抗VEGF療法と報告された眼の有害事象の関連性: グローバルな医薬品警戒分析
Moiz Lakhani1, Angela T H Kwan1, Deeksha Kundapur2
1Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; The University of Ottawa Eye Institute, Ottawa, Ontario, Canada.
Ophthalmology. Retina
|September 3, 2025
まとめ
抗血管内皮成長因子 (VEGF) 療法では,眼の有害事象のプロファイルが多様です. ブロルチズマブは眼内炎のリスクが最も高く,アフリベルセプトは内視炎のリスクが最も高かった.
科学分野:
- 眼科について
- 薬用警戒について
- 網膜 疾患
背景:
- 抗血管内皮成長因子 (VEGF) 治療は,新血管性老化性斑点変性,糖尿病性斑点腫,網膜静脈閉塞の治療に不可欠です.
- 広く使用されているこれらの薬物の安全性を理解するために,実際のデータが不可欠です.
研究 の 目的:
- 報告された眼の有害事象 (AEs) の不釣り合いを評価し,異なる抗VEGF剤を比較する.
- ラニビズマブ,アフリベルセプト,ブロルシズマブ,ファリシマブに関連した特定の眼部AEプロフィールを特定する.
主な方法:
- 2004年1月から2024年9月までのFDA有害事象報告システム (FAERS) のデータを用いた集団ベースの観察用医薬品監視試験.
- 報告確率比 (RORs) を用いて,各抗VEGF剤の眼性AE報告を背景値と比較する不均衡分析.
- 4つの抗VEGF剤の眼内炎症と内視炎を含む眼内AE信号の評価
主要な成果:
- ブロルシズマブは眼内炎症に対する最も強い信号を示した (ROR=633. 32),次にファリシマブ,アフリベルセプト,ラニビズマブが続いた.
- ファリシマブは前部炎症と視内炎の信号の増加と関連していました.
- 他の薬剤でもこの重症合併症の兆候を示した.
結論:
- 抗VEGF剤の眼性有害事象プロファイルには大きな変動がある.
- ブロルシズマブとアフリベルセプトは,それぞれ炎症と内視炎に関する明確な安全性に関する懸念を示しています.
- これらの重要な治療法の安全性の状況の変化を監視し,定義するために,継続的な現実世界の医薬品監視が必要である.
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