Ospedale San Salvatore, L’Aquila Mauro Zaffaroni, Centro SM di Gallarate, ASST della Valle Olona, Gallarate, (VA) Giancarlo Comi, Dipartimento di Neurologia, Centro SM, Istituto Scientifico San Raffaele, Milano Maria Pia Amato, Dipartimento NEUROFARBA, Divisione di Riabilitazione Neurologica, Azienda Ospedaliero-Universitaria Careggi; IRCCS Fondazione Don Carlo Gnocchi, Firenze
OUTCOME
Introduction and aims The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies. To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS ‘real-world’ settings. The multicentre, observational, retrospectively acquired cohort study evaluate the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register.
Results We evaluated 1152 RMS-naïve patients after propensity-score adjustment. Patients included were receiving: interferon beta-1a (IFN-β1a) 44 μg switching to fingolimod (FTY; IFN-switchers; n = 97); FTY only (FTY-stayers; n = 157); IFN-β1a only (IFN-stayers; n = 849). CDP and relapses did not differ between FTY-stayers and IFN-switchers [HR (95% CI) 0.99 (0.48–2.04), p = 0.98 and 0.81 (0.42–1.58), p = 0.55, respectively]. However, IFN-stayers showed increased risk of relapses compared with FTY-stayers [HR (95% CI) 1.46 (1.00–2.12), p = 0.05].
Conclusions The ideal treatment option for MS is becoming increasingly complex, with the need to balance benefit and risks. Our results suggest that starting with FTY affects the long-term disease outcome similarly to escalating from IFN-β1a to FTY.
Pubblicazioni e Comunicazioni a Congressi/ Publications and Congress Presentations Paolicelli D, Lucisano G, Manni A, Avolio C, Bonavita S, Brescia Morra V, Capobianco M, Cocco E, Conte A, De Luca G, De Robertis F, Gasperini C, Gatto M, Gazzola P, Lus G, Iaffaldano A, Iaffaldano P, Maimone D, Mallucci G, Maniscalco GT, Marfia GA, Patti F, Pesci I, Pozzilli C, Rovaris M, Salemi G, Salvetti M, Spitaleri D, Totaro R, Zaffaroni M, Comi G, Amato MP, Trojano M; Italian MS Register. Retrospectively acquired cohort study to evaluate the long-term impact of two different treatment strategies on disability outcomes in patients with relapsing multiple sclerosis (RE.LO.DI.MS): data from the Italian MS Register. J Neurol. 2019 Dec;266(12):3098-3107. doi: 10.1007/s00415-019-09531-6
PUBLICATIONS
Paolicelli D, Lucisano G, Manni A, Avolio C, Bonavita S, Brescia Morra V, Capobianco M, Cocco E, Conte A, De Luca G, De Robertis F, Gasperini C, Gatto M, Gazzola P, Lus G, Iaffaldano A, Iaffaldano P, Maimone D, Mallucci G, Maniscalco GT, Marfia GA, Patti F, Pesci I, Pozzilli C, Rovaris M, Salemi G, Salvetti M, Spitaleri D, Totaro R, Zaffaroni M, Comi G, Amato MP, Trojano M; Italian MS Register. Retrospectively acquired cohort study to evaluate the long-term impact of two different treatment strategies on disability outcomes in patients with relapsing multiple sclerosis (RE.LO.DI.MS): data from the Italian MS Register. J Neurol. 2019 Dec;266(12):3098-3107.
Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS. Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109
Retrospective study to evaluate the long-term impact of different treatment strategies on disability outcomes in patients with Relapsing Multiple Sclerosis. Italian IMedWeb MS Registry. RE.LO.DI.MS Study
The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies.
To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS ‘real-world’ settings.
The multicentre, observational, retrospectively acquired cohort study evaluate the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register.
Carlo Avolio, Dipartimento Scienze Mediche e Chirurgiche, Università degli Studi di Foggia, Foggia
Simona Bonavita, Giacomo Lus, Centro SM, Università della Campania "L. Vanvitelli", Napoli
Vincenzo Brescia Morra, Centro Sclerosi Multipla, Dipartimento di Neuroscienze, Scienze della Riproduzione e Odontostomatologia, Università Federico II, Napoli
Marco Capobianco, Centro Regionale di riferimento per la SM, Unità Neurologica, Ospedale Universitario San Luigi, Orbassano, TO
Eleonora Cocco, Dipartimento di Scienze Mediche e Salute Pubblica, Università di Cagliari, Centro SM, Cagliari
Antonella Conte, Dipartimento di Neuroscienze Umane, Sapienza Università di Roma, Roma
Giovanna De Luca, Università degli Studi Gabriele D'annunzio, Clinica Neurologica, Dipartimento di Neuroscienze e Imaging Università "G. D'Annunzio", Chieti, Pescara
Francesca De Robertis, Ospedale Vito Fazzi, Lecce
Claudio Gasperini, Dipartimento di Neuroscienze, Azienda Ospedaliera San Camillo-Forlanini, Roma
Maurizia Gatto, Neurologia e Stroke Unit, Ente Ecclesiastico, Ospedale Generale Regionale Mulli, Acquaviva delle Fonti (BA)
Paola Gazzola, Centro Sclerosi Multipla, ASL3 Genovese, Ospedale P.A. Micone, Genova
Antonio Iaffaldano, Ospedale Antonio Perrino, Università degli studi di Bari, Bari
Alessia Manni, Pietro Iaffaldano, Maria Trojano, Dipartimento di scienze mediche di base, Neuroscienze ed organi di senso, Università degli Studi di Bari, Bari
Giuseppe Lucisano, Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara; Dipartimento di scienze mediche di base, Neuroscienze ed organi di senso, Università degli Studi di Bari, Bari
Davide Maimone, Centro SM, Neurologia, Azienda Ospedaliera Garibaldi, Catania
Giulia Mallucci Dipartimento di Neurologia, IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia
Giorgia Teresa Maniscalco, Neurologia, Ospedale Cardarelli, Centro Regionale per la Sclerosi Multipla, Napoli
Girolama Alessandra Marfia, Clinica Neurologica, Dipartimento di Neuroscienze, Policlinico Tor Vergata, Roma
Francesco Patti, Centro SM, Azienda Ospedaliera-Universitaria, Policlinico Vittorio Emanuele, Università degli Studi di Catania, Catania
Ilaria Pesci, Centro SM, UO Neurologia, Ospedale Fidenza, Fidenza
Carlo Pozzilli, Centro SM, Ospedale S. Andrea, Sapienza Università di Roma, Roma
Marco Rovaris, Fondazione Don Carlo Gnocchi, Milano
Giuseppe Salemi, Dipartimento di Biomedicina, Neuroscienze e Diagnostica Avanzata, Università degli Studi di Palermo, Palermo
Marco Salvetti, CENTERS Centro Neurologico Terapie Sperimentali, Sapienza Università di Roma, Azienda Ospedaliera S. Andrea, Roma
Daniele Spitaleri, Dipartimento di Neurologia, Azienda Ospedaliera S. G. Moscati, Avellino
Rocco Totaro, Centro Malattie Demielinizzanti presso la Clinica Neurologica, Ospedale San Salvatore, L’Aquila
Mauro Zaffaroni, Centro SM di Gallarate, ASST della Valle Olona, Gallarate, (VA)
Giancarlo Comi, Dipartimento di Neurologia, Centro SM, Istituto Scientifico San Raffaele, Milano
Maria Pia Amato, Dipartimento NEUROFARBA, Divisione di Riabilitazione Neurologica, Azienda Ospedaliero-Universitaria Careggi; IRCCS Fondazione Don Carlo Gnocchi, Firenze
Introduction and aims
The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies.
To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS ‘real-world’ settings.
The multicentre, observational, retrospectively acquired cohort study evaluate the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register.
Results
We evaluated 1152 RMS-naïve patients after propensity-score adjustment. Patients included were receiving: interferon beta-1a (IFN-β1a) 44 μg switching to fingolimod (FTY; IFN-switchers; n = 97); FTY only (FTY-stayers; n = 157); IFN-β1a only (IFN-stayers; n = 849). CDP and relapses did not differ between FTY-stayers and IFN-switchers [HR (95% CI) 0.99 (0.48–2.04), p = 0.98 and 0.81 (0.42–1.58), p = 0.55, respectively]. However, IFN-stayers showed increased risk of relapses compared with FTY-stayers [HR (95% CI) 1.46 (1.00–2.12), p = 0.05].
Conclusions
The ideal treatment option for MS is becoming increasingly complex, with the need to balance benefit and risks. Our results suggest that starting with FTY affects the long-term disease outcome similarly to escalating from IFN-β1a to FTY.
Pubblicazioni e Comunicazioni a Congressi/ Publications and Congress Presentations
Paolicelli D, Lucisano G, Manni A, Avolio C, Bonavita S, Brescia Morra V, Capobianco M, Cocco E, Conte A, De Luca G, De Robertis F, Gasperini C, Gatto M, Gazzola P, Lus G, Iaffaldano A, Iaffaldano P, Maimone D, Mallucci G, Maniscalco GT, Marfia GA, Patti F, Pesci I, Pozzilli C, Rovaris M, Salemi G, Salvetti M, Spitaleri D, Totaro R, Zaffaroni M, Comi G, Amato MP, Trojano M; Italian MS Register. Retrospectively acquired cohort study to evaluate the long-term impact of two different treatment strategies on disability outcomes in patients with relapsing multiple sclerosis (RE.LO.DI.MS): data from the Italian MS Register. J Neurol. 2019 Dec;266(12):3098-3107. doi: 10.1007/s00415-019-09531-6
Paolicelli D, Lucisano G, Manni A, Avolio C, Bonavita S, Brescia Morra V, Capobianco M, Cocco E, Conte A, De Luca G, De Robertis F, Gasperini C, Gatto M, Gazzola P, Lus G, Iaffaldano A, Iaffaldano P, Maimone D, Mallucci G, Maniscalco GT, Marfia GA, Patti F, Pesci I, Pozzilli C, Rovaris M, Salemi G, Salvetti M, Spitaleri D, Totaro R, Zaffaroni M, Comi G, Amato MP, Trojano M; Italian MS Register. Retrospectively acquired cohort study to evaluate the long-term impact of two different treatment strategies on disability outcomes in patients with relapsing multiple sclerosis (RE.LO.DI.MS): data from the Italian MS Register. J Neurol. 2019 Dec;266(12):3098-3107.
https://doi.org/10.1007/s00415-019-09531-6
https://pubmed.ncbi.nlm.nih.gov/31535270/