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Osimertinib-related myotoxicity: a disproportionality analysis of the FDA adverse event reporting system
Yaqian Tan1,2, Qi Song3
1Department of Pharmacy, The Affiliated Brain Hospital, Guangzhou Medical University, Mingxin Road 36, Liwan District, Guangzhou, 510370, China. tanyaqian2013@163.com.
Background:
Osimertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor that has been widely applied as a standard first-line treatment in advanced non-small cell lung cancer. However, the risk signals of osimertinib-related myotoxicity have not yet been fully examined. This study aimed to explore osimertinib-related myotoxicity by conducting a real-world disproportionality analysis.
Methods:
Data from January 1st 2015 to March 31st 2024 were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System database. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were employed to perform disproportionality analysis.
Results:
A total of 121 cases with osimertinib-related myotoxicity were identified and analyzed. The adverse events were mostly reported in females (n = 74, 61.2%) and patients aged over 65 years old (n = 56, 46.3%). The median value of adverse event onset time was 40 (13.3, 164.5). Disproportionality analysis revealed that blood creatine phosphokinase increased (ROR025 = 5.00, IC025 = 2.07, PRR = 6.18), myositis (ROR025 = 2.72, IC025 = 1.26, PRR = 4.22), and myopathy (ROR025 = 1.28, IC025 = 0.63, PRR = 2.32) carried significant risk signals of osimertinib-related myotoxicity.
Conclusions:
Our study comprehensively revealed the safety characteristics of osimertinib-associated myotoxicity. The results would offer referable evidence on the safety and prognosis of osimertinib.
Insights
This study investigated osimertinib-related myotoxicity using real-world data. Increased creatine phosphokinase, myositis, and myopathy were identified as significant risk signals, offering insights into drug safety.
Area of Science:
- Pharmacovigilance
- Oncology
- Clinical Toxicology
Background:
- Osimertinib is a first-line treatment for advanced non-small cell lung cancer.
- The myotoxicity risk associated with osimertinib requires thorough investigation.
- Real-world data analysis is crucial for understanding drug safety profiles.
Purpose of the Study:
- To explore osimertinib-related myotoxicity.
- To identify specific adverse events indicative of myotoxicity.
- To provide evidence for the safe use of osimertinib.
Main Methods:
- Utilized the U.S. Food and Drug Administration Adverse Event Reporting System database (January 2015 - March 2024).
- Conducted a disproportionality analysis using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC).
- Analyzed 121 identified cases of osimertinib-related myotoxicity.
Main Results:
- Osimertinib-related myotoxicity predominantly affected females and individuals over 65 years old.
- Significant risk signals included elevated blood creatine phosphokinase (ROR=5.00), myositis (ROR=2.72), and myopathy (ROR=1.28).
- Median onset time for adverse events was 40 days.
Conclusions:
- This study comprehensively characterizes the safety profile of osimertinib concerning myotoxicity.
- Identified risk factors and specific adverse events provide valuable evidence for clinical practice.
- Findings support informed decision-making regarding osimertinib treatment and patient monitoring.
