Hesitancy for SARS-CoV-2 vaccines and post-vaccination flares in patients with systemic lupus erythematosus.

Objectives: To study the rate of SARS-CoV-2 vaccination and post-vaccination disease flares in patients with systemic lupus erythematosus (SLE).

Methods: Patients who fulfilled ≥ 4 of the ACR criteria for SLE were identified and their SARS-CoV-2 vaccination status was traced. Flares of SLE at 6-week post-vaccination were reviewed retrospectively. Clinical characteristics of patients with and without vaccination, and those who did or did not experience post-vaccination flares were compared by statistical analyses.

Results: 914 adult patients with SLE were studied (92.5 % women, age 48.6 ± 14.0 years; SLE duration 14.5 ± 8.6 years). Two doses of the SARS-Cov-2 vaccines (61.5 % BioNTech; 38.5 % CoronaVac) were received by 449 (49.1 %) patients. The vaccination rate in SLE was significantly lower than that of the adult general population (77.8 %; p < 0.001) at the time of data analysis. Patients who were hesitant for vaccination were more likely to be hypertensive, have a history of neuromuscular manifestations, and a significantly higher organ damage score (1.10 ± 1.45 vs 0.74 ± 1.15; p < 0.001). However, none of these factors were significantly associated with vaccine hesitancy on multivariate analysis. Among 449 vaccinated patients, 37(8.2 %) experienced SLE flares: mild/moderate in 34; severe in 3. In an equal number of unvaccinated SLE controls randomly matched for the post-vaccination observation period, 28(6.2 %) had SLE flares: mild/moderate in 17; severe in 11 (odds ratio [OR] for flare in vaccinated patients 1.40[0.81-2.43]; p = 0.23, adjusted for age, sex, active serology, SLE duration and prednisolone use). In vaccinated patients, logistic regression revealed that active lupus serology before vaccination (OR 2.63[1.05-6.62]; p = 0.04) and a history of arthritis (OR 2.71[1.05-7.00]; p = 0.04) or discoid skin lesion (OR 4.73[1.90-11.8]; p = 0.001) were associated with SLE flares following vaccination, adjusted for confounders.

Conclusion: Hesitancy for COVID-19 vaccination is common in SLE patients. Vaccination against SARS-CoV-2 is not significantly associated with increased SLE flares. Patients with active SLE serology or a history of arthritis/discoid lesion are more likely to flare after vaccination.