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Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database

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International Journal of Clinical Pharmacy Aims and scope Submit manuscript

Abstract

Background

Emicizumab is the latest treatment for patients with hemophilia A. Its safety in real-world data is limited, and regulatory agencies and clinical researchers have raised concerns about the risk of adverse events.

Aim

This study aimed to detect potential adverse event signals of emicizumab using the FDA Adverse Event Reporting System (FAERS) database.

Method

Data in FAERS from the fourth quarter of 2017 to the second quarter of 2021 were searched. Cases of adverse events were extracted using the Preferred Term in the Medical Dictionary for Regulatory Activities (version 24.0). Disproportionality analysis was performed using the reporting odds ratio (ROR) and information component (IC) methods based on statistical shrinkage transformation.

Results

A total of 5,598,717 patients were included, of which 1,244 took emicizumab. A total of 703 emicizumab-related adverse event signals were mined, and 101 positive signals were detected. Haemarthrosis (ROR/ROR975/ROR025 = 155.62/184.34/131.38, IC/IC975/IC025 = 7.28/7.48/7.01), haemorrhage (ROR/ROR975/ROR025 = 71.01/81.18/62.12, IC/IC975/IC025 = 6.15/6.31/5.94), muscle haemorrhage (ROR/ROR975/ROR025 = 53.38/75.83/37.58, IC/IC975/IC025 = 5.74/6.16/5.15), traumatic haemorrhage (ROR/ROR975/ROR025 = 27.78/46.29/16.67, IC/IC975/IC025 = 4.80/5.40/3.92), haematoma (ROR/ROR975/ROR025 = 18.15/26.35/12.51, IC/IC975/IC025 = 4.18/4.63/3.55), device-related thrombosis (ROR/ROR975/ROR025 = 21.27/37.57/12.04, IC/IC975/IC025 = 4.41/5.08/3.43), and activated partial thromboplastin time prolonged (ROR/ROR975/ROR025 = 20.68/36.51/11.71, IC/IC975/IC025 = 4.37/5.04/3.39) had the strongest signal intensities. Haemorrhage, haemarthrosis, arthralgia, fall, and injection site pain were reported more frequently.

Conclusion

This study found that mild arthralgia and injection site reaction were associated with emicizumab. Attention should also be paid to other serious adverse events related to emicizumab, such as acute myocardial infarction and sepsis, to ensure patient safety.

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Acknowledgements

We thank for Dr Yuchen Qin for his help in the language polish of the manuscript revision.

Funding

This study was supported by the China Natural Science Foundation (No. 82073671), the Leading Talents of Public Health in Shanghai (No. GWV-10.2-XD22), the Excellent Young Scholars of Public Health in Shanghai (No. GWV-10.2-YQ33), the Construction Plan of Key Disciplines of Public Health system in Shanghai (GWV-10.1-XK05), and the Military Key Discipline Construction Project (Health Service-Naval Health Service Organization and Command) (No.03).

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Author notes

  1. Lianhui Wei, Ye Tian and Xiao Chen have contributed equally to this work and share first authorship.

Authors and Affiliations

  1. Department of Health Statistics, Faculty of Health Service, Naval Medical University, Shanghai, 200433, China

    Lianhui Wei, Xiao Chen, Xiaojing Guo, Chenxin Chen, Yi Zheng, Jinfang Xu & Xiaofei Ye

  2. Dapartment of Anesthesiology, The Sixth Medical Center of Chinese PLA General Hospital, Beijing, China

    Ye Tian

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Wei, L., Tian, Y., Chen, X. et al. Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database. Int J Clin Pharm 45, 622–629 (2023). https://doi.org/10.1007/s11096-022-01514-4

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