Data mining and analysis of adverse events based on FAERS for tildrakizumab
Objective To mine adverse drug event risk signals related to tildrakizumab using the FAERS database,and to warn potential adverse reactions of tildrakizumab,providing objective data for clinical application and subsequent research.Methods The original data of FAERS database from the first quarter of 2018 to the second quarter of 2024 were queried and extracted,and the adverse drug event reports involving tildrakizumab were screened out.The ROR and PRR were used as signal detection indicators,and the corresponding threshold conditions were set for statistical analysis and system classification of adverse drug event.Results A total of 1 599 adverse drug event reports related to tildrakizumab were retrieved,with the proportion of male patients slightly higher than that of female patients(43.0%vs 41.6%).The proportion of patients aged 45-64 was higher(14.8%).A total of 57 effective signals were mined,involving 13 system organ classes(SOCs),of which 51 effective signals involved 11 SOCs that were not mentioned in the domestic and foreign drug of tildrakizumab.The main effective signals were vulvovaginal candidiasis,increased viscosity of upper respiratory tract secretions,ureteral calculi,malignant melanoma in situ,followed by hypertrophic cardiomyopathy,Pap's esophagus,weight support difficulties,aortic insufficiency,etc.The main SOCs included systemic diseases and various reactions at the administration site(277 cases),infection and infectious diseases(196 cases),skin and subcutaneous tissue diseases(43 cases),benign,malignant and unknown tumors(including cystic and polyp)(41 cases),and heart organ diseases(36 cases).The median duration of adverse events was 189 d(IQR:70-426.25)and the mean was 302.69 d.Conclusion Utilizing data mining of the FAERS database can provide a comprehensive and in-depth analysis of adverse drug events associated with tildrakizumab monoclonal antibody after its marketing,providing evidence for safe and rational drug use in clinical practice.Attention should be paid to male patients with a high incidence of adverse drug events,and new adverse drug event such as vulvovaginal candidiasis,ureteral stones,and Barrett's esophagus should be discovered,which should be closely monitored during clinical use of tildrakizumab monoclonal antibody to ensure the safety and effectiveness of drug use for patients.
tildrakizumab monoclonal antibodyFAERS databaseadverse drug eventsrisk signal miningproportional imbalance methodvulvovaginal candidiasisincreased viscosity of upper respiratory tract secretions
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