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Machado PM, Lawson-Tovey S, Strangfeld A, 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. Ann Rheum Dis. 2021;doi: 10.1136/annrheumdis-2021-221490.
Machado, P. M., Lawson-Tovey, S., Strangfeld, A., Mateus, E. F., Hyrich, K. L., Gossec, L., Carmona, L., Rodrigues, A., Raffeiner, B., Duarte, C., Hachulla, E., Veillard, E., Strakova, E., Burmester, G. R., Yardımcı, G. K., Gomez-Puerta, J. A., Zepa, J., Kearsley-Fleet, L., Trefond, L., Cunha, M., Mosca, M., Cornalba, M., Soubrier, M., Roux, N., Brocq, O., Durez, P., Conway, R., Goulenok, T., Bijlsma, J. W., McInnes, I. B., & Mariette, X. (2021). 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, . https://doi.org/10.1136/annrheumdis-2021-221490
Machado, Pedro M, 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 vol. (2021). doi: https://doi.org/10.1136/annrheumdis-2021-221490
Machado PM, Lawson-Tovey S, Strangfeld A, Mateus EF, Hyrich KL, Gossec L, Carmona L, Rodrigues A, Raffeiner B, Duarte C, Hachulla E, Veillard E, Strakova E, Burmester GR, Yardımcı GK, Gomez-Puerta JA, Zepa J, Kearsley-Fleet L, Trefond L, Cunha M, Mosca M, Cornalba M, Soubrier M, Roux N, Brocq O, Durez P, Conway R, Goulenok T, Bijlsma JW, McInnes IB, Mariette X. Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. Ann Rheum Dis. 2021 Dec 31; doi: 10.1136/annrheumdis-2021-221490. Epub 2021 Dec 31. PMID: 34972811; PMCID: PMC8720639.
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Ann Rheum Dis. 2021 Dec 31; doi: 10.1136/annrheumdis-2021-221490. Epub 2021 Dec 31.

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

Pedro M Machado, Saskia Lawson-Tovey, Anja Strangfeld, Elsa F Mateus, Kimme L Hyrich, Laure Gossec, Loreto Carmona, Ana Rodrigues, Bernd Raffeiner, Catia Duarte, Eric Hachulla, Eric Veillard, Eva Strakova, Gerd R Burmester, Gözde Kübra Yardımcı, Jose A Gomez-Puerta, Julija Zepa, Lianne Kearsley-Fleet, Ludovic Trefond, Maria Cunha, Marta Mosca, Martina Cornalba, Martin Soubrier, Nicolas Roux, Olivier Brocq, Patrick Durez, Richard Conway, Tiphaine Goulenok, Johannes Wj Bijlsma, Iain B McInnes, Xavier Mariette

Affiliations

  1. Centre for Rheumatology & Department of Neuromuscular Diseases, University College London (UCL), London, UK [email protected].
  2. National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.
  3. Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK.
  4. Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
  5. National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
  6. Epidemiology and Health Care Research, German Rheumatism Research Center (DRFZ Berlin), Berlin, Germany.
  7. People with Arthritis/Rheumatism in Europe (PARE), European Alliance of Associations for Rheumatology (EULAR), Kilchberg, Switzerland.
  8. Portuguese League Against Rheumatic Diseases (LPCDR), Lisbon, Portugal.
  9. Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université, Paris, France.
  10. Department of Rheumatology, Pitié-Salpêtrière hospital, AP-HP, Paris, France.
  11. Instituto de Salud Musculoesquelética, Madrid, Spain.
  12. Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
  13. EpiDoC unit, CEDOC, Nova Medical School, Lisbon, Portugal.
  14. Rheumatology Unit, Hospital dos Lusíadas, Lisbon, Portugal.
  15. Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy.
  16. Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
  17. Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
  18. Département de Médecine Interne et Immunologie Clinique, CHU Lille, Referral Center for Rare Systemic Autoimmune Diseases North and Northwest of France, INSERM U995, Lille Inflammation Research International Center (LIRIC), University of Lille, Lille, France.
  19. Cabinet de Rhumatologie des "Marines de Chasles", Saint Malo, France.
  20. Department of Internal Medicine, Faculty Hospital Prešov, Prešov, Slovakia.
  21. Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  22. Division of Rheumatology, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, Turkey.
  23. Department of Rheumaology, Hospital Clinic, Barcelona, Spain.
  24. University of Barcelona, Barcelona, Spain.
  25. Pauls Stradins Clinical University Hospital, Riga, Latvia.
  26. Riga Stradins University, Riga, Latvia.
  27. Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
  28. Université Clermont Auvergne, CHU Clermont-Ferrand, Service de Médecine Interne, Hôpital Gabriel Montpied, INSERM U1071, Clermont-Ferrand, France.
  29. Hospital Garcia de Orta EPE, Almada, Setúbal, Portugal.
  30. University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
  31. Dipartimento di Reumatologia e Scienze Mediche, ASST Gaetano Pini-CTO, Milan, Italy.
  32. Department of Rheumatology, CHU Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand, France.
  33. Service de Rhumatologie, Hôpital Robert Schuman, Metz, France.
  34. Department of Rheumatology, Princess Grace Hospital, Monaco.
  35. University Hospital Saint-Luc, Brussels, Belgium.
  36. Department of Rheumatology, St. James's Hospital, Dublin, Ireland.
  37. Service de Médecine Interne, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Université de Paris, Paris, France.
  38. Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands.
  39. Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
  40. Department of Rheumatology, Université Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, INSERM UMR1184, Le Kremlin Bicêtre, Paris, France.

PMID: 34972811 PMCID: PMC8720639 DOI: 10.1136/annrheumdis-2021-221490

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.

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: COVID-19; antirheumatic agents; autoimmune diseases; epidemiology; vaccination

Conflict of interest statement

Competing interests: PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscr

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