Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. Issue 5 (31st December 2021)

• Record Type: Journal Article
• Authors: Machado, Pedro M; Lawson-Tovey, Saskia; Strangfeld, Anja; Mateus, Elsa F; Hyrich, Kimme L; Gossec, Laure; Carmona, Loreto; Rodrigues, Ana; Raffeiner, Bernd; Duarte, Catia; Hachulla, Eric; Veillard, Eric; Strakova, Eva; Burmester, Gerd R; Yardımcı, Gözde Kübra; Gomez-Puerta, Jose A; Zepa, Julija; Kearsley-Fleet, Lianne; Trefond, Ludovic; Cunha, Maria; Mosca, Marta; Cornalba, Martina; Soubrier, Martin; Roux, Nicolas; Brocq, Olivier; Durez, Patrick; Conway, Richard; Goulenok, Tiphaine; Bijlsma, Johannes WJ; McInnes, Iain B; Mariette, Xavier;
• Is Part Of: Annals of the rheumatic diseases. Volume 81:Issue 5(2022)
• Page Start: 695
• Page End: 709
• Publication Date: 2021-12-31
• Subjects: COVID-19 -- vaccination -- autoimmune diseases -- antirheumatic agents -- epidemiology; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2021-221490
• Languages: English
• ISSNs: 0003-4967

Abstract

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.