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

Abstract

ObjectivesTo describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD).MethodsPhysician-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.ResultsThe 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).ConclusionThe 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.

Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine

“…The low rate of disease flares in RD was consistent with other publications [ 17 – 25 ]. It has been also suggested that the underlying risk of flare may differ among RD [ 17 ].…”

Colchicine prophylaxis is associated with fewer gout flares after COVID-19 vaccination

“…Recently, a case-crossover study conducted by Yokose et al 2 revealed that recombinant herpes zoster vaccine (RZV) in the prior 2 days was associated with a twofold increased odds of gout flare when compared with no vaccine periods (adjusted OR 1.99; 95% CI 1.01 to 3.89). A study conducted by the European Alliance of Associations for Rheumatology Coronavirus Vaccine physician-reported Registry reported 4.4% of flare following mRNA vaccination in inflammatory/autoimmune rheumatic and musculoskeletal disease cases from 30 countries 3. However, to date, no systemic analysis, even real-world data, investigated the association between COVID-19 vaccine and gout flare.…”

Overview of infections as an etiologic factor and complication in patients with vasculitides

“…However, a booster dose may be met with greater success in these patients and is, therefore, warranted [101]. It is also worthwhile mentioning that vaccination against SARS-CoV-2 is well-tolerated and generally safe in patients with inflammatory rheumatic diseases, including vasculitides, with low rates of breakthrough infections [102]. However, disease relapses have been reported in patients with AAV and HSP [103,104].…”