| アブストラクト | PurposeThis study evaluated the potential association between programmed cell death protein-1/ligand-1 (PD-1/PD-L1) inhibitors and adrenal insufficiency (AI) in the Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore drug safety signals. MethodsThis study extracted real-world adverse event reports from the FAERS database spanning 2004 Q1 to 2024 Q4. Multiple disproportionality analysis methods were employed to evaluate the association between PD-1/PD-L1 inhibitors and AI, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) based on Information Component (IC), and Multi-item Gamma Poisson Shrinker (MGPS) methods. ResultsA total of 164,152 adverse events related to PD-1/PD-L1 inhibitors were identified in the FAERS database, among which 1,023 cases were associated with AI. The top three drugs with the highest signal strength, measured by IC(025), tislelizumab (IC(025) = 5.53), pembrolizumab (IC(025) = 4.01), and cemiplimab (IC(025) = 3.53). Time-to-onset analysis indicated that durvalumab and pembrolizumab were associated with the highest risk of AI during the initial treatment period (3-6 months), followed by a declining trend. Subgroup analysis showed a higher risk in patients over 65, males at significantly higher risk than females, and a stronger association of gastric cancer with AI risk signals than other cancers. Additionally, combination therapy with paclitaxel or lenvatinib mesylate was associated with an increased risk of AI onset.ConclusionsPD-1/PD-L1 inhibitors carry a potential risk of AI, and emphasis should be placed on early monitoring during clinical use to reduce the occurrence of adverse events. |
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| ジャーナル名 | Journal of endocrinological investigation |
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| Pubmed追加日 | 2026/5/6 |
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| 投稿者 | Pan, Ruoxuan; Chen, Tingting; Guo, Guimu; Chang, Sijie; Zhou, Jintuo; Niu, Peiguang; Zeng, Xiaoping; Zhang, Jinhua |
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| 組織名 | Department of Pharmacy, College of Clinical Medicine for Obstetrics & Gynecology;and Pediatrics, Fujian Maternity and Child Health Hospital, Fujian Medical;University, #18 Daoshan Road, Fuzhou, 350001, China.;University, #18 Daoshan Road, Fuzhou, 350001, China. pollyzhang2006@126.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42090113/ |
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