Signals mining and analysis of inebilizumab adverse events
- VernacularTitle:伊奈利珠单抗不良事件信号挖掘与分析
- Author:
Jiayi ZHANG
1
;
Chen LIU
2
;
Xiaotong ZHANG
2
Author Information
1. Dept. of Pharmacy，Xuanwu Hospital，Capital Medical University，Beijing 100053，China;College of Pharmacy，Capital Medical University，Beijing 100069，China
2. Dept. of Pharmacy，Xuanwu Hospital，Capital Medical University，Beijing 100053，China
- Publication Type:Journal Article
- Keywords:
inebilizumab;
adverse events;
FAERS database;
neuromyelitis optica spectrum disorders
- From:
China Pharmacy
2026;37(2):215-219
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine and analyze adverse event signals associated with inebilizumab， and to provide reference for safe and rational clinical use. METHODS Reports of adverse event related to inebilizumab were collected from the FDA adverse event reporting system （FAERS） database， from Q2 2020 to Q4 2024. Adverse events were standardized and categorized according to the preferred term （PT） and system organ class （SOC） of the Medical Dictionary for Regulatory Activities （MedDRA） version 26.0. Signals were mined using the reporting odds ratio （ROR） method and the Bayesian confidence propagation neural network （BCPNN） method. RESULTS A total of 783 adverse event reports with inebilizumab as the primary suspected drug were identified， involving 297 patients. Most reports originated from the United States and Japan， with physicians being the primary reporters. Female patients outnumbered males， and the most common age group was 45-64 years. Using the ROR method and BCPNN method， a total of 29 valid adverse event signals were detected， involving 12 SOCs and comprising 225 adverse event reports. The five most frequently reported PTs were headache， nausea， fatigue， infectious pneumonia and arthralgia. The five PTs with the strongest signal intensity were： B-cell recovery， decreased blood immunoglobulin G， spinal compression fracture， COVID-19 and acute respiratory distress syndrome. Among the 29 valid signals for adverse event， 19 were not documented in the drug package inserts， involving 10 SOCs and comprising 107 adverse event reports. These encompassed nervous system disorders， general disorders and administration site conditions， eye disorders， among others. CONCLUSIONS Inebilizumab treatment not only causes adverse events documented in the product information， such as infections， immunoglobulin reduction and infusion-related reactions but also leads to potential signals， including B-cell recovery， spinal compression fracture. When using this drug in clinical practice， the patient’s risk of infection and baseline immune status should be assessed， relevant indicators should be closely monitored， and targeted preventive measures should be considered when necessary.
