Comparative pharmacovigilance of herpetic infections with dupilumab and JAK inhibitors in atopic dermatitis.

BACKGROUND

Targeted systemic therapies for atopic dermatitis (AD), including biologics and Janus kinase (JAK) inhibitors, are increasingly used. However, comparative post-marketing evidence on herpetic infection-related safety signals across these therapies remains limited.

OBJECTIVES

To compare safety signals of herpetic infections associated with targeted AD therapies using the Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS

FAERS reports (Q2 2017 to Q1 2025) involving dupilumab, abrocitinib, baricitinib, or upadacitinib were included if these agents were designated as the primary suspect drug and the indication was AD. Disproportionality analyses using four algorithms were performed to detect signals for overall and virus-specific herpetic events. Subgroup analyses by age and sex and time-to-onset (TTO) analyses were conducted.

RESULTS

All therapies demonstrated positive signals for herpetic infections. Baricitinib and abrocitinib showed the strongest signals, followed by upadacitinib, whereas dupilumab showed comparatively lower signals overall. Notably, dupilumab demonstrated a herpes simplex virus (HSV) signal comparable to abrocitinib and higher than upadacitinib, and a signal for eczema herpeticum (EH) was also identified. Signals were generally higher in females, except for upadacitinib. Age-stratified analyses showed varying signal patterns across age groups. Median TTO differed between therapies, with an earlier onset for upadacitinib.

CONCLUSIONS

Herpetic infection reporting patterns differ across targeted AD therapies. Disproportionate reporting of HSV and EH with dupilumab warrants further investigation. Differences across sex, age groups, and TTO suggest potential heterogeneity in reporting patterns, which may reflect underlying patient characteristics and reporting behaviours.