Data Mining and Analysis for Adverse Event Signals of Emicizumab Based on Food and Drug Administration Adverse Event Reporting System Database

Abstract Background: Emicizumab is the latest treatment for patients with hemophilia A. Its safety in real-world data is limited, and both regulatory agencies and clinical researchers have raised concerns about its risk of adverse events.Aim: This study utilized the Food and Drug Administration Adverse Event Reporting System database to tap into potential adverse event signals of Emicizumab to inform its clinical use and further protect patient health.Method: The analysis was carried out by searching data from the fourth quarter of 2017 to the second quarter of 2021 in the Food and Drug Administration Adverse Event Reporting System database. Adverse events were defined as the preferred term in the International Council for Harmonisation Medical Dictionary for Regulatory Activities version 24.0. Disproportionality analysis was performed using the reporting odds ratio and information component methods based on statistical shrinkage transformation.Results: A total of 5,598,717 records were included, of which 1,244 were emicizumab-related adverse event records. A total of 703 emicizumab-related adverse event signals were mined, and 101 positive signals were detected. Adverse events such as haemarthrosis, haemorrhage, haematoma muscle, and traumatic haemorrhage had stronger signal intensity, while haemorrhage, haemarthrosis, arthralgia, fall, and injection site pain were reported more frequently.Conclusion: Emicizumab has an adequate safety profile, with adverse drug reactions mostly consisting of arthralgia and injection site reactions with mild symptoms. Attention should be paid to potential adverse drug reactions such as acute myocardial infarction and sepsis, and certain precautions should be taken to ensure patient safety.