COVID-19 vaccination and the incidence of de novo or recurrent rheumatoid arthritis: a French and international (VigiBase) signal detection study.

COVID-19 vaccination is critical in frequently immunocompromised rheumatoid arthritis (RA) patients. However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare-ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID-19 vaccination. We performed a "case-non-case" method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID-19 vaccination compared with other non-live vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out of RA cases after COVID-19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new-onset vs. flare-up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 Adverse Drug Reactions associated with COVID-19 vaccines recorded in VigiBase. The reporting odds ratio (ROR) of RA onset with COVID-19 vaccines compared to the other non-live vaccines was 0.66 (p < 0.0001). The FPVD reported 161 cases of RA with COVID-19 vaccines, including 77 new-onset RA and 84 cases of RA flare-up. In 88 cases (84.7%), RA occurred after the first dose. The mean time between vaccination and disease onset was 14±21 days, and the delay was significantly shorter in the flare-up group. We do not show a higher risk of RA after COVID-19 vaccination compared to other non-live vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in RA patients.