Risk signal mining of adverse events of satralizumab treatment for neuromyelitis optica spectrum disorder: based on the US Food and Drug Administration Adverse Event Reporting System
10.3760/cma.j.cn114015-20240531-00407
- VernacularTitle:萨特利珠单抗治疗视神经脊髓炎谱系疾病的不良事件风险信号挖掘：基于美国FDA不良事件报告系统数据库的研究
- Author:
Huahui SHI
1
;
Chunmei JI
1
Author Information
1. 南京医科大学第一附属医院药学部，南京 210029
- Publication Type:Journal Article
- Keywords:
Neuromyelitis optica;
Adverse event signal detection;
Data mining;
Satralizumab
- From:
Adverse Drug Reactions Journal
2025;27(1):25-29
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the risk signals of adverse events (AE) of satralizumab for treatment of neuromyelitis optica spectrum disorder (NMOSD) and provide reference for safe use of the drug in clinic.Methods:AE reports on satralizumab from the 1st quarter of 2020 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the preferred term (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds radio (ROR) method and Bayesian confidence progressive neural network (BCPNN) method were used to mine the AE risk signals. An AE with ≥3 reports, lower limit of the 95% confidence interval ( CI) of ROR >1, and the information component ( IC) of BCPNN method minus 2 times of standard deviation ( IC-2 SD) >0 were defined as a risk signal. Descriptive analysis on the signals was performed. Results:A total of 526 AE reports were collected, 39 risk signals (PT) were mined by ROR and BCPNN methods, involving 13 SOCs. Among the 39 PTs, 11 were adverse reactions recorded in the label, including blood triglycerides increased, hepatic function abnormal, cellulitis, and etc. Twenty-eight PTs were not recorded in the label, 11 of which involved infections and infestations. The top 5 PTs in signal intensity were atypical mycobacterium infection, pyelonephritis, compression fracture, spinal compression fractures, and lymphocyte count decreased. The top 5 PTs in number of reports were urinary tract infection, pneumonia, corona virus disease 2019, sepsis, and herpes zoster.Conclusion:In addition to the blood triglycerides increased, hepatic function abnormal, cellulitis, and other AEs recorded in the label, NMOSD treatment with satralizumab may also cause atypical mycobacterial infection, pyelonephritis, compression fracture and other AEs not recorded in the label, which clinical physicians should be vigilant.
