Potential use of the SARS-CoV-2 monoclonal antibody sipavibart in people with multiple sclerosis: definition of different patient archetypes from an Italian expert group perspective

  • J Neurol. 2025 Jun 6;272(7):446. doi: 10.1007/s00415-025-13188-9.
Chiara Zanetta  1  2 Claudio Gasperini  3 Maria Pia Amato  4  5 Diego Centonze  6  7 Paolo Gallo  8 Francesco Patti  9  10 Agostino Riva  11 Massimo Filippi  12  13  14  15  16  17
Affiliations
  • 1. Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • 2. Multiple Sclerosis Center, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • 3. Department of Neuroscience, San Camillo Forlanini Hospital, Rome, Italy.
  • 4. Department NEUROFARBA, University of Florence, Florence, Italy.
  • 5. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
  • 6. Dipartimento di Medicina dei Sistemi, Università Tor Vergata, Rome, Italy.
  • 7. Neurology Unit, IRCCS Neuromed, Pozzilli, IS, Italy.
  • 8. Neurorehabilitation Centre, City of Rovigo Clinic, Veneto Region, Italy.
  • 9. Multiple Sclerosis Unit, University-Hospital G. Rodolico - San Marco, Catania, Italy.
  • 10. Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, Catania, Italy.
  • 11. Department of Infectious Diseases, Luigi Sacco Hospital, Milan and Department of Biomedical and Clinical Sciences (DIBIC), University of Milan, Milan, Italy.
  • 12. Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. [email protected].
  • 13. Multiple Sclerosis Center, IRCCS San Raffaele Scientific Institute, Milan, Italy. [email protected].
  • 14. Vita-Salute San Raffaele University, Milan, Italy. [email protected].
  • 15. Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy. [email protected].
  • 16. Neurorehabilitation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. [email protected].
  • 17. Neurophysiology Service, IRCCS San Raffaele Scientific Institute, Milan, Italy. [email protected].
Abstract

Introduction: Immunocompromised people, including people with MS (PwMS) remain at increased risk of severe COVID-19 outcomes, highlighting how this population needs additional preventive measures beyond current vaccination. Seven neurologists with experience in the MS field and one infectivologist discussed the use of COVID-19 pre-exposure prophylaxis (PrEP) in PwMS, identifying patients' archetypes for PrEP with the monoclonal antibody sipavibart.

Methods: The following topics were discussed: description of the current SARS-CoV-2 Infection scenario; identification of the characteristics of the fragile patient; identification of the ideal candidate for PrEP with sipavibart. The recommendations were then produced accordingly.

Results: Vaccination remains a crucial preventive measure for COVID-19. Age, male sex, and comorbidities are associated with severe outcomes among patients with MS. MS-specific risk factors include higher disability, a progressive disease course, a recent administration of Steroids and the treatment with anti-CD20 agents, S1P receptor modulators, cladribine, and anti-CD52 antibodies. Pediatric patients and subjects with neuromyelitis optica spectrum disorder should also be considered fragile subjects. Subjects who could benefit from PrEP include: PwMS who present risk factors similar to the general population or who present disease-specific risk factors, non-vaccinated PwMS, and PwMS under S1P receptor modulators, anti-CD20 agents, alemtuzumab or cladribine and who present at least one risk factor similar to the general population or one disease-specific risk factor.

Discussion: Subjects with general or disease specific risk factors for severe infections, patients treated with S1P receptor modulators, anti-CD20 agents, alemtuzumab or cladribine, pediatric patients, and pregnant women with MS could represent the ideal candidates for PrEP with sipavibart.

Keywords
Multiple sclerosis; Pre-exposure profilaxis; SARS-CoV-2; Sipavibart.
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