To analyze adverse drug event (ADE) signals associated with dupilumab based on the date from the U.S. Food and Drug Administration Adverse Event Reporting System(FAERS), and to provide insights for rational medication use in clinical settings.

ADE reports of dupilumab as the primary suspected drug were obtained by collecting the data of FAERS database from the first quarter 2017 to the third quarter 2024. ADE signals were analyzed by joint reporting odds ratio (ROR) method and bayesian confidence interval progressive neural network (BCPNN) method.

After data cleaning, 669 761 reports of dupilumab-related ADEs were collected, involving 264 882 patients. A total of 461 ADE signals were detected across 18 system-organ classes (SOC), which had a good coincidence with the adverse reactions in the current Chinese and English drug instructions, and also found some new high-intensity positive signals that were not included in the instructions. Including ocular hyperaemia, erythema of eyelid, eyelid exfoliation, periorbital irritation, skin fissures, neurodermatitis, injection site exfoliation, cutaneous T-cell lymphoma, etc. The median time to onset of ADE reported by patients <18 years old, 18-65 years old, and ≥65 years old was 75 days, 98 days, and 110.5 days, respectively (P<0.000 1 according to Log-rank test). Weibull distribution test was performed on time to onset of 20 ADE signals that were not included in the manual. It was found that cutaneous T-cell lymphoma, hyposmia, parosmia, and sinus headache, occurred continuously over time, and the incidence of the others decreased gradually over time.

When clinically using dupriumab, it is essential to controll the indications and conduct a thorough medication assessment. Monitoring should be strengthened near the time window of adverse events. The latent ADEs that are not mentioned in the instructions should be noticed to ensure safe medication.