Analysis on the risk of diabetes mellitus related to immune checkpoint inhibitors based on the US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20211022-01092
- VernacularTitle:基于美国FDA不良事件报告系统数据库的免疫检查点抑制剂致糖尿病风险分析
- Author:
Jing PENG
1
;
Mingli WU
;
Xiaolei REN
;
Kaijie JIANG
;
Lanfang LI
;
Zhen LIU
;
Tiantian WEI
;
Luhua MENG
;
Meixia WANG
;
Bo BAN
Author Information
1. 济宁医学院附属医院药学部，济宁 272029
- Publication Type:Journal Article
- Keywords:
Antineoplastic agents, immunological;
Diabetes mellitus;
Diabetic ketoacidosis;
Adverse drug reaction reporting systems;
Signal processing, computer-assis
- From:
Adverse Drug Reactions Journal
2022;24(3):123-129
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the risk of diabetes mellitus related to immune checkpoint inhibitors (ICI).Methods:The adverse event (AE) reports on fulminant type 1 diabetes mellitus (FT1DM), type 1 diabetes mellitus (T1DM), diabetic ketoacidosis (DKA), which were related to duvalizumab, pabolizumab, nivolumab, and atezolizumab in the US FDA Adverse Event Reporting System from the first quarter of 2004 to the second quarter of 2021, were collected.The correlation between the 4 drugs and FT1DM, T1DM,and DKA were evaluated using proportional reporting odds ratio ( PRR) method.AE with reports ≥3, PRR value≥2, and χ2≥4 were judged to have statistical correlations with drugs. The greater the PRR value, the stronger the correlation between AE and drugs and the stronger the risk signals. Results:A total of 1 468 AE reports on diabetes mellitus were collected, 53, 386, 957, and 72 of which were related toduvalizumab, pabolizumab, nivolumab, and atezolizumab, respectively. For duvalizumab, pabolizumab, nivolumab, and atezolizumab, the PRR reflecting the correlation with FT1DM were 21.97 ( χ2=40.71), 71.50 ( χ2=3 531.21), 294.30 ( χ2=4 3915.75), and 33.58 ( χ2=279.70), respectively; the PRR reflecting correlation with T1DM were 12.12 ( χ2=162.08), 21.04 ( χ2=3391.17), 20.99 ( χ2=5816.11), and 9.71 ( χ2=224.81), respectively; the PRR reflecting correlation with DKA were 6.93 ( χ2=161.26), 4.78 ( χ2=426.52), 6.82 ( χ2=1797.15), and 3.04 ( χ2=41.84), respectively. The 4 drugs were statistically correlated with their corresponding AE. The order of risk signal intensity for corresponding AE was FT1DM > T1DM > DKA. The order of risk signal intensity for FT1DM were nivolumab > pabolizumab > duvalizumab > atezolizumab, for T1DM were pabolizumab ≈ nivolumab > duvalizumab > atezolizumab, for DKA were duvalizumab ≈ nivolumab > pabolizumab > atezolizumab. Conclusions:Duvalizumab, pabolizumab, nivolumab, and atezolizumab all can cause diabetes mellitus. The risk signal intensity was the strongest for FT1DM, followed by T1DM and DKA in order.
