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05-06-2021 | EULAR 2021 | Conference coverage | News

Patients with RMDs not at increased risk for severe COVID-19 vaccine side effects

Author:
Lucy Piper

medwireNews: Initial data from the COVAX Registry offer reassurance for patients with rheumatic and musculoskeletal diseases (RMDs) that adverse events with the COVID-19 vaccines are similar to those seen in the general population.

The observational COVAX Registry has collected voluntary, physician-reported data from February to April 2021 on 1519 patients with an RMD who have been vaccinated against SARS-CoV-2.

Speaking at the EULAR 2021 Virtual Congress, Pedro Machado (University College London, UK) said that the “overwhelming majority of patients tolerated their vaccination well with rare reports of inflammatory RMD flare and very rare reports of severe adverse events.”


Pedro Machado presents COVID-19 vaccine safety data supporting their use for patients with rheumatic and musculoskeletal diseases (4:28).

Read transcript


In all, 31% of patients had any type of side effect following vaccination, and these were typical of what has been seen in the general population, including pain at the injection site (19%), fatigue (11%), headache (7%), and generalized muscle pain (6%).

There were 33 cases of organ or system side effects, of which only two were severe. These included vasculitis in an osteoarthritis patient that resulted in hospitalization but has since resolved and ongoing transient hemiparesis in a patient with overlapping systemic sclerosis and systemic lupus erythematosus.

The remaining 31 cases of side effects were mild to moderate in severity and 22 of these resolved without sequelae.

The patients involved had a mean age of 63 years and were predominantly women, at 68%. Data were available from 28 countries, with France and Italy making up the majority, at 60% and 13%, respectively.

Inflammatory joint disease was the primary diagnostic group, at 51%, followed by connective tissue diseases (19%) and vasculitis (16%), and the predominant diagnosis was rheumatoid arthritis, experienced by 30% of patients.

The participants were mainly taking DMARDs and glucocorticoids, with 29% of patients taking methotrexate, 18% tumor necrosis factor inhibitors, and 6% rituximab.

All of the vaccines were represented in the registry and the Pfizer–BioNTech (BNT162b2) vaccine was the one most commonly administered, at 78%.

Machado reported that 5% of patients with RMDs experienced disease flares, including 2.5% of patients with arthritis and 2.1% with arthralgia, and for 1.2% of patients these were classified as severe. He noted, however, that it is difficult to determine whether or not these flares are related to the vaccine.

“These initial findings should provide reassurance to rheumatologists and vaccine recipients, and promote confidence in COVID-19 vaccine safety in RMD patients, particularly those with inflammatory RMDs and/or taking immunomodulatory agents,” he concluded.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

5 June 2021: The coronavirus pandemic is affecting all healthcare professionals across the globe. Medicine Matters’ focus, in this difficult time, is the dissemination of the latest data to support you in your research and clinical practice, based on the scientific literature. We will update the information we provide on the site, as the data are published. However, please refer to your own professional and governmental guidelines for the latest guidance in your own country.

EULAR 2021 Virtual Congress; 2–5 June

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