Cross-sectional analysis of the humoral response after SARS-CoV-2 vaccination in Sardinian multiple sclerosis patients, a follow-up study

  1. Maria Laura Idda
  2. Maristella Pitzalis
  3. Valeria Lodde
  4. Annalisa Loizedda
  5. Jessica Frau
  6. Monia Lobina
  7. Magdalena Zoledziewska
  8. Francesca Virdis
  9. Giuseppe Delogu
  10. Maria Giuseppina Marini
  11. Maura Mingoia
  12. Marco Masala
  13. Lorena Lorefice
  14. Marzia Fronza
  15. Daniele Carmagnini
  16. Elisa Carta
  17. Silvy Pilotto
  18. Paolo Castiglia
  19. Paola Chessa
  20. Sergio Uzzau
  21. Gabriele Farina
  22. Paolo Solla
  23. Maristella Steri
  24. Marcella Devoto
  25. Edoardo Fiorillo
  26. Matteo Floris
  27. Roberto Ignazio Zarbo
  28. Eleonora Cocco
  29. Francesco Cucca

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Abstract

Monitoring immune responses to SARS-CoV-2 vaccination and its clinical efficacy over time in Multiple Sclerosis (MS) patients treated with disease-modifying therapies (DMTs) help to establish the optimal strategies to ensure adequate COVID-19 protection without compromising disease control offered by DMTs. Following our previous observations on the humoral response one month after two doses of BNT162b2 vaccine (T1) in MS patients differently treated, here we present a cross-sectional and longitudinal follow-up analysis six months following vaccination (T2, n=662) and one month following the first booster (T3, n=185). Consistent with results at T1, humoral responses were decreased in MS patients treated with fingolimod and anti-CD20 therapies compared with untreated patients also at the time points considered here (T2 and T3). Interestingly, a strong upregulation one month after the booster was observed in patients under every DMTs analyzed, including those treated with fingolimod and anti-CD20 therapies. Although patients taking these latter therapies had a higher rate of COVID-19 infection five months after the first booster, only mild symptoms that did not require hospitalization were reported for all the DMTs analyzed here. Based on these findings we anticipate that additional vaccine booster shots will likely further improve immune responses and COVID-19 protection in MS patients treated with any DMT.

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  1. Version published to 10.3389/fimmu.2022.946356
  2. ScreenIT

    SciScore for 10.1101/2022.05.19.22275317: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Ethics and data collection: The study was reviewed and approved by the Ethical Review Boards ATS Sardegna - Prot. N° 2492/CE.
    Consent: The patients/participants provided their written informed consent to participate in this study.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Quantification of SARS-CoV-2 antibodies direct against the proteins Spike (S) or Nucleocapsid (N) in human serum was performed using the electrochemiluminescence immunoassays Elecsys® Anti-SARS-CoV-S and Elecsys® Anti-SARS-CoV-N (Roche).
    SARS-CoV-2
    suggested: None
    Anti-SARS-CoV-N
    suggested: None
    Differences between patient groups - stratified according to therapy and selected for Anti-N antibody negativity - were assessed with a negative binomial generalized linear mixed-effects model, which takes into account the nature of the outcome variable (anti-S, non-negative count data); in addition to therapy, the models also consider the contribution of other variables such as age, smoke, sex, Expanded Disability Status Scale (EDSS), disease duration, and clinical sampling center.
    Anti-N
    suggested: None
    anti-S
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2022.05.19.22275317v1 on medRxiv