
Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)
Published: March 12, 2025
This study aims to explore potential adverse events (AEs) related Dupilumab using data from the US FDA Adverse Event Reporting System (FAERS) database. The FAERS database Q2 2017 Q4 2023 was mined for AEs Dupilumab. types of reported, along with gender, age distribution, and severity, were evaluated. Signal detection methods including Odds Ratio, Proportional Bayesian Confidence Propagation Neural Network, Empirical Geometric Mean used. A total 11,547,571 AE reports collected, 5335 suspected being Dupilumab, identifying 307 Preferred Terms involving 27 Organ Classes. Reports female patients outnumbered males (56.08% vs. 34.65%). Patients aged 45–65 years reported most (21.34%). number increased significantly in (34.25%) compared (0.42%), highest reporting rate (98.07%). Common included Pruritus, Product use unapproved indication, Rash, dose omission issue indicating widespread misuse High signal strength Rebound atopic dermatitis, eczema, Dermatitis atopic, Dry skin; injection site like Injection dryness eczema; new such as eye, Eye pruritus, Ocular hyperaemia, irritation, Conjunctivitis, Vision blurred, Sleep disorder. reveals various associated newly identified risks. Future research needs delve deeper into safety better guide its clinical application.
Language: Английский