TOPLINE:

Postmarket surveillance data revealed that enfortumab vedotin (EV) skin toxicity is associated with high hospitalization and mortality rates, especially with Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN); but use of programmed cell death protein 1 (PD-1) inhibitors or systemic corticosteroids did not augment this risk.

METHODOLOGY:

• The analysis included 1396 evaluable postmarketing adverse event reports involving EV, a nectin-4-targeting antibody-drug conjugate approved for advanced urothelial carcinoma (mean age, 70.8 years; 73.6% men), from the FDA Adverse Event Reporting System (FAERS).
• The researchers assessed frequency, severity, and outcomes related to skin toxicities. They also assessed association between PD-1 inhibitors and systemic corticosteroids with the outcomes.

TAKEAWAY:

• Rash was the most common skin toxicity in 42% of reports, followed by pruritus (14.5%), alopecia (13.5%), erythema (10.1%), and “skin disorder” (8.7%), followed by SJS (8.6%) and TEN (5.8%). Treatments included topical corticosteroids (5.7%), systemic corticosteroids (5.4%), and antihistamines (3.8%).
• Hospitalization occurred in 35.3% of the cases; 16.1% of all cases were fatal, including 50.2% of the SJS/TEN cases.
• Concomitant PD-1 inhibitor use was reported in 9.5% of the cases and in 9.4% of SJS/TEN cases. PD-1 inhibitor use showed no significant association with the risk for hospitalization (odds ratio [OR], 1.23; P = .25), SJS/TEN (OR, 0.98; P = 1.0), or death (OR, 1.16; P = .53).
• Use of systemic corticosteroids in the SJS/TEN cases demonstrated no significant association with mortality (Mantel-Haenszel OR, 3.79; 95% CI, 1.00-14.31; P = .03).

IN PRACTICE:

“Our study emphasizes the importance of correctly identifying culprit medications and the potential role of corticosteroids,” the authors wrote. “Clinicians,” they added “should maintain a high index of suspicion for EV-induced SJS/TEN and report cases to improve pharmacovigilance and guide management strategies.”

SOURCE:

The study was led by Mackenzie M. Kilton, University of Nebraska College of Medicine, Omaha, Nebraska, and was published online on November 1 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS relies on voluntary reporting, which favors severe events. Diagnostic accuracy of reports can vary, and causality could not be confirmed.

DISCLOSURES:

The authors reported no funding source or relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.