Data mining of severe cutaneous adverse reactions related to immune checkpoint inhibitors in the FAERS
- VernacularTitle:FAERS中免疫检查点抑制剂相关严重皮肤不良反应数据挖掘
- Author:
Xia LONG
1
;
Mengwen HUANG
2
;
Shiyun PU
1
;
Lichen WANG
3
;
Mengjiao TANG
4
;
Houfeng ZHOU
1
Author Information
1. Dept. of Pharmacy，Chengdu Fifth People’s Hospital，Chengdu 611130，China
2. School of Pharmacy，Chengdu University of Traditional Chinese Medicine，Chengdu 611137，China
3. School of Pharmacy，North Sichuan Medical College，Sichuan Nanchong 637100，China
4. School of Pharmacy，Southwest Medical University，Sichuan Luzhou 646099，China
- Publication Type:Journal Article
- Keywords:
immune checkpoint inhibitors;
severe cutaneous adverse reactions;
adverse drug reactions;
signal detection
- From:
China Pharmacy
2023;34(22):2760-2765
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine and analyze severe cutaneous adverse reaction signals of 5 commonly used immune checkpoint inhibitors （ICIs）， and to provide reference for clinically safe use of drugs. METHODS Based on the FDA adverse events reporting system （FAERS） database，adverse drug events （ADEs） reports about severe cutaneous adverse reactions related to ipilimumab， nivolumab， pembrolizumab， atezolizumab and durvalumab were collected from listing in the United States to the fourth quarter of 2022. The ADE signals were mined and analyzed with reporting odds ratio （ROR） and Bayesian confidence propagation neural network （BCPNN）. RESULTS A total of 5 726 reports of severe cutaneous adverse reactions were collected， including 3 037 reports for nivolumab，1 465 reports for pembrolizumab， 130 reports for durvalumab， 429 reports for atezolizumab and 665 reports for ipilimumab. All 5 kinds of ICIs caused positive signals， the correlation degree of which was as follows： pembrolizumab＞atezolizumab＞nivolumab＞ipilimumab＞durvalumab. Stevens-Johnson syndrome（SJS） and toxic epidermal necrolysis （TEN） have been reported for all 5 ICIs， and the association was the strongest with pembrolizumab. CONCLUSIONS All 5 kinds of ICIs are associated with the risk of severe skin adverse reactions， and close attention should be paid to their clinical use， especially being cautious when using pembrolizumab. The combination of ICIs should be avoided as much as possible.
