Background Although the safety profile of COVID-19 vaccines was shown to be acceptable in the clinical trials, risk and benefit of the vaccines in patients with systemic lupus erythematosus (SLE) are not known, as these patients have been excluded in the trials. The aim of the COVID-19 Vaccine In Lupus (C1VIL) study was to assess the risk and benefits of COVID-19 vaccines in on patients with systemic lupus erythematosus (SLE).
Methods Information regarding COVID-19 vaccination and COVID-19 infection were collected from 207 SLE patients seen at 12 academic medical centers, affiliated with the Korean society of SLE research (KSSR) by patient self-reported, descriptive questionnaire from DEC 2022 to JAN 2023. Primary outcomes included status of COVID-19 vaccination/infection, vaccination-related adverse events (AEs), and disease flares after COVID-19 vaccination/infection.
Results As of JAN 2023, 77.5% of patients had received at least 1 shot of the COVID-19 vaccine. Overall, vaccine-related AE occurred in 66% of the patients, and 4.5% of the patients had serious vaccine-related AE requiring hospitalization. The most common AE pain/redness on the injection site, followed by myalgia, and/or arthralgia. COVID-19 was confirmed in 156 patients, and 3.2% of the infected patients required hospitalization. The incidence of Covid-19 was higher in the age group of >40 years (p=0.049), but not significantly different between vaccinated and never-vaccinated groups (69.9% vs 55.6%, p=0.489). Disease flare requiring medication change or hospitalization occurred in 10.3% of patients after COVID-19 vaccination, whereas in 14.9% of patients after COVID-19 infection. Disease flare also occurred more frequently in the age group of >40 years (p=0.046).
Conclusions Vaccine hesitancy was observed in Korean patients with SLE, although vaccine-related AEs were mild to modest and disease flares were more frequent after COVID-19 infection than vaccination. Our data suggest that benefit of the COVID-19 vaccines appears to outweigh the risk in patients with SLE.
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