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

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 list

 

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

Novel Coronavirus SARS-CoV-2

10.1136/annrheumdis-2021-221490

BMJ - Annals of the Rheumatic Diseases