Lupus risk higher after mRNA vaccination against COVID-19
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Key takeaways:
- Women and older adults also had higher risks for bullous pemphigoid.
- The risks for most autoimmune connective tissue diseases did not increase with mRNA vaccination
Patients who received an mRNA COVID-19 vaccine demonstrated a 1.16-fold higher long-term risk for systemic lupus erythematosus, while a booster was linked to higher risk for psoriasis and rheumatoid arthritis, according to data.
However, the risks for developing most autoimmune connective tissue diseases — such as systemic sclerosis, Sjögren’s disease and ankylosing spondylitis — did not increase with mRNA vaccination, according to the study published in Nature Communications.
“While previous studies have suggested an association between mRNA vaccines and several systemic autoimmune diseases, there are limited studies demonstrating the development of [autoimmune connective tissue diseases (AI-CTDs)] following mRNA vaccination in large populations over a period of >1 year, despite the low incidence and slow development of AI-CTDs,” Seung-Won Jung, MD, of the department of dermatology at Yonsei University, in South Korea, and colleagues wrote.
“These uncertainties and adverse effects of mRNA vaccines have heightened public skepticism regarding vaccination and necessitated a risk-benefit analysis,” they added.
To examine whether mRNA vaccination against COVID-19 is linked to autoimmune connective tissue disease risk, Jung and colleagues conducted a nationwide, population-based cohort study. Using Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency databases, the study included 9,258,803 individuals vaccinated with at least one dose of mRNA COVID-19 vaccine before Dec. 31, 2022.
Half the cohort was analyzed as the vaccination group (n = 4,629,401), while an unvaccinated control group (n = 4,629,402) was constructed via shifting the other half of the group’s data back by 2 years from the date of their first dose. All patients in the study were observed for 1 year or longer, with follow-up ending at disease diagnosis, emigration, death or the end of the study period. The researchers observed the vaccination group Dec. 31, 2022, while the historical group was followed until Dec. 31, 2020.
According to the researchers, the vaccinated group showed “considerably higher risk” for developing SLE (adjusted HR = 1.16; 95% CI, 1.02-1.32) vs. the historical control group. Subgroup analysis additionally revealed significantly higher risks for developing bullous pemphigoid among women (adjusted HR = 2.67; 95% CI, 1.11-6.42), as well as individuals aged older than 40 years (adjusted HR = 1.53; 95% CI, 0.9-2.61).
For 2,284,342 individuals who received a third COVID-19 vaccine dose, the researchers conducted extended Cox proportional hazard analyses with booster doses treated as a time-varying covariate. Compared with those who did not receive the booster, those who received it demonstrated greater risk for alopecia areata (adjusted HR = 1.12; 95% CI, 1.05-1.19), psoriasis (adjusted HR = 1.16; 95% CI, 1.06-1.27) and RA (adjusted HR = 1.14; 95% CI, 1.08-1.21), according to the researchers.
“Our study results suggest that mRNA vaccination is generally not associated with a higher risk of most AI-CTDs,” Jung and colleagues wrote. “However, given that the risk of SLE and [bullous pemphigoid] was increased in certain demographic conditions, such as age and sex, long-term monitoring is necessary after mRNA vaccination for the development of AI-CTDs. Our results can provide critical insights into mRNA therapeutics, and further research is needed regarding the association between mRNA-based vaccines and AI-CTDs.”
Perspective
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Daniel J. Wallace, MD, FACP, MACR
Nealy 10 million South Koreans were divided into two groups — those who received a mRNA COVID-19 vaccine and historical controls, all of whom were followed for a little more than 1 year. The researchers studied 16 autoimmune features to determine if the vaccine had any influence upon their development. Only systemic lupus erythematosus showed an increased HR — along with possibly pemphigoid — that was not statistically significant.
The number of lupus patients is not provided, no charts were reviewed to validate the diagnosis of SLE, and it is not stated how the diagnosis was made. In addition, multiple comparisons confounded the significance of these results. This warrants further investigation, and other studies are in progress.
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