COVID-19 VACCINE SAFETY IN PATIENTS WITH RHEUMATIC AND MUSCULOSKELETAL DISEASE
Authors: P. M. Machado et al.
In an elegant case-crossover study, these Italian investigators explored the association between RA flares and air
The EULAR COVID-19 Vaccination (COVAX) registry is an observational study aiming to collect safety data among RMD patients receiving COVID-19 vaccines. A total of 1519 patients were reported to the registry, mostly with rheumatoid arthritis or other inflammatory joint diseases. Patients were receiving conventional synthetic DMARDs (45%), biological DMARDs (36%), systemic glucocorticoids (31%) and other antirheumatic therapies.
The vaccines administered were: 78% Pfizer, 16% AstraZeneca, 5% Moderna. COVID-19 diagnosis after vaccination was reported in 1% (18/1519) of cases. Disease flares were reported by 5% (73/1375) of patients, with 1.2% (17/1375) classified as severe flares, which occurred on average 5 days after vaccination. Potential vaccine adverse events were reported by 31% of patients: pain at the site of injection (281/1519=19%), fatigue (171/1519=11%) and headache (103/1519=7%), but only 0.1% (2/1519) reported severe adverse events.
It has been known for a long time that active and passive smoking is a risk factor for developing RA. Once RA has deCOVID-19 vaccination raises questions, in particular for patients with inflammatory RMDs, because of fears the vaccination could trigger a flare of their underlying disease or because of concerns of a potential interaction with their immunomodulatory therapy. Overall the safety profiles of this first analysis of COVID-19 vaccines safety in RMD patients is reassuring, as most adverse events were non-serious and comparable to those in the general population. It is important to acknowledge that some rare patients seem to have suffered from inflammatory RMD flares, but we do not yet know if the incidence of new flares is increased beyond what occurs at baseline. Furthermore, it is currently still unknown to what extent the concomitant DMARDS therapy affects vaccine response.