Chiara Zecca1, Francesca Bovis2, Giovanni Novi3, Marco Capobianco4, Roberta Lanzillo5, Jessica Frau6, Anna Maria Repice7, Bahia Hakiki8, Sabrina Realmuto9, Simona Bonavita10, Erica Curti11, Laura Brambilla12, Giorgia Mataluni13, Paola Cavalla14, Alessia Di Sapio15, Elisabetta Signoriello16, Stefania Barone17, Giorgia T Maniscalco18, Ilaria Maietta2, Isabella Maraffi19, Giacomo Boffa3, Simona Malucchi4, Agostino Nozzolillo5, Giancarlo Coghe6, Claudia Mechi7, Giuseppe Salemi20, Antonio Gallo10, Rosaria Sacco19, Maria Cellerino3, Maria Malentacchi4, Marcello De Angelis5, Lorena Lorefice6, Eliana Magnani7, Elio Prestipino21, Francesca Sperli4, Vincenzo Brescia Morra5, Giuseppe Fenu6, Alessandro Barilaro7, Gianmarco Abbadessa10, Alessio Signori2, Franco Granella11, Maria Pia Amato22, Antonio Uccelli3, Claudio Gobbi19, Maria Pia Sormani23. 1. Neurocentre of Southern Switzerland, Department of Neurology, Ospedale Civico, Lugano, Switzerland; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland. 2. Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. 3. Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Sciences (DINOGMI), University of Genoa, Genoa, Italy/IRCCS Ospedale Policlinico San Martino, Genoa, Italy. 4. SCDO Neurologia e Centro di Riferimento Regionale Sclerosi Multipla, AOU San Luigi, Orbassano, Italy. 5. Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Sciences and Odontostomatology, University of Naples Federico II, Naples, Italy. 6. Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. 7. Regional MS Center, Careggi University Hospital, Florence, Italy. 8. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy. 9. Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Italy/AOOR Villa Sofia-Cervello, Centro di Neuroimmunologia, UOC di Neurologia e Stroke Unit, Palermo, Italy. 10. Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli," Naples, Italy. 11. Neurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy. 12. Department of Neuroimmunology and Neuromuscular Diseases, Foundation IRCCS Neurological Institute Carlo Besta, Milan, Italy. 13. Multiple Sclerosis Unit, Department of System Medicine, University of Rome Tor Vergata, Rome, Italy. 14. Multiple Sclerosis Center, Department of Neurosciences and Mental Health, City of Health and Science University Hospital of Turin, Turin, Italy. 15. Department of Neurology, Ospedale Regina Montis Regalis-ASLCN1, Mondovì, Italy. 16. Multiple Sclerosis Center, II Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy. 17. Institute of Neurology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy. 18. Neurological Clinic and Multiple Sclerosis Center, "AORN A.Cardarelli," Naples, Italy. 19. Neurocentre of Southern Switzerland, Department of Neurology, Ospedale Civico, Lugano, Switzerland. 20. Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Italy. 21. NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy. 22. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy/NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy. 23. Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy/IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
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.
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 MSpatients 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) MSpatients (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.
Authors: Hilde Marie Torgauten; Kjell-Morten Myhr; Stig Wergeland; Lars Bø; Jan H Aarseth; Øivind Torkildsen Journal: Mult Scler J Exp Transl Clin Date: 2021-01-31
Authors: Tobias Zrzavy; Esther Daniels; Niklas Stuka; Dennis Weber; Alexander Winkelmann; Helmut Rauschka; Michael Hecker; Fahmy Aboulenein-Djamshidian; Stefanie Meister; Fritz Leutmezer; Thomas Berger; Gabriel Bsteh; Uwe Klaus Zettl; Paulus Rommer Journal: Ther Adv Chronic Dis Date: 2021-07-28 Impact factor: 5.091