RT Journal Article
SR Electronic
T1 Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
JF Lupus Science & Medicine
JO Lupus Sci Med
FD Lupus Foundation of America
SP e000727
DO 10.1136/lupus-2022-000727
VO 9
IS 1
A1 Tsuneyasu Yoshida
A1 Hideaki Tsuji
A1 Akira Onishi
A1 Yudai Takase
A1 Mirei Shirakashi
A1 Hideo Onizawa
A1 Ryosuke Hiwa
A1 Koji Kitagori
A1 Shuji Akizuki
A1 Ran Nakashima
A1 Masao Tanaka
A1 Hajime Yoshifuji
A1 Akio Morinobu
YR 2022
UL http://lupus.bmj.com/content/9/1/e000727.abstract
AB Objectives Numerous case reports have referred to new onset or flare of SLE after SARS-CoV-2 messenger RNA (mRNA) vaccines. Several observational studies showed that the short-term flare rate of SLE after SARS-CoV-2 vaccination is low. However, well-controlled clinical surveys are unavailable and the medium-term impact of the SARS-CoV-2 mRNA vaccines against the flare of SLE is uncertain. Therefore, we aimed to analyse the association between vaccination and medium-term subjective and objective disease activities of SLE and flares using matched pair methods.Methods Altogether, 150 patients with SLE from the Kyoto Lupus Cohort were included. Patients who received two doses of the SARS-CoV-2 mRNA vaccines were 1:1 matched with unvaccinated patients based on the first vaccination date. The outcome measures were the SLE Disease Activity Index-2000 (SLEDAI-2K), the Japanese version of the SLE Symptom Checklist Questionnaire (SSC-J) and the Safety of Estrogens in Lupus Erythematosus National Assessment-SLEDAI flare index at 30, 60 and 90 days after vaccination.Results SLEDAI-2K levels were not significantly different in vaccinated and unvaccinated patients with SLE at 30, 60 and 90 days after the second vaccination (adjusted estimate (95% CI): 30 days: −0.46 (−1.48 to 0.56), p=0.39; 60 days: 0.38 (−0.64 to 1.40), p=0.47; 90 days: 0.40 (−0.54 to 1.34), p=0.41). Similar results were observed in the SSC-J score (adjusted estimate (95% CI), 30 days: 0.05 (−1.46 to 1.56), p=0.95; 60 days: −0.63 (−2.08 to 0.82), p=0.40; 90 days: 0.27 (−1.04 to 1.58), p=0.69) and flare index (adjusted OR (95% CI), 30 days: 0.81 (0.36 to 1.85), p=0.62; 60 days: 1.13 (0.50 to 2.54), p=0.77; 90 days: 0.85 (0.32 to 2.26), p=0.74).Conclusion SARS-CoV-2 vaccination did not significantly influence the medium-term subjective and objective disease activities or flares of SLE until 90 days after the second vaccination.All data relevant to the study are included in the article or uploaded as supplementary information.