Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus

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 th...

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Main Authors: Akira Onishi, Hideaki Tsuji, Shuji Akizuki, Masao Tanaka, Ryosuke Hiwa, Ran Nakashima, Hajime Yoshifuji, Tsuneyasu Yoshida, Yudai Takase, Mirei Shirakashi, Hideo Onizawa, Koji Kitagori, Akio Morinobu
Format: Article
Language:English
Published: BMJ Publishing Group 2022-08-01
Series:Lupus Science and Medicine
Online Access:https://lupus.bmj.com/content/9/1/e000727.full
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author Akira Onishi
Hideaki Tsuji
Shuji Akizuki
Masao Tanaka
Ryosuke Hiwa
Ran Nakashima
Hajime Yoshifuji
Tsuneyasu Yoshida
Yudai Takase
Mirei Shirakashi
Hideo Onizawa
Koji Kitagori
Akio Morinobu
author_facet Akira Onishi
Hideaki Tsuji
Shuji Akizuki
Masao Tanaka
Ryosuke Hiwa
Ran Nakashima
Hajime Yoshifuji
Tsuneyasu Yoshida
Yudai Takase
Mirei Shirakashi
Hideo Onizawa
Koji Kitagori
Akio Morinobu
author_sort Akira Onishi
collection DOAJ
description 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.
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spelling doaj.art-26029197e0b9491799688df8513387212022-12-22T01:35:37ZengBMJ Publishing GroupLupus Science and Medicine2053-87902022-08-019110.1136/lupus-2022-000727Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosusAkira Onishi0Hideaki Tsuji1Shuji Akizuki2Masao Tanaka3Ryosuke Hiwa4Ran Nakashima5Hajime Yoshifuji6Tsuneyasu Yoshida7Yudai Takase8Mirei Shirakashi9Hideo Onizawa10Koji Kitagori11Akio Morinobu124 Department of Rheumatology and Clinical Immunology, Kobe University Graduate School of Medicine, Kobe, Japan1 Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan1 Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Advanced Medicine for Rheumatic Diseases, Graduate School of Medicine, Kyoto University, Kyoto, Japan5 Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan5 Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan12Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, JapanDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Advanced Medicine for Rheumatic Diseases, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, JapanObjectives 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.https://lupus.bmj.com/content/9/1/e000727.full
spellingShingle Akira Onishi
Hideaki Tsuji
Shuji Akizuki
Masao Tanaka
Ryosuke Hiwa
Ran Nakashima
Hajime Yoshifuji
Tsuneyasu Yoshida
Yudai Takase
Mirei Shirakashi
Hideo Onizawa
Koji Kitagori
Akio Morinobu
Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
Lupus Science and Medicine
title Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
title_full Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
title_fullStr Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
title_full_unstemmed Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
title_short Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus
title_sort medium term impact of the sars cov 2 mrna vaccine against disease activity in patients with systemic lupus erythematosus
url https://lupus.bmj.com/content/9/1/e000727.full
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