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.
Radiation recall reactions are inflammatory reactions confined to previously irradiated tissues, often of drug‐induced etiology, particularly with anticancer therapies. Other drugs, in particular COVID‐19 vaccines, may also be involved. To describe radiation recall reactions under non‐anticancer drugs more precisely, we extracted the cases of radiation recall reactions associated with non‐anticancer drugs from WHO pharmacovigilance database VigiBase®. We performed two analyses from this extraction: a global analysis and an analysis focusing on vaccination‐related issues. We extracted 120 cases corresponding to 269 drugs, of which 130 were non‐anticancer (22 vaccines). Among the non‐anticancer drugs, tozinameran was the most reported treatment (4.46% of cases), followed by levofloxacin (2.97%) and folinic acid (2.60%), dexamethasone (2.23), and ChAdOx1 nCoV‐19 vaccine and prednisone (1.86% each). Among vaccines, tozinameran (54.55% of cases) was the most reported, followed by ChAdOx1 nCoV‐19 (22.73%), HPV and inactivated influenza vaccine (9.09% each), and elasomeran (4.55%). Our study first describes the occurrence of radiation recall reactions during non‐anticancer treatment. It also highlights a potential safety signal with COVID‐19 vaccines.
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