Analysis and mining of Dupilumab adverse events based on FAERS database

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