PMID- 35216790 OWN - NLM STAT- MEDLINE DCOM- 20220301 LR - 20220301 IS - 2211-0356 (Electronic) IS - 2211-0348 (Print) IS - 2211-0348 (Linking) VI - 58 DP - 2022 Feb TI - Anti-Spike IgG in multiple sclerosis patients after BNT162b2 vaccine: An exploratory case-control study in Italy. PG - 103415 LID - S2211-0348(21)00681-7 [pii] LID - 10.1016/j.msard.2021.103415 [doi] AB - BACKGROUND: Patients with neuroimmunological conditions such as multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) or immunosuppressants which may reduce the response to vaccines. BNT162b2 (Pfizer-BioNTech) is the first COVID-19 vaccine authorized in Italy. Its clinical efficacy and serological response were not evaluated in MS patients receiving DMTs or immunosuppressants. This early multicenter study evaluated serological response to BNT162b2 and safety in these patients. METHODS: From February 2021 we enrolled consecutive MS patients, treated with at least one DMT and all healthcare workers (HCWs), having received or being scheduled to receive the first dose of BNT162b2. Blood samples were collected after the second vaccine dose and analyzed to quantitatively detect the presence of anti-Spike antibodies. Serological response was compared to the one from a control population of HCWs, with neither neuroimmunological conditions nor receiving immunosuppressants. Patients receiving treatments associated with a possible reduced response (Under-scrutiny treatment group) were also compared to those undergoing other treatments. Anti-Spike levels were described as median and interquartile range (IQR). Comparisons were performed with Wilcoxon-Mann-Whitney test. Solicited and unsolicited adverse events (AEs) were collected. RESULTS: 39 MS patients and a control population of 273 HCWs were included. One patient, under treatment with ocrelizumab, did not respond to BNT162b2, while all the remaining patients and all controls developed a serological response to the vaccine. Median anti-Spike levels were similar between patients (1471.0 BAU/ml; IQR 779.7 to 2357.0) and controls (1479.0 BAU/ml; IQR 813.1 to 2528.0) (p = 0.53). Patients included in the Under-scrutiny treatments group showed reduced anti-Spike levels (156.4 BAU/ml; IQR 33.4 to 559.1) compared to those receiving other treatments (1582.4 BAU/ml; IQR 1296.5 to 2219.0) (p = 0.001). Solicited AEs were all mild to moderate in severity, generally reported in the first days after vaccination, and resolved in the following days. Two MS patients reported a clinical relapse after the second vaccine dose. CONCLUSION: BNT162b2 induced a serological response in MS patients treated with DMTs similar to controls not receiving DMTs or immunosuppressants. Some treatments were associated with reduced levels of anti-Spike antibodies in patients. These observations have relevant implications for treated patients receiving BNT162b2 and the community. CI - Copyright (c) 2021 Elsevier B.V. All rights reserved. FAU - Giossi, Riccardo AU - Giossi R AD - Department of Oncology and Onco-Hematology, Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, Via Vanvitelli 32, Milan 20129, Italy; Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. Electronic address: riccardo.giossi@unimi.it. FAU - Consonni, Alessandra AU - Consonni A AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Torri Clerici, Valentina AU - Torri Clerici V AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Zito, Antonio AU - Zito A AD - Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy. FAU - Rigoni, Eleonora AU - Rigoni E AD - Multiple Sclerosis Centre, IRCCS Mondino Foundation, Via Mondino 2, Pavia 27100, Italy. FAU - Antozzi, Carlo AU - Antozzi C AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Brambilla, Laura AU - Brambilla L AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Crisafulli, Sebastiano Giuseppe AU - Crisafulli SG AD - Department of Human Neurosciences, Sapienza University of Rome, Piazzale Aldo Moro 5, Rome 00185, Italy. FAU - Bellino, Antonella AU - Bellino A AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Frangiamore, Rita AU - Frangiamore R AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Bonanno, Silvia AU - Bonanno S AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Vanoli, Fiammetta AU - Vanoli F AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy; Department of Human Neurosciences, Sapienza University of Rome, Piazzale Aldo Moro 5, Rome 00185, Italy. FAU - Ciusani, Emilio AU - Ciusani E AD - Laboratory of Neurological Biochemistry and Neuropharmacology, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Corsini, Elena AU - Corsini E AD - Laboratory of Neurological Biochemistry and Neuropharmacology, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Andreetta, Francesca AU - Andreetta F AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Baggi, Fulvio AU - Baggi F AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Tramacere, Irene AU - Tramacere I AD - Department of Research and Clinical Development, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Mantegazza, Renato AU - Mantegazza R AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. FAU - Conte, Antonella AU - Conte A AD - Department of Human Neurosciences, Sapienza University of Rome, Piazzale Aldo Moro 5, Rome 00185, Italy; IRCCS Istituto Neurologico Mediterraneo (INM) Neuromed, Pozzilli, Italy. FAU - Bergamaschi, Roberto AU - Bergamaschi R AD - Multiple Sclerosis Centre, IRCCS Mondino Foundation, Via Mondino 2, Pavia 27100, Italy. FAU - Confalonieri, Paolo AU - Confalonieri P AD - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Via Celoria 11, Milan 20133, Italy. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20211122 PL - Netherlands TA - Mult Scler Relat Disord JT - Multiple sclerosis and related disorders JID - 101580247 RN - 0 (Antibodies, Viral) RN - 0 (COVID-19 Vaccines) RN - 0 (Immunoglobulin G) RN - N38TVC63NU (BNT162 Vaccine) SB - IM MH - Antibodies, Viral MH - BNT162 Vaccine MH - *COVID-19/prevention & control MH - COVID-19 Vaccines/adverse effects MH - Case-Control Studies MH - Humans MH - Immunoglobulin G MH - *Multiple Sclerosis/drug therapy MH - SARS-CoV-2 PMC - PMC8614185 OTO - NOTNLM OT - COVID-19 OT - Disease-modifying therapies OT - Multiple sclerosis OT - Vaccine, BNT162b2 COIS- R.G. received support for congress participation from Mylan. A.C. has nothing to disclose. V.T.C. acted as an Advisory Board member of Biogen Idec, Novartis, Merck, Roche, Genzyme, and Almirall and received funding for traveling and honoraria for speaking or writing from Teva, Novartis, Genzyme, and Almirall. She received support for research project by Almirall. A.Z. has nothing to disclose. E.R. received support for travel and congress from Merck-Serono, Sanofi-Genzyme. C.A. received funding for congress participation from Biogen. L.B. received honoraria for speaking from Novartis and for traveling from Sanofi-Genzyme and Roche; for Advisory Board from Sanofi-Genzyme, Biogen, and Novartis and is involved as principal investigator in clinical trials for Roche, Merck-Serono, and Novartis. S.G.C. has nothing to disclose. A.B. has nothing to disclose. R.F. received support for congress participation from Argenx, Biogen, Catalyst, Merck, Momenta, Novartis, and Sanofi Genzyme. S.B. has nothing to disclose. F.V. received support for congress participations from Biogen, Kedrion, and Sanofi Genzyme. E.C. has nothing to disclose. E.C. has nothing to disclose. F.A. has nothing to disclose. F.B. received honoraria from Immunovant and Prescript. I.T. has nothing to disclose. R.M. received fees and honoraria for meeting, travel, and advisory board from Alexion, Argenx, Biomarin, Catalyst, Merck Serono, UCB. A.C. has served on scientific advisory boards for Merck-Serono, Sanofi-Genzyme, Biogen, Novartis, Almirall. She has received institutional research support from Roche and Biogen. R.B. has served on scientific advisory boards for Biogen, Merck-Serono, Novartis, Sanofi-Genzyme; he received research support from Almirall, Bayer, Biogen, Merck- Serono, Novartis, Sanofi-Genzyme; he received support for travel and congress from Biogen, Roche, Merck-Serono, Sanofi-Genzyme, Teva; received honoraria for speaking engagement from Biogen, Merck-Serono, Novartis, Sanofi-Genzyme. P.C. received honoraria for speaking or consultation fees from Novartis and Biogen, funding for travel to attend scientific events, or speaker honoraria from Merck Serono, Biogen Idec, Teva, and Roche. He received institutional research support from Merk-Serono, Novartis, and Roche. EDAT- 2022/02/27 06:00 MHDA- 2022/03/03 06:00 PMCR- 2021/11/22 CRDT- 2022/02/26 05:31 PHST- 2021/05/19 00:00 [received] PHST- 2021/11/09 00:00 [revised] PHST- 2021/11/19 00:00 [accepted] PHST- 2022/02/26 05:31 [entrez] PHST- 2022/02/27 06:00 [pubmed] PHST- 2022/03/03 06:00 [medline] PHST- 2021/11/22 00:00 [pmc-release] AID - S2211-0348(21)00681-7 [pii] AID - 103415 [pii] AID - 10.1016/j.msard.2021.103415 [doi] PST - ppublish SO - Mult Scler Relat Disord. 2022 Feb;58:103415. doi: 10.1016/j.msard.2021.103415. Epub 2021 Nov 22.