Association of immunomodulatory therapies with COVID-19 mortality in rheumatoid arthritis: An analysis of the FDA adverse event reporting system

Abstract

Background

The COVID-19 pandemic significantly affects patients with RA and other rheumatic diseases. Our study aims to explore the factors associated with COVID-19-related fatality among Rheumatoid Arthritis (RA) patients, especially immunomodulatory therapies, using the international Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Methods

Reportes from FAERS were extracted from February 2020 to September 2022, and uesd for this cross-sectional analysis. The investigative outcome was COVID-19-related death. Age, sex, region, event date, and immunomodulatory medications classies were included as co-variates in multivariable logistic regression. In view of the different targeting and affinity of individual JAKi, Tofacitinib, Upadacitinib and Baricitinib was respectively analyzed.

Results

In all, 3808 cases (mean age 58.85 years, 82.8% female), 267 (7.0%) died. JAKi therapies (41.2%), followed by TNFi (37.7%), IL-1i (12.2%), IL-6i (4.1%) and Anti-CD20 (3%) were reported. Risk factors associated with COVID-19-related death in RA patients were age (odds ratio [OR]: 1.06; 95% confidence interval [CI]: 1.05–1.08; p ​< ​0.01), male sex (1.71, 1.26–2.33; p ​= ​0.01) and anti-CD20 therapies (5.05; 1.40–18.19; p ​= ​0.013). With TNFi conference, anti-CD20 was still a risk predictor (4.29; 2.39–7.70; p ​< ​0.01). Other DMARDs except for anti-CD20, did not confer a significant association with mortality, compared with csDMARDs or TNFi. Individual JAKi showed no obvious difference in the risk of death, compared with csDMARDs or TNFis.

Conclusions

Conclusions Using FAERS open access data for risk prediction of death, anti-CD20 therapies were recognized as a risk factor for COVID-19-related fatalities among RA patients, other immunomodulatory therapies were not associated with mortality, compared with csDMARDs or TNFis.