| アブストラクト | OBJECTIVE: This study aimed to compare adverse event (AE) profiles between Avastin and bevacizumab biosimilars to support clinical decision-making, given the limited availability of real-world data. METHODS: A disproportionality analysis was conducted using the FDA Adverse Event Reporting System (FAERS) to identify and compare AE signals. Signals were evaluated at the system organ classes (SOCs) and preferred term (PT) levels, focusing on the Top 20 PTs by report number, key SOCs and outcomes. RESULTS: Injury, poisoning and procedural complications and general disorders and administration site conditions were the most frequent SOCs in both groups. Common label-listed AEs, including hypertension, proteinuria and thrombocytopenia, were frequently reported. Shared risks also included gastrointestinal perforation/ulceration and thromboembolism. Avastin was more associated with red blood cell disorders and ureteric disorders and bladder and bladder-neck disorders, while biosimilars were linked to a broader range of high-level group terms in gastrointestinal disorders and generated more renal and urinary signals. CONCLUSION: Hypertension, proteinuria, thrombocytopenia, gastrointestinal perforation and thromboembolism remain key concerns. Clinicians should monitor renal and urinary function when administering Avastin. Immune-induced renal disorders associated with biosimilars highlight the importance of assessing the treatment rationale in patients with chronic kidney disease, autoimmune disorders or other comorbid conditions. |
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| ジャーナル名 | Basic & clinical pharmacology & toxicology |
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| Pubmed追加日 | 2025/8/29 |
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| 投稿者 | Zhang, Xiaoyu; Zhang, Yupeng; Tang, Xinghang; Chen, Li |
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| 組織名 | Department of Equipment, West China Hospital, Sichuan University, Chengdu, China.;Evidence-Based Pharmacy Center, West China Second Hospital, Sichuan University,;Chengdu, China.;Key Laboratory of Birth Defects and Related Diseases of Women and Children;(Sichuan University), Ministry of Education, Chengdu, China.;West China School of Pharmacy, Sichuan University, Chengdu, China.;Department of Pharmacy, West China Second Hospital, Sichuan University, Chengdu,;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40867018/ |
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