Multiple Sclerosis immunotherapies and COVID-19 mortality: an analysis of the FDA Adverse Event Reporting System

Maximilian Pistor; Robert Hoepner; Andreas G F Hoepner; Yanan Lin; Simon Jung; Claudio L Bassetti; Andrew Chan; Anke Salmen

doi:10.1177/17562864221129383

Multiple Sclerosis immunotherapies and COVID-19 mortality: an analysis of the FDA Adverse Event Reporting System

Ther Adv Neurol Disord. 2022 Oct 10:15:17562864221129383. doi: 10.1177/17562864221129383. eCollection 2022.

Authors

Maximilian Pistor¹, Robert Hoepner², Andreas G F Hoepner^{3

4}, Yanan Lin³, Simon Jung², Claudio L Bassetti², Andrew Chan², Anke Salmen²

Affiliations

¹ Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse, 3010 Bern, Switzerland.
² Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
³ Department of Banking & Finance, Michael Smurfit Graduate Business School, University College Dublin, Dublin, Republic of Ireland.
⁴ Platform for Sustainable Finance, Department for Financial Stability and Capital Markets (DG FISMA), European Commission, European Union (EU), Brussels, Belgium.

Abstract

Background: Evidence on mortality risks associated with MS-immunotherapies during the SARS-CoV2 pandemic derived thus far mainly from single country experiences.

Objective: In this analysis, we aim to determine the frequency of COVID-19 associated fatality reports of patients receiving an MS-immunotherapy as reported to the international Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from February 2020 to March 2021.

Methods: In all, 1071 cases for this cross-sectional analysis were retrieved from FAERS and a multivariable logistic regression was performed. We adjusted for sex, age, region, month of report to FDA, immunotherapy-class and additionally for healthcare-system and pandemic-related metrics.

Result: Anti-CD20 therapies (60%) followed by sphingosine-1 phosphate modulators (12%) and dimethylfumarat (10%) were reported most frequently. In 50% of the cases, MS-phenotype is not reported, relapsing MS in 35% and progressive MS in 15%. Besides older age (odds ratio [OR]: 1.1; 95% confidence interval [CI]: 1.07-1.13; p < 0.01), anti-CD20 therapies were significantly associated with a higher risk of death (OR: 4.1; 95% CI: 1.17-14.46; p = 0.03), whereas female sex was associated with a reduced mortality risk (OR: 0.4, 95% CI: 0.22-0.72; p < 0.01).

Conclusion: Using international open access data and a multidisciplinary approach for risk prediction, we identified an increased mortality risk associated with anti-CD20 therapies, which is in line with national and multi-national cohort studies.

Keywords: SARS-CoV2; disease-modifying therapy; immunosuppression; multiple sclerosis; pharmacovigilance.