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Efficacy and safety of tixagevimab-cilgavimab (Evusheld®) in people with Multiple Sclerosis on Ocrelizumab: preliminary evidence

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Abstract

Background

Evusheld (EVS) was authorized by FDA and EMA as pre-exposure prophylaxis (PrEP) in people at high risk of severe Covid-19 outcomes, including people with Multiple Sclerosis (pwMS) on B-cell depleting (BCD) therapies—such as Ocrelizumab (OCR). In this population, no data on possible adverse drug reactions (ADRs) to EVS, B-lymphocytes (CD20 +) counts pre- and post-EVS injection, and comparison of percentage increase of IgG antibodies directed against SARS-CoV-2 trimeric spike protein (anti-TSP IgG) post-EVS and Covid-19 vaccine was available. The aim of this study was to better characterize the efficacy and safety profile of EVS in pwMS on BCD agents.

Methods

17 pwMS on OCR agreed to receive EVS as PrEP for Covid-19. Sera samples were collected before the first dose of Covid-19 vaccine (T0), 4 weeks after the second dose (T1), 4 weeks after third dose (T2), immediately before (T3) and 4 weeks after (T4) EVS.

Results

Covid-19 vaccine ADRs were mild-to-moderate, whereas no ADRs were reported after EVS injection. A significant increase of anti-TSP IgG was found only at T0-T1 (Z = -3.059, p = .002) and T3-T4 (Z = -3.621, p < .001) time-points. The median percentage increase between T3-T4 was significantly higher with respect to the T0-T1(Z = -3.296, p = .001) and T1-T2 (Z = -3.059, p = .002) time-points.

Conclusions

These results further support EVS safety and efficacy in boosting anti-TSP IgG titers in pwMS on OCR, with a statistically greater increase than that observed after completion of a full Covid-19 vaccine cycle, plus a booster dose.

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Fig. 1

Data Availability

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

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Funding

No financial support was received by the authors.

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Authors and Affiliations

  1. Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy

    Manuela Altieri, Rosario Domenico Melisi, Miriana Conte, Rocco Capuano, Mario Risi, Alessandro d’Ambrosio, Alvino Bisecco & Antonio Gallo

  2. Department of Experimental Medicine, Division of Pharmacology, University of Campania “Luigi Vanvitelli”, Naples, Italy

    Rosario Domenico Melisi

  3. Department of Medical Sciences, Neurology Unit, AOU San Giovanni and Ruggi, Salerno, Italy

    Rocco Capuano

  4. Department of Experimental Medicine, Division of Microbiology and Clinical Microbiology, University of Campania “Luigi Vanvitelli”, Naples, Italy

    Giovanna Donnarumma & Elena Grimaldi

  5. Department of Mental Health and Public Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy

    Nicola Coppola & Stefania De Pascalis

Authors
  1. Manuela Altieri
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  2. Rosario Domenico Melisi
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  3. Miriana Conte
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  4. Rocco Capuano
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  5. Giovanna Donnarumma
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  6. Elena Grimaldi
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  7. Nicola Coppola
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  8. Stefania De Pascalis
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  9. Mario Risi
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  10. Alessandro d’Ambrosio
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  11. Alvino Bisecco
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  12. Antonio Gallo
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Corresponding author

Correspondence to Antonio Gallo.

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Ethical approval

The study was approved by the ethics committee of University of Campania “Luigi Vanvitelli” (approval code: 0015914) and it was performed in accordance with the Declaration of Helsinki and its later amendments.

Informed consent

Each participant provided a written informed consent to the study.

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The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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Altieri, M., Melisi, R.D., Conte, M. et al. Efficacy and safety of tixagevimab-cilgavimab (Evusheld®) in people with Multiple Sclerosis on Ocrelizumab: preliminary evidence. Neurol Sci 44, 4107–4110 (2023). https://doi.org/10.1007/s10072-023-06975-7

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  • DOI: https://doi.org/10.1007/s10072-023-06975-7

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