COVID-19 vaccine safe in people with rheumatic diseases

Data from the EULAR COVID-19 Vaccination (COVAX) Registry showed that available COVID-19 vaccines were safe and well tolerated in patients with rheumatic and musculoskeletal diseases (RMDs).

“The safety profile for COVID-19 vaccines in RMD patients was reassuring,” said Dr Pedro Machado of University College London, London, UK, who presented the findings during the virtual EULAR 2021 Congress.  

“The overwhelming majority of patients tolerated their vaccination well with rare reports of inflammatory RMD flares and very rare reports of severe adverse events [AEs],” he reported.

Disease flares occurred in 5 percent of the 1,375 patients with inflammatory RMDs, with 1.2 percent being considered as severe cases. The flares most commonly manifested as arthritis, occurring in 2.5 percent of the patients, followed by arthralgia (2.1 percent), cutaneous flare (0.8 percent), and increased fatigue (0.8 percent). The flares took an average of 5 days from the last vaccination dose to manifest. [EULAR 2021, abstract LB0002] 

There were also few organ or systemic AEs, affecting only 2 percent of the entire population. Organ/systemic AEs that were considered serious were even rarer, reported in only two patients: one was a giant cell arteritis case in a patient with osteoarthritis, who subsequently recovered without further sequelae; and the other was hemiparesis in a patient with systemic sclerosis/systemic lupus erythematosus overlap syndrome, which was ongoing.  

“Most AEs were the same as in the general population, they were non-serious and involved short-term local and systemic symptoms,” Machado noted.

AEs of any type occurred at a rate of 31 percent, with the most common being pain at the injection site (19 percent), followed by fatigue (11 percent), headache (7 percent), and generalized muscle pain (6 percent). Most were early side effects, occurring within 7 days of vaccination.

“While vaccines are key pillar of public health … and they save millions of lives every year, vaccination also raises questions, especially for patients with inflammatory RMDs and/or treated with drugs that influence their immune system,” Machado pointed out.

As such, the EULAR COVAX registry was launched in Feb, 2021 to collect safety data among RMD patients receiving COVID-19 vaccines. A total of 1,519 patients (mean age 63 years, 68 percent female) from 28 countries were included in the analysis, with major contributors from France (60 percent) and Italy (13 percent).

Majority of the participants (91 percent) had inflammatory RMDs, with 51 percent of the cases being inflammatory joint diseases, 19 percent were connective tissue diseases, 16 percent were vasculitis, 9 percent being non-inflammatory/mechanical RMDs, and the remaining 4 percent were due to other immune-mediated inflammatory diseases.

The most common therapies used were conventional synthetic DMARDs* (45 percent), followed by biological DMARDs (36 percent), and systemic glucocorticoids (31 percent). Majority of vaccination involved the BNT162b2 mRNA vaccine in 78 percent of the patients. The remaining 16 percent and 5 percent received the AZD1222 and the mRNA-1273 vaccines, respectively. 

“These initial findings should provide reassurance to rheumatologists and vaccine recipients, and promote confidence in COVID-19 vaccine safety in RMD patients, namely those with inflammatory RMDs and/or taking treatments that influence their immune system,” Machado concluded.

*DMARDs: Disease-modifying antirheumatic drugs