| アブストラクト | BACKGROUND: Zolbetuximab is a novel monoclonal antibody targeting CLDN18.2 for advanced gastric or gastroesophageal junction adenocarcinoma. However, its large-scale, real-world safety profile remains incompletely characterized. This study aimed to analyze its post-marketing adverse events using the FDA Adverse Event Reporting System (FAERS). METHODS: Adverse event reports from FAERS (Q1 2024 - Q3 2025) with zolbetuximab as the primary suspect were analyzed. Disproportionality analysis using four algorithms (ROR, PRR, IC, and EBGM) was performed to detect potential safety signals. Time-to-onset analysis was also conducted. RESULTS: A total of 676 reports were analyzed. Disproportionality analysis confirmed known gastrointestinal and metabolic disorders while identifying several unlabeled adverse events, including but not limited to gastritis, protein-losing gastroenteropathy, peripheral edema, compression fracture, and vascular pain. The median time-to-onset was 0 days, with 82.9% of events occurring within the first 30 days. CONCLUSION: This first large-scale pharmacovigilance study of zolbetuximab detected several potential safety signals not currently listed in the prescribing information. These findings highlight the importance of post-marketing surveillance and should be interpreted as hypothesis-generating, warranting further validation in clinical and real-world studies. |
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| ジャーナル名 | Frontiers in oncology |
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| Pubmed追加日 | 2026/7/25 |
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| 投稿者 | Lin, Li; Chen, Maohua; Wu, Chenmin; Chen, Hong |
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| 組織名 | Department of Medical Oncology, Shengli Clinical Medical College of Fujian;Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated;Provincial Hospital, Fuzhou, China.;Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital,;Fuzhou, China.;Department of Rheumatology and Immunology, Shengli Clinical Medical College of;Fujian Medical University, Fujian Provincial Hospital, Fuzhou University;Affiliated Provincial Hospital, Fuzhou, China.;Department of Neurology, Shengli Clinical Medical College of Fujian Medical;University, Fujian Provincial Hospital, Fuzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42500287/ |
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