Cutaneous adverse events with antibody-drug conjugates: a FAERS-based pharmacovigilance study
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By
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Huiwen Sun
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Jinhan Chen
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Qian Xu
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Chen Chen
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Jinsheng Yu
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Qijin Shu
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May 25, 2026
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Clinical Scorecard: Skin-Related Adverse Reactions Linked to Antibody-Drug Conjugates: Insights from a Pharmacovigilance Analysis of FAERS Data
At a Glance
| Category | Detail |
|---|
| Condition | Cutaneous Adverse Events (CAEs) associated with Antibody-Drug Conjugates (ADCs) |
| Key Mechanisms | Integration of monoclonal antibodies with cytotoxic payloads leading to targeted delivery and potential skin toxicity. |
| Target Population | Patients receiving ADCs for advanced or refractory solid tumors and hematological malignancies. |
| Care Setting | Oncology clinics and post-marketing surveillance. |
Key Highlights
- 3,631 CAEs identified from FAERS data.
- 31 positive safety signals detected, including common and severe skin reactions.
- Elderly patients and males showed higher susceptibility to CAEs.
- Median time-to-onset of CAEs was 15 days.
- Hospitalization occurred in 23.4% and death in 7.7% of cases.
Guideline-Based Recommendations
Diagnosis
- Monitor for cutaneous adverse events in patients receiving ADCs.
Management
- Implement risk-stratified monitoring and personalized management strategies.
Monitoring & Follow-up
- Conduct ongoing surveillance for CAEs linked to ADCs.
Risks
- Recognize the potential for severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Patient & Prescribing Data
Patients treated with various ADCs, including enfortumab vedotin and trastuzumab deruxtecan.
Different ADCs exhibit varying profiles of cutaneous adverse events.
Clinical Best Practices
- Utilize real-world data for risk assessment of ADC-related CAEs.
- Educate patients about potential skin reactions associated with ADC therapy.
- Consider patient demographics when assessing risk for CAEs.
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