Unknown

Dataset Information

0

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


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.

SUBMITTER: Pistor M 

PROVIDER: S-EPMC9551667 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

altmetric image

Publications

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

Pistor Maximilian M   Hoepner Robert R   Hoepner Andreas G F AGF   Lin Yanan Y   Jung Simon S   Bassetti Claudio L CL   Chan Andrew A   Salmen Anke A  

Therapeutic advances in neurological disorders 20221010


<h4>Background</h4>Evidence on mortality risks associated with MS-immunotherapies during the SARS-CoV2 pandemic derived thus far mainly from single country experiences.<h4>Objective</h4>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.<h4>Methods</h4>In all, 1071 cases for t  ...[more]

Similar Datasets

| S-EPMC10538962 | biostudies-literature
| S-EPMC8213312 | biostudies-literature
| S-EPMC11510275 | biostudies-literature
| S-EPMC10401141 | biostudies-literature
| S-EPMC11335658 | biostudies-literature
| S-EPMC11743753 | biostudies-literature
| S-EPMC11894037 | biostudies-literature
| S-EPMC11768236 | biostudies-literature
| S-EPMC3857139 | biostudies-literature
| S-EPMC11409130 | biostudies-literature