Adverse event signals of risankizumab based on OpenFDA data mining and analysis
Objective To mine and analyze adverse reaction event reports of risankizumab through the OpenFDA database,providing reference for clinical rational drug use.Methods Extract and analyze adverse reaction events related to risankizumab recorded by the US Food and Drug Administration(FDA)from January 2019 to August 2023.By analyzing the gender,age group,occupation and other information of the reporter,and using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods,the adverse event signals with the top 80 reported cases were screened and analyzed.Results The database showed 31 985 reported adverse reactions related to risankizumab,with 16 511 reported in 2022,the highest number in history.The reported gender was 17 120 females(53.53%)and 13 322 males(41.65%),respectively.The report mainly comes from consumers or non healthcare professionals(85%).Seventy five clinically significant adverse reaction signals were obtained by the reported ratio method,including psoriasis(ROR=30.42),shortened treatment response(ROR=27.69),tinea arthritis(ROR=7.51),neocoronavirus disease(ROR=7.26),and skin exfoliation(ROR=3.81).Conclusion By mining and analyzing the adverse event signals of risankizumab through the OpenFDA database,potential adverse reaction risks during the treatment process are identified and pointed out,providing reference for clinical safety and rational medication,and effectively ensuring patient medication safety.
RisankizumabAdverse reaction eventsReport ratio method
NETL
NSTL
万方数据
