Investigating tralokinumab-related adverse events in treating atopic dermatitis: insights from the FAERS database - PubMed
14 hours ago
- #pharmacovigilance
- #atopic dermatitis
- #adverse events
- Study analyzes tralokinumab-related adverse events (AEs) in atopic dermatitis treatment using FAERS database.
- Comparison of AE frequency between tralokinumab and dupilumab, focusing on injection-site reactions, conjunctivitis, and keratitis.
- Disproportionality analysis methods (ROR, MHRA, BCPNN, MGPS) used to quantify tralokinumab-associated AE signals.
- 1,770 out of 1,591,367 AE reports identified tralokinumab as primary suspect, affecting 25 System Organ Classes.
- 49 significant disproportionality primary terms detected, including eczema herpeticum, alopecia, and blepharitis.
- Most AEs occurred within first month of treatment, median onset time 37 days.
- Dupilumab had higher reporting proportion for injection site reactions; tralokinumab for conjunctivitis and keratitis.
- Findings suggest need for clinical monitoring of tralokinumab-associated AEs, especially conjunctivitis and keratitis.