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Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry.
Iaffaldano, Pietro; Lucisano, Giuseppe; Guerra, Tommaso; Patti, Francesco; Cocco, Eleonora; De Luca, Giovanna; Brescia Morra, Vincenzo; Pozzilli, Carlo; Zaffaroni, Mauro; Ferraro, Diana; Gasperini, Claudio; Salemi, Giuseppe; Bergamaschi, Roberto; Lus, Giacomo; Inglese, Matilde; Romano, Silvia; Bellantonio, Paolo; Di Monte, Elisabetta; Maniscalco, Giorgia Teresa; Conte, Antonella; Lugaresi, Alessandra; Vianello, Marika; Torri Clerici, Valentina Liliana Adriana; Di Sapio, Alessia; Pesci, Ilaria; Granella, Franco; Totaro, Rocco; Marfia, Girolama Alessandra; Danni, Maura Chiara; Cavalla, Paola; Valentino, Paola; Aguglia, Umberto; Montepietra, Sara; Ferraro, Elisabetta; Protti, Alessandra; Spitaleri, Daniele; Avolio, Carlo; De Riz, Milena; Maimone, Davide; Cavaletti, Guido; Gazzola, Paola; Tedeschi, Gioacchino; Sessa, Maria; Rovaris, Marco; Di Palma, Franco; Gatto, Maurizia; Cargnelutti, Daniela; De Robertis, Francesca; Logullo, Francesco Ottavio; Rini, Augusto.
Afiliación
  • Iaffaldano P; Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.
  • Lucisano G; Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.
  • Guerra T; Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
  • Patti F; Department of Translational Biomedicine and Neurosciences-DiBraiN, University of Bari "Aldo Moro", Piazza G. Cesare 11, 70124, Bari, Italy.
  • Cocco E; Dipartimento di Scienze Mediche E Chirurgiche E Tecnologie Avanzate, GF Ingrassia, Università di Catania, Via Santa Sofia 78, 95123, Catania, Italy.
  • De Luca G; UOS Sclerosi Multipla, AOU Policlinico G Rodolico-San Marco, Università di Catania, Catania, Italy.
  • Brescia Morra V; Department of Medical Science and Public Health, University of Cagliari/Centro Sclerosi Multipla, ATS Sardegna, Cagliari, Italy.
  • Pozzilli C; Centro Sclerosi MultiplaClinica Neurologica, Policlinico SS Annunziata, Università "G. d'Annunzio", Chieti-Pescara, Italy.
  • Zaffaroni M; 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.
  • Ferraro D; Department of Human Neurosciences, Sapienza University of Roma, Rome, Italy.
  • Gasperini C; Neuroimmunology Unit and Multiple Sclerosis Center, ASST Della Valle Olona, Hospital of Gallarate, Via Pastori 4, 21013, Gallarate, VA, Italy.
  • Salemi G; Department of Neurosciences, Ospedale Civile di BaggiovaraAzienda Ospedaliero-Universitaria di Modena, Modena, Italy.
  • Bergamaschi R; Dipartimento di Neuroscienze, Ospedale San Camillo-Forlanini, Rome, Italy.
  • Lus G; Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Via del Vespro 141, 90127, Palermo, Italy.
  • Inglese M; IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy.
  • Romano S; Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Bellantonio P; Dipartimento di NeuroscienzeRiabilitazioneOftalmologiaGenetica e Scienze Materno-Infantili (DINOGMI), Universita' di Genova, Genova, Italy.
  • Di Monte E; IRCCS, Ospedale Policlinico San Martino, Genova, Italy.
  • Maniscalco GT; Department of Neurosciences, Mental Health and Sensory Organs (NESMOS), Sant'Andrea Hospital, Sapienza University of Rome, 00189, Rome, Italy.
  • Conte A; Unit of Neurology, IRCCS Neuromed, Pozzilli, Italy.
  • Lugaresi A; Center for Multiple Sclerosis, Hospital ASL 4 "Madonna delle Grazie", 75100, Matera, Italy.
  • Vianello M; Neurology and Stroke Unit, MS Center "A. Cardarelli Hospital", Naples, Italy.
  • Torri Clerici VLA; Department of Human Neurosciences, Sapienza, University of Rome, Rome, Italy.
  • Di Sapio A; Neurophysiopatology Unit, IRCCS Neuromed, Pozzilli, IS, Italy.
  • Pesci I; IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
  • Granella F; Dipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.
  • Totaro R; MS Unit, OU Neurology "Ca' Foncello" Hospital, Treviso, Italy.
  • Marfia GA; Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.
  • Danni MC; Department of Neurology, Regional Referral Multiple Sclerosis Center, University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy.
  • Cavalla P; Neurology Unit, Ospedale Vaio-Fidenza, Parma, Italy.
  • Valentino P; Unit of Neurosciences, Department of Medicine and Surgery, University of Parma, Parma, Italy.
  • Aguglia U; Centro Malattie Demielinizzanti-Clinica Neurologica, Ospedale San Salvatore, L'Aquila, Coppito, Italy.
  • Montepietra S; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, 00133, Rome, Italy.
  • Ferraro E; Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.
  • Protti A; 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.
  • Spitaleri D; Istituto di neurologia, Università Magna Graecia Catanzaro, Catanzaro, Italy.
  • Avolio C; Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.
  • De Riz M; MS Centre, SMN Hospital, AUSL Reggio Emilia, Reggio Emilia, Italy.
  • Maimone D; Centro SM, PO San Filippo Neri, ASL Roma 1, Rome, Italy.
  • Cavaletti G; MS Center, Neuroscience Department, Niguarda Hospital, Milan, Italy.
  • Gazzola P; MS Center, Neurology UNIT- Hospital San G. Moscati, Avellino, Italy.
  • Tedeschi G; MS Center, University of Neurology, Foggia, Italy.
  • Sessa M; Centro Sclerosi Multipla-Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.
  • Rovaris M; Centro Sclerosi Multipla, ARNAS Garibaldi, Catania, Italy.
  • Di Palma F; IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy.
  • Gatto M; SC Neurologia, Ospedale P. Antero Micone-ASL 3 Genovese, Genoa, Italy.
  • Cargnelutti D; I Division of Neurology, Universita della Campania "L. Vanvitelli", Naples, Italy.
  • De Robertis F; Centro Provinciale Sclerosi Multipla, ASST papa Giovanni XXIII, Bergamo, Italy.
  • Logullo FO; MS Center, Scientific Institute Fondazione Don Carlo Gnocchi, Milan, Italy.
  • Rini A; SM Center Neurology Department, ASST Lariana S. Anna Hospital, Como, Italy.
J Neurol ; 271(3): 1150-1159, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38135850
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Crónica Progresiva / Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Límite: Humans País/Región como asunto: Europa Idioma: En Revista: J Neurol Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Alemania

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Crónica Progresiva / Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Límite: Humans País/Región como asunto: Europa Idioma: En Revista: J Neurol Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Alemania