RT Journal Article
SR Electronic
T1 Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 695
OP 709
DO 10.1136/annrheumdis-2021-221490
VO 81
IS 5
A1 Pedro M Machado
A1 Saskia Lawson-Tovey
A1 Anja Strangfeld
A1 Elsa F Mateus
A1 Kimme L Hyrich
A1 Laure Gossec
A1 Loreto Carmona
A1 Ana Rodrigues
A1 Bernd Raffeiner
A1 Catia Duarte
A1 Eric Hachulla
A1 Eric Veillard
A1 Eva Strakova
A1 Gerd R Burmester
A1 Gözde Kübra Yardımcı
A1 Jose A Gomez-Puerta
A1 Julija Zepa
A1 Lianne Kearsley-Fleet
A1 Ludovic Trefond
A1 Maria Cunha
A1 Marta Mosca
A1 Martina Cornalba
A1 Martin Soubrier
A1 Nicolas Roux
A1 Olivier Brocq
A1 Patrick Durez
A1 Richard Conway
A1 Tiphaine Goulenok
A1 Johannes WJ Bijlsma
A1 Iain B McInnes
A1 Xavier Mariette
YR 2022
UL http://ard.bmj.com/content/81/5/695.abstract
AB 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.Data are available on reasonable request. Applications to access the data should be made to the European Alliance of Associations for Rheumatology (EULAR).