| アブストラクト | BACKGROUND: Antibody-drug conjugates (ADCs) have demonstrated remarkable therapeutic efficacy in refractory cancers, however, ophthalmotoxicity remains a serious concern. This study aimed to investigate the association between ADCs and ophthalmotoxicity. RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance study was conducted utilizing data extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from 2004 to 2023. Disproportionality analyses were performed using the reporting odds ratio (ROR) and information component (IC), with sensitivity analyses and subgroup evaluations by age and sex. RESULTS: A total of 1992 cases of ophthalmotoxicity linked to ADCs were identified, with a median latency of 40 days. The correlation between ophthalmotoxicity and ADCs was higher than with other medications (IC = 0.67, 95% CI:0.64-0.70). Signal detection revealed 36 adverse events unreported in product labeling. Sensitivity analyses confirmed the robustness of our results on the association between ADCs and ocular toxicity, with higher reporting in females compared to males (OR = 1.25, 95% CI: 1.11-1.40). CONCLUSIONS: ADCs had different profiles of ophthalmotoxicity. Our pharmacovigilance study suggested increased reporting of ophthalmotoxicity associated with ADCs. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/4/9 |
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| 投稿者 | Zhao, Wenxia; Feng, Xin; Yang, Shan; Yuan, Guosen; Huang, Min; Ding, LinXiaoxiao; He, Zhichao; Wu, Junyan |
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| 組織名 | Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,;Guangzhou, China.;Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene;Regulation, Guangzhou, China.;School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, China.;School of Pharmacy, Guangdong Medical University, Dongguan, China.;Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40202446/ |
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