Functional determination of emicizumab in presence of factor VIII activity

Article Chemistry, Analytical

Development of simple and rapid method for Emicizumab quantification by LC-MS/MS in human plasma

Laurie Josset et al.

Summary: This study developed a method for absolute quantification of emicizumab using LC-MS/MS, which was validated according to FDA recommendations and showed good correlation with the traditional FVIII activity assay.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2023)

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Article Hematology

Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study

Claude Négrier et al.

Lancet Haematology (2023)

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Article Hematology

A prospective, multicenter, open-label phase III study of emicizumab prophylaxis in patients with acquired hemophilia A

Midori Shima et al.

Summary: This study evaluated the efficacy, safety, and pharmacokinetics of emicizumab in patients with acquired hemophilia A. The results showed that 91.7% of patients completed emicizumab treatment without experiencing any major bleeds. There were no deaths or serious adverse events related to bleeding or infection reported.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2023)

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Review Hematology

Revealing and IgG4 analysis to factor VIII in haemophilia-A patients with and without inhibitors

Namrata Punit Awasthi et al.

Summary: This study standardized and evaluated an in-house IgG4 ELISA for the detection of haemophilia A inhibitors. The results showed that the IgG4 ELISA method can effectively differentiate healthy controls and HA patients with or without inhibitors, and can be particularly useful in resource-constrained settings where quantification of inhibitors is required.

TRANSFUSION AND APHERESIS SCIENCE (2022)

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Article Multidisciplinary Sciences

Optimization and evaluation of a two-stage chromogenic assay procedure for measurement of emicizumab plasma levels

Nasim Shahidi Hamedani et al.

Summary: This study optimized and evaluated a two-stage chromogenic assay (emi-tenase) for the measurement of emicizumab in plasma samples. Heat inactivation was established to eliminate the influence of endogenous or substituted factor VIII. The emi-tenase assay allows specific measurement of emicizumab plasma levels over a broad concentration range and can be applied in a routine laboratory setting.

PLOS ONE (2022)

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Article Hematology

Quantification of emicizumab by mass spectrometry in plasma of people with hemophilia A: A method validation study

Anouk A. M. T. Donners et al.

Summary: The study developed an LC-MS/MS method for quantifying Emicizumab and validated its effectiveness in the plasma of patients with hemophilia A. Results showed the method had a wide linear range, excellent accuracy, and precision, and can be interchangeably used with the OSA-based method.

RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS (2022)

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Article Medical Laboratory Technology

Emicizumab, the factor VIII mimetic bi-specific monoclonal antibody and its measurement in plasma

Armando Tripodi et al.

Summary: This study demonstrates that by making slight modifications to the OSA for FVIII, it can reliably measure the concentration of emicizumab and assist clinicians in managing patients on emicizumab. Additionally, the use of CA assay with bovine reagents can effectively measure the inhibitors to FVIII in patients receiving emicizumab treatment.

CLINICAL CHEMISTRY AND LABORATORY MEDICINE (2021)

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Article Hematology

Emicizumab prophylaxis: Prospective longitudinal real-world follow-up and monitoring

Assaf A. Barg et al.

Summary: A study on the efficacy and safety of long-term prophylaxis with emicizumab in patients with severe haemophilia A found that most patients tolerated the treatment well, although some experienced breakthrough bleeding. Further studies are needed to explore the potential benefits in specific patient populations.

HAEMOPHILIA (2021)

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Letter Hematology