Background: Rituximab, an anti-CD20 monoclonal antibody leading to B lymphocyte depletion, is increasingly used as an off-label treatment option for multiple sclerosis (MS). Objective: To investigate the effectiveness and safety of rituximab in relapsing–remitting (RR) and progressive MS. Methods: This is a multicenter, retrospective study on consecutive MS patients treated off-label with rituximab in 22 Italian and 1 Swiss MS centers. Relapse rate, time to first relapse, Expanded Disability Status Scale (EDSS) progression, incidence of adverse events, and radiological outcomes from 2009 to 2019 were analyzed. Results: A total of 355/451 enrolled subjects had at least one follow-up visit and were included in the outcome analysis. Annualized relapse rate significantly decreases after rituximab initiation versus the pre-rituximab start year in RRMS (from 0.86 to 0.09, p <.0001) and in secondary-progressive (SP) MS (from 0.34 to 0.06, p <.0001) and had a slight decrease in primary-progressive (PP) MS patients (from 0.12 to 0.07, p = 0.45). After 3 years from rituximab start, the proportion of patients with a confirmed EDSS progression was 14.6% in the RRMS group, 24.7% in the SPMS group, and 41.5% in the PPMS group. No major safety concerns arose. Conclusion: Consistently with other observational studies, our data show effectiveness of rituximab in reducing disease activity in patients with MS.
Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience / Zecca, C.; Bovis, F.; Novi, G.; Capobianco, M.; Lanzillo, R.; Frau, J.; Repice, A. M.; Hakiki, B.; Realmuto, S.; Bonavita, S.; Curti, E.; Brambilla, L.; Mataluni, G.; Cavalla, P.; Di Sapio, A.; Signoriello, E.; Barone, S.; Maniscalco, G. T.; Maietta, I.; Maraffi, I.; Boffa, G.; Malucchi, S.; Nozzolillo, A.; Coghe, G.; Mechi, C.; Salemi, G.; Gallo, A.; Sacco, R.; Cellerino, M.; Malentacchi, M.; De Angelis, M.; Lorefice, L.; Magnani, E.; Prestipino, E.; Sperli, F.; Brescia Morra, V.; Fenu, G.; Barilaro, A.; Abbadessa, G.; Signori, A.; Granella, F.; Amato, M. P.; Uccelli, A.; Gobbi, C.; Sormani, M. P.. - In: MULTIPLE SCLEROSIS. - ISSN 1352-4585. - 26:12(2020), pp. 1519-1531. [10.1177/1352458519872889]
Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience
Lanzillo R.;Nozzolillo A.;De Angelis M.;Brescia Morra V.;Barilaro A.;Amato M. P.;
2020
Abstract
Background: Rituximab, an anti-CD20 monoclonal antibody leading to B lymphocyte depletion, is increasingly used as an off-label treatment option for multiple sclerosis (MS). Objective: To investigate the effectiveness and safety of rituximab in relapsing–remitting (RR) and progressive MS. Methods: This is a multicenter, retrospective study on consecutive MS patients treated off-label with rituximab in 22 Italian and 1 Swiss MS centers. Relapse rate, time to first relapse, Expanded Disability Status Scale (EDSS) progression, incidence of adverse events, and radiological outcomes from 2009 to 2019 were analyzed. Results: A total of 355/451 enrolled subjects had at least one follow-up visit and were included in the outcome analysis. Annualized relapse rate significantly decreases after rituximab initiation versus the pre-rituximab start year in RRMS (from 0.86 to 0.09, p <.0001) and in secondary-progressive (SP) MS (from 0.34 to 0.06, p <.0001) and had a slight decrease in primary-progressive (PP) MS patients (from 0.12 to 0.07, p = 0.45). After 3 years from rituximab start, the proportion of patients with a confirmed EDSS progression was 14.6% in the RRMS group, 24.7% in the SPMS group, and 41.5% in the PPMS group. No major safety concerns arose. Conclusion: Consistently with other observational studies, our data show effectiveness of rituximab in reducing disease activity in patients with MS.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
