Flares, breakthroughs rare after COVID-19 vaccination in inflammatory rheumatic disease
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Just 0.7% of fully vaccinated patients with inflammatory rheumatic and musculoskeletal disease experience a breakthrough COVID-19 infection, while only 4.4% demonstrate disease flare reactions, according to data.
“This study addresses specific concerns related to COVID-19 vaccination in people with autoimmune/inflammatory rheumatic diseases, who often have an underlying immune dysfunction and are treated with drugs that interfere with the immune system — immunosuppressive or immunomodulatory drugs,” Pedro M. Machado, MD, PhD, of University College London, told Healio.
To analyze the safety of COVID-19 vaccines among patients with inflammatory/autoimmune rheumatic and musculoskeletal disease, Machado and colleagues studied data from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. The researchers reviewed data from a total of 5,121 patients vaccinated against COVID-19 from 30 countries, including 4,605 with inflammatory rheumatic and musculoskeletal disease and 517 with non-inflammatory disease, with the latter group used as a control.
Data collection was conducted from Feb. 5, 2021, to July 27, 2021, and included demographics, vaccination information, disease diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events and COVID-19 breakthrough infections. Regarding adverse events, the researchers specifically sought out early effects within 7 days from vaccination, as well as effects of special interest based on the organ or system impacted.
Among the included patients, 58% had inflammatory joint disease, 18% had connective tissue disease and 12% had vasculitis. The most common inflammatory rheumatic and musculoskeletal diseases were rheumatoid arthritis, at 33%; axial spondyloarthritis, at 11%; and psoriatic arthritis, at 10%. Meanwhile the most frequent non-inflammatory rheumatic and musculoskeletal diseases were osteoarthritis, at 5%, and osteoporosis, at 2%. Regarding treatments, 54% received conventional synthetic DMARDs, 42% were treated with biological disease-modifying antirheumatic drugs and 35% received immunosuppressants.
Approximately 70% of the included patients received the Pfizer-BioNTech COVID-19 vaccine, while 17% received the AstraZeneca-Oxford vaccine and 8% had the Moderna vaccine.
Mean ages were 60.5 years in the inflammatory group and 71.4 years in the non-inflammatory group.
According to the researchers, who published their findings in the Annals of the Rheumatic Diseases, breakthrough COVID-19 infections were reported in 0.7% of inflammatory patients who were fully vaccinated, compared with 1.1% of fully vaccinated patients in the non-inflammatory group. Among the inflammatory group, flares were reported in 4.4% of cases, with 0.6% being severe and 1.5% resulting in medication changes.
Adverse events were reported in 37% of cases, including in 37% of inflammatory patients and in 40% of non-inflammatory patients. Serious adverse events occurred in 0.5% of cases — 0.4% in the inflammatory group and 1.9% for non-inflammatory patients.
“We showed that the safety profile of COVID-19 vaccines in people with inflammatory rheumatic and musculoskeletal diseases (RMDs) is similar to that in other groups of people,” Machado said. “There were also very few breakthrough infections in people with inflammatory RMDs. Our findings should provide reassurance to rheumatologists, other health professionals and vaccine recipients, and promote confidence in the safety of COVID-19 vaccination in people with inflammatory rheumatic diseases.”
“Our data will support discussions about the safety and positive benefit-risk ratio of COVID-19 vaccination for people with inflammatory rheumatic diseases,” he added. “This information will also help support the development of new and updated recommendations by competent organizations.”
Perspective
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Earlier this year, the United States eclipsed 900,000 deaths from COVID-19. As a consequence of this pandemic, 1 in 400 Americans are no longer with us, with the worldwide known deaths attributable to COVID-19 is approaching 6 million.
Vaccine development and deployment for COVID-19 accelerated at an unprecedented rate. These vaccines are highly effective in reducing the requirement for hospitalization and mechanical ventilation, and death attributable to the SARS CoV-2 virus. But the use of a vaccine for COVID-19 in patients with autoimmune rheumatic diseases raises some questions. Are the vaccines safe in this population? Can an immune-stimulating vaccine increase autoimmune disease activity? What influence do immunomodulating medications have on the safety and efficacy of these novel vaccines?
The analysis by Machado and colleagues demonstrates the overwhelming majority of patients with inflammatory rheumatic diseases tolerated the COVID-19 vaccines without significant adverse consequences. The safety profile of COVID-19 vaccines was comparable to patients with non-inflammatory rheumatic diseases and the general population. In patients with an autoimmune disorder, disease flares occurred 4% of the time. Severe disease flares occurred 0.4% of the time.
These findings suggest a favorable risk/benefit outcome for COVID-19 vaccine recipients with inflammatory rheumatic conditions on immunomodulating medications. These findings are reassuring and promote confidence in the COVID-19 vaccine to rheumatologists and to patients.
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