TY - JOUR
T1 - Treatment of multiple sclerosis with rituximab
T2 - A multicentric Italian–Swiss experience
AU - Zecca, Chiara
AU - Bovis, Francesca
AU - Novi, Giovanni
AU - Capobianco, Marco
AU - Lanzillo, Roberta
AU - Frau, Jessica
AU - Repice, Anna Maria
AU - Hakiki, Bahia
AU - Realmuto, Sabrina
AU - Bonavita, Simona
AU - Curti, Erica
AU - Brambilla, Laura
AU - Mataluni, Giorgia
AU - Cavalla, Paola
AU - Di Sapio, Alessia
AU - Signoriello, Elisabetta
AU - Barone, Stefania
AU - Maniscalco, Giorgia T.
AU - Maietta, Ilaria
AU - Maraffi, Isabella
AU - Boffa, Giacomo
AU - Malucchi, Simona
AU - Nozzolillo, Agostino
AU - Coghe, Giancarlo
AU - Mechi, Claudia
AU - Salemi, Giuseppe
AU - Gallo, Antonio
AU - Sacco, Rosaria
AU - Cellerino, Maria
AU - Malentacchi, Maria
AU - De Angelis, Marcello
AU - Lorefice, Lorena
AU - Magnani, Eliana
AU - Prestipino, Elio
AU - Sperli, Francesca
AU - Brescia Morra, Vincenzo
AU - Fenu, Giuseppe
AU - Barilaro, Alessandro
AU - Abbadessa, Gianmarco
AU - Signori, Alessio
AU - Granella, Franco
AU - Amato, Maria Pia
AU - Uccelli, Antonio
AU - Gobbi, Claudio
AU - Sormani, Maria Pia
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - multiple sclerosis
KW - primary progressive
KW - real life
KW - relapsing–remitting
KW - Rituximab
KW - secondary progressive
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U2 - 10.1177/1352458519872889
DO - 10.1177/1352458519872889
M3 - Article
AN - SCOPUS:85074037726
JO - Multiple Sclerosis
JF - Multiple Sclerosis
SN - 1352-4585
ER -