Experience with rituximab therapy in a real-life sample of multiple sclerosis patients
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ORIGINAL ARTICLE
Experience with rituximab therapy in a real-life sample of multiple sclerosis patients Angelo Bellinvia 1 & Elio Prestipino 1 & Emilio Portaccio 2 & Lorenzo Razzolini 1 & Mattia Fonderico 1 & Roberto Fratangelo 1 & Laura Tudisco 1 & Luisa Pastò 3 & Maria P. Amato 1,4 Received: 11 February 2020 / Accepted: 16 April 2020 # Fondazione Società Italiana di Neurologia 2020
Abstract Background Multiple sclerosis (MS) is an autoimmune, neuroinflammatory, and neurodegenerative disease of the central nervous system. B cells have recently emerged as a promising target to significantly reduce inflammatory disease activity in MS, with successful trial studies using antiCD20 therapies. However, real-life data about safety and efficacy are limited. Objectives To analyze the clinical and radiological inflammatory activity, adherence to therapy, and safety of rituximab (RTX) in an MS patients’ sample, treated from 2015 to 2018 in our center Patients and methods Retrospective study on prospectively collected data about relapses, disability progression, and radiological activity (new T2 lesions and Gd-enhancing lesions) were recorded and used to assess no evidence of disease activity (NEDA) at 12 months. RTX-related adverse events were recorded. RTX was administered intravenously at a dosage of 1000 mg twice 2 weeks apart, then every 6 months. Results Sixty-nine patients were included. Fifty-three (76.8%) had a relapsing-remitting, two a primary progressive course, and 14 a secondary progressive course. The mean follow-up period was 16 ± 9.7 months. Thirty-five (50.7%) patients had relapses in the year prior to RTX therapy, with a mean annualized relapse rate of 0.75, significantly reduced to 0.36 at 12 months (p < 0.001). Among the 36 patients included in the study who had an MRI available at 12 months, MRI activity was reduced from 88% (n = 32) to 8.3% (n = 3) at follow-up (p < 0.001). Twelve (17.4%) patients suspended RTX during the study. Conclusions Our real-life experience confirms that off-label therapy with RTX may represent a valid, cost-effective therapeutic option in MS. Keywords Multiple sclerosis . Monoclonal antibodies . AntiCD20 therapies . Rituximab . Real-life experience
Introduction Multiple sclerosis (MS) is an autoimmune, neuroinflammatory, and neurodegenerative disease of the central nervous system, most often characterized at onset by a relapsing-remitting (RR)
* Maria P. Amato [email protected] 1
Department NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy
2
SOC Neurologia, AUSL Toscana Centro, San Giovanni di Dio Hospital, Florence, Italy
3
SOD Neurological Rehabilitation, Careggi University Hospital, Florence, Italy
4
IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy
course. In the past few years, B cells have emerged as a promising target to significantly reduce inflammatory disease activity, with the first successful trials using rituximab (RTX) in RRMS [1–3]. The standard administration dosage for MS patients consists of an induction phase, with
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