Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
Lupus Sci Med. 2022 Aug;9(1). doi: 10.1136/lupus-2022-000727.
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.
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.
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).
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.
大量病例报告指出，在接种 SARS-CoV-2 信使 RNA（mRNA）疫苗后，SLE 会出现新发病例或病情加重。一些观察性研究表明，SLE 在接种 SARS-CoV-2 疫苗后的短期病情加重率较低。然而，目前尚无良好控制的临床研究，因此尚不确定 SARS-CoV-2 mRNA 疫苗对 SLE 加重的中期影响。因此，我们旨在通过配对方法分析接种疫苗与 SLE 患者的中期主观和客观疾病活动及病情加重之间的关联。
共纳入来自京都狼疮队列的 150 名 SLE 患者。基于首次接种日期，将接受两剂 SARS-CoV-2 mRNA 疫苗的患者与未接种疫苗的患者按 1:1 进行匹配。结局指标为 SLE 疾病活动指数-2000（SLEDAI-2K）、日本版 SLE 症状清单问卷（SSC-J）和雌激素治疗红斑狼疮国家评估-SLEDAI 加重指数在接种疫苗后 30、60 和 90 天的变化。
接种疫苗和未接种疫苗的 SLE 患者在第二次接种疫苗后 30、60 和 90 天的 SLEDAI-2K 水平无显著差异（调整后的估计值（95%CI）：30 天：-0.46（-1.48 至 0.56），p=0.39；60 天：0.38（-0.64 至 1.40），p=0.47；90 天：0.40（-0.54 至 1.34），p=0.41）。SSC-J 评分也观察到相似的结果（调整后的估计值（95%CI），30 天：0.05（-1.46 至 1.56），p=0.95；60 天：-0.63（-2.08 至 0.82），p=0.40；90 天：0.27（-1.04 至 1.58），p=0.69）和加重指数（调整后的比值比（95%CI），30 天：0.81（0.36 至 1.85），p=0.62；60 天：1.13（0.50 至 2.54），p=0.77；90 天：0.85（0.32 至 2.26），p=0.74）。
直到第二次接种疫苗后 90 天，SARS-CoV-2 疫苗接种并未显著影响 SLE 的中期主观和客观疾病活动或病情加重。
