PT - JOURNAL ARTICLE AU - Tsuneyasu Yoshida AU - Hideaki Tsuji AU - Akira Onishi AU - Yudai Takase AU - Mirei Shirakashi AU - Hideo Onizawa AU - Ryosuke Hiwa AU - Koji Kitagori AU - Shuji Akizuki AU - Ran Nakashima AU - Masao Tanaka AU - Hajime Yoshifuji AU - Akio Morinobu TI - Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus AID - 10.1136/lupus-2022-000727 DP - 2022 Aug 01 TA - Lupus Science & Medicine PG - e000727 VI - 9 IP - 1 4099 - http://lupus.bmj.com/content/9/1/e000727.short 4100 - http://lupus.bmj.com/content/9/1/e000727.full SO - Lupus Sci Med2022 Aug 01; 9 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.