Lan Zhen, Hong Chen, Wuyuan Pan, Jianrong Song, Huan Yi, Hong Zhou
{"title":"与免疫检查点抑制剂相关的系统性红斑狼疮的特征:使用FAERS数据库的药物警戒研究。","authors":"Lan Zhen, Hong Chen, Wuyuan Pan, Jianrong Song, Huan Yi, Hong Zhou","doi":"10.1136/lupus-2025-001653","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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-Q4 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.</p><p><strong>Results: </strong>146 066 ICI-related adverse events cases from patients with cancer were identified. Among these, 209 (median (IQR) age 63 (55.3-71.7) 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).</p><p><strong>Conclusion: </strong>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).</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 2","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481352/pdf/","citationCount":"0","resultStr":"{\"title\":\"Characterisation of systemic lupus erythematosus associated with immune checkpoint inhibitors: a pharmacovigilance study using FAERS database.\",\"authors\":\"Lan Zhen, Hong Chen, Wuyuan Pan, Jianrong Song, Huan Yi, Hong Zhou\",\"doi\":\"10.1136/lupus-2025-001653\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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-Q4 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.</p><p><strong>Results: </strong>146 066 ICI-related adverse events cases from patients with cancer were identified. Among these, 209 (median (IQR) age 63 (55.3-71.7) 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).</p><p><strong>Conclusion: </strong>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).</p>\",\"PeriodicalId\":18126,\"journal\":{\"name\":\"Lupus Science & Medicine\",\"volume\":\"12 2\",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-09-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481352/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lupus Science & Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/lupus-2025-001653\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lupus Science & Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/lupus-2025-001653","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Characterisation of systemic lupus erythematosus associated with immune checkpoint inhibitors: a pharmacovigilance study using FAERS database.
Objectives: 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.
Methods: 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-Q4 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.
Results: 146 066 ICI-related adverse events cases from patients with cancer were identified. Among these, 209 (median (IQR) age 63 (55.3-71.7) 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).
Conclusion: 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).
期刊介绍:
Lupus Science & Medicine is a global, peer reviewed, open access online journal that provides a central point for publication of basic, clinical, translational, and epidemiological studies of all aspects of lupus and related diseases. It is the first lupus-specific open access journal in the world and was developed in response to the need for a barrier-free forum for publication of groundbreaking studies in lupus. The journal publishes research on lupus from fields including, but not limited to: rheumatology, dermatology, nephrology, immunology, pediatrics, cardiology, hepatology, pulmonology, obstetrics and gynecology, and psychiatry.