Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies
oleh: Maria Pia Sormani, Matilde Inglese, Irene Schiavetti, Luca Carmisciano, Alice Laroni, Caterina Lapucci, Giorgio Da Rin, Carlo Serrati, Ilaria Gandoglia, Tiziana Tassinari, Germana Perego, Giampaolo Brichetto, Paola Gazzola, Antonio Mannironi, Maria Laura Stromillo, Cinzia Cordioli, Doriana Landi, Marinella Clerico, Elisabetta Signoriello, Jessica Frau, Maria Teresa Ferrò, Alessia Di Sapio, Livia Pasquali, Monica Ulivelli, Fabiana Marinelli, Graziella Callari, Rosa Iodice, Giuseppe Liberatore, Francesca Caleri, Anna Maria Repice, Susanna Cordera, Mario Alberto Battaglia, Marco Salvetti, Diego Franciotta, Antonio Uccelli, Alessandro Maglione, Alessia Di Sapio, Alessio Signori, Alice Laroni, Aniello Iovino, Anna Maria Repice, Antonio Mannironi, Antonio Uccelli, Carlo Serrati, Carolina Gabri Nicoletti, Caterina Lapucci, Chiara Rosa Mancinelli, Cinzia Cordioli, Daiana Bezzini, Daniele Carmagnini, Davide Brogi, Diego Franciotta, Doriana Landi, Eduardo Nobile Orazio, Eleonora Cocco, Elisabetta Signoriello, Enri Nako, Ester Assandri, Fabiana Marinelli, Federica Baldi, Filippo Ansaldi, Francesca Bovis, Francesca Caleri, Gabriele Siciliano, Gaia Cola, Germana Perego, Giacomo Lus, Giampaolo Brichetto, Giancarlo Icardi, gianmarco bellucci, Giorgio Da Rin, Girolama Alessandra Marfia, Giulia Vazzoler, Giuseppe Liberatore, Giuseppe Trivelli, Graziella Callari, Ilaria Gandoglia, Ilaria Maietta, Irene Schiavetti, Jessica Frau, Laura Sticchi, Livia Pasquali, Lorena Lorefice, Luca Carmisciano, Lucia Ruggiero, Marcello Manzino, Marco Salvetti, Margherita Monti Bragadin, Maria Chiara Buscarinu, Maria Gagliardi, Maria Laura Stromillo, Maria Pia Sormani, Maria Teresa Ferrò, Maria Teresa Rilla, Marinella Clerico, Mario Alberto Battaglia, Marta Ponzano, Marzia Fronza, Massimo Del Sette, Matilde Inglese, Matteo Scialabba, Michele Bedognetti, Monica Ulivelli, Nicola De Rossi, Nicola De Stefano, Paola Gazzola, Rachele Bigi, Raffaele Dubbioso, Roberta Reniè, Rosa Iodice, Sabrina Fabbri, Sarah Rasia, Simona Rolla, Stefan Platzgummer, Susanna Cordera, Tiziana Tassinari, Valentina Carlini
| Format: | Article |
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| Diterbitkan: | Elsevier 2021-10-01 |
Deskripsi
Background: In patients with Multiple Sclerosis (pwMS) disease-modifying therapies (DMTs) affects immune response to antigens. Therefore, post-vaccination serological assessments are needed to evaluate the effect of the vaccine on SARS-CoV-2 antibody response. Methods: We designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARS-Cov-2 vaccination with mRNA vaccines (BNT162b2, Pfizer/BioNTech,Inc or mRNA-1273, Moderna Tx,Inc). A blood collection before the first vaccine dose and 4 weeks after the second dose was planned, with a centralized serological assessment (electrochemiluminescence immunoassay, ECLIA, Roche-Diagnostics). The log-transform of the antibody levels was analyzed by multivariable linear regression. Findings: 780 pwMS (76% BNT162b2 and 24% mRNA-1273) had pre- and 4-week post-vaccination blood assessments. 87 (11·2%) were untreated, 154 (19·7%) on ocrelizumab, 25 (3·2%) on rituximab, 85 (10·9%) on fingolimod, 25 (3·2%) on cladribine and 404 (51·7%) on other DMTs. 677 patients (86·8%) had detectable post-vaccination SARS-CoV-2 antibodies. At multivariable analysis, the antibody levels of patients on ocrelizumab (201-fold decrease (95%CI=128–317), p < 0·001), fingolimod (26-fold decrease (95%CI=16–42), p < 0·001) and rituximab (20-fold decrease (95%CI=10–43), p < 0·001) were significantly reduced as compared to untreated patients. Vaccination with mRNA-1273 resulted in a systematically 3·25-fold higher antibody level (95%CI=2·46–4·27) than with the BNT162b2 vaccine (p < 0·001). The antibody levels on anti-CD20 therapies correlated to the time since last infusion, and rituximab had longer intervals (mean=386 days) than ocrelizumab patients (mean=129 days). Interpretation: In pwMS, anti-CD20 treatment and fingolimod led to a reduced humoral response to mRNA-based SARS-CoV-2 vaccines. As mRNA-1273 elicits 3·25-higher antibody levels than BNT162b2, this vaccine may be preferentially considered for patients under anti-CD20 treatment or fingolimod. Combining our data with those on the cellular immune response to vaccines, and including clinical follow-up, will contribute to better define the most appropriate SARS-CoV-2 vaccine strategies in the context of DMTs and MS. Funding: FISM[2021/Special-Multi/001]; Italian Ministry of Health‘Progetto Z844A 5 × 1000′.