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Ophthalmotoxicity induced by antibody-drug conjugates: a pharmacovigilance study of the FDA adverse event reporting
Wenxia Zhao1,2, Xin Feng3, Shan Yang1,2
1Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
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.
Insights
Antibody-drug conjugates (ADCs) show cancer treatment promise but can cause eye problems. This study found a significant association between ADCs and increased reporting of ophthalmotoxicity, particularly in females.
Area of Science:
- Oncology
- Pharmacovigilance
- Ophthalmology
Background:
- Antibody-drug conjugates (ADCs) are effective in treating refractory cancers.
- Ophthalmotoxicity is a significant adverse event associated with ADCs.
- Understanding this link is crucial for patient safety and treatment management.
Purpose of the Study:
- To investigate the association between antibody-drug conjugates (ADCs) and the risk of developing ophthalmotoxicity.
- To analyze the reporting trends and characteristics of ocular adverse events linked to ADCs.
Main Methods:
- Retrospective pharmacovigilance study using the FDA Adverse Events Reporting System (FAERS) data (2004-2023).
- Disproportionality analyses (ROR, IC) and signal detection were employed.
- Sensitivity analyses and subgroup evaluations by age and sex were conducted.
Main Results:
- 1992 cases of ophthalmotoxicity linked to ADCs were identified, with a median latency of 40 days.
- A significant correlation was found between ADCs and ophthalmotoxicity (IC=0.67).
- Ophthalmotoxicity reporting was higher in females (OR=1.25), and 36 unreported adverse events were detected.
Conclusions:
- Antibody-drug conjugates (ADCs) exhibit varying ophthalmotoxicity profiles.
- Pharmacovigilance data indicates an increased reporting of eye-related adverse events associated with ADCs.
- These findings highlight the need for monitoring and managing ocular toxicity in patients receiving ADCs.
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