Abstract
OBJECTIVES: Dupilumab and tralokinumab are FDA-approved biological agents for the treatment of atopic dermatitis (AD). This study analyzed tralokinumab-related adverse events (AEs) reported by healthcare professionals, utilizing data mined from the FDA Adverse Event Reporting System (FAERS). Furthermore, we compared the frequency of reports for common AEs with dupilumab or tralokinumab as the primary suspect, focusing on injection-site reactions, conjunctivitis, and keratitis. METHODS: Disproportionality analysis methods, including the reporting odds ratio (ROR), the Medicines and Healthcare products Regulatory Agency (MHRA) comprehensive method, the Bayesian confidence propagation neural network (BCPNN), and the Multi-item gamma Poisson shrinker (MGPS), were employed to quantify tralokinumab-associated AE signals. Then, the occurrence risk of common AEs between dupilumab and tralokinumab was further compared. RESULTS: Among 1,591,367 AE reports, 1,770 identified tralokinumab as the primary suspect. Tralokinumab-related AEs affected 25 System Organ Classes (SOC), with 49 significant disproportionality primary terms (PTs) consistently detected across all four algorithms. Notable potential AEs included eczema herpeticum, generalized exfoliative dermatitis, alopecia, skin exfoliation, and blepharitis. Most tralokinumab-related AEs occurred within the first month of treatment, with a median onset time of 37 days (interquartile range [IQR]: 13-111 days). The reporting proportion of injection site reactions was significantly higher with dupilumab than with tralokinumab (p < 0.001). In contrast, tralokinumab was associated with a substantially higher reporting proportion of conjunctivitis (p = 0.001) and keratitis (p = 0.039). CONCLUSION: This study identified potential AE signals that could aid clinical monitoring and risk identification for tralokinumab. Additionally, close monitoring is warranted for dupilumab-associated injection site reactions and tralokinumab-associated conjunctivitis and keratitis throughout treatment.