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Published on: May 22, 2020
Assessment of distributions and gender difference in adverse events related to faricimab: a real-world study based on
Linshan Li1,2, Zhengyan Ge3, Yan Dai1
1Geriatric Diseases Institute of Chengdu/Cancer Prevention and Treatment Institute of Chengdu, Department of Ophthalmology, Chengdu Fifth People's Hospital (The Second Clinical Medical College, Affiliated Fifth People's Hospital of Chengdu University of Traditional Chinese Medicine), Chengdu, China.
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.
