Zhao Pengfei, Li Jia, Yu Lihong, Ma Wenming, Zhao Ting
Department of Clinical Pharmacy, Weifang People's Hospital, Shandong Second Medical University, Weifang, Shandong, China.
Department of Adverse Drug Reaction Monitoring, Weifang Market Regulation Development Service Center, Weifang, Shandong, China.
Front Immunol. 2025 Apr 28;16:1581057. doi: 10.3389/fimmu.2025.1581057. eCollection 2025.
Immune checkpoint inhibitors (ICPIs) have emerged as a powerful strategy to cancer treatment. However, while demonstrating antitumor efficacy, they can also induce a range of immune-related adverse events (irAEs). Immune-related thyroid dysfunction is one of the most common irAEs. This study aims to investigate the clinical characteristics and identify potential risk factors associated with PD-1 inhibitor-induced immune-related thyroid dysfunction in real-world.
A retrospective analysis was conducted on the clinical data of cancer patients treated with PD-1 inhibitors at Weifang People's Hospital from January 2021 to December 2024. The incidence, clinical subtypes, onset time, and prognostic outcomes of thyroid dysfunction were analyzed. Univariate and multivariate logistic regression analyses were performed to identify risk factors.
119 patients of PD-1 inhibitor-associated thyroid dysfunction were identified. The overall incidence of thyroid dysfunction was 2.97%, with hypothyroidism occurring in 1.20%, hyperthyroidism in 1.77%, and thyroiditis in 0.50% of patients. Tislelizumab exhibited the highest incidence at 3.48%, followed by camrelizumab at 3.10%, sintilimab at 2.24%, and toripalimab at 1.75%. The median time from the initiation of immunotherapy to the onset of thyroid dysfunction was 67 days, with hypothyroidism and hyperthyroidism developing at median times of 64.5 and 69 days, respectively. 77.31% of cases occurred within the first four months of immunotherapy. Female gender, lower baseline FT3 levels, history of targeted therapy, and baseline TgAb positivity were identified as independent risk factors for PD-1 inhibitor-associated thyroid dysfunction. Furthermore, higher baseline TSH levels, younger age, and treatment with tislelizumab or camrelizumab were associated with an increased risk of immune-related hypothyroidism, whereas lower baseline TSH levels were linked to a higher risk of immune-related hyperthyroidism.
Close clinical and hormonal monitoring is recommended for patients with high-risk factors before and throughout the course of immunotherapy, particularly during the initial 2 to 4 months of PD-1 inhibitor treatment.
免疫检查点抑制剂（ICPIs）已成为一种强大的癌症治疗策略。然而，在显示抗肿瘤疗效的同时，它们也会引发一系列免疫相关不良事件（irAEs）。免疫相关甲状腺功能障碍是最常见的irAEs之一。本研究旨在调查现实世界中与PD-1抑制剂诱导的免疫相关甲状腺功能障碍相关的临床特征并确定潜在风险因素。
对2021年1月至2024年12月在潍坊市人民医院接受PD-1抑制剂治疗的癌症患者的临床资料进行回顾性分析。分析甲状腺功能障碍的发病率、临床亚型、发病时间和预后结果。进行单因素和多因素逻辑回归分析以确定风险因素。
确定了119例与PD-1抑制剂相关的甲状腺功能障碍患者。甲状腺功能障碍的总体发病率为2.97%，其中甲状腺功能减退的发生率为1.20%，甲状腺功能亢进为1.77%，甲状腺炎为0.50%。替雷利珠单抗的发病率最高，为3.48%，其次是卡瑞利珠单抗，为3.10%，信迪利单抗为2.24%，特瑞普利单抗为1.75%。从免疫治疗开始到甲状腺功能障碍发作的中位时间为67天，甲状腺功能减退和甲状腺功能亢进分别在中位时间64.5天和69天出现。77.31%的病例发生在免疫治疗的前四个月内。女性、较低的基线FT3水平、靶向治疗史和基线TgAb阳性被确定为与PD-1抑制剂相关的甲状腺功能障碍的独立风险因素。此外，较高的基线TSH水平、较年轻的年龄以及使用替雷利珠单抗或卡瑞利珠单抗治疗与免疫相关甲状腺功能减退的风险增加相关，而较低的基线TSH水平与免疫相关甲状腺功能亢进的风险较高相关。
对于在免疫治疗前及整个过程中具有高危因素的患者，建议密切进行临床和激素监测，尤其是在PD-1抑制剂治疗的最初2至4个月期间。
