Abstract 124P
Background
Cutaneous adverse drug reactions (cADRs) are occasionally severe events with poorly understood risk factors. Despite their frequency and clinical significance, large-scale, data-driven analyses of regional differences in cADR incidence remain scarce. This study aimed to investigate regional disparities in cADR prevalence and associated factors using a comprehensive global database.
Methods
A retrospective observational study was conducted using spontaneous adverse event reports from the FDA Adverse Event Reporting System (FAERS) database between January 2010 and January 2023. Reports from the United States (USA), the European Union (EU), and Japan (JP) were analyzed for regional disparities in cADR incidence. Multivariate logistic regression, adjusted for age, sex, and reporting year, was used to calculate reporting odds ratios (RORs) with 95% confidence intervals (CIs). Subgroup analyses focused on specific anticancer agents: tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), antibody–drug conjugates (ADCs), and cytotoxic agents.
Results
We analyzed cADR reports from the USA (3,496,090), EU (148,480), and JP (35,481). Univariable analysis showed significant regional disparities in RORs for overall cADR reports, with lower RORs in JP (0.955 [95% CI, 0.947–0.964]) and the EU (0.902 [95% CI, 0.898–0.906]) compared to the USA. Multivariable analysis of specific anticancer drug regimens revealed significant findings. Reports from JP showed higher RORs for ICIs(1.507 [95% CI, 1.386–1.640]) and lower RORs for ADCs (0.749 [95% CI, 0.594–0.945]) compared to the USA. EU reports indicated moderate differences for ICIs (1.273 [95% CI, 1.167–1.389]), but no significant differences for ADCs (0.855 [95% CI, 0.645–1.135], p=0.2787).
Conclusions
This study highlights significant regional differences in cADR reporting. Higher RORs for ICIs and lower RORs for ADCs were observed in JP compared to the USA, while moderate differences for ICIs but no significant differences for ADCs were noted in the EU. These findings emphasize the importance of considering regional disparities in drug safety evaluations and underline their critical implications for patient safety in drug development and clinical practice.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.