Safety of Vaccination against SARS-CoV-2 in People with Rheumatic and Musculoskeletal Diseases: Results from the EULAR Coronavirus Vaccine (COVAX) Physician-Reported Registry - Sorbonne Université Access content directly
Journal Articles Annals of the Rheumatic Diseases Year : 2022

Safety of Vaccination against SARS-CoV-2 in People with Rheumatic and Musculoskeletal Diseases: Results from the EULAR Coronavirus Vaccine (COVAX) Physician-Reported Registry

Elsa F Mateus
  • Function : Author
Ana Rodrigues
  • Function : Author
Eric Veillard
  • Function : Author
Eva Strakova
  • Function : Author
Jose A Gomez-Puerta
  • Function : Author
Julija Zepa
  • Function : Author
Maria Cunha
  • Function : Author
Martina Cornalba
  • Function : Author
Martin Soubrier
Nicolas Roux
  • Function : Author
Richard Conway
  • Function : Author
Iain B Mcinnes
  • Function : Author

Abstract

Objectives To describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD). Methods Physician-reported registry of I-RMD and non-inflammatory RMD (NI-RMDs) patients vaccinated against SARS-CoV-2. From 5 February 2021 to 27 July 2021, we collected data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events (AEs) and SARS-CoV-2 breakthrough infections. Data were analysed descriptively. Results The study included 5121 participants from 30 countries, 90% with I-RMDs (n=4604, 68% female, mean age 60.5 years) and 10% with NI-RMDs (n=517, 77% female, mean age 71.4). Inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnostic groups; 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants. Most patients received the Pfizer/BioNTech vaccine (70%), 17% AstraZeneca/Oxford and 8% Moderna. In fully vaccinated cases, breakthrough infections were reported in 0.7% of I-RMD patients and 1.1% of NI-RMD patients. I-RMD flares were reported in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. AEs were reported in 37% of cases (37% I-RMD, 40% NI-RMD), serious AEs in 0.5% (0.4% I-RMD, 1.9% NI-RMD). Conclusion The safety profiles of SARS-CoV-2 vaccines in patients with I-RMD was reassuring and comparable with patients with NI-RMDs. The majority of patients tolerated their vaccination well with rare reports of I-RMD flare and very rare reports of serious AEs. These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients.
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hal-03896047 , version 1 (30-04-2024)

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Pedro M Machado, Saskia Lawson-Tovey, Anja Strangfeld, Elsa F Mateus, Kimme L Hyrich, et al.. Safety of Vaccination against SARS-CoV-2 in People with Rheumatic and Musculoskeletal Diseases: Results from the EULAR Coronavirus Vaccine (COVAX) Physician-Reported Registry. Annals of the Rheumatic Diseases, 2022, 81 (5), pp.695--709. ⟨10.1136/annrheumdis-2021-221490⟩. ⟨hal-03896047⟩
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