{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T16:43:49Z","timestamp":1788194629952,"version":"build-2803163510"},"reference-count":48,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T00:00:00Z","timestamp":1759190400000},"content-version":"unspecified","delay-in-days":91,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Natural Science Foundation of Fujian Province of China","award":["2024J08264"],"award-info":[{"award-number":["2024J08264"]}]},{"name":"Joint Funds for the Innovation of Science and Technology, Fujian Province","award":["2024Y9567"],"award-info":[{"award-number":["2024Y9567"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Lupus Sci Med"],"accepted":{"date-parts":[[2025,9,7]]},"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>SLE associated with immune checkpoint inhibitors (ICIs) is rare, and a comprehensive profile of ICI-induced SLE remains poorly characterised. This study aimed to explore the potential association between ICIs and SLE and characterise clinical features.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We extracted adverse event reports of patients with cancer with SLE from the FAERS (US Food and Drug Administration Adverse Event Reporting System) database (Q1 2011\u2013Q4 2024). A disproportionality analysis was conducted using the reporting OR (ROR) and the information component, with adjusted ROR calculated via logistic regression to control for confounders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>146\u2009066 ICI-related adverse events cases from patients with cancer were identified. Among these, 209 (median (IQR) age 63 (55.3\u201371.7) years; 106 (51%) female) cases of SLEs were reported. Our analysis detected significant positive signals for SLE associated with ICIs overall, particularly for anti-programmed cell death protein 1 (PD-1) and anti-programmed death-ligand 1 therapy. Eight positive signals of SLEs were identified, predominantly cutaneous lupus and SLE. The risk of ICI-related SLEs was significantly higher in females than in males. However, age and chemotherapy were not significant risk factors for the incidence of ICI-related SLEs. The risk was higher with anti-PD-1 therapy compared with other ICI therapies. Patients with lung cancer, melanoma or breast cancer appeared to be at higher risk. Most patients experienced serious outcomes, with a mortality rate of 4.31% (nine cases).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This first pharmacovigilance study identified a significant association between ICI use and SLEs, suggesting ICIs may constitute a novel class of drug-induced SLE triggers. Personalised long-term safety monitoring for ICIs is warranted for high-risk patients (eg, females, anti-PD-1 recipients).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/lupus-2025-001653","type":"journal-article","created":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T06:00:37Z","timestamp":1759212037000},"page":"e001653","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Characterisation of systemic lupus erythematosus associated with immune checkpoint inhibitors: a pharmacovigilance study using FAERS database"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-4555-7099","authenticated-orcid":false,"given":"Lan","family":"Zhen","sequence":"first","affiliation":[{"name":"Department of Gynecology Oncology, Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 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