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.
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; Meucci, Giuseppe; Ardito, Bonaventura; Banfi, Paola; Nasuelli, Davide; Paolicelli, Damiano; Rocca, Maria Assunta; Portaccio, Emilio; Chisari, Clara Grazia; Fenu, Giuseppe; Onofrj, Marco; Carotenuto, Antonio; Ruggieri, Serena; Tortorella, Carla; Ragonese, Paolo; Nica, Mihaela; Amato, Maria Pia; Filippi, Massimo; Trojano, Maria. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 271:3(2024), pp. 1150-1159. [10.1007/s00415-023-12137-8]
Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry
Rocca, Maria Assunta;Filippi, MassimoPenultimo
;
2024-01-01
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.| File | Dimensione | Formato | |
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