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A disproportionality analysis of real-world events from the FDA Adverse Event Reporting System (FAERS) for
Zhuoyang Li1, Ning Zhu2, Yuwei Liu1
1School of Medicine, Wuhan University of Science and Technology, Wuhan, 430065, China.
Background:
An increasing number of clinical studies have highlighted the use of atezolizumab in tumor immunotherapy. However, There is still a lack of comprehensive research on its associated adverse events (AEs). To improve our understanding of its toxicological profile and to provide valuable clinical insights regarding into the effectiveness of immunotherapy, this study utilized data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) to conduct a retrospective analysis of AEs linked to atezolizumab.
Methods:
We extracted the reports of AEs related to atezolizumab from the FAERS database from the first quarter of 2004 to the first quarter of 2024. We quantified them using the reporting odds ratio (ROR) and proportional reporting ratio (PRR), along with chi-square value (χ²), and conducted systematic classification of the AE signal mining results through SAS 9.4 software.
Results:
A total of 19,563 valid reports were incorporated, involving 20 distinct system organ class categories. The AEs related to atezolizumab, reported at the preferred term level, mainly encompassed anemia [ROR 2.33, 95% confidence interval (CI) lower limit 2.09, PRR 2.31, χ² 255.977], febrile neutropenia (ROR 2.81, 95% CI lower limit 2.50, PRR 2.79, χ² 333.586), neutrophil count decreased (ROR 2.14, 95% CI lower limit 1.89, PRR 2.13, χ² 150.688), white blood cell count decreased (ROR 2.35, 95% CI lower limit 2.03, PRR 2.34, χ² 136.673), sepsis (ROR 2.21, 95% CI lower limit 1.91, PRR 2.20, χ² 117.741), alanine aminotransferase increased (ALT) (ROR 2.86, 95% CI lower limit 2.44, PRR 2.85, χ² 180.031), and aspartate aminotransferase increased (AST) (ROR 2.79, 95% CI lower limit 2.38, PRR 2.78, χ² 170.955).
Conclusions:
Apart from various degrees of hepatotoxicity, such as increased ALT and AST, the immune-related hematological toxicity of atezolizumab should also be noted. In clinical practice, healthcare providers should always be vigilant for the occurrence of such medication-related AEs and take measures to enhance the safety of clinical medication use.
Insights
This study analyzed 19,563 adverse event reports for atezolizumab, revealing immune-related hematological toxicities like febrile neutropenia and increased liver enzymes (ALT/AST). Healthcare providers should monitor for these adverse events to ensure patient safety during immunotherapy.
Area of Science:
- Oncology
- Immunology
- Pharmacovigilance
Background:
- Atezolizumab is increasingly used in tumor immunotherapy.
- Comprehensive research on atezolizumab's adverse events (AEs) is lacking.
- Understanding its toxicological profile is crucial for effective immunotherapy.
Purpose of the Study:
- To conduct a retrospective analysis of AEs associated with atezolizumab.
- To identify and quantify the safety profile of atezolizumab using FAERS data.
- To provide clinical insights into atezolizumab's adverse events.
Main Methods:
- Extracted AE reports for atezolizumab from the FAERS database (2004-2024).
- Quantified AEs using reporting odds ratio (ROR) and proportional reporting ratio (PRR).
- Systematic classification of AE signal mining results using SAS 9.4 software.
Main Results:
- Analyzed 19,563 valid AE reports across 20 system organ classes.
- Identified significant AEs including anemia, febrile neutropenia, decreased neutrophil and white blood cell counts, sepsis, and increased ALT/AST.
- Quantified risks with ROR and PRR, highlighting specific safety signals.
Conclusions:
- Atezolizumab is associated with immune-related hematological toxicities and hepatotoxicity (increased ALT/AST).
- Clinical vigilance for these AEs is essential for safe atezolizumab use.
- Monitoring and management strategies should address these identified adverse events.
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