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Epidemiology
Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry
  1. Pedro M Machado1,2,3,
  2. Saskia Lawson-Tovey4,5,
  3. Anja Strangfeld6,
  4. Elsa F Mateus7,8,
  5. Kimme L Hyrich4,5,
  6. Laure Gossec9,10,
  7. Loreto Carmona11,
  8. Ana Rodrigues12,13,14,
  9. Bernd Raffeiner15,
  10. Catia Duarte12,16,17,
  11. Eric Hachulla18,
  12. Eric Veillard19,
  13. Eva Strakova20,
  14. Gerd R Burmester21,
  15. Gözde Kübra Yardımcı22,
  16. Jose A Gomez-Puerta23,24,
  17. Julija Zepa25,26,
  18. Lianne Kearsley-Fleet27,
  19. Ludovic Trefond28,
  20. Maria Cunha12,29,
  21. Marta Mosca30,
  22. Martina Cornalba31,
  23. Martin Soubrier32,
  24. Nicolas Roux33,
  25. Olivier Brocq34,
  26. Patrick Durez35,
  27. Richard Conway36,
  28. Tiphaine Goulenok37,
  29. Johannes WJ Bijlsma38,
  30. Iain B McInnes39,
  31. Xavier Mariette40
  1. 1Centre for Rheumatology & Department of Neuromuscular Diseases, University College London (UCL), London, UK
  2. 2National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK
  3. 3Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK
  4. 4Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK
  5. 5National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
  6. 6Epidemiology and Health Care Research, German Rheumatism Research Center (DRFZ Berlin), Berlin, Germany
  7. 7People with Arthritis/Rheumatism in Europe (PARE), European Alliance of Associations for Rheumatology (EULAR), Kilchberg, Switzerland
  8. 8Portuguese League Against Rheumatic Diseases (LPCDR), Lisbon, Portugal
  9. 9Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université, Paris, France
  10. 10Department of Rheumatology, Pitié-Salpêtrière hospital, AP-HP, Paris, France
  11. 11Instituto de Salud Musculoesquelética, Madrid, Spain
  12. 12Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal
  13. 13EpiDoC unit, CEDOC, Nova Medical School, Lisbon, Portugal
  14. 14Rheumatology Unit, Hospital dos Lusíadas, Lisbon, Portugal
  15. 15Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy
  16. 16Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
  17. 17Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal
  18. 18Département 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. 19Cabinet de Rhumatologie des "Marines de Chasles", Saint Malo, France
  20. 20Department of Internal Medicine, Faculty Hospital Prešov, Prešov, Slovakia
  21. 21Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany
  22. 22Division of Rheumatology, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, Turkey
  23. 23Department of Rheumaology, Hospital Clinic, Barcelona, Spain
  24. 24University of Barcelona, Barcelona, Spain
  25. 25Pauls Stradins Clinical University Hospital, Riga, Latvia
  26. 26Riga Stradins University, Riga, Latvia
  27. 27Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK
  28. 28Université Clermont Auvergne, CHU Clermont-Ferrand, Service de Médecine Interne, Hôpital Gabriel Montpied, INSERM U1071, Clermont-Ferrand, France
  29. 29Hospital Garcia de Orta EPE, Almada, Setúbal, Portugal
  30. 30University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
  31. 31Dipartimento di Reumatologia e Scienze Mediche, ASST Gaetano Pini-CTO, Milan, Italy
  32. 32Department of Rheumatology, CHU Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand, France
  33. 33Service de Rhumatologie, Hôpital Robert Schuman, Metz, France
  34. 34Department of Rheumatology, Princess Grace Hospital, Monaco
  35. 35University Hospital Saint-Luc, Brussels, Belgium
  36. 36Department of Rheumatology, St. James’s Hospital, Dublin, Ireland
  37. 37Service de Médecine Interne, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Université de Paris, Paris, France
  38. 38Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands
  39. 39Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
  40. 40Department of Rheumatology, Université Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, INSERM UMR1184, Le Kremlin Bicêtre, Paris, France
  1. Correspondence to Dr Pedro M Machado, Centre for Rheumatology, University College London, London, UK; p.machado{at}ucl.ac.uk

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.

  • COVID-19
  • vaccination
  • autoimmune diseases
  • antirheumatic agents
  • epidemiology

Data availability statement

Data are available on reasonable request. Applications to access the data should be made to the European Alliance of Associations for Rheumatology (EULAR).

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

https://doi.org/10.1136/annrheumdis-2021-221490

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    Data availability statement

    Data are available on reasonable request. Applications to access the data should be made to the European Alliance of Associations for Rheumatology (EULAR).

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    Footnotes

    • Handling editor Josef S Smolen

    • Twitter @pedrommcmachado, @saskiaamber, @carmona_loreto

    • Contributors PMM is responsible for the overall content as the guarantor, and accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish. PMM and SL-T had access to the study data, developed the figures and tables, wrote the first draft of the manuscript and vouch for the data and analyses. PMM, KLH, LG, AR, BR, CD, EH, EV, ES, GRB, GKY, JAG-P, JZ, LF, LK-F, MCU, MM, MCo, MS, NR, OB, PD, RC, TG and XM contributed to data collection and interpretation of the data. PMM, SL-T, AS, EFM, KLH, LG, LC, EH, MM, GRB, JWJB, IBM and XM contributed to study design and questionnaire development. PMM directed the work and had final responsibility for the decision to submit for publication. All authors contributed intellectual content during the drafting and revision of the work and approved the final version to be published.

    • 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 manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre. SL-T does not report conflicts of interest. AS has received personal fees from lectures for AbbVie, MSD, Lilly, Roche, BMS and Pfizer. EFM has received personal consultant fees from Boehringer Ingelheim Portugal, Lda; LPCDR received support for specific activities: grants from Abbvie, Novartis, Lilly Portugal, Amgen Biofarmacêutica, Grünenthal S.A., MSD, Medac and from A. Menarini Portugal - Farmacêutica, S.A.; grants and non-financial support from Pfizer, and non-financial support from Grünenthal GmbH, outside the submitted work. KLH has received non-personal speaker’s fees from Abbvie and grant income from BMS, UCB and Pfizer, all unrelated to this manuscript, and is supported by the NIHR Manchester Biomedical Research Centre. LG has received personal consultant fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB, and grants from Amgen, Galapagos, Lilly, Pfizer, Sandoz and Sanofi, all unrelated to this manuscript. LC has not received any fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH and UCB Pharma. AR has received research grants and consultant fees from Amgen and Pfizer, all unrelated to this manuscript. BR does not report conflicts of interest. CD does not report conflicts of interest. EH does not report conflicts of interest. EV reports personal consultant fees from Theramex, unrelated to this manuscript. ES does not report conflicts of interest. G-RRB reports personal consultant fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis, UCB, all unrelated to this manuscript. GKY does not report conflicts of interest. JAG-P reports speaker fees from Abbvie, Astra-Zeneca, BMS, Galapagos, GSK, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis and Roche, all unrelated to this manuscript. JZ reports speaker fees from Abbvie, Novartis, Janssen/Johnson & Johnson, all unrelated to this manuscript. LK-F does not report conflicts of interest. LT does not report conflicts of interest. MCu does not report conflicts of interest. MM does not report conflicts of interest. MCo does not report conflicts of interest. MS does not report conflicts of interest. NR does not report conflicts of interest. OB does not report conflicts of interest. PD does not report conflicts of interest. RC reports speaker’s fees from Janssen, Roche, Sanofi, Abbvie, all unrelated to this work. TG does not report conflicts of interest. JWJB does not report conflicts of interest. IM does not report conflicts of interest. XM reports personal consultant fees from BMS, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sanofi-Aventis, UCB and grant from Ose, all unrelated to this manuscript.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.