Data mining of hematological adverse events related to antibody-drug conjugate based on FAERS
10.12173/j.issn.1005-0698.202304131
- VernacularTitle:基于FAERS数据库的抗体药物偶联物相关血液系统不良事件数据挖掘
- Author:
Huijie DENG
1
,
2
;
Xia LIU
;
Bing LI
;
Qing SHAN
;
Yan CHEN
;
Yuhang GUO
;
Jinmin GUO
Author Information
1. 中国人民解放军联勤保障部队第九六○医院临床药学科(济南 250031)
2. 中国人民解放军联勤保障部队第九六○医院药剂科(济南 250031)
- Keywords:
Antibody drug conjugates;
Hematological adverse events;
FAERS database;
Data mining;
Report ratio ratio method;
Information component method;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(2):158-165
- CountryChina
- Language:Chinese
-
Abstract:
Objective Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,data mining was conducted on hematological adverse events related to antibody drug conjugates(ADC),providing reference for the safe use of ADC drugs in clinical practice.Methods The report data from the third quarter of 2011 to the fourth quarter of 2022 were retrieved from the FAERS database.After data cleaning such as deduplication and name standardization,extract hematological adverse events related to ADC,and use report odds ratio method and the information component method for signal detection.Results A total of 101 610 adverse event reports were extracted,with 8 ADC drugs as the primary suspected drugs,and 5 768 ADC related hematological adverse event reports.Among them,3 423 cases of agranulocytosis were involved,and the signal intensity from strong to weak were sacituzumab govitecan(SG),gemtuzumab ozogamicin(GO),brentuximab vedotin(BV),polatuzumab vedotin(PV),enfortumab vedotin(EV),trastuzumab deruxtecan(TD),inotuzumab ozogamicin(IO)and ado-trastuzumab emtansine(TDM-1).There were 2 327 cases hematopoietic cell deficiency,with signals ranging from strong to weak were IO,SG,BV,EV,PV,TD,TDM-1,and GO.Report with clinical outcome of death of ADC drug related hematological adverse events included BV 179(16.84％),TDM-1 102(13.01％),TD 88(27.08％),GO 12(16.90％),IO 8(11.59％),EV 54(24.32％),PV 22(27.16％),and SG 84(21.05％).Adverse event time analysis showed that the number of events on the first day of TD,IO,and SG medication accounts for ≥ 40％of the total number of cases.The median time of hematological adverse events in TD,GO,IO,EV,PV,and SG was within one treatment course(21 days).Conclusion Attention should be paid to the risk of ADC drug-related hematological adverse event,during the clinical medication process,blood cell count changes should be closely monitored,and any abnormalities should be promptly diagnosed and treated.
