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Experience with rituximab therapy in a real-life sample of multiple sclerosis patients

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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.

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Data availability

The data that support the findings of this study are available from the corresponding author, MPA, upon reasonable request.

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Authors and Affiliations

  1. Department NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy

    Angelo Bellinvia, Elio Prestipino, Lorenzo Razzolini, Mattia Fonderico, Roberto Fratangelo, Laura Tudisco & Maria P. Amato

  2. SOC Neurologia, AUSL Toscana Centro, San Giovanni di Dio Hospital, Florence, Italy

    Emilio Portaccio

  3. SOD Neurological Rehabilitation, Careggi University Hospital, Florence, Italy

    Luisa Pastò

  4. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy

    Maria P. Amato

Authors
  1. Angelo Bellinvia
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  2. Elio Prestipino
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  3. Emilio Portaccio
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  4. Lorenzo Razzolini
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  9. Maria P. Amato
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Corresponding author

Correspondence to Maria P. Amato.

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Conflicts of interest

MP Amato received research grants and honoraria as a speaker and member of advisory boards from Bayer, Biogen, Merck, Novartis, Sanofi Genzyme, Teva, Almirall, and Roche. E Portaccio served as scientific advisory board for Biogen Idec and Merck Serono; received honoraria for speaking and funding for traveling from Biogen, Genzyme, Novartis, Merck, and Teva; and received research support from Merck Serono. L. Pastò and L. Razzolini received editorial grant from Teva, Almirall, Genzyme, and Merck. All other authors declare that they have no conflict of interest.

Ethics approval

This study was approved by the institutional review board of the University of Florence, Italy, and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Consent to participate

Informed consent was obtained from all patients.

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The authors declare that neither the article nor portions of it have been previously published elsewhere, that the manuscript is not under consideration for publication in another journal, and will not be submitted elsewhere until the Neurol Sci editorial process is completed. All authors consent for the publication of the manuscript in Neurol Sci, should the article be accepted by the Editor-in-Chief upon completion of the refereeing process.

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Bellinvia, A., Prestipino, E., Portaccio, E. et al. Experience with rituximab therapy in a real-life sample of multiple sclerosis patients. Neurol Sci 41, 2939–2945 (2020). https://doi.org/10.1007/s10072-020-04434-1

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  • DOI: https://doi.org/10.1007/s10072-020-04434-1

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