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. 2022 Jul 5:10.1111/ene.15488.
doi: 10.1111/ene.15488. Online ahead of print.

Impact of vaccination on COVID-19 outcome in multiple sclerosis

Gabriel Bsteh  1 , Christiane Gradl  2 , Bettina Heschl  3 , Harald Hegen  4 , Franziska Di Pauli  4 , Hamid Assar  5 , Fritz Leutmezer  1 , Gerhard Traxler  6 , Nik Krajnc  1 , Gudrun Zulehner  1 , Maria-Sophia Hiller  7 , Paulus Rommer  1 , Peter Wipfler  8 , Michael Guger  9 , Christian Enzinger  4 , Thomas Berger  1 ; AUT-MuSC investigators
Collaborators, Affiliations

Impact of vaccination on COVID-19 outcome in multiple sclerosis

Gabriel Bsteh et al. Eur J Neurol. .

Abstract

Background: COVID-19 continues to challenge neurologists in counselling persons with multiple sclerosis (pwMS) regarding disease-modifying treatment (DMT) and vaccination. The objective here was to characterize predictors of COVID-19 outcome in pwMS.

Methods: We included pwMS with PCR-confirmed COVID-19 diagnosis from a nationwide population-based registry. COVID-19 outcome was classified as either mild or severe. Impact of DMT, specifically anti-CD20 monoclonal antibodies, and vaccination on COVID-19 outcome was determined by multivariable models adjusted for a-priori-risk (determined by a cumulative risk score comprising age, disability and comorbidities).

Results: Of 317 pwMS with COVID-19 (mean age 41.8 years [SD 12.4], 72.9% female, median EDSS 1.5 [range 0-8.5], 77% on DMT [16% on antiCD20]), 92.7% had a mild course and 7.3% a severe course with 2.2% dying from COVID-19. Ninety-seven pwMS (30.6%) were fully vaccinated. After a median 5 months from vaccination to SARS-CoV-2 infection (range 1-9), severe COVID-19 occurred in 2.1% of fully vaccinated pwMS compared to 9.5% in unvaccinated pwMS (p=0.018). A-priori-risk robustly predicted COVID-19 severity (R2 0.605; p<0.001). Adjusting for a-priori-risk, anti-CD20 treatment was associated with increased COVID-19 severity (odds ratio [OR] 3.3; R2 0.113; p=0.003), but exposure to any other DMT was not. Fully vaccinated pwMS showed a significantly decreased risk for severe COVID-19 (OR 0.21, R2 0.144, p<0.001).

Conclusions: In a population-based MS cohort, COVID-19 course is primarily predicted by a-priori-risk (depending on age, disability and comorbidities) explaining about 60% of variance. Anti-CD20 treatment is associated with a moderately increased risk, while reassuringly vaccination provides protection from severe COVID-19.

Keywords: COVID-19; Multiple sclerosis; SARS-CoV-2; disease-modifying treatment; severity; vaccination.

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Conflict of interest statement

G.B. has participated in meetings sponsored by or received speaker honoraria or travel funding from Biogen, Celgene/BMS, Lilly, Merck, Novartis, Roche, Sanofi‐Genzyme, and Teva, and has received honoraria for consulting from Biogen, Celgene/BMS, Novartis, Roche, Sanofi‐Genzyme, and Teva. He has received research grants from Celgene/BMS and Novartis. C.G. has participated in meetings sponsored by or received honoraria (lectures, consultations) and/or travel funding from Biogen, D‐Pharma, Merck, Novartis, Roche, Sanofi‐Genzyme, and Teva. H.H. has participated in meetings sponsored by or received speaker honoraria or travel funding from Bayer, Biogen, Merck, Novartis, Roche, Sanofi‐Genzyme, Siemens, and Teva, and has received honoraria for consulting Biogen, Celgene/BMS, Novartis, and Teva. F.D.P. has participated in meetings sponsored by or received honoraria (lectures, advisory boards, consultations) or travel funding from Almirall, Bayer, Biogen, Celgene/BMS, Janssen, Merck, Novartis, Sanofi‐Genzyme, Roche, and Teva. Her institution has received research grants from Roche. H.A. has participated in meetings sponsored by or received honoraria (advisory boards, consultations) or travel funding from Biogen, Merck, Novartis, Roche, Sanofi‐Genzyme, Celgene/BMS, Janssen‐Cilag, and Teva. F.L. has participated in meetings sponsored by or received honoraria for acting as an advisor/speaker for Bayer, Biogen, Celgene, MedDay, Merck, Novartis, Roche, Sanofi‐Genzyme, and Teva. G.T. has participated in meetings sponsored by or received honoraria (lectures, advisory boards, consultations) or travel funding from Biogen, Celgene/BMS, Merck, Novartis, Roche, Sanofi‐Genzyme, and Teva. N.K. has participated in meetings sponsored by or received speaker honoraria or travel funding from Roche, Novartis, and Merck, and has held a grant for a Multiple Sclerosis Clinical Training Fellowship Programme from the European Committee for Treatment and Research in Multiple Sclerosis. G.Z. has participated in meetings sponsored by or received travel funding from Biogen, Merck, Novartis, Roche, Sanofi‐Genzyme, and Teva. P.R. has received honoraria for consultancy/speaking from AbbVie, Allmiral, Alexion, Biogen, Merck, Novartis, Roche, Sandoz, and Sanofi‐Genzyme, and has received research grants from Amicus, Biogen, Merck, and Roche. P.W. has received funding for travel and honoraria (lectures, advisory boards) from Bayer, Biogen, Celgene/BMS, Janssen‐Cilag, Merck, Novartis, Roche, Sandoz, Sanofi‐Genzyme, and Teva. M.G. has received support and honoraria for research, consultation, lectures, and education from Almirall, Biogen, Celgene/BMS, Genzyme, Janssen, Merck, Novartis, Roche, Sanofi‐Aventis, and Teva Ratiopharm. C.E. has received funding for travel and speaker honoraria from Biogen, Bayer, Merck, Novartis, Roche, Shire, Genzyme, and Teva; has received research support from Biogen, Merck, and Teva; and is serving on scientific advisory boards for Bayer, Biogen, Celgene/BMS, Merck, Novartis, Roche, and Teva. T.B. has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for MS, including Allergan, Bayer, Biogen, Bionorica, Celgene/BMS, GSK, Janssen‐Cilag, MedDay, Merck, Novartis, Octapharma, Roche, Sandoz, Sanofi‐Genzyme, and Teva. His institution has received financial support in the past 12 months through unrestricted research grants (Bayer, Biogen, Celgene/BMS, Merck, Novartis, Sanofi Aventis, Teva) and for participation in clinical trials in multiple sclerosis sponsored by Alexion, Bayer, Biogen, Celgene/BMS, Merck, Novartis, Octapharma, Roche, Sanofi‐Genzyme, and Teva. Neither of the other authors has any conflict of interest to disclose.

Figures

FIGURE 1
FIGURE 1
COVID‐19 severity according to disease‐modifying treatment (DMT) and vaccination status. antiCD20, anti‐CD20 monoclonal antibodies, comprising ocrelizumab, ofatumumab, and rituximab; H‐DMT, highly effective DMT, comprising alemtuzumab, cladribine, fingolimod, natalizumab, ozanimod, ponesimod, and siponimod; M‐DMT, moderately effective DMT comprising dimethyl fumarate, glatiramer acetate, interferon‐beta preparations, and teriflunomide. Probability values were calculated by chi‐squared test
FIGURE 2
FIGURE 2
COVID‐19 severity is associated with a priori risk, anti‐CD20 monoclonal antibody treatment, and vaccination in multivariate analyses. Values were calculated by a multivariate binary logistic regression model with severe COVID‐19 as the dependent variable adjusted for sex (age is already included in the MS‐COV‐risk score). Values >/< 1 indicate higher/lower probability of severe COVID‐19. "Fully vaccinated" indicates having received two doses of BNT162b2 (Pfizer‐BioNtech), mRNA‐1273 (Moderna), or ChAdOx1 nCoV‐19 (Astra‐Zeneca); or one dose of Ad26.COV2.S (Janssen). "MS‐COV‐risk score" indicates MS COVID‐19 severity risk score (range from −6 to 15), with higher scores predicting increased COVID‐19 severity, taking into account age, Expanded Disability Status Scale, smoking status, obesity, arterial hypertension, cardiovascular disease (coronary heart disease and/or ischemic heart failure and/or cardiac valve disease), chronic pulmonary disease (asthma, obstructive pulmonary disease, or pulmonary fibrosis), diabetes mellitus, and chronic kidney disease [14]. antiCD20, anti‐CD20 monoclonal antibodies, comprising ocrelizumab, ofatumumab, and rituximab; CI, confidence interval; H‐DMT, highly effective DMT, comprising alemtuzumab, cladribine, fingolimod, natalizumab, ozanimod, ponesimod, and siponimod; M‐DMT, moderately effective DMT comprising dimethyl fumarate, glatiramer acetate, interferon‐beta preparations, and teriflunomide; OR, odds ratio
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