Analysis of post-market adverse events of panitumumab: a real-world study base on FAERS database

Background: Colorectal cancer (CRC) is a significant public health issue, with metastatic disease posing a considerable challenge despite therapeutic advancements. Panitumumab, an EGFR inhibitor, has been a ray of hope for patients with chemorefractory metastatic CRC. However, understanding the safety profile of panitumumab is crucial for optimizing patient care. Methods: This study leveraged the FDA's Adverse Event Reporting System (FAERS) to scrutinize ADR reports linked to panitumumab from September 27, 2006, to December 31, 2023. Utilizing statistical methods such as Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), the study conducted a disproportionality analysis to identify potential safety signals. Results: The analysis of 5,166 ADR reports revealed a significant association between panitumumab and a spectrum of ADRs. Notable adverse events included skin toxicities, hematologic and lymphatic system disorders, gastrointestinal issues, electrolyte imbalances, and neurological reactions. The study also highlighted the need for close monitoring of serious outcomes like hospitalization, death, and life-threatening conditions. Conclusion: The study presents a comprehensive analysis of ADRs associated with panitumumab, emphasizing the necessity for continuous pharmacovigilance and the implementation of strategies to ensure patient safety. The limitations of spontaneous reporting systems are acknowledged, and the call for further research to refine the safety profile of panitumumab is made.