Data on safety profile of COVID-19 vaccines in rheumatic disease patients ‘reassuring’


‘Very reassuring’ data has been presented on COVID-19 vaccine safety in patients with rheumatic diseases at the 2021 virtual EULAR Congress.

A dedicated EULAR COVID-19 Vaccination (COVAX) registry launched in February has provided the first evidence showing no real difference between vaccine side effects in patients with rheumatic diseases and the general population.

Presenting the late breaking research, Dr Pedro Machado Associate Professor and Consultant Rheumatologist at University College London said the results would be reassuring for both patients and clinicians.

Between 5th February and 27th April, data was collected on more than 1500 patients from 28 countries with France and Italy contributing most patients to the voluntary register.

The majority of patients were female (68%) with a median age of 63 years, he told the meeting.

Nine in ten patients had inflammatory rheumatic disease, with just over half having an inflammatory joint disease.

At the time of vaccination, 45% of patients were taking conventional synthetic disease modifying anti-rheumatic drugs (DMARDs), 36% biological DMARDs, and 31% glucocorticoids. The most frequently use drug was methotrexate followed by TNF-inhibitors.

Most patients had received the Pfizer vaccine (78%) but 16% had AstraZeneca and 5% Moderna. Two thirds of patients had received two vaccine doses at the time of analysis.

Disease flares occurred in 5% of the patients with inflammatory rheumatic diseases with 1.2% classified as severe flares, he reported.

The most common types of flare were arthritis (2.5%), arthralgia (2.1%), and cutaneous flare 0.8%, he said.

In all potential vaccine side effects were reported by 31% of the patients. The majority were the typical early adverse reactions seen in the general population such as pain at the site of infection, fatigue, headache and generalised muscle pain.

There were a small number of (33 or 2%) of cases of organ or system side effects of special interest but there were only two severe adverse events reported to the registry, Dr Machado said.

Those were a case of transient hemiparesis in a patient with systemic sclerosis/SLE overlap syndrome and a case of giant cell arteritis in a patient with osteoarthritis which then resolved.

“These initial findings should provide reassurance to rheumatologists and vaccine recipients and they should promote confidence in COVID-19 vaccine safety in patients with rheumatic disease particularly those with inflammatory conditions and or taking immunomodulatory agents,” he said.

“The safety profile of COVID-19 vaccines in patients with rheumatic diseases was very reassuring. Most adverse events were the same as reported in the general population and have been reported with many other types of vaccines.”

“The overwhelming majority of patients tolerated their vaccination very well with rare reports of rheumatic disease flare and very rate reports of severe adverse events.”

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