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

Maria Sessa, Giuseppe Meucci, Augusto Rini, Francesco Ottavio Logullo, Francesca De Robertis, Daniela Cargnelutti, Maurizia Gatto, Franco Di Palma, Marco Rovaris, Bonaventura Ardito, Gioacchino Tedeschi, Paola Gazzola, Guido Cavaletti, Davide Maimone, Milena De Riz, Carlo Avolio, Daniele Spitaleri, Marco Onofrj, Maria Trojano, Massimo Filippi, Maria Pia Amato, Mihaela Nica, Paolo Ragonese, Carla Tortorella, Serena Ruggieri, Antonio Carotenuto, Alessandra Protti, Giuseppe Fenu, Clara Grazia Chisari, Emilio Portaccio, Maria Assunta Rocca, Damiano Paolicelli, Davide Nasuelli, Paola Banfi, Mauro Zaffaroni, Paolo Bellantonio, Silvia Romano, Matilde Inglese, Giacomo Lus, Roberto Bergamaschi, Giuseppe Salemi, Claudio Gasperini, Diana Ferraro, Elisabetta Di Monte, Carlo Pozzilli, Vincenzo Brescia Morra, Giovanna De Luca, Eleonora Cocco, Francesco Patti, Tommaso Guerra, Giuseppe Lucisano, Franco Granella, Elisabetta Ferraro, Sara Montepietra, Umberto Aguglia, Paola Valentino, Paola Cavalla, Maura Chiara Danni, Girolama Alessandra Marfia, Rocco Totaro, Pietro Iaffaldano, Ilaria Pesci, Alessia Di Sapio, Valentina Liliana Adriana Torri Clerici, Marika Vianello, Alessandra Lugaresi, Antonella Conte, Giorgia Teresa Maniscalco

Journal: Journal of neurology 2024;271(3):1150-1159

PMID: 38135850

Full Text on Springer View on PubMed

Abstract

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

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

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

More than 50% of RMS switched therapy due to disease activity. HE DMTs, especially anti-CD20 drugs, significantly reduce the risk of treatment switch.

Address: 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.; 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.; Department of Medical Science and Public Health, University of Cagliari/Centro Sclerosi Multipla, ATS Sardegna, Cagliari, Italy.; Centro Sclerosi MultiplaClinica Neurologica, Policlinico SS Annunziata, Università "G. d'Annunzio", Chieti-Pescara, Italy.; 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.; Department of Human Neurosciences, Sapienza University of Roma, Rome, Italy.; Neuroimmunology Unit and Multiple Sclerosis Center, ASST Della Valle Olona, Hospital of Gallarate, Via Pastori 4, 21013, Gallarate, VA, Italy.; Department of Neurosciences, Ospedale Civile di BaggiovaraAzienda Ospedaliero-Universitaria di Modena, Modena, Italy.; Dipartimento di Neuroscienze, Ospedale San Camillo-Forlanini, Rome, Italy.; Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Via del Vespro 141, 90127, Palermo, Italy.; IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy.; Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.; Dipartimento di NeuroscienzeRiabilitazioneOftalmologiaGenetica e Scienze Materno-Infantili (DINOGMI), Universita' di Genova, Genova, Italy.; IRCCS, Ospedale Policlinico San Martino, Genova, Italy.; Department of Neurosciences, Mental Health and Sensory Organs (NESMOS), Sant'Andrea Hospital, Sapienza University of Rome, 00189, Rome, Italy.; Unit of Neurology, IRCCS Neuromed, Pozzilli, Italy.; Center for Multiple Sclerosis, Hospital ASL 4 "Madonna delle Grazie", 75100, Matera, Italy.; Neurology and Stroke Unit, MS Center "A. Cardarelli Hospital", Naples, Italy.; Department of Human Neurosciences, Sapienza, University of Rome, Rome, Italy.; Neurophysiopatology Unit, IRCCS Neuromed, Pozzilli, IS, Italy.; IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.; Dipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.; MS Unit, OU Neurology "Ca' Foncello" Hospital, Treviso, Italy.; Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.; Department of Neurology, Regional Referral Multiple Sclerosis Center, University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy.; Neurology Unit, Ospedale Vaio-Fidenza, Parma, Italy.; Unit of Neurosciences, Department of Medicine and Surgery, University of Parma, Parma, Italy.; Centro Malattie Demielinizzanti-Clinica Neurologica, Ospedale San Salvatore, L'Aquila, Coppito, Italy.; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, 00133, Rome, Italy.; Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.; 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.; Istituto di neurologia, Università Magna Graecia Catanzaro, Catanzaro, Italy.; Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.; MS Centre, SMN Hospital, AUSL Reggio Emilia, Reggio Emilia, Italy.; Centro SM, PO San Filippo Neri, ASL Roma 1, Rome, Italy.; MS Center, Neuroscience Department, Niguarda Hospital, Milan, Italy.; MS Center, Neurology UNIT- Hospital San G. Moscati, Avellino, Italy.; MS Center, University of Neurology, Foggia, Italy.; Centro Sclerosi Multipla-Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.; Centro Sclerosi Multipla, ARNAS Garibaldi, Catania, Italy.; IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy.; SC Neurologia, Ospedale P. Antero Micone-ASL 3 Genovese, Genoa, Italy.; I Division of Neurology, Universita della Campania "L. Vanvitelli", Naples, Italy.; Centro Provinciale Sclerosi Multipla, ASST papa Giovanni XXIII, Bergamo, Italy.; MS Center, Scientific Institute Fondazione Don Carlo Gnocchi, Milan, Italy.; SM Center Neurology Department, ASST Lariana S. Anna Hospital, Como, Italy.; Centro Malattie Demielinizzanti, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, Italy.; SOC Neurologia-ASUFC, Udine, Italy.; MS Ambulatory Neurological Clinical of Lecce, Lecce, Italy.; UOC Neurologia, AST Pesaro, Urbino, Italy.; Centro Sclerosi Multipla, Ospedale A. Perrino, Brindisi, Italy.; Ambulatorio Sclerosi MultiplaUnita' Operativa di Neurologia e Neurofisiopatologia, Spedali Riuniti di Livorno, Livorno, Italy.; Centro Sclerosi Mutipla UOC di Neurologia, Ospedale Della Murgia Fabio Perinei, Altamura, Italy.; Dipartimento di Neurologia, Ospedale di Circolo e Fondazione Macchi, Varese, Italy.; ASST Della Valle Olona Presidio Ospedaliero di Saronno Ambulatorio Sclerosi Multipla, Saronno, Italy.; Neurology Unit and Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.; Department of NEUROFARBA, University of Florence, Viale Pieraccini 6, Florence, Italy.; Novartis Italia, Milan, Italy.; IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.; 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.; School of Medicine, University "Aldo Moro" Bari, Piazza Giulio Cesare 11, Bari, Italy. [email protected].

DOI: 10.1007/s00415-023-12137-8

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https://dx.doi.org/10.1007/s00415-023-12137-8

MeSH Terms: Humans, Multiple Sclerosis, Immunologic Factors, Multiple Sclerosis, Relapsing-Remitting, Cross-Sectional Studies, Multiple Sclerosis, Chronic Progressive, Recurrence, Italy