Table 2_Immune checkpoint inhibitor-induced diabetes mellitus: clinical characteristics and risk factors.docx

BackgroundEmerging evidence indicates that immune checkpoint inhibitor-induced diabetes mellitus (ICI-DM) might be more common than initially reported, and more different clinical pictures associated with ICI-DM were described.
ObjectiveThe aim of our study was to identify the clinical characteristics and possible predictive factors of ICI-DM.
MethodsWe conducted a retrospective review of patients who received immune checkpoint inhibitors (ICI) at West China Hospital, Sichuan University until June 2023. Patients were reviewed at death or on 7 May 2024. We applied logistic regression to study the associations between clinical characteristics and ICI-DM.
ResultsOur study included 8,199 participants who received ICI between October 2014 and June 2023. Among them, 1,077 patients (13.14%) developed ICI-DM according to diagnostic criteria based on guidelines. By excluding patients influenced by glucocorticoids or immunosuppressants, ICI-DM was observed in 713 of 8,199 (8.70%) patients. In all patients, hypertension, hyperlipidemia, using glucocorticoids or immunosuppressants, lung cancer, and using more than one pathway of ICI were associated with a higher risk of ICI-DM. However, the risk factors for ICI-DM in patients without the influence of glucocorticoids or immunosuppressants were only hypertension, hyperlipidemia, and pancreatic lesions. In all patients and those patients without the influence of glucocorticoids and immunosuppressants, hypertension and hyperlipidemia may increase the risk for ICI-DM.
ConclusionsThis large, real-world cohort demonstrates that the incidence of ICI-DM may be underestimated in previous literature. Blood glucose monitoring is needed in patients receiving ICI therapy.
Clinical trial registrationhttps://www.chictr.org.cn, identifier ChiCTR2300075974.

研究背景 越来越多的证据显示，免疫检查点抑制剂诱导的糖尿病（immune checkpoint inhibitor-induced diabetes mellitus, ICI-DM）的实际发病率可能较最初报道的更高，目前已有更多与ICI-DM相关的不同临床表型被报道。
研究目的 本研究旨在明确免疫检查点抑制剂诱导糖尿病的临床特征及潜在预测因素。
研究方法 本研究回顾性分析了2014年10月至2023年6月期间在四川大学华西医院接受免疫检查点抑制剂（immune checkpoint inhibitors, ICI）治疗的患者，随访终点为患者死亡或2024年5月7日。采用logistic回归分析临床特征与ICI-DM的关联。
研究结果 本研究共纳入8199例于2014年10月至2023年6月期间接受ICI治疗的患者。其中，按照指南制定的诊断标准，共有1077例（13.14%）患者发生ICI-DM；排除受糖皮质激素或免疫抑制剂影响的患者后，8199例患者中共有713例（8.70%）确诊ICI-DM。在全部患者中，高血压、高脂血症、使用糖皮质激素或免疫抑制剂、肺癌以及接受多于一种免疫检查点抑制剂通路治疗的患者发生ICI-DM的风险更高。而在排除受糖皮质激素或免疫抑制剂影响的患者后，仅高血压、高脂血症及胰腺病变为ICI-DM的危险因素。无论在全部患者还是排除糖皮质激素与免疫抑制剂影响的患者中，高血压与高脂血症均可能增加ICI-DM的发病风险。
研究结论 本项大规模真实世界队列研究表明，既往文献可能低估了ICI-DM的发病率。接受ICI治疗的患者需进行血糖监测。
临床试验注册 注册平台：https://www.chictr.org.cn，注册编号：ChiCTR2300075974。