Frequency and Predictors of Relapses following SARS-CoV-2 Vaccination in Patients with Multiple Sclerosis: Interim Results from a Longitudinal Observational Study

Author:

Frahm Niklas12ORCID,Fneish Firas1,Ellenberger David1ORCID,Haas Judith3,Löbermann Micha4,Peters Melanie15,Pöhlau Dieter3,Röper Anna-Lena13,Schilling Sarah1,Stahmann Alexander1ORCID,Temmes Herbert3,Paul Friedemann678,Zettl Uwe Klaus2

Affiliation:

1. MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), 30171 Hannover, Germany

2. Department of Neurology, Neuroimmunological Section, University Medical Center of Rostock, 18147 Rostock, Germany

3. Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V. (German MS Society Federal Association [DMSG]), 30171 Hannover, Germany

4. Department of Tropical Medicine, Infectious Diseases and Nephrology, University Medical Center of Rostock, 18057 Rostock, Germany

5. Gesellschaft für Versorgungsforschung mbH (Society for Health Care Research [GfV]), 30171 Hannover, Germany

6. Experimental and Clinical Research Center, a Joint Cooperation between the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and the Charité Medical Faculty, Campus Berlin-Buch, 13125 Berlin, Germany

7. Department of Neurology, Charité—Universitätsmedizin, 10117 Berlin, Germany

8. NeuroCure Clinical Research Center, Charité—Universitätsmedizin, 10117 Berlin, Germany

Abstract

Despite protection from severe COVID-19 courses through vaccinations, some people with multiple sclerosis (PwMS) are vaccination-hesitant due to fear of post-vaccination side effects/increased disease activity. The aim was to reveal the frequency and predictors of post-SARS-CoV-2-vaccination relapses in PwMS. This prospective, observational study was conducted as a longitudinal Germany-wide online survey (baseline survey and two follow-ups). Inclusion criteria were age ≥18 years, MS diagnosis, and ≥1 SARS-CoV-2 vaccination. Patient-reported data included socio-demographics, MS-related data, and post-vaccination phenomena. Annualized relapse rates (ARRs) of the study cohort and reference cohorts from the German MS Registry were compared pre- and post-vaccination. Post-vaccination relapses were reported by 9.3% PwMS (247/2661). The study cohort’s post-vaccination ARR was 0.189 (95% CI: 0.167–0.213). The ARR of a matched unvaccinated reference group from 2020 was 0.147 (0.129–0.167). Another reference cohort of vaccinated PwMS showed no indication of increased post-vaccination relapse activity (0.116; 0.088–0.151) compared to pre-vaccination (0.109; 0.084–0.138). Predictors of post-vaccination relapses (study cohort) were missing immunotherapy (OR = 2.09; 1.55–2.79; p < 0.001) and shorter time from the last pre-vaccination relapse to the first vaccination (OR = 0.87; 0.83–0.91; p < 0.001). Data on disease activity of the study cohort in the temporal context are expected for the third follow-up.

Funder

multistakeholder sponsors organized by the DMSG

Biogen

Bristol Myers Squibb

Merck Serono

Mylan

Novartis

Roche

Sanofi-Aventis

Publisher

MDPI AG

Subject

General Medicine

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