| アブストラクト | PURPOSE: The safety profiles of high-dose intravitreal anti-vascular endothelial growth factor (VEGF) agents remain incompletely characterized. This study aimed to compare ocular adverse events, especially intraocular inflammation, associated with brolucizumab, faricimab, and 8 mg aflibercept. METHODS: Adverse event reports for high-dose anti-VEGF agents were extracted from the FDA Adverse Event Reporting System (FAERS) database. After data standardization, quantitative signal detection analyses were performed using multiple pharmacovigilance tools. Clinical characteristics and time-to-onset profiles of adverse events were also assessed. RESULTS: Among 8,470 reports where high-dose anti-VEGF agents were designated as primary suspects, intraocular inflammation (IOI) was the primary adverse reaction. The strongest signals were: retinal vasculitis with brolucizumab (retinal perivascular sheathing; reporting odds ratio (ROR) = 7,451.51 [95% CI: 4,528.22- 12 261.99]), vitritis with faricimab (ROR = 655.54 [95% CI: 548.85-782.95]), and anterior chamber inflammation with 8 mg aflibercept (anterior chamber cells: ROR = 1,749.13 [95% CI: 1,149.34-2,661.92]). Using Standardized MedDRA Queries (SMQ) analysis, adverse events associated with IOI were classified into four phenotypes: anterior chamber inflammation, vitritis, retinal vasculitis, and non-infectious endophthalmitis not otherwise classified, and the results showed a descending gradient of signal strength in all phenotypes: brolucizumab exhibited the strongest signals, followed by aflibercept 8 mg, then faricimab. CONCLUSION: IOI profiles differ significantly among high-dose anti-VEGF agents. Comprehensive evaluation of individual patients' risk factors is recommended to guide clinical decision-making. |
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