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Published on: May 22, 2020
Cutaneous adverse events with antibody-drug conjugates: a FAERS-based pharmacovigilance study
Huiwen Sun1, Jinhan Chen1, Qian Xu1
1First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China.
Introduction:
Antibody-drug conjugates (ADCs) have revolutionized oncology by integrating the target specificity of monoclonal antibodies with the potency of cytotoxic payloads. However, despite a subset of clinical trials and case reports documenting cutaneous adverse events (CAEs) associated with these agents, comprehensive systematic characterization of ADC-related CAEs remains elusive.
Methods:
Data extracted from the FDA Adverse Event Reporting System (FAERS) spanning Q1 2004 to Q2 2025 included patient baseline characteristics. Disproportionality analyses-reporting odds ratio (ROR) and information component (IC)-were employed to identify safety signals, along with supplementary assessments of time-to-onset (TTO), clinical outcomes, and age- and gender-stratified risks.
Results:
A total of 3,631 CAEs were identified. Concomitantly, a set of 31 positive signals (PT) was detected at the preferred term level, encompassing common manifestations such as rash, alopecia, bullous dermatitis, generalized exfoliative dermatitis, onycholysis, spider naevus, as well as rare but severe events with robust signals including Stevens-Johnson syndrome (SJS)-toxic epidermal necrolysis (TEN) overlap and generalized exfoliative dermatitis. Notably, positive PTs exhibited marked drug specificity: enfortumab vedotin was associated with the highest number of positive signals, whereas belantamab mafodotin displayed minimal signals. The median TTO of CAEs was 15 days, with trastuzumab deruxtecan demonstrating the shortest latency. Regarding clinical outcomes, hospitalization (23.4%) and death (7.7%) were prominent. Stratified analyses further revealed that elderly patients and males were more susceptible to ADC-related CAEs.
Conclusion:
Our findings highlight significant risks of CAEs linked to ADCs, emphasizing the need for risk-stratified monitoring and personalized management. Furthermore, we identified some safety signals of CAEs that are not currently annotated in drug labeling, which provide critical real-world evidence to supplement and extend the limited clinical trial safety data.
Insights
Antibody-drug conjugates (ADCs) can cause serious skin reactions, including severe conditions like Stevens-Johnson syndrome. Elderly patients and males are at higher risk, necessitating careful monitoring and personalized management strategies for these potent cancer therapies.
Area of Science:
- Oncology
- Dermatology
- Pharmacovigilance
Background:
- Antibody-drug conjugates (ADCs) are advanced cancer therapies combining targeted antibody delivery with potent cytotoxic agents.
- While effective, ADCs are associated with cutaneous adverse events (CAEs), requiring systematic characterization.
- Existing data on ADC-related CAEs from clinical trials are limited.
Purpose of the Study:
- To systematically characterize the spectrum and risk factors of cutaneous adverse events (CAEs) associated with antibody-drug conjugates (ADCs).
- To identify specific safety signals for ADC-related CAEs using real-world data.
- To provide evidence for improved monitoring and management of CAEs in patients receiving ADCs.
Main Methods:
- Utilized FDA Adverse Event Reporting System (FAERS) data from Q1 2004 to Q2 2025.
- Employed disproportionality analyses (ROR, IC) to detect safety signals.
- Assessed time-to-onset, clinical outcomes, and performed age- and gender-stratified risk analyses.
Main Results:
- Identified 3,631 CAEs, with 31 significant safety signals including rash, alopecia, and severe events like Stevens-Johnson syndrome/toxic epidermal necrolysis overlap.
- Enfortumab vedotin showed the most associated signals; belantamab mafodotin had minimal signals.
- Median time-to-onset was 15 days; hospitalization (23.4%) and death (7.7%) were notable outcomes. Elderly males faced higher risks.
Conclusions:
- ADCs pose significant risks for CAEs, underscoring the need for risk-stratified monitoring and personalized patient management.
- Identified novel CAE safety signals not present in current drug labeling, offering crucial real-world evidence.
- Findings supplement limited clinical trial data, aiding in safer application of ADC therapies.
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