Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry.


Journal

Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161

Informations de publication

Date de publication:
Mar 2024
Historique:
received: 08 08 2023
accepted: 23 11 2023
revised: 22 11 2023
medline: 27 2 2024
pubmed: 23 12 2023
entrez: 22 12 2023
Statut: ppublish

Résumé

Active relapsing-remitting (RR) and secondary progressive (SP) multiple sclerosis (MS) are currently defined as "relapsing MS" (RMS). The aim of this cross-sectional study was to assess drivers of treatment switches due to clinical relapses in a population of RMS patients collected in the Italian MS and Related Disorders Register (I-MS&RD). RRMS and SPMS patients with at least one relapse in a time window of 2 years before of data extraction were defined as RMS. Factors associated with disease-modifying therapy (DMT) switching due to clinical activity were assessed through multivariable logistic regression models in which treatment exposure was included as the last recorded DMT and the last DMT's class [moderate-efficacy (ME), high-efficacy (HE) DMTs and anti-CD20 drugs]. A cohort of 4739 RMS patients (4161 RRMS, 578 SPMS) was extracted from the I-MS&RD. A total of 2694 patients switching DMTs due to relapses were identified. Switchers were significantly (p < 0.0001) younger, less disabled, more frequently affected by an RR disease course in comparison to non-switcher patients. The multivariable logistic regression models showed that Alemtuzumab (OR 0.08, 95% CI 0.02-0.37), Natalizumab (0.48, 0.30-0.76), Ocrelizumab (0.1, 0.02-0.45) and Rituximab (0.23, 0.06-0.82) exposure was a protective factor against treatment switch due to relapses. Moreover, the use of HE DMTs (0.43, 0.31-0.59), especially anti-CD20 drugs (0.14, 0.05-0.37), resulted to be a protective factor against treatment switch due to relapses in comparison with ME DMTs. More than 50% of RMS switched therapy due to disease activity. HE DMTs, especially anti-CD20 drugs, significantly reduce the risk of treatment switch.

Sections du résumé

BACKGROUND BACKGROUND
Active relapsing-remitting (RR) and secondary progressive (SP) multiple sclerosis (MS) are currently defined as "relapsing MS" (RMS). The aim of this cross-sectional study was to assess drivers of treatment switches due to clinical relapses in a population of RMS patients collected in the Italian MS and Related Disorders Register (I-MS&RD).
METHODS METHODS
RRMS and SPMS patients with at least one relapse in a time window of 2 years before of data extraction were defined as RMS. Factors associated with disease-modifying therapy (DMT) switching due to clinical activity were assessed through multivariable logistic regression models in which treatment exposure was included as the last recorded DMT and the last DMT's class [moderate-efficacy (ME), high-efficacy (HE) DMTs and anti-CD20 drugs].
RESULTS RESULTS
A cohort of 4739 RMS patients (4161 RRMS, 578 SPMS) was extracted from the I-MS&RD. A total of 2694 patients switching DMTs due to relapses were identified. Switchers were significantly (p < 0.0001) younger, less disabled, more frequently affected by an RR disease course in comparison to non-switcher patients. The multivariable logistic regression models showed that Alemtuzumab (OR 0.08, 95% CI 0.02-0.37), Natalizumab (0.48, 0.30-0.76), Ocrelizumab (0.1, 0.02-0.45) and Rituximab (0.23, 0.06-0.82) exposure was a protective factor against treatment switch due to relapses. Moreover, the use of HE DMTs (0.43, 0.31-0.59), especially anti-CD20 drugs (0.14, 0.05-0.37), resulted to be a protective factor against treatment switch due to relapses in comparison with ME DMTs.
CONCLUSIONS CONCLUSIONS
More than 50% of RMS switched therapy due to disease activity. HE DMTs, especially anti-CD20 drugs, significantly reduce the risk of treatment switch.

Identifiants

pubmed: 38135850
doi: 10.1007/s00415-023-12137-8
pii: 10.1007/s00415-023-12137-8
doi:

Substances chimiques

Immunologic Factors 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1150-1159

Subventions

Organisme : Novartis Pharmaceuticals Corporation
ID : This project was supported by Novartis Italy on a basis of a sponsored research agreement between Novartis
Organisme : Novartis Pharmaceuticals Corporation
ID : the University of Bari Aldo Moro.

Informations de copyright

© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

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Auteurs

Pietro Iaffaldano (P)

Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.

Giuseppe Lucisano (G)

Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.
Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.

Tommaso Guerra (T)

Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.

Francesco Patti (F)

Dipartimento di Scienze Mediche E Chirurgiche E Tecnologie Avanzate, GF Ingrassia, Università di Catania, Via Santa Sofia 78, 95123, Catania, Italy.
UOS Sclerosi Multipla, AOU Policlinico G Rodolico-San Marco, Università di Catania, Catania, Italy.

Eleonora Cocco (E)

Department of Medical Science and Public Health, University of Cagliari/Centro Sclerosi Multipla, ATS Sardegna, Cagliari, Italy.

Giovanna De Luca (G)

Centro Sclerosi MultiplaClinica Neurologica, Policlinico SS Annunziata, Università "G. d'Annunzio", Chieti-Pescara, Italy.

Vincenzo Brescia Morra (V)

Department of Neurosciences, Reproductive and Odontostomatological Sciences, Multiple Sclerosis Clinical Care and Research Center, University of Naples Federico II, Via Pansini 5, 80131, Naples, Italy.

Carlo Pozzilli (C)

Department of Human Neurosciences, Sapienza University of Roma, Rome, Italy.

Mauro Zaffaroni (M)

Neuroimmunology Unit and Multiple Sclerosis Center, ASST Della Valle Olona, Hospital of Gallarate, Via Pastori 4, 21013, Gallarate, VA, Italy.

Diana Ferraro (D)

Department of Neurosciences, Ospedale Civile di BaggiovaraAzienda Ospedaliero-Universitaria di Modena, Modena, Italy.

Claudio Gasperini (C)

Dipartimento di Neuroscienze, Ospedale San Camillo-Forlanini, Rome, Italy.

Giuseppe Salemi (G)

Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Via del Vespro 141, 90127, Palermo, Italy.

Roberto Bergamaschi (R)

IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy.

Giacomo Lus (G)

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

Matilde Inglese (M)

Dipartimento di NeuroscienzeRiabilitazioneOftalmologiaGenetica e Scienze Materno-Infantili (DINOGMI), Universita' di Genova, Genova, Italy.
IRCCS, Ospedale Policlinico San Martino, Genova, Italy.

Silvia Romano (S)

Department of Neurosciences, Mental Health and Sensory Organs (NESMOS), Sant'Andrea Hospital, Sapienza University of Rome, 00189, Rome, Italy.

Paolo Bellantonio (P)

Unit of Neurology, IRCCS Neuromed, Pozzilli, Italy.

Elisabetta Di Monte (E)

Center for Multiple Sclerosis, Hospital ASL 4 "Madonna delle Grazie", 75100, Matera, Italy.

Giorgia Teresa Maniscalco (GT)

Neurology and Stroke Unit, MS Center "A. Cardarelli Hospital", Naples, Italy.

Antonella Conte (A)

Department of Human Neurosciences, Sapienza, University of Rome, Rome, Italy.
Neurophysiopatology Unit, IRCCS Neuromed, Pozzilli, IS, Italy.

Alessandra Lugaresi (A)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Dipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.

Marika Vianello (M)

MS Unit, OU Neurology "Ca' Foncello" Hospital, Treviso, Italy.

Valentina Liliana Adriana Torri Clerici (VLA)

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

Alessia Di Sapio (A)

Department of Neurology, Regional Referral Multiple Sclerosis Center, University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy.

Ilaria Pesci (I)

Neurology Unit, Ospedale Vaio-Fidenza, Parma, Italy.

Franco Granella (F)

Unit of Neurosciences, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Rocco Totaro (R)

Centro Malattie Demielinizzanti-Clinica Neurologica, Ospedale San Salvatore, L'Aquila, Coppito, Italy.

Girolama Alessandra Marfia (GA)

Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, 00133, Rome, Italy.

Maura Chiara Danni (MC)

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.

Paola Cavalla (P)

Centro Sclerosi Multipla e Neurologia 1 D.U, Dipartimento di Neuroscienze e Salute Mentale, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.

Paola Valentino (P)

Istituto di neurologia, Università Magna Graecia Catanzaro, Catanzaro, Italy.

Umberto Aguglia (U)

Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.

Sara Montepietra (S)

MS Centre, SMN Hospital, AUSL Reggio Emilia, Reggio Emilia, Italy.

Elisabetta Ferraro (E)

Centro SM, PO San Filippo Neri, ASL Roma 1, Rome, Italy.

Alessandra Protti (A)

MS Center, Neuroscience Department, Niguarda Hospital, Milan, Italy.

Daniele Spitaleri (D)

MS Center, Neurology UNIT- Hospital San G. Moscati, Avellino, Italy.

Carlo Avolio (C)

MS Center, University of Neurology, Foggia, Italy.

Milena De Riz (M)

Centro Sclerosi Multipla-Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.

Davide Maimone (D)

Centro Sclerosi Multipla, ARNAS Garibaldi, Catania, Italy.

Guido Cavaletti (G)

IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy.

Paola Gazzola (P)

SC Neurologia, Ospedale P. Antero Micone-ASL 3 Genovese, Genoa, Italy.

Gioacchino Tedeschi (G)

I Division of Neurology, Universita della Campania "L. Vanvitelli", Naples, Italy.

Maria Sessa (M)

Centro Provinciale Sclerosi Multipla, ASST papa Giovanni XXIII, Bergamo, Italy.

Marco Rovaris (M)

MS Center, Scientific Institute Fondazione Don Carlo Gnocchi, Milan, Italy.

Franco Di Palma (F)

SM Center Neurology Department, ASST Lariana S. Anna Hospital, Como, Italy.

Maurizia Gatto (M)

Centro Malattie Demielinizzanti, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, Italy.

Daniela Cargnelutti (D)

SOC Neurologia-ASUFC, Udine, Italy.

Francesca De Robertis (F)

MS Ambulatory Neurological Clinical of Lecce, Lecce, Italy.

Francesco Ottavio Logullo (FO)

UOC Neurologia, AST Pesaro, Urbino, Italy.

Augusto Rini (A)

Centro Sclerosi Multipla, Ospedale A. Perrino, Brindisi, Italy.

Giuseppe Meucci (G)

Ambulatorio Sclerosi MultiplaUnita' Operativa di Neurologia e Neurofisiopatologia, Spedali Riuniti di Livorno, Livorno, Italy.

Bonaventura Ardito (B)

Centro Sclerosi Mutipla UOC di Neurologia, Ospedale Della Murgia Fabio Perinei, Altamura, Italy.

Paola Banfi (P)

Dipartimento di Neurologia, Ospedale di Circolo e Fondazione Macchi, Varese, Italy.

Davide Nasuelli (D)

ASST Della Valle Olona Presidio Ospedaliero di Saronno Ambulatorio Sclerosi Multipla, Saronno, Italy.

Damiano Paolicelli (D)

Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.

Maria Assunta Rocca (MA)

Neurology Unit and Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.

Emilio Portaccio (E)

Department of NEUROFARBA, University of Florence, Viale Pieraccini 6, Florence, Italy.

Clara Grazia Chisari (CG)

Dipartimento di Scienze Mediche E Chirurgiche E Tecnologie Avanzate, GF Ingrassia, Università di Catania, Via Santa Sofia 78, 95123, Catania, Italy.
UOS Sclerosi Multipla, AOU Policlinico G Rodolico-San Marco, Università di Catania, Catania, Italy.

Giuseppe Fenu (G)

Department of Medical Science and Public Health, University of Cagliari/Centro Sclerosi Multipla, ATS Sardegna, Cagliari, Italy.

Marco Onofrj (M)

Centro Sclerosi MultiplaClinica Neurologica, Policlinico SS Annunziata, Università "G. d'Annunzio", Chieti-Pescara, Italy.

Antonio Carotenuto (A)

Department of Neurosciences, Reproductive and Odontostomatological Sciences, Multiple Sclerosis Clinical Care and Research Center, University of Naples Federico II, Via Pansini 5, 80131, Naples, Italy.

Serena Ruggieri (S)

Department of Human Neurosciences, Sapienza University of Roma, Rome, Italy.

Carla Tortorella (C)

Dipartimento di Neuroscienze, Ospedale San Camillo-Forlanini, Rome, Italy.

Paolo Ragonese (P)

Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Via del Vespro 141, 90127, Palermo, Italy.

Mihaela Nica (M)

Novartis Italia, Milan, Italy.

Maria Pia Amato (MP)

Department of NEUROFARBA, University of Florence, Viale Pieraccini 6, Florence, Italy.
IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.

Massimo Filippi (M)

Neurology and Neurorehabilitation Units, Neurophysiology Service, Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.

Maria Trojano (M)

School of Medicine, University "Aldo Moro" Bari, Piazza Giulio Cesare 11, Bari, Italy. maria.trojano@uniba.it.

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