LONG Xia,HUANG Mengwen,PU Shiyun,et al.Data mining of severe cutaneous adverse reactions related to immune checkpoint inhibitors in the FAERS[J].ZHONGGUO YAOFANG,2023,34(22):2760-2765.
LONG Xia,HUANG Mengwen,PU Shiyun,et al.Data mining of severe cutaneous adverse reactions related to immune checkpoint inhibitors in the FAERS[J].ZHONGGUO YAOFANG,2023,34(22):2760-2765. DOI: 10.6039/j.issn.1001-0408.2023.22.13.
Data mining of severe cutaneous adverse reactions related to immune checkpoint inhibitors in the FAERS
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
2
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
2
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
2
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.
关键词
免疫检查点抑制剂严重皮肤不良反应药物不良事件信号检测
Keywords
severe cutaneous adverse reactionsadverse drug reactionssignal detection
GUO X M,ZHOU J X,ZHANG W. Progress in diagnosis and treatment of rheumatic adverse events associated with immune checkpoint inhibitors[J]. J Clin Intern Med,2023,40(2):82-85.
JIN X H,ZHANG Y,ZHUANG J L. Progress in diagnosis and treatment of hematologic toxicity associated with immune checkpoint inhibitors[J]. J Clin Intern Med,2023,40(2):73-78.
WU T X,ZHANG Y,SHI Y F,et al. Analysis of neurological toxicities associated with immune checkpoint inhibitor based on the FDA adverse event reporting system[J]. Chin J Drug Appl Monit,2023,20(1):50-54.
TANG S Q,TANG L L,MAO Y P,et al. The pattern of time to onset and resolution of immune-related adverse events caused by immune checkpoint inhibitors in cancer:a pooled analysis of 23 clinical trials and 8 436 patients[J]. Cancer Res Treat,2021,53(2):339-354.
THOMPSON J A,SCHNEIDER B J,BRAHMER J,et al. Management of immunotherapy-related toxicities,version 1.2019[J]. J Natl Compr Canc Netw,2019,17(3):255-289.
LI H R,ZOU Z Y. Research progress and management strategies about skin adverse reactions of immune checkpoint inhibitors[J]. J Clin Dermatol,2023,52(3):187-189.
FAN X C,BAI R,LI Y L,et al. Fatal Stevens-Johnson syndrome/toxic epidermal necrolysis caused by pembrolizumab:one case report[J]. Chin J Hosp Pharm,2021,41(12):1281-1282.
SU Y,WANG Q Q,WANG M R,et al. A case of toxic epidermal necrolysis associated with immune checkpoint inhibitor[J]. China Clin Pract Med,2022,13(2):77-78.
Adverse Drug Reaction Research Center of Chinese So-ciety of Dermatology. Expert consensus on the diagnosis and treatment of Stevens-Johnson syndrome/toxic epidermal necrolysis[J]. Chin J Dermatol,2021,54(5):376-381.
SARBIYA·YUNUSAJI,XIONG D Q,WU B,et al. FAERS-based data mining study of glucocorticoid-drug related osteoporosis and osteonecrosis[J]. Her Med,2023,42(4):591-596.
HUANG J,ZHAO Y B,CAO Y N,et al. Anaplastic lymphoma kinase tyrosine kinase inhibitors associated gastrointestinal obstruction,perforation,and ulceration:an analysis of the FDA adverse event reporting system database(FAERS)[J]. Int J Clin Pharm,2022,44(4):993-1003.
ZHANG W X,GUO H J,PAN X H,et al. Research pro-gress of immune checkpoint inhibitors[J]. Prog Pharm Sci,2022,46(12):910-921.
MELLMAN I,COUKOS G,DRANOFF G. Cancer immunotherapy comes of age[J]. Nature,2011,480(7378):480-489.
INTHAGARD J,EDWARDS J,ROSEWEIR A K. Immunotherapy:enhancing the efficacy of this promising therapeutic in multiple cancers[J]. Clin Sci,2019,133(2):181-193.
BAI L,WANG K. Research progress of immune-related adverse reactions caused by immune checkpoint inhibitors[J]. J Chang Univ Chin Med,2023,39(2):229-236.
ZHANG J,QIN X H,DU L,et al. Progress in diagnosis and treatment of non-myocarditis cardiotoxicity asso-ciated with immune checkpoint inhibitors[J]. J Clin Intern Med,2023,40(2):79-82.
ZHANG L L,REYNOLDS K L,LYON A R,et al. The evolving immunotherapy landscape and the epidemiology,diagnosis,and management of cardiotoxicity:JACC: CardioOncology primer[J]. JACC CardioOncol,2021,3(1):35-47.
WALIANY S,LEE D,WITTELES R M,et al. Immune checkpoint inhibitor cardiotoxicity:understanding basic mechanisms and clinical characteristics and finding a cure[J]. Annu Rev Pharmacol Toxicol,2021,61:113-134.
LI Z H,WANG R,MA L,et al. Literature analysis of severe skin adverse event induced by immune checkpoint inhibitors[J]. Chin J Drug Appl Monit,2022,19(5):326-330,349.
CHENG H X,ZHANG D J,HAO F. Skin adverse reactions associated with immune checkpoint inhibitors[J]. Chin J Dermatovenereol,2023,37(6):727-731.
PANPRUK R,PUANGSRICHARERN V,KLAEWSONGKRAM J,et al. Clinical parameters and biological markers associated with acute severe ocular complications in Stevens-Johnson syndrome and toxic epidermal necrolysis[J]. Sci Rep,2021,11(1):20275.
Detection and evaluation of the signals of amlodipine and lercanidipine based on FAERS database
Data Analysis of the Risks of Abnormal Female Reproductive System Haemorrhages Induced by Novel Oral An- ticoagulants Based on FAERS
Related Author
ZHONG Guizun
ZHANG Ni
WANG Hongli
CHEN Siqi
GONG Li
PAN Lingyun
JIA Yuntao
TIAN Xiaojiang
Related Institution
School of Pharmacy,Chongqing Medical University
Dept. of Pharmacy, Army Medical Characteristic Center of PLA
Key Lab of Researches on Transformation of Tumor Metastasis and Individualized Diagnosis and Treatment, Chongqing University Cancer Hospital
Dept. of Pharmacy, Chongqing University Cancer Hospital
Dept. of Pharmacy, Children’s Hospital Affiliated to Chongqing Medical University/Key Laboratory of Child Development Disease Research, Ministry of Education/National Science and Technology Cooperation Base of Major Child Development Diseases/Chongqing Key Laboratory of Pediatrics/National Clinical Medicine Research Center of Child Health and Diseases