Breakthrough SARS-CoV-2 infections in MS patients on disease modifying therapies

  1. Irene Schiavetti
  2. Cinzia Cordioli
  3. Maria Laura Stromillo
  4. Maria Teresa Ferrò
  5. Alice Laroni
  6. Eleonora Cocco
  7. Gaia Cola
  8. Livia Pasquali
  9. Maria Teresa Rilla
  10. Elisabetta Signoriello
  11. Rosa Iodice
  12. Alessia Di Sapio
  13. Roberta Lanzillo
  14. Francesca Caleri
  15. Pietro Annovazzi
  16. Antonella Conte
  17. Giuseppe Liberatore
  18. Francesca Ruscica
  19. Renato Docimo
  20. Simona Bonavita
  21. Monica Ulivelli
  22. Paola Cavalla
  23. Francesco Patti
  24. Diana Ferraro
  25. Marinella Clerico
  26. Paolo Immovilli
  27. Massimiliano Di Filippo
  28. Marco Salvetti
  29. Maria Pia Sormani
  30. the “Breakthrough infections in MS” study group
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Abstract

Background

Patients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a reduced humoral response to SARS-CoV-2 vaccines. In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection in pwMS on different Disease Modifying Therapy (DMT).

Methods

Data on number of vaccinated patients and of patients with a breakthrough infection were retrospectively collected in 27 Italian MS centers. We estimated the rate of breakthrough infections and of infection requiring hospitalization per DMT.

Findings

19641 vaccinated pwMS were included in the database. After a median follow-up of 8 months, we observed 137 breakthrough infections. As compared to the other DMTs, the rate of breakthrough infections was significantly higher on ocrelizumab (0.57% vs 2.00%, RR=3.55,95%CI=2.74-4.58, p<0.001) and fingolimod (0.58% vs 1.62%, RR=2.65,95%CI=1.75-4.00, p<0.001), while there were no significant differences in any other DMT group. In the ocrelizumab group the hospitalization rate was 16.7% vs 19.4% in the pre-vaccination era (RR=0.86,p=0.74) and it was 3.9% in all the other DMT groups vs 11.9% in the pre-vaccination period (RR=0.33,p=0.02).

Interpretation

The risk of breakthrough SARS-CoV-2 infections is higher in patients treated with ocrelizumab and fingolimod, and the rate of severe infections was significantly reduced in all the DMTs excluding ocrelizumab.

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