Safety of Vaccination Against Coronavirus Disease-19 (COVID-19) in Rheumatic and Musculoskeletal Diseases (Rmds) Patients: Results from the (ECR)-COVID-19 Group

Objectives: To investigate the incidence and associated risk factors of adverse events following COVID-19 vaccination in patients with inflammatory and non-inflammatory rheumatic and musculoskeletal diseases (I-RMD and NI-RMD, respectively). Methods: The Egyptian College of Rheumatology COVID-19 Study Group investigated physician-reported data (ECR-VaXurvey3) of RMD patients vaccinated against COVID-19 from December 2021 to June 2022, including their demographics, vaccination type, RMD diagnosis, treatments, post-vaccine flares, and other adverse events. The control group consisted of healthy, vaccinated individuals. Results: The ECR-VaXurvey3 included 890 vaccinated RMD patients, predominantly women (73.3%) with a mean age of 44.4 ± 12.1 years, and 172 controls. The RMD group comprised 816 (91.7%) with I-RMD and 74 (8.3%) with NI-RMD. The frequency of adverse events was comparable between the RMD and control groups. In RMD patients, injection site pain (59.9%) was the most reported adverse event. Post-vaccination COVID-19 infections and disease flares were reported in 2.9% and 12.1% of I-RMD patients and in 8.1% and 9.5% of NI-RMD patients (p =0.018 and p =0.497, respectively). The severity of prior COVID-19 infection (odds ratio (OR) = 2.4, 95% CI: 1.0–5.8; p =0.040) and azathioprine use (OR = 2.6, 95% CI: 1.1–5.9; p =0.024) were associated with higher post-vaccine adverse events, while biologic use was associated with fewer adverse events (OR = 0.5, 95% CI: 0.3–0.8; p =0.010). Conclusions: Adverse events following COVID-19 vaccinations in patients with RMD are comparable to controls.