Immunotherapies and COVID-19 mortality: a multidisciplinary open data analysis based on FDA's Adverse Event Reporting System.

During the COVID-19 pandemic, the risks and potential benefits of immunotherapies for the treatment of autoimmune disorders are still not well defined, and many cohort studies neither took the epidemiological dynamics of COVID-19 nor the potential capacities of the local healthcare systems in their outcome analysis into account. Due to a pronounced heterogeneity in the outcome reports of different participating countries, the large ‘COVID-19 Global Rheumatology Alliance registry’ addressed this issue using a ‘cluster design’ and shed light on factors associated with a more severe COVID-19 course in their study population.1 We here present data of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS),2 a postmarketing, self-reporting, open-access pharmacovigilance platform that contains international data of COVID-19 cases. Sources of FAERS are voluntary reports from healthcare professionals and consumers. We combine this data set with local measurements of the course of the pandemic (from Oxford University’s ‘Our World in Data’3) and the potential resiliency of the respective healthcare systems (from ‘World Bank’; see online supplemental table 1 for full source information). Only patients with the diagnosis of an autoimmune disorder and a single immunotherapy (required group size: n≥100) at the time point of COVID-19 were analysed by multivariable regression analysis (online supplemental figure 1), limiting the generalisability of our data, for example, concerning combination therapy scenarios (online supplemental figure 1).### Supplementary data [annrheumdis-2021-220679supp001.pdf] The mean age of patients in our cohort (n=2103) was 51.3 years (range 3–92 years; SD 14.9), female sex was more prevalent (1372/2103, 65.2%) and the majority of cases was reported in the USA/Canada (1285/2103, 61.1%). Inflammatory joint disease (846/2103, 40.2%), multiple sclerosis (474/2103, 22.5%) and inflammatory skin disease (435/2103, 20.7%) were the most prevalent diagnoses. Anti-tumour necrosis factor α (TNFα) therapies were the most frequently used medications for the …