Expert opinion on drug safety · 2024
Assessment of distributions and gender difference in adverse events related to faricimab: a real-world study based on FDA adverse event reporting system.
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Li Linshan, Ge Zhengyan, Dai Yan
Аннотация
BACKGROUND: Faricimab is a novel bispecific antibody drug for treating retinal disease. We aim to study the adverse events of faricimab based on the FDA Adverse Event Reporting System (FAERS) database.
RESEARCH DESIGN AND METHODS: The FAERS data from 2020 to 2024 was extracted to conduct disproportionality analysis. The risk signals were mined by using reporting odds ratio (ROR) and proportional reporting ratio (PRR).
RESULTS: A total of 1401 cases with adverse events were reported. Eye disorders were the most frequent AEs. New ocular AEs were identified, such as diplopia, metamorphopsia, blindness transient, visual field defect, subretinal fibrosis. New non-ocular AEs were also found such as cellulitis, acute respiratory failure, end stage renal disease, proteinuria, nephropathy, VIth nerve paralysis, and deafness. It was found that there is a difference between men and women on the ocular adverse events. Adverse events happened in the initial month of the treatment, but mostly happened between the 91 to 180 days.
CONCLUSIONS: Faricimab have ocular and non-ocular adverse events, in which some ocular adverse events differ across genders. Important potential adverse events should be considered in the clinical practice to provide better individualized treatment.
RESEARCH DESIGN AND METHODS: The FAERS data from 2020 to 2024 was extracted to conduct disproportionality analysis. The risk signals were mined by using reporting odds ratio (ROR) and proportional reporting ratio (PRR).
RESULTS: A total of 1401 cases with adverse events were reported. Eye disorders were the most frequent AEs. New ocular AEs were identified, such as diplopia, metamorphopsia, blindness transient, visual field defect, subretinal fibrosis. New non-ocular AEs were also found such as cellulitis, acute respiratory failure, end stage renal disease, proteinuria, nephropathy, VIth nerve paralysis, and deafness. It was found that there is a difference between men and women on the ocular adverse events. Adverse events happened in the initial month of the treatment, but mostly happened between the 91 to 180 days.
CONCLUSIONS: Faricimab have ocular and non-ocular adverse events, in which some ocular adverse events differ across genders. Important potential adverse events should be considered in the clinical practice to provide better individualized treatment.