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Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event
Hongxia Shi1, Yunhua He1, Siyuan Dan1
1Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Background:
Various immune checkpoint inhibitors, such as programmed cell death protein-1 (PD-1) and its ligand (PD-L1), have been approved for use, but they have side effects on the endocrine glands.
Methods:
Adverse event reports related to PD-1/PD-L1 inhibitors from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2019 to the first quarter of 2023 were extracted, and the reported Odds ratio methods (ROR method) and comprehensive standard methods (MHRA methods) were used for data mining and analysis.
Results:
A total of 5,322 reports (accounts for 6.68% of the total reports)of AEs in endocrine system were collected, including 1852 of pabolizumab (34.80%), 2,326 of navuliumab (43.71%), 54 of cimipriliumab (1.01%), 800 of atilizumab (15.03%), 222 of duvariumab (4.17%) and 68 of averumab (1.28%). Endocrine system-related AEs were mainly present in men (excluding those treated with pembrolizumab) aged ≥65 years. The ratio of AEs components in the endocrine system for the six drugs was approximately 3-8%. The main endocrine glands involved in AEs were the thyroid (pembrolizumab), pituitary and adrenal (nivolumab), adrenal (cemiplimab, atezolizumab, and avelumab), and thyroid (durvalumab). Most patients experienced AEs between 30 and 365 (mean, 117) days,the median time was 61d. AEs resulted in prolonged hospitalization in >40% and death in >10% of cases after administration of pembrolizumab, nivolumab, or durvalumab.
Conclusion:
Men aged ≥65 years should be concerned about endocrine-related AEs. There was a lengthy interval between the use of PD-1/PD-L1 inhibitors and endocrine system-related AEs, but the outcome was serious. Special attention should be given to endocrine system-related AEs when using pembrolizumab, nivolumab, or durvalumab.
Insights
Immune checkpoint inhibitors like PD-1/PD-L1 therapies can cause serious endocrine side effects, particularly in men over 65. These adverse events, though delayed, require careful monitoring and attention, especially with specific drugs.
Area of Science:
- Oncology
- Immunology
- Endocrinology
Background:
- Immune checkpoint inhibitors, including programmed cell death protein-1 (PD-1) and its ligand (PD-L1), are widely used cancer therapies.
- These therapies, while effective, are associated with significant side effects impacting endocrine glands.
Purpose of the Study:
- To analyze the incidence and characteristics of endocrine system-related adverse events (AEs) associated with PD-1/PD-L1 inhibitors.
- To identify specific drugs and patient demographics at higher risk for these endocrine AEs.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database for reports from Q1 2019 to Q1 2023.
- Employed reported Odds Ratio (ROR) and comprehensive standard (MHRA) methods for data mining and analysis of adverse event reports.
Main Results:
- Collected 5,322 endocrine system AEs (6.68% of total reports), with pembrolizumab and nivolumab accounting for the majority.
- Endocrine AEs were more prevalent in men aged ≥65 years and involved the thyroid, pituitary, and adrenal glands.
- AEs occurred with a median onset of 61 days, leading to prolonged hospitalization (>40%) and death (>10%) in severe cases, particularly with pembrolizumab, nivolumab, and durvalumab.
Conclusions:
- Men aged 65 and older are at increased risk for endocrine AEs from PD-1/PD-L1 inhibitors.
- A significant delay exists between treatment initiation and the onset of endocrine AEs, which can have serious outcomes.
- Close monitoring for endocrine AEs is crucial, especially for patients receiving pembrolizumab, nivolumab, or durvalumab.
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