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Neuromuscular junction dysfunctions due to immune checkpoint inhibitors therapy: An analysis of FAERS data in the
Ping Zhang1, Donghui Lao2, Haoyan Chen1
1Department of Pharmacy, Tongren Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China.
Introduction:
The adverse effects of neuromuscular junction dysfunctions caused by immune checkpoint inhibitor (ICI) drugs have not been thoroughly assessed in the clinics.
Objective:
To 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.
Methods:
The 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.
Results:
Out 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).
Conclusions:
Analysis 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.
Insights
Immune checkpoint inhibitor (ICI) drugs can cause neuromuscular junction dysfunctions. Analysis of adverse event reports revealed a significant association between ICI use and these serious conditions, with over 30% resulting in death.
Area of Science:
- Pharmacovigilance
- Neurology
- Oncology
Background:
- Immune checkpoint inhibitors (ICIs) are crucial cancer therapies.
- Adverse effects of ICIs on neuromuscular junctions are not fully understood.
- Neuromuscular junction dysfunctions can significantly impact patient health.
Purpose of the Study:
- To assess neuromuscular junction dysfunctions in cancer patients receiving ICI therapy.
- To analyze adverse events reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- To quantify the association between ICI use and neuromuscular junction dysfunctions.
Main Methods:
- Utilized FAERS data from January 2004 to December 2020.
- Employed disproportionate and Bayesian analysis to assess ICI-neuromuscular junction dysfunction association.
- Compared onset time and outcomes across different ICI regimens.
Main Results:
- Identified 557 reports of neuromuscular junction dysfunctions (0.63%) out of 88,617 adverse events.
- Confirmed positive associations between multiple ICIs (ipilimumab, nivolumab, pembrolizumab, etc.) and neuromuscular junction dysfunctions.
- Nivolumab and pembrolizumab showed similar rates of neuromuscular junction dysfunctions, with no significant difference in onset time.
Conclusions:
- Over 30% of reported neuromuscular junction dysfunctions linked to ICIs resulted in patient death.
- Highlights the critical need for ongoing monitoring and risk evaluation of ICI-induced neuromuscular toxicity.
- Recommends further comparative studies to better understand ICI-specific risks.
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