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The COVID-19 vaccine was safe and well tolerated among patients with rheumatic diseases, analysis of data from a large European registry found.

Among 1,519 patients enrolled in the European League Against Rheumatism (EULAR) COVID-19 Vaccination Registry, severe adverse events were very rare, being reported in only two patients, according to Pedro M. Machado, MD, PhD, of University College London.

One of these events was a case of giant cell arteritis in a patient with osteoarthritis, which resolved without sequelae, and the other was a case of hemiparesis in a patient with systemic lupus erythematosus/systemic sclerosis overlap syndrome, which was ongoing at last report.

"Most of the adverse events were the same as in the general population and as have been seen for other vaccines, mainly being nonserious short-term local and systemic symptoms," Machado said during a late-breaking session at the EULAR virtual congress.

"The consequences of the COVID-19 outbreak are unprecedented and have been felt by everyone around the world, including people with rheumatic and musculoskeletal diseases. With the development of vaccines, the future is becoming brighter," Machado said.

Vaccines are a key pillar of public health. They have been proven to prevent many serious diseases and save millions of lives every year, but questions have arisen about their safety in patients with inflammatory diseases who take medications influencing the immune system. These questions have included concerns about disease flares, immunocompromise, and immunogenicity.

Therefore, to gather a wide range of safety data, the EULAR registry was launched on Feb. 5, 2021, and has now received reports from 28 countries, with France and Italy being the largest contributors.

Among the 1,519 cases reported as of April 27, 2021, more than two-thirds were in women whose mean age was 63. The most common diagnoses were rheumatoid arthritis (30%), ankylosing spondyloarthritis (8%), psoriatic arthritis (8%), systemic lupus erythematosus (7%), and polymyalgia rheumatica (6%). The diseases were considered inflammatory in 91%.

At the time of vaccination, 45% of patients were taking conventional disease-modifying antirheumatic drugs (DMARDs), 36% were on biologics, 31% were using systemic corticosteroids, 6% were receiving other immunosuppressants such as azathioprine, mycophenolate, or cyclophosphamide, and 3% were receiving targeted synthetic DMARDs.

The majority of vaccine recipients (78%) were given the Pfizer/BioNTech vaccine, while 16% received the AstraZeneca vaccine, 5% had the Moderna vaccine, and the remainder were other/unknown.

A post-vaccine COVID-19 diagnosis was reported in 1%.

Disease flares occurred in 5%, with the flares being considered severe in 1.2%. Flare manifestations included arthritis in 2.5%, arthralgia in 2.1%, cutaneous flare in 0.8%, and increased fatigue in 0.8%.

Potential vaccine side effects of any type were reported by 31% of patients. These included pain at the injection site in 19%, fatigue in 11%, headache in 7%, and generalized muscle pain in 6%. Most occurred within 7 days of the injection.

Among organ system adverse events of special interest other than the single cases of hemiparesis and giant cell arteritis were one case of mild cardiac arrhythmia, which resolved, one case of moderate arthritis, with the outcome unknown, two cases of liver injury, with one being mild and the other moderate and one having resolved, and a single case of mild anosmia/ageusia, which also resolved.

"In conclusion, the safety profile for COVID-19 vaccine in patients with rheumatic and musculoskeletal disorders was very reassuring," Machado said.

"These initial findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in COVID-19 vaccine safety in rheumatic patients, particularly those with inflammatory disease and/or are taking immunomodulatory treatments," he concluded.

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