A real-world disproportionality analysis of dupilumab safety in children aged 0-5 years with atopic dermatitis - PubMed
6 hours ago
- #Pediatric Pharmacovigilance
- #Atopic Dermatitis
- #Dupilumab Safety
- Dupilumab's real-world safety in children aged 0-5 years with atopic dermatitis is analyzed using FAERS data from 2022 to 2025.
- Disproportionality signals were detected for skin and subcutaneous tissue disorders and eye disorders at the System Organ Class level.
- Common adverse events included pruritus, dry skin, rash, and eczema, while high-disproportionality terms involved eyelid exfoliation and dry eye.
- Most skin and ocular adverse events occurred within 30 days after dupilumab initiation.
- No disproportionality signals were found for infections or neoplasms, but rare risks cannot be excluded, suggesting continued surveillance.