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Occurrence and Risk Factors of Relapse Activity after Vaccination against COVID-19 in People with Multiple Sclerosis: 1-Year Follow-Up Results from a Nationwide Longitudinal Observational Study

Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Fneish, Firas;
ORCID
0000-0002-4655-774X
Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Frahm, Niklas;
Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Peters, Melanie;
ORCID
0000-0002-2274-5025
Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Ellenberger, David;
Affiliation
Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V. (German MS Society Federal Association [DMSG]), 30171 Hannover, Germany;(J.H.);(D.P.);(H.T.)
Haas, Judith;
Affiliation
Department of Tropical Medicine, Infectious Diseases and Nephrology, University Medical Center of Rostock, 18057 Rostock, Germany;
Löbermann, Micha;
Affiliation
Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V. (German MS Society Federal Association [DMSG]), 30171 Hannover, Germany;(J.H.);(D.P.);(H.T.)
Pöhlau, Dieter;
Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Röper, Anna-Lena;
Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Schilling, Sarah;
ORCID
0000-0001-5308-105X
Affiliation
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany;(F.F.);(M.P.);(D.E.);(A.-L.R.);(S.S.);(A.S.)
Stahmann, Alexander;
Affiliation
Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V. (German MS Society Federal Association [DMSG]), 30171 Hannover, Germany;(J.H.);(D.P.);(H.T.)
Temmes, Herbert;
Affiliation
Experimental and Clinical Research Center, Joint Cooperation between the Max Delbrück Center for Molecular Medicine in the Helmholtz Association, The Charité Medical Faculty, Campus Berlin-Buch, 13125 Berlin, Germany;
Paul, Friedemann;
Affiliation
Neuroimmunological Section, Department of Neurology, University Medical Center of Rostock, 18147 Rostock, Germany;
Zettl, Uwe K.

Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify sociodemographic/clinical risk factors for PV relapses. PwMS were surveyed several times at baseline and four follow-ups as part of a longitudinal observational study regarding the safety and tolerability of the SARS-CoV-2 vaccination. The inclusion criteria for this analysis were age ≥18 years, ≥1 SARS-CoV-2 vaccination, and ≥1-year observation period since initial vaccination. Of 2466 PwMS, 13.8% reported PV relapses (mostly after second [N = 147] or booster vaccination [N = 145]) at a median of 8.0 (first/third quantile: 3.55/18.1) weeks PV, with the shortest period following initial vaccination (3.95 weeks). The ARR was 0.153 (95% confidence interval: 0.138–0.168), with a median observation period since initial vaccination of 1.2 years. Risk factors for PV relapses were younger age, female gender, moderate-severe disability levels, concurrent autoimmune diseases, relapsing-remitting MS courses, no DMT, and relapses within the year prior to the first vaccination. Patients’ health conditions before/during initial vaccination may play a more important role in PV relapse occurrence than vaccination per se.

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