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].

PMID: 40481170 DOI: 10.1007/s00415-025-13188-9

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.

Products

Cat. No.

Product Name

Description

Target

Research Area
HY-P990766

Sipavibart

98.00%, Anti-SARS-CoV-2 Monoclonal Antibody

SARS-CoV

Infection

Name
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