Machado, P. M. et al. (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. Annals of the Rheumatic Diseases, 81(5), pp. 695-709. (doi: 10.1136/annrheumdis-2021-221490) (PMID:34972811) (PMCID:PMC8720639)
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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.
| Item Type: | Articles |
|---|---|
| Keywords: | COVID-19, vaccination, autoimmune diseases, antirheumatic agents, epidemiology. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | McInnes, Professor Iain |
| Authors: | 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.J., McInnes, I. B., and Mariette, X. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Infection & Immunity |
| Research Centre: | College of Medical Veterinary and Life Sciences > School of Infection & Immunity > Centre for Immunobiology |
| Journal Name: | Annals of the Rheumatic Diseases |
| Publisher: | BMJ Publishing Group |
| ISSN: | 0003-4967 |
| ISSN (Online): | 1468-2060 |
| Published Online: | 31 December 2021 |
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