To systematically analyze the risks, temporal patterns, and outcome disparities of ADC-related cutaneous adverse events (CAEs) using FAERS data, highlighting the need for improved monitoring.
Key Findings:
3,631 CAEs were identified, with 31 positive signals detected at the preferred term level.
Common manifestations included rash, alopecia, and bullous dermatitis, while severe events included Stevens-Johnson syndrome and toxic epidermal necrolysis.
Enfortumab vedotin was associated with the highest number of positive signals, while belantamab mafodotin showed minimal signals.
The median time-to-onset of CAEs was 15 days, with trastuzumab deruxtecan showing the shortest latency.
Hospitalization occurred in 23.4% of cases, and 7.7% resulted in death.
Stratified analyses revealed that elderly patients and males were more susceptible to ADC-related CAEs.
Interpretation:
The study highlights significant risks of CAEs linked to ADCs, indicating a need for enhanced monitoring and management strategies in clinical practice.
Limitations:
The study relies on FAERS data, which may have reporting biases.
The analysis may not capture all CAEs due to underreporting, potentially affecting the reliability of the findings.
Conclusion:
The findings provide critical real-world evidence regarding ADC-related CAEs, suggesting the need for risk-stratified monitoring to enhance patient safety.
