Excavation for adverse events signals of atezolizumab
- VernacularTitle:阿替利珠单抗的不良事件风险信号挖掘
- Author:
Panpan DI
1
;
Yunfei HU
2
;
Xiangsong MENG
2
;
Hui QIAN
3
;
Shuyun JIA
1
Author Information
1. Pharmacy Intravenous Admixture Services，Bozhou Municipal People’s Hospital，Anhui Bozhou 236800，China
2. School of Traditional Chinese Medicine，Bozhou University，Anhui Bozhou 236800，China
3. Dept. of Respiratory and Critical Care Medicine，Bozhou Municipal People’s Hospital，Anhui Bozhou 236800，China
- Publication Type:Journal Article
- Keywords:
atezolizumab;
adverse drug events;
warning signal;
data mining
- From:
China Pharmacy
2022;33(24):3025-3028
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To excavate the risk signals of adverse drug events （ADEs） of atezolizumab after marketing， so as to provide a reference for rational use of atezolizumab. METHODS Using the FAERS database， the ADEs of atezolizumab were collected from marketing on May 18th 2016 to Mar. 31st 2022. The ADEs risk signals were mined by reported odds ratio （ROR） and medicines and Healthcare Products Regulatory Agency method （MHRA）， and then described and classified by preferred term （PT） and system organ classification （SOC） in the adverse drug reaction glossary of Medical Dictionary for Regulatory Activities （MedDRA） （23.0 edition）. RESULTS A total of 16 051 ADEs reports with atezolizumab as the primary suspected drug were collected， and 401 PT were mined， involving 17 SOC. In 16 051 ADEs reports， the majority of patients were male （51.64%）， with main age distribution of 19 to 64 years old and more than 65 years old. According to the number of reports， ADEs were mainly focusing on pyrexia， disease progression， interstitial lung disease， anaemia， pneumonia， etc. The involved SOC includes kidney and urinary system diseases， benign， malignant and unknown tumors （including cysts and polyps）， endocrine system diseases， etc. According to the signal intensity， the new ADEs not specified in the drug instructions were macular thickening， paraneoplastic neurological syndrome， reactive perforating collagenosis， paraneoplastic dermatomyositis， anti-erythrocyte antibody positive and liver sarcoidosis. CONCLUSIONS In addition to the ADEs mentioned in the drug instructions，when using atezolizumab in clinic，attention should also be closely paid to ADEs of eyes， nervous and skin system， so as to ensure the safety of drug use in patients.
