Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience

Author:

Zecca Chiara1ORCID,Bovis Francesca2,Novi Giovanni3ORCID,Capobianco Marco4,Lanzillo Roberta5,Frau Jessica6,Repice Anna Maria7,Hakiki Bahia8,Realmuto Sabrina9,Bonavita Simona10,Curti Erica11ORCID,Brambilla Laura12,Mataluni Giorgia13,Cavalla Paola14,Di Sapio Alessia15,Signoriello Elisabetta16,Barone Stefania17,Maniscalco Giorgia T18,Maietta Ilaria2,Maraffi Isabella19,Boffa Giacomo3,Malucchi Simona4,Nozzolillo Agostino5,Coghe Giancarlo6,Mechi Claudia7,Salemi Giuseppe20,Gallo Antonio10,Sacco Rosaria19,Cellerino Maria3,Malentacchi Maria4,De Angelis Marcello5,Lorefice Lorena6,Magnani Eliana7,Prestipino Elio21,Sperli Francesca4,Brescia Morra Vincenzo5,Fenu Giuseppe6,Barilaro Alessandro7,Abbadessa Gianmarco10,Signori Alessio2,Granella Franco11,Amato Maria Pia22,Uccelli Antonio3,Gobbi Claudio19,Sormani Maria Pia23ORCID

Affiliation:

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.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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