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)

Italian MS Register, Damiano Paolicelli, Giuseppe Lucisano, Alessia Manni, Carlo Avolio, Simona Bonavita, Vincenzo Brescia Morra, Marco Capobianco, Eleonora Cocco, Antonella Conte, Giovanna De Luca, Francesca De Robertis, Claudio Gasperini, Maurizia Gatto, Paola Gazzola, Giacomo Lus, Antonio Iaffaldano, Pietro Iaffaldano, Davide Maimone, Giulia MallucciGiorgia T Maniscalco, Girolama A Marfia, Francesco Patti, Ilaria Pesci, Carlo Pozzilli, Marco Rovaris, Giuseppe Salemi, Marco Salvetti, Daniele Spitaleri, Rocco Totaro, Mauro Zaffaroni, Giancarlo Comi, Maria Pia Amato, Maria Trojano

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Abstract

BACKGROUND: 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.OBJECTIVE: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings.METHODS: Multicentre, observational, retrospectively acquired cohort study evaluating 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].CONCLUSION: 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.
Original languageEnglish
JournalJournal of Neurology
DOIs
Publication statusPublished - Sep 18 2019

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Multiple Sclerosis
Cohort Studies
Recurrence
Therapeutics
Propensity Score
Pharmaceutical Preparations
Interferon beta-1a

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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). / Register, Italian MS; Paolicelli, Damiano; Lucisano, Giuseppe; Manni, Alessia; Avolio, Carlo; Bonavita, Simona; Brescia Morra, Vincenzo; Capobianco, Marco; Cocco, Eleonora; Conte, Antonella; De Luca, Giovanna; De Robertis, Francesca; Gasperini, Claudio; Gatto, Maurizia; Gazzola, Paola; Lus, Giacomo; Iaffaldano, Antonio; Iaffaldano, Pietro; Maimone, Davide; Mallucci, Giulia; Maniscalco, Giorgia T; Marfia, Girolama A; Patti, Francesco; Pesci, Ilaria; Pozzilli, Carlo; Rovaris, Marco; Salemi, Giuseppe; Salvetti, Marco; Spitaleri, Daniele; Totaro, Rocco; Zaffaroni, Mauro; Comi, Giancarlo; Amato, Maria Pia; Trojano, Maria.

In: Journal of Neurology, 18.09.2019.

Research output: Contribution to journalArticle

Register, IMS, 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 2019, '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)', Journal of Neurology. https://doi.org/10.1007/s00415-019-09531-6
Register, Italian MS ; Paolicelli, Damiano ; Lucisano, Giuseppe ; Manni, Alessia ; Avolio, Carlo ; Bonavita, Simona ; Brescia Morra, Vincenzo ; Capobianco, Marco ; Cocco, Eleonora ; Conte, Antonella ; De Luca, Giovanna ; De Robertis, Francesca ; Gasperini, Claudio ; Gatto, Maurizia ; Gazzola, Paola ; Lus, Giacomo ; Iaffaldano, Antonio ; Iaffaldano, Pietro ; Maimone, Davide ; Mallucci, Giulia ; Maniscalco, Giorgia T ; Marfia, Girolama A ; Patti, Francesco ; Pesci, Ilaria ; Pozzilli, Carlo ; Rovaris, Marco ; Salemi, Giuseppe ; Salvetti, Marco ; Spitaleri, Daniele ; Totaro, Rocco ; Zaffaroni, Mauro ; Comi, Giancarlo ; Amato, Maria Pia ; Trojano, Maria. / 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). In: Journal of Neurology. 2019.
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title = "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)",
abstract = "BACKGROUND: 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.OBJECTIVE: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings.METHODS: Multicentre, observational, retrospectively acquired cohort study evaluating 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-na{\"i}ve 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].CONCLUSION: 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.",
author = "Register, {Italian MS} and Damiano Paolicelli and Giuseppe Lucisano and Alessia Manni and Carlo Avolio and Simona Bonavita and {Brescia Morra}, Vincenzo and Marco Capobianco and Eleonora Cocco and Antonella Conte and {De Luca}, Giovanna and {De Robertis}, Francesca and Claudio Gasperini and Maurizia Gatto and Paola Gazzola and Giacomo Lus and Antonio Iaffaldano and Pietro Iaffaldano and Davide Maimone and Giulia Mallucci and Maniscalco, {Giorgia T} and Marfia, {Girolama A} and Francesco Patti and Ilaria Pesci and Carlo Pozzilli and Marco Rovaris and Giuseppe Salemi and Marco Salvetti and Daniele Spitaleri and Rocco Totaro and Mauro Zaffaroni and Giancarlo Comi and Amato, {Maria Pia} and Maria Trojano",
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month = "9",
day = "18",
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language = "English",
journal = "Journal of Neurology",
issn = "0340-5354",
publisher = "Dr. Dietrich Steinkopff Verlag GmbH and Co. KG",

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TY - JOUR

T1 - 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)

AU - Register, Italian MS

AU - Paolicelli, Damiano

AU - Lucisano, Giuseppe

AU - Manni, Alessia

AU - Avolio, Carlo

AU - Bonavita, Simona

AU - Brescia Morra, Vincenzo

AU - Capobianco, Marco

AU - Cocco, Eleonora

AU - Conte, Antonella

AU - De Luca, Giovanna

AU - De Robertis, Francesca

AU - Gasperini, Claudio

AU - Gatto, Maurizia

AU - Gazzola, Paola

AU - Lus, Giacomo

AU - Iaffaldano, Antonio

AU - Iaffaldano, Pietro

AU - Maimone, Davide

AU - Mallucci, Giulia

AU - Maniscalco, Giorgia T

AU - Marfia, Girolama A

AU - Patti, Francesco

AU - Pesci, Ilaria

AU - Pozzilli, Carlo

AU - Rovaris, Marco

AU - Salemi, Giuseppe

AU - Salvetti, Marco

AU - Spitaleri, Daniele

AU - Totaro, Rocco

AU - Zaffaroni, Mauro

AU - Comi, Giancarlo

AU - Amato, Maria Pia

AU - Trojano, Maria

PY - 2019/9/18

Y1 - 2019/9/18

N2 - BACKGROUND: 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.OBJECTIVE: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings.METHODS: Multicentre, observational, retrospectively acquired cohort study evaluating 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].CONCLUSION: 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.

AB - BACKGROUND: 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.OBJECTIVE: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings.METHODS: Multicentre, observational, retrospectively acquired cohort study evaluating 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].CONCLUSION: 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.

U2 - 10.1007/s00415-019-09531-6

DO - 10.1007/s00415-019-09531-6

M3 - Article

JO - Journal of Neurology

JF - Journal of Neurology

SN - 0340-5354

ER -