Mining and Analysis of Adverse Event Signals of Abrocitinib Based on FAERS Database
OBJECTIVE To identify adverse event signals associated with Abrocitinib from the real world and provide a reference for its clinical safe and rational use.METHODS Data on Abrocitinibfrom the Adverse Event Reporting System(FAERS)of the US Food and Drug Administration(FDA)between January 1,2022,and September 30,2023,were retrieved.The signals were analyzed using the Reporting Odds Ratio(ROR)method and a Bayesian confidence interval progressive neural network method.RESULTS A total of 41 adverse drug event signals were obtained.The most frequent ADE signals included worsening of the condition,unexpected treatment response,acne,elevated blood cholesterol,and herpes zoster,respectively.The ADE signals with the top 5 ROR values were herpetic simplex eczema,ocular herpes simplex,lipid elevation,pustulosis,and venous embolism.Additionally,21 new suspected adverse reactions not listed were discovered,including worsening of the condition,unexpected treatment reactions,herpetic eczema,elevated liver enzymes,decreased hearing,and cellulitis.CONCLUSION When using Abrocitinib in the clinical treatment of atopic dermatitis,relevant preventive measures should be taken,monitoring for infection and abnormal laboratory test indicators to reduce minimize the risks associated with its use.
abrocitinibsignal miningadverse drug eventsreport ratio method
万方数据
维普
