Evidence map›Paper›PMID 34563483›Full record

Observational studyEBioMedicine2021

Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies.

Maria Pia Sormani, Matilde Inglese, Irene Schiavetti, Luca Carmisciano, Alice Laroni, Caterina Lapucci, Giorgio Da Rin, Carlo Serrati, Ilaria Gandoglia, Tiziana Tassinari and 26 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in EBioMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 142 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
142citing papers in PubMed, 6 pooled it
13.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

142 citing papers in PubMed, 6 syntheses or guidelines pooled it, 223 citations in OpenAlex.

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  11. CD56Clinical & translational immunology · 2026
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82 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 2 countries.

Maria Pia SormaniDepartment of Health Sciences, Section of Biostatistics, University of Genova, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy. Electronic address: mariapia.sormani@unige.it.
Matilde IngleseIRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy.
Irene SchiavettiDepartment of Health Sciences, Section of Biostatistics, University of Genova, Italy.
Luca CarmiscianoDepartment of Health Sciences, Section of Biostatistics, University of Genova, Italy.
Alice LaroniIRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy.
Caterina LapucciIRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy.
Giorgio Da RinLaboratory Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Carlo SerratiDepartment of Neurology, Imperia Hospital, Imperia, Italy.
Ilaria GandogliaNeurology Unit, Galliera Hospital.
Tiziana TassinariS.C. Neurologia - Ospedale Santa Corona Pietra Ligure (Sv).
Germana PeregoSC Neurologia ASL 4 Chiavarese.
Giampaolo BrichettoAISM Rehabilitation Center, Genoa, Italy.
Paola GazzolaCentro Sclerosi Multipla S.C. Neurologia Asl 3 Genovese.
Antonio MannironiDepartment of Neurology, Sant'Andrea Hospital, La Spezia, Italy.
Maria Laura StromilloClinica Neurologica e Malattie Neurometaboliche, Università degli Studi di Siena.
Cinzia CordioliCentro Sclerosi Multipla ASST Spedali Civili di Brescia.
Doriana LandiMultiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University and Hospital, Rome, Italy.
Marinella ClericoDipartimento di Scienze Cliniche e Biologiche, Università di Torino Università di Torino.
Elisabetta SignorielloCentro Sclerosi Multipla, II Clinica Neurologica, Università della Campania Luigi Vanvitelli.
Jessica FrauCentro Sclerosi Multipla Ospedale Binaghi Cagliari - ATS Sardegna, Università di Cagliari.
Maria Teresa FerròNeuroimmunology, Center for Multiple Sclerosis, Cerobrovascular Department, Neurological Unit, ASST Crema.
Alessia Di SapioDepartment of Neurology, Regina Montis Regalis Hospital, Mondovì, Italy.
Livia PasqualiDepartment of Clinical and Experimental Medicine, Neurology Unit, University of Pisa, Italy.
Monica UlivelliDepartment of Medicine, Surgery and Neuroscience, University of Siena.
Fabiana MarinelliMultiple Sclerosis Center, Fabrizio Spaziani Hospital, via Armando Fabi, Frosinone, Italy.
Graziella CallariUOC Neurologia e Centro SM Fondazione Istituto G. Giglio, Cefalù.
Rosa IodiceClinica Neurologica, DSNRO Università Federico II di Napoli.
Giuseppe LiberatoreNeuromuscular and Neuroimmunology Service, IRCCS Humanitas Research Hospital, Rozzano, Italy.
Francesca CaleriMS Center, Department of Neurology, F. Tappeiner Hospital Meran (BZ), Italy.
Anna Maria RepiceDepartment of Neurology 2, Careggi University Hospital, Florence, Italy.
Susanna CorderaDepartment of Neurology, Ospedale Regionale, Aosta, Italy.
Mario Alberto BattagliaResearch Department, Italian Multiple Sclerosis Foundation, Genoa, Italy; Department of Life Sciences, University of Siena, Italy.
Marco SalvettiCentre for Experimental Neurological Therapies (CENTERS), Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome, Italy; IRCCS Istituto Neurologico Mediterraneo Neuromed, Pozzilli, Italy.
Diego FranciottaAutoimmunology Laboratory, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Antonio UccelliIRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy.
CovaXiMS study group on behalf of the Italian Covid-19 Alliance in MS
Ospedale Policlinico San Martino · ITUniversity of Genoa · ITAssociazione Italiana Sclerosi Multipla · ITAzienda USL della Valle d’Aosta · ITATS Sardegna (Italy) · ITIRCCS Humanitas Research Hospital · ITKrankenhaus Meran · ITUniversity of Siena · ITUniversity of Turin · ITAurelia Hospital · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITCTO Andrea Alesini · ITEnte Ospedaliero Ospedali Galliera · ITFondazione Istituto G. Giglio di Cefalù · ITInstitute of Neuroimmunology of the Slovak Academy of Sciences · SKOspedale Santa Corona · ITUniversity of Pisa · ITFederico II University Hospital · ITIstituto Neurologico Mediterraneo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsWe 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.

findings780 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).

interpretationIn 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.

fundingFISM[2021/Special-Multi/001]; Italian Ministry of Health'Progetto Z844A 5 × 1000'.

Indexed as

2019-nCoV Vaccine mRNA-1273AdultAntibodies, Monoclonal, HumanizedAntibody FormationBNT162 VaccineCladribineCOVID-19COVID-19 VaccinesFemaleFingolimod HydrochlorideHumansImmunosuppressive AgentsItalyMaleMiddle AgedMultiple Sclerosis2019-nCoV Vaccine mRNA-1273Antibodies, Monoclonal, HumanizedBNT162 VaccineCladribineCOVID-19 VaccinesFingolimod HydrochlorideImmunosuppressive AgentsocrelizumabRituximabCoronavirusImmunomodulatory therapiesMultiple sclerosis

Identifiers

PMID34563483
PMCPMC8456129
OpenAlexW3199233027

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.