Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years

IntroductionThe adverse effects of neuromuscular junction dysfunctions caused by immune checkpoint inhibitor (ICI) drugs have not been thoroughly assessed in the clinics.ObjectiveTo assess the neuromuscular junction dysfunctions in cancer patients with adverse events caused by ICI therapy by searchi...

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Main Authors: Ping Zhang, Donghui Lao, Haoyan Chen, Bin Zhao, Qiong Du, Qing Zhai, Xuan Ye, Bo Yu
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-08-01
Series:Frontiers in Immunology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2022.778635/full
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author Ping Zhang
Donghui Lao
Haoyan Chen
Bin Zhao
Qiong Du
Qiong Du
Qing Zhai
Qing Zhai
Xuan Ye
Xuan Ye
Bo Yu
author_facet Ping Zhang
Donghui Lao
Haoyan Chen
Bin Zhao
Qiong Du
Qiong Du
Qing Zhai
Qing Zhai
Xuan Ye
Xuan Ye
Bo Yu
author_sort Ping Zhang
collection DOAJ
description IntroductionThe adverse effects of neuromuscular junction dysfunctions caused by immune checkpoint inhibitor (ICI) drugs have not been thoroughly assessed in the clinics.ObjectiveTo assess the neuromuscular junction dysfunctions in cancer patients with adverse events caused by ICI therapy by searching the Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodsThe FAERS data from January 2004 to December 2020 were collected to analyze the association between neuromuscular connection dysfunction and ICI use. Disproportionate analysis and Bayesian analysis were used to quantify the association between the neuromuscular junction dysfunctions and ICIs. The onset time and outcome of neuromuscular junction dysfunctions in different ICI regimens were also compared.ResultsOut of 88,617 adverse event reports, 557 neuromuscular junction dysfunction reports (0.63%) were analyzed. Marketed ICI drugs, including ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, cemiplimab, avelumab, as well as their combinations, showed positive associations with four detection methods. Most of the adverse event reports were associated with the use of nivolumab (53.32%) and pembrolizumab (31.96%). However, nivolumab-related neuromuscular junction dysfunctions were similar with pembrolizumab (33.33% vs 33.14%, p > 0.05). The onset time of neuromuscular junction dysfunctions showed no significant difference among different ICIs (p > 0.05).ConclusionsAnalysis of FAERS data identified that over 30% (32.85%) of reports of neuromuscular junction dysfunctions resulted in death. Ongoing monitoring, risk evaluations, and further comparative studies of ICIs should be considered.
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spelling doaj.art-156d8e469e7d48f19dd3eb35ff4b51b32022-12-22T04:01:09ZengFrontiers Media S.A.Frontiers in Immunology1664-32242022-08-011310.3389/fimmu.2022.778635778635Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 yearsPing Zhang0Donghui Lao1Haoyan Chen2Bin Zhao3Qiong Du4Qiong Du5Qing Zhai6Qing Zhai7Xuan Ye8Xuan Ye9Bo Yu10Department of Pharmacy, Tongren Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, ChinaDepartment of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, ChinaDepartment of Pharmacy, Tongren Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, ChinaDepartment of Pharmacy Pharmacology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, ChinaSchool of Medicine, Fudan University, Shanghai, ChinaDepartment of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, ChinaSchool of Medicine, Fudan University, Shanghai, ChinaDepartment of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, ChinaSchool of Medicine, Fudan University, Shanghai, ChinaDepartment of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, ChinaDepartment of Pharmacy, Tongren Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, ChinaIntroductionThe adverse effects of neuromuscular junction dysfunctions caused by immune checkpoint inhibitor (ICI) drugs have not been thoroughly assessed in the clinics.ObjectiveTo assess the neuromuscular junction dysfunctions in cancer patients with adverse events caused by ICI therapy by searching the Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodsThe FAERS data from January 2004 to December 2020 were collected to analyze the association between neuromuscular connection dysfunction and ICI use. Disproportionate analysis and Bayesian analysis were used to quantify the association between the neuromuscular junction dysfunctions and ICIs. The onset time and outcome of neuromuscular junction dysfunctions in different ICI regimens were also compared.ResultsOut of 88,617 adverse event reports, 557 neuromuscular junction dysfunction reports (0.63%) were analyzed. Marketed ICI drugs, including ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, cemiplimab, avelumab, as well as their combinations, showed positive associations with four detection methods. Most of the adverse event reports were associated with the use of nivolumab (53.32%) and pembrolizumab (31.96%). However, nivolumab-related neuromuscular junction dysfunctions were similar with pembrolizumab (33.33% vs 33.14%, p > 0.05). The onset time of neuromuscular junction dysfunctions showed no significant difference among different ICIs (p > 0.05).ConclusionsAnalysis of FAERS data identified that over 30% (32.85%) of reports of neuromuscular junction dysfunctions resulted in death. Ongoing monitoring, risk evaluations, and further comparative studies of ICIs should be considered.https://www.frontiersin.org/articles/10.3389/fimmu.2022.778635/fullimmune checkpoint inhibitorneuromuscular junction dysfunctionadverse eventdata miningFAERS
spellingShingle Ping Zhang
Donghui Lao
Haoyan Chen
Bin Zhao
Qiong Du
Qiong Du
Qing Zhai
Qing Zhai
Xuan Ye
Xuan Ye
Bo Yu
Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years
Frontiers in Immunology
immune checkpoint inhibitor
neuromuscular junction dysfunction
adverse event
data mining
FAERS
title Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years
title_full Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years
title_fullStr Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years
title_full_unstemmed Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years
title_short Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the past 15 years
title_sort neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy an analysis of faers data in the past 15 years
topic immune checkpoint inhibitor
neuromuscular junction dysfunction
adverse event
data mining
FAERS
url https://www.frontiersin.org/articles/10.3389/fimmu.2022.778635/full
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