ArticleClinical pharmacokinetics2021
Exposure-Bleeding Count Modeling of Emicizumab for the Prophylaxis of Bleeding in Persons with Hemophilia A with/Without Inhibitors Against Factor VIII.
Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06320626 (Pharmacokinetic-guided Dosing of Emicizumab in Congenital Haemophilia A Patients - The DosEmi Study), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pharmacokinetic-guided Dosing of Emicizumab in Congenital Haemophilia A Patients - The DosEmi Study
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Pharmacokinetics and Associated Efficacy of Emicizumab in Humans: A Systematic Review.Clinical pharmacokinetics · 2021Pooled it
- Emicizumab dose up-titration in case of suboptimal bleeding control in people with haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2023Trial
- [Clinical efficacy and safety of Octocog alfa in Chinese patients with hemophilia A: One-year follow-up results from the Antihemophilic Factor Hemophilia A Outcome Database (AHEAD) study].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Article
- Automated Poisson regression exposure-response analysis for binary outcomes with PoissonERM.CPT: pharmacometrics & systems pharmacology · 2024Article
- Article
- Efficacy of emicizumab is maintained throughout dosing intervals for bleed prophylaxis.Research and practice in thrombosis and haemostasis · 2023Article
- Optimizing maintenance dosing of emicizumab-kxwh as prophylaxis in hemophilia A: Dosing to product labeling while minimizing drug waste.Journal of managed care & specialty pharmacy · 2023Article
- Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY).Research and practice in thrombosis and haemostasis · 2022Article
- Emicizumab in children: bleeding episodes and outcome before and after transition to Emicizumab.BMC pediatrics · 2022Article
- Prophylactic emicizumab for hemophilia A in the Asia-Pacific region: A randomized study (HAVEN 5).Research and practice in thrombosis and haemostasis · 2022Article
- A Model-Based Framework to Inform the Dose Selection and Study Design of Emicizumab for Pediatric Patients With Hemophilia A.Journal of clinical pharmacology · 2022Article
- Low immunogenicity of emicizumab in persons with haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2021Article
- Reference Values for the Haemophilia Joint Health Score in Patients With Severe Haemophilia Derived From the Canadian Bleeding Disorder Registry.Haemophilia : the official journal of the World Federation of HemophiliaArticle
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveEmicizumab is a monoclonal antibody that bridges activated coagulation factor IX and factor X to restore effective hemostasis in persons with hemophilia A. It is indicated for routine prophylaxis of bleeding episodes in persons with hemophilia A. The aim of the present study is to describe the exposure-response relationship between emicizumab concentrations and bleeding frequency, and to confirm adequate bleeding control of the investigated dosing regimens 1.5 mg/kg once weekly, 3 mg/kg every 2 weeks, and 6 mg/kg every 4 weeks.
methodsTreated bleeding events were pooled from 445 persons with hemophilia A with and without inhibitors against factor VIII, participating in six clinical studies. Emicizumab concentrations were predicted using a previously developed population pharmacokinetic model. A count model was used to quantify the exposure-response relationship. These models were used to illustrate the relationship between emicizumab concentrations and cumulative count of bleeding over 1 year (annualized bleeding rate).
resultsThe final exposure-response model, based on a generalized Poisson distribution and an inhibitory E
conclusionsThese results confirm that average emicizumab concentrations achieved with all three emicizumab dosing regimens provide adequate bleeding control.
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