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<p><b>Purpose</b></p><p>This 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. </p><p><b>Methods</b></p><p>This 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. </p><p><b>Results</b></p><p>A 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<sub><b>025</b></sub>, tislelizumab (IC<sub><b>025</b></sub> = 5.53), pembrolizumab (IC<sub><b>025</b></sub> = 4.01), and cemiplimab (IC<sub><b>025</b></sub> = 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.</p><p><b>Conclusions</b></p><p>PD-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.</p>

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Mining safety signals of PD-1/PD-L1 inhibitor-related adrenal insufficiency: a study based on the FAERS database

  • 期刊论文

  • 发表日期：

    2026年5月6日

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  • Ruoxuan Pan,
  • Tingting Chen,
  • Guimu Guo,
  • Sijie Chang,
  • Jintuo Zhou,
  • Peiguang Niu,
  • Xiaoping Zeng,
  • Jinhua Zhang

摘要

Purpose

This 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.

Methods

This 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.

Results

A 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 IC025, tislelizumab (IC025 = 5.53), pembrolizumab (IC025 = 4.01), and cemiplimab (IC025 = 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.

Conclusions

PD-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.