In a large registry of I-RMD people vaccinated against coronavirus infection, the majority of people displayed good vaccine tolerability with rare reports of I-RMD flare and very rare reports of breakthrough infections and serious noxious events in fully vaccinated people.

This study was carried out to investigate safety of vaccines against coronavirus in individuals having inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD).

A physician-reported registry (EULAR Coronavirus Vaccine [COVAX]) of I-RMD and non-inflammatory RMD (NI-RMDs) included individuals vaccinated against coronavirus. Overall, 5121 people from thirty countries, 10% with NI-RMDs (n=517) and 90% with I-RMDs (n=4604) were incorporated. Data was gathered on noxious events, demographics, coronavirus breakthrough infections, vaccination, activity and diagnosis of RMD, immunomodulatory/immunosuppressive therapies, and flares. Descriptive analysis of data was done.

The most frequent diagnostic groups were vasculitis (12%), inflammatory joint diseases (58%), and connective tissue diseases (18%). Overall, 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 35% received immunosuppressants, and 42% received biological DMARDs.

Most participants were given the Pfizer/BioNTech vaccine (70%), 8% were given Moderna, and 17% were given AstraZeneca/Oxford. In fully vaccinated cases, the percentage of I-RMD and NI-RMD people reporting breakthrough infections are shown in Table 1:

Notably, I-RMD flares were witnessed in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. Severe adverse events were witnessed in 0.5% (0.4% I-RMD, 1.9% NI-RMD) while adverse events were witnessed in 37% of cases (37% I-RMD, 40% NI-RMD).

To sum up, the safety profile of COVID-19 vaccination in I-RMD people was reassuring and similar when compared to NI-RMDs people. A greater proportion of people showed good vaccine tolerability. These findings offer reassurance to rheumatologists, vaccine recipients, medical caregivers and boost confidence in vaccine safety in I-RMD people.