COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study

Abstract

COVID‐19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). 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–noncase” method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID‐19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for 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 of RA onset with COVID‐19 vaccines compared with the other nonlive 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 with other nonlive vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in patients with RA.