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Background <p>Antiangiogenic monoclonal antibodies are increasingly used for various cancers. Although studies have reported thromboembolic events (TEEs) in patients receiving antiangiogenic monoclonal antibodies (mAbs), a comprehensive analysis of various thromboembolic events and their correlation with clinical outcomes is lacking.</p> Objectives <p>To evaluate potential signals and clinical outcomes of thromboembolic events associated with antiangiogenic monoclonal antibodies.</p> Design <p>An observational, retrospective, and pharmacovigilance study based on the FAERS database collected from the first quarter of 2004 to the third quarter of 2024 was conducted.</p> Methods <p>The reporting odds ratio (ROR) and the Bayesian Information Criterion (IC) with 95% confidence intervals (CIs) were employed to assess the disproportionate reporting of TEEs linked with antiangiogenic mAbs. A multivariable logistic regression model was implemented to evaluate the association between TEEs and mortality outcomes.</p> Results <p>A total of 3319 TEEs with antiangiogenic mAbs were identified including bevacizumab intravenously (3117 reports), ramucirumab (95 reports), and aflibercept intravenously (107 reports) from health professionals. All three antiangiogenic mAbs detected positive signals, including VTE, PE, ATE, and overall TEEs. Interestingly, no positive signals for myocardial Infarction were detected for all the three antiangiogenic mAbs, and no cerebral ATE was detected for aflibercept. Additionally, no signal was detected when comparing the antiangiogenic mAbs directly with one another. Multivariable logistic regression analysis revealed that fatal TEEs occurred more frequently compared to non-TEE outcomes. This association reached statistical significance in the subgroup of reports for bevacizumab in colorectal cancer.</p> Conclusion <p>This post-marketing data revealed that antiangiogenic mAbs had similar risks of TEEs. However, the occurrence of TEEs was associated with a higher risk of mortality. Due to the inherent limitations of pharmacovigilance data, these findings represent signals that require validation in prospective studies to establish causality.</p>

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Thromboembolic events associated with antiangiogenic monoclonal antibodies: a disproportionality analysis from FDA adverse event reporting system (FAERS) database

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月17日

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  • Hong Zhou,
  • Yanzhao Su,
  • Jianrong Song,
  • Lan Zhen

摘要

Background

Antiangiogenic monoclonal antibodies are increasingly used for various cancers. Although studies have reported thromboembolic events (TEEs) in patients receiving antiangiogenic monoclonal antibodies (mAbs), a comprehensive analysis of various thromboembolic events and their correlation with clinical outcomes is lacking.

Objectives

To evaluate potential signals and clinical outcomes of thromboembolic events associated with antiangiogenic monoclonal antibodies.

Design

An observational, retrospective, and pharmacovigilance study based on the FAERS database collected from the first quarter of 2004 to the third quarter of 2024 was conducted.

Methods

The reporting odds ratio (ROR) and the Bayesian Information Criterion (IC) with 95% confidence intervals (CIs) were employed to assess the disproportionate reporting of TEEs linked with antiangiogenic mAbs. A multivariable logistic regression model was implemented to evaluate the association between TEEs and mortality outcomes.

Results

A total of 3319 TEEs with antiangiogenic mAbs were identified including bevacizumab intravenously (3117 reports), ramucirumab (95 reports), and aflibercept intravenously (107 reports) from health professionals. All three antiangiogenic mAbs detected positive signals, including VTE, PE, ATE, and overall TEEs. Interestingly, no positive signals for myocardial Infarction were detected for all the three antiangiogenic mAbs, and no cerebral ATE was detected for aflibercept. Additionally, no signal was detected when comparing the antiangiogenic mAbs directly with one another. Multivariable logistic regression analysis revealed that fatal TEEs occurred more frequently compared to non-TEE outcomes. This association reached statistical significance in the subgroup of reports for bevacizumab in colorectal cancer.

Conclusion

This post-marketing data revealed that antiangiogenic mAbs had similar risks of TEEs. However, the occurrence of TEEs was associated with a higher risk of mortality. Due to the inherent limitations of pharmacovigilance data, these findings represent signals that require validation in prospective studies to establish causality.