Antibody response elicited by the SARS-CoV-2 vaccine booster in patients with multiple sclerosis: Who gains from it?

Schiavetti I.;Inglese M.;Frau J.;Signoriello E.;Caleri F.;Stromillo M. L.;Ferro M. T.;Rilla M. T.;Gandoglia I.;Gazzola P.;Brichetto G.;Pasquali L.;Grimaldi L.;Ulivelli M.;Marinelli F.;Cordera S.;Clerico M.;Conte A.;Salvetti M.;Battaglia M. A.;Franciotta D.;Uccelli A.;Sormani M. P.;Maglione A.;Di Sapio A.;Laroni A.;Iovino A.;Mannironi A.;Uccelli A.;Nucciarone B.;Serrati C.;Nicoletti C. G.;Lapucci C.;Mancinelli C. R.;Cordioli C.;Bezzini D.;Carmagnini D.;Brogi D.;Nicola D. S.;Landi D.;Nobile Orazio E.;Cocco E.;Signoriello E.;Nako E.;Assandri E.;Marinelli F.;Baldi F.;Caleri F.;Siciliano G.;Cola G.;Perego G.;Lus G.;Brichetto G.;Bellucci G.;Da Rin G.;Marfia G. A.;Vazzoler G.;Liberatore G.;Trivelli G.;Callari G.;Gandoglia I.;Schiavetti I.;Frau J.;Pasquali L.;Petrucci L.;Lorefice L.;Ruggiero L.;Salvetti M.;Monti Bragadin M.;Buscarinu M. C.;Gagliardi M.;Sormani M. P.;Ferro M. T.;Rilla M. T.;Clerico M.;Battaglia M. A.;Fronza M.;Del Sette M.;Inglese M.;Scialabba M.;Bedognetti M.;Ulivelli M.;De Rossi N.;Gazzola P.;Bigi R.;Dubbioso R.;Renie R.;Iodice R.;Fabbri S.;Rasia S.;Parodi S.;Rolla S.;Platzgummer S.;Maria Laura S.;Tassinari T.;Carlini V.

2023-01-01

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Abstract

Background and purpose: Although two doses of COVID-19 vaccine elicited a protective humoral response in most persons with multiple sclerosis (pwMS), a significant group of them treated with immunosuppressive disease-modifying therapies (DMTs) showed less efficient responses. Methods: This prospective multicenter observational study evaluates differences in immune response after a third vaccine dose in pwMS. Results: Four hundred seventy-three pwMS were analyzed. Compared to untreated patients, there was a 50-fold decrease (95% confidence interval [CI] = 14.3–100.0, p < 0.001) in serum SARS-CoV-2 antibody levels in those on rituximab, a 20-fold decrease (95% CI = 8.3–50.0, p < 0.001) in those on ocrelizumab, and a 2.3-fold decrease (95% CI = 1.2–4.6, p = 0.015) in those on fingolimod. As compared to the antibody levels after the second vaccine dose, patients on the anti-CD20 drugs rituximab and ocrelizumab showed a 2.3-fold lower gain (95% CI = 1.4–3.8, p = 0.001), whereas those on fingolimod showed a 1.7-fold higher gain (95% CI = 1.1–2.7, p = 0.012), compared to patients treated with other DMTs. Conclusions: All pwMS increased their serum SARS-CoV-2 antibody levels after the third vaccine dose. The mean antibody values of patients treated with ocrelizumab/rituximab remained well below the empirical "protective threshold" for risk of infection identified in the CovaXiMS study (>659 binding antibody units/mL), whereas for patients treated with fingolimod this value was significantly closer to the cutoff.