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

Niklas Frahm; Firas Fneish; David Ellenberger; Judith Haas; Micha Löbermann; Melanie Peters; Dieter Pöhlau; Anna-Lena Röper; Sarah Schilling; Alexander Stahmann; Herbert Temmes; Friedemann Paul; Uwe Klaus Zettl

doi:10.3390/jcm12113640

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

J Clin Med. 2023 May 24;12(11):3640. doi: 10.3390/jcm12113640.

Authors

Niklas Frahm^{1

2}, Firas Fneish¹, David Ellenberger¹, Judith Haas³, Micha Löbermann⁴, Melanie Peters^{1

5}, Dieter Pöhlau³, Anna-Lena Röper^{1

3}, Sarah Schilling¹, Alexander Stahmann¹, Herbert Temmes³, Friedemann Paul^{6

7

8}, Uwe Klaus Zettl²

Affiliations

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.

Keywords: COVID-19; SARS-CoV-2; multiple sclerosis; relapse; vaccination.

Grants and funding

The conduct of this study was supported by multistakeholder sponsors organized by the DMSG. The list of sponsors included (in alphabetical order) Biogen, Bristol Myers Squibb, Merck Serono, Mylan, Novartis, Roche, and Sanofi-Aventis. Industry funding did not result in restrictions to publishing data, nor did the funders have access to the raw data or exert any influence over the scientific conduct of the study.