Vaccination against COVID-19 was not found to increase incidence of disease flares in patients with systemic lupus erythematosus (SLE) compared with those who were unvaccinated, according to study findings published in Vaccine.
Researchers at the Department of Medicine at Tuen Mun Hospital in Hong Kong conducted a retrospective study to analyze patterns of vaccine hesitancy, vaccination status, and post-vaccination flares in patients with SLE.
The outcomes of adults with SLE were studied who received care at the rheumatology and lupus clinics between April 2021 and March 2022 and who scored a 4 or greater according to the American College of Rheumatology (ACR) criteria for SLE classification.
The researchers confirmed patient vaccination status using the government-run COVID-19 vaccine registry. The 2 publicly available vaccines, Pfizer-BioNTech and CoronaVac, China, were administered in 2 doses at 28 and 21 days apart, respectively.
At 6 weeks after full COVID-19 vaccination, the researchers reviewed participants’ medical records to assess for SLE flares. Complement 3 and 4 (C3/C4) and anti-dsDNA levels were compared before the administration of the first dose and after the second dose, indicating changes in SLE disease activity.
Primary outcomes of the study included the rate of SARS-CoV-2 vaccination and the incidence of disease flares after vaccination.
Of the 914 adults (92.5% women; mean age, 48.6±14.0 years) with SLE included in the analysis, 449 (49.1%) achieved full COVID-19 vaccination status. The majority (61.5%) of participants received 2 doses of the Pfizer vaccine and the remaining received the CoronaVac.
Patients with SLE vs the general population showed lower vaccination rates (49.1% vs 77.8%; P <.001).
Patients with SLE with COVID-19 vaccine hesitancy vs those who were fully vaccinated had higher cumulative organ damage scores on the SLE damage index (SDI) (1.10±1.45 vs 0.74±1.15; P <.001). Unvaccinated vs vaccinated patients with SLE were also more likely to have hypertension (23.4% vs 17.8%; P =.04) and a history of myositis or severe neuropsychiatric manifestations requiring immunosuppressive treatments, especially cyclophosphamide (22.8% vs 17.4%; P =.04) and calcineurin inhibitors (26.0% vs 20.0%; P =.03).
Postvaccination flares occurred in 37 (8.2%) of the 449 patients with SLE following the second dose. The researchers did not detect elevated SLE disease activity levels after the initial dose. Mild to moderate flares occurred in 34 patients and the remaining 3 patients had severe flares; however, all flares resolved with treatment.
Mild or moderate flares frequently involved the kidneys (n=16) followed by mucocutaneous lesions (n=13), arthritis (n=8), serositis (n=3), and thrombocytopenia (n=2). Severe flares affected the kidneys (n=2) and gastrointestinal system (n=1). All patients, except 1, who had post-vaccination renal flares reported a history of lupus nephritis.
As observed with prevaccination C3/C4 and anti-dsDNA levels, 78% of patients with postvaccination flares demonstrated active SLE serology. Anti-dsDNA serum levels significantly increased from baseline following both the Pfizer (P =.008) and CoronaVac (P =.004) vaccinations; however, the C3/C4 complement levels did not significantly change.
The researchers compared rate of SLE flares among vaccinated vs unvaccinated patients (8.2% vs 6.2%). Vaccinated patients with SLE did not experience flares at higher rates than unvaccinated patients (odds ratio [OR], 1.40; 95% CI, 0.81-2.43; P =.23).
The sample size and low number of SLE flares prevented multivariate analyses of all variables influencing vaccine hesitancy and postvaccination flares. Other study limitations included lack of data on COVID-19 vaccine immunogenicity and the effect of concurrent medications on immunogenicity, and the lack of consideration for self-reported reasons for vaccine hesitancy.
“Taken all these data together, the safety of COVID-vaccination in SLE patients in terms of disease flares is reassuring,” the study authors said. “The benefit of the SARS-CoV-2 vaccinaes far outweigh the risk of side effects or disease flares in patients with SLE.”
“The knowledge that [patients with] SLE with neuromuscular manifestations, organ damage, and medical comorbidities tend to be more hesitant to receive COVID-19 vaccination should alert physicians to give extra counseling to these patient subsets,” they advised.
Mok CC, Chan KL, Tse SM. Hesitancy for SARS-CoV-2 vaccines and post-vaccination flares in patients with systemic lupus erythematosus. Vaccine. 2022;40(41):5959-5964. doi:10.1016/j.vaccine.2022.08.068