Risk of disease flares after SARS-CoV-2 mRNA vaccination in patients with systemic lupus erythematosus

• Published in: Immunological medicine Vol. 47; no. 2; pp. 76 - 84
• Main Authors: Kikuchi, Jun, Kondo, Yasushi, Kojima, Shuichiro, Kasai, Shiho, Sakai, Yuma, Takeshita, Masaru, Hiramoto, Kazuoto, Saito, Shuntaro, Fukui, Hiroyuki, Hanaoka, Hironari, Suzuki, Katsuya, Kaneko, Yuko
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis Group 01.06.2024
• Subjects: 2019-nCoV Vaccine mRNA-1273 - administration & dosage; 2019-nCoV Vaccine mRNA-1273 - adverse effects; 2019-nCoV Vaccine mRNA-1273 - immunology; Adult; Antibodies, Antinuclear - blood; Antibodies, Antinuclear - immunology; Antibodies, Neutralizing - blood; Antibodies, Viral - blood; BNT162 Vaccine - administration & dosage; BNT162 Vaccine - adverse effects; BNT162 Vaccine - immunology; COVID-19; COVID-19 - immunology; COVID-19 - prevention & control; COVID-19 Vaccines - administration & dosage; COVID-19 Vaccines - adverse effects; COVID-19 Vaccines - immunology; disease flares; Female; Humans; Lupus Erythematosus, Systemic - immunology; Male; Middle Aged; SARS-CoV-2 - immunology; Severity of Illness Index; Symptom Flare Up; Systemic lupus erythematosus; vaccination; Vaccination - adverse effects; COVID-19; Systemic lupus erythematosus; disease flares; vaccination
• ISSN: 2578-5826; 2578-5826
• DOI: 10.1080/25785826.2023.2300163

This study aims to elucidate the effectiveness and safety of SARS-CoV-2 mRNA vaccination in patients with systemic lupus erythematosus (SLE). We enrolled uninfected SLE patients who received two vaccine doses (BNT162b2 or mRNA-1273) and historical unvaccinated patients. Neutralizing antibodies, adverse reactions, and disease flares were evaluated 4 weeks after the second vaccination. Ninety patients were enrolled in each group. Among the vaccinated patients, SLE Disease Activity Index (SLEDAI), and prednisolone doses before vaccination were 2, and 5 mg/d, respectively. After the second vaccination, 19 (21.1%) had no neutralizing antibodies. Adverse reactions occurred in 88.9% within 3 d. Negative antibodies were associated with anemia and mycophenolate mofetil administration. SLEDAI increased modestly but significantly after vaccination, with 13 (14.4%) experiencing flares and 4 (4.4%) severe flares (nephritis in three and vasculitis in one). The flare rate was higher in vaccinated patients than unvaccinated controls. The mean duration between the second vaccination and flares was 35 d, and flares occurred at least 8 days after vaccination. Multivariable analysis showed that high SLEDAI and anti-dsDNA antibodies were associated with flares. The vaccine type, neutralizing antibody titer, and adverse reaction frequency did not affect flares. Therefore, residual disease activity before vaccination increases flare risk.