Manuscripts

 

This section includes a list of publications related to emicizumab and specific topics of interest. The publications included aim to provide scientific, objective and balanced information about emicizumab. You can find the criteria used to collect these lists below*. They will be updated periodically by the Roche scientific team.

Due to copyrights, we can not provide access to all the publications included. If you are unable to access any of these manuscripts via your existing subscriptions, please contact your local Roche medical information department for assistance.

*The first search included all publications with the words 'emicizumab' and 'ACE910'. Due to the aim of this website, the following types of publications were not included:

  • Letter to the editor, Editorials, Commentaries and News.
  • Publications that are not specific about emicizumab.
  • Publications containing off-label information about emicizumab.
  • Publications that use emicizumab in animal models.
Recurrent intracranial bleed in a child receiving prophylaxis with emicizumab

Teo HKW, Wong WH, Lam JCM. [published online ahead of print, 2021 Feb 15] Haemophilia. 2021 Feb 15. doi: 10.1111/hae.14274.

Clot waveform analysis for perioperative hemostatic monitoring of arthroscopic synovectomy in a pediatric patient with hemophilia A and inhibitor receiving emicizumab prophylaxis

Mizumachi K, Tsumura Y, Nakajima Y et al. [published online ahead of print, 2021 Feb 10] Int J Hematol. 2021 Feb 10. doi: 10.1007/s12185-021-03095-w.

Long-term outcomes with emicizumab prophylaxis for hemophilia A with/without FVIII inhibitors from the HAVEN 1-4 studies

Callaghan MU, Negrier CG, Paz-Priel I. [published online ahead of print, 2020 Dec 10] Blood. 2020 Dec 10. doi: 10.1182/blood.2020009217.

Emicizumab prophylaxis in a Korean child with severe hemophilia A and high titer inhibitor: a case report

Ahn JH, Jung N, Shim YJ, Kim HS.  [published online ahead of print, 2021 Jan 28] Blood Res. 2021 Jan 28. doi: 10.5045/br.2021.2020184.

Development and testing of the Satisfaction Questionnaire with Intravenous or Subcutaneous Hemophilia Injection and results from the Phase 3 HAVEN 3 study of emicizumab prophylaxis in persons with haemophilia A without FVIII inhibitors

Kempton C, Trask P, Parnes A et al. [published online ahead of print, 2021 Jan 28] Haemophilia. 2021 Jan 28. doi: 10.1111/hae.14222.

Characterization of the neutralizing anti-emicizumab antibody in a patient with hemophilia A and inhibitor

Valsecchi C, Gobbi M, Beeg M et al. [published online ahead of print, 2020 Dec 28] J Thromb Haemost. 2020 Dec 28. doi: 10.1111/jth.15226.

Application of a hemophilia mortality framework to the Emicizumab Global Safety Database.

Peyvandi F, Mahlangu JN, Pipe SW et al. J Thromb Haemost. 2021;19(Suppl. 1):32-41.

Emicizumab in tolerized patients with hemophilia A with inhibitors: A single‐institution pediatric cohort assessing inhibitor status

Batsuli G, Greene A, Meeks SL, Sidonio RF. [published online ahead of print, 2021 Feb 8] Res Pract Thromb Haemost. 2021 Feb 8:00:1–7 doi: 10.1002/rth2.12475.

Approximation of emicizumab plasma levels in emergency situations. A practical approach

Pekrul I, Pfrepper C, Calatzis G et al. [published online ahead of print, 2021 Feb 1] Haemophilia. 2021 Feb 1. doi: 10.1111/hae.14264.

Long-term safety and efficacy of emicizumab for up to 5.8 years and patients' perceptions of symptoms and daily life: A phase 1/2 study in patients with severe haemophilia A

Shima M, Nagao A, Taki M, et al. Haemophilia. 2021 Jan;27(1):81-89.

Emicizumab therapy in a haemophilia patient with previous pulmonary embolism

Holzmann J, Coulsen H, Poulsen W et al. Paediatr Child Health. 2020 Dec;56(12):2001-2002.

Cost-effectiveness of emicizumab vs bypassing agents in the prevention of bleeding episodes in haemophilia A patients with anti-FVIII inhibitors in France

Polack B, Trossaërt M, Cousin M, et al. Haemophilia. 2021 Jan;27(1):e1-e11.

Establishment of a framework for assessing mortality in persons with congenital hemophilia A and its application to an adverse event reporting database.

Pipe SW, Kruse-Jarres R, Mahlangu JN et al. J Thromb Haemost. 2021;19(Suppl. 1):21–31.

Real-world case series and summary of current literature of infants and toddlers with severe hemophilia A with inhibitor on prophylaxis with emicizumab

Garcia J, Zia A. [published online ahead of print, 2021 Feb 8] Pediatr Blood Cancer. 2021 Feb 8:e28942. doi: 10.1002/pbc.28942.

Validation of the chromogenic Bethesda assay for factor VIII inhibitors in hemophilia a patients receiving Emicizumab

Miller CH, Boylan B, Payne AB et al. [published online ahead of print, 2020 Nov 10] Int J Lab Hematol. 2020 Nov 10. doi: 10.1111/ijlh.13384.

Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human fviia) and emicizumab in congenital haemophilia A plasma

Grandoni J, Duretz V, Bonzo D et al. [published online ahead of print, 2021 Feb 6] Haemophilia. 2021 Feb 6. doi: 10.1111/hae.14253.

Determining meaningful health-related quality-of-life improvement in persons with haemophilia A using the Haemophilia Quality of Life Questionnaire for Adults (Haem-A-QoL)

von Mackensen S, Catalani O, Asikanius E, et al. Haemophilia. 2020 Nov;26(6):1019-1030.

Key questions in the new hemophilia era: update on concomitant use of FVIII and emicizumab in hemophilia A patients with inhibitors

Carcao M, Mancuso ME, Young G, Jiménez-Yuste V. [published online ahead of print, 2021 Jan 27] Expert Rev Hematol. 2021 Jan 27:1-6. doi: 10.1080/17474086.2021.1875817.

Emicizumab-Induced Seronegative Full-House Lupus Nephritis in a Child

Chehade H, Cachat F, Beck-Popovic M, et al. Pediatrics. 2020 Nov;146(5):e20200123.

Pharmacokinetics and Pharmacodynamics of Emicizumab in Persons with Hemophilia A with Factor VIII Inhibitors: HAVEN 1 Study.

Schmitt C, Adamkewicz JI, Xu J, et al. [published online ahead of print Oct 21] Thromb Haemost. 2020 Oct 21. doi: 10.1055/s-0040-1717114.

Modelling future usage and cost of factor and emicizumab to treat haemophilia A for the US Western States Region IX haemophilia treatment centres

Stonebraker JS, Ducore JM. Haemophilia. 2021 Jan;27(1):e22-e29.

Mortality in congenital hemophilia A – A systematic literature review.

Hay CRM, Nissen F, Pipe SW. J Thromb Haemost. 2021;19(Suppl. 1):6-20.

Management of people with haemophilia A undergoing surgery while receiving emicizumab prophylaxis: Real-world experience from a large comprehensive treatment centre in the US

Lewandowska M, Randall N, Bakeer N, et al. Haemophilia. 2021 Jan;27(1):90-99.

Effects of Emicizumab on APTT, FVIII assays and FVIII Inhibitor assays using different reagents: Results of a UK NEQAS proficiency testing exercise

Lowe A, Kitchen S, Jennings I, et al. Haemophilia. 2020 Nov;26(6):1087-1091.

Comparison of bypassing agents in patients on emicizumab using global hemostasis assays

Kizilocak H, Marquez-Casas E, Phei Wee C, et al. Haemophilia. 2021 Jan;27(1):164-172.

Health-related quality of life and caregiver burden of emicizumab in children with haemophilia A and factor VIII inhibitors-Results from the HAVEN 2 study

Mancuso ME, Mahlangu J, Sidonio R Jr, et al.  Haemophilia. 2020 Nov;26(6):1009-1018.

Optimizing the management of patients with haemophilia A and inhibitors in the era of emicizumab: Recommendations from a German expert panel.

Escuriola-Ettingshausen C, Auerswald G, Königs C, et al.  [published online ahead of print Sep 16] Haemophilia. 2020 Sep 16. doi: 10.1111/hae.14010.

Consecutive complex percutaneous coronary interventions using emicizumab and recombinant activated factor VII in a patient with severe haemophilia A and high-titre inhibitor.

Chen YW, Chen WJ, Tseng MS, et al. [published online ahead of print Sep 30] Haemophilia. 2020 Sep 30. doi: 10.1111/hae.14165.

Population Pharmacokinetic Analysis and Exploratory Exposure–Bleeding Rate Relationship of Emicizumab in Adult and Pediatric Persons with Hemophilia A

Retout S, Schmitt C, Petry C, Mercier F, Frey N. [published online ahead of print, 2020 Jun 5]. Clin Pharmacokinet. 2020;10.1007/s40262-020-00904-z.

A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A.

Yoneyama K, Schmitt C, Kotani N, et al. Clin Pharmacokinet 2018;57:1123–1134.

Immune tolerance induction in paediatric patients with haemophilia A and inhibitors receiving emicizumab prophylaxis.

Batsuli G, Zimowski KL, Tickle K, et al. Haemophilia 2019;25:789–796.    

Cost-Effectiveness and Budget Impact of Emicizumab Prophylaxis in Haemophilia A Patients with Inhibitors

Cortesi PA, Castaman G, Trifirò G, et al. Thromb Haemost. 2020;120(2):216-228.

Model of Short- and Long-Term Outcomes of Emicizumab Prophylaxis Treatment for Persons with Hemophilia A.

Zhou ZY, Raimundo K, Patel AM, et al. J Manag Care Spec Pharm 2020:1–12.

Emicizumab treatment and monitoring in a paediatric cohort: real‐world data

Barg AA, Livnat T, Budnik I, et al. [published online ahead of print, 2020 Jul 12]. Br J Haematol. 2020;10.1111/bjh.16964.

Concomitant Use of rFVIIa and Emicizumab in People With Hemophilia A With Inhibitors: Current Perspectives and Emerging Clinical Evidence.

Linari S and Castaman G. Ther Clin Risk Manag 2020;16:461–469.    

Emicizumab, A Bispecific Antibody to Factors IX/IXa and X/Xa, Does Not Interfere with Antithrombin or TFPI Activity In Vitro.

Noguchi-Sasaki M, Soeda T, Ueyama A, et al. TH Open 2018;2:e96–e103.    

Emicizumab treatment: Impact on coagulation tests

Nougier C, Jeanpierre E, Ternisien C, et al. [published online ahead of print, 2020 Jul 15]. Eur J Haematol. 2020;10.1111/ejh.13490.

Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity.

Sampei Z, Igawa T, Soeda T, et al. PLoS One 2013;8:e57479.

A modified thrombin generation assay to evaluate the plasma coagulation potential in the presence of emicizumab, the bispecific antibody to factors IXa/X

Ogiwara K, Nogami K, Matsumoto N, et al. [published online ahead of print, 2020 Aug 3]. Int J Hematol. 2020;10.1007/s12185-020-02959-x.

Outcomes in children with hemophilia A with inhibitors: Results from a noninterventional study

Oldenburg J, Shima M, Kruse-Jarres R, et al. [published online ahead of print, 2020 Aug 9]. Pediatr Blood Cancer. 2020;e28474.

Bridging the Missing Link with Emicizumab: A Bispecific Antibody for Treatment of Hemophilia A

Gelbenegger G, Schoergenhofer C, Knoebl P, Jilma B. [published online ahead of print, 2020 Jul 27]. Thromb Haemost. 2020;10.1055/s-0040-1714279.

Case report of a fatal rectal haemorrhage in a person with severe haemophilia A receiving emicizumab and high‐dose bypassing agents in the HAVEN 1 study

Khoo L, Matthews S, Kershaw G, et al. [published online ahead of print, 2020 Jul 22]. Haemophilia. 2020;10.1111/hae.14110.

Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A.

Shima M, Hanabusa H, Taki M, et al. N Engl J Med 2016;374:2044–53.

Evaluation of the Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose of Emicizumab in Healthy Chinese Subjects

Li H, Zhang W, Petry C, et al. [published online ahead of print, 2020 May 20]. Clin Pharmacol Drug Dev. 2020;10.1002/cpdd.805.

The changing face of immune tolerance induction in haemophilia A with the advent of emicizumab

Carcao M, Escuriola-Ettingshausen C, Santagostino E, et al. Haemophilia. 2019;25(4):676-684.

Real‐world use of emicizumab in patients with haemophilia A: Bleeding outcomes and surgical procedures

McCary I, Guelcher C, Kuhn J, et al. Haemophilia. 2020;26(4):631-636.

Spotlight on Emicizumab in the Management of Hemophilia A: Patient Selection and Special Considerations.

Yada K and Nogami K. J Blood Med 2019;10:171–181.

Laboratory issues in gene therapy and emicizumab.

Bowyer AE, Lowe AE and Tiefenbacher S. Haemophilia 2020;doi: 10.1111/hae.13976 (ePub ahead of print).

Anti-factor IXa/X Bispecific Antibody (ACE910): Hemostatic Potency Against Ongoing Bleeds in a Hemophilia A Model and the Possibility of Routine Supplementation.

Muto A, Yoshihashi K, Takeda M, et al. J Thromb Haemost 2014;12:206–213.

Non‐additive effect on thrombin generation when a plasma‐derived factor VIII/von Willebrand factor (FVIII/VWF) is combined with emicizumab in vitro

Bravo MI, Raventós A, Pérez A, Costa M, Willis T. J Thromb Haemost. 2020;18(8):1934-1939.

A Multicenter, Open-Label Phase 3 Study of Emicizumab Prophylaxis in Children With Hemophilia A With Inhibitors.

Young G, Liesner R, Chang T, et al. Blood 2019;134:2127–2138.

Bispecific Antibodies and Advances in Non–Gene Therapy Options in Hemophilia

Shima M. Res Pract Thromb Haemost. 2020;4(4):446-454.

Neutralizing antidrug antibody to emicizumab in a patient with severe hemophilia A with inhibitors: New case with detailed laboratory evaluation

Harkins Druzgal C, Kizilocak H, Brown J, Sennett M, Young G. [published online ahead of print, 2020 Jun 16]. J Thromb Haemost. 2020;10.1111/jth.14957.

Emicizumab should be prescribed independent of immune tolerance induction

Le Quellec S, Negrier C. Blood Adv. 2018;2(20):2783-2786.

Economic impact model of delayed inhibitor development in patients with hemophilia a receiving emicizumab for the prevention of bleeding events.

Patel AM, Corman SL, Chaplin S, et al. J Med Econ 2019;22:1328–1337.

Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program.

Levy GG, Asikanius E, Kuebler P, et al. J Thromb Haemost 2019;17:1470–1477.    

Emicizumab prophylaxis in patients with haemophilia A with and without inhibitors.

Ebbert PT, Xavier F, Seaman CD, et al. Haemophilia 2020;26:41-46. DOI: 10.1111/hae.13877.

Emicizumab (ACE910): Clinical background and laboratory assessment of hemophilia A

Lippi G, Favaloro EJ. Adv Clin Chem. 2019;88:151-167.

Prediction of the haemostatic effects of bypassing therapy using comprehensive coagulation assays in emicizumab prophylaxis‐treated haemophilia A patients with inhibitors

Furukawa S, Nogami K, Shimonishi N, Nakajima Y, Matsumoto T, Shima M. [published online ahead of print, 2020 Mar 12]. Br J Haematol. 2020;10.1111/bjh.16574.

A multicentre, open‐label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors

Shima M, Nogami K, Nagami S, et al. Haemophilia. 2019;25(6):979-987.

Clinical Evidence and Safety Profile of Emicizumab for the Management of Children with Hemophilia A

Le Quellec S. Drug Des Devel Ther. 2020;14:469-481. Published 2020 Feb 3.

Effect of emicizumab on thrombin generation: A case report of breakthrough bleeding during emicizumab treatment

Valke LLFG, Beckers EAM, Blijlevens NMA, van Heerde WL, Schols SEM. [published online ahead of print, 2020 Jun 28]. Haemophilia. 2020;10.1111/hae.14085.

Population Pharmacokinetic Analysis and Exploratory Exposure-Bleeding Rate Relationship of Emicizumab in Adult and Pediatric Persons With Hemophilia A.

Retout S, Schmitt C, Petry C, et al. Clin Pharmacokinet 2020;doi: 10.1007/s40262-020-00904-z (epub ahead of print).

Implementing emicizumab in hemophilia inhibitor management: emicizumab should be prescribed after tolerance

Young G. Blood Adv. 2018;2(20):2780-2782.

Efficacy of emicizumab prophylaxis versus factor VIII prophylaxis for treatment of hemophilia A without inhibitors: network meta-analysis and sub-group analyses of the intra-patient comparison of the HAVEN 3 trial

Reyes A, Révil C, Niggli M, et al. Curr Med Res Opin. 2019;35(12):2079-2087.

Emicizumab prophylaxis among infants and toddlers with severe hemophilia A and inhibitors-a single-center cohort.

Barg AA, Avishai E, Budnik I, et al. Pediatr Blood Cancer 2019;66(11):e27886. DOI: 10.1002/pbc.27886.

Evaluating the safety of emicizumab in patients with hemophilia A

Langer AL, Etra A, Aledort L. Expert Opin Drug Saf. 2018;17(12):1233-1237.

Global coagulation function assessed by rotational thromboelastometry predicts coagulation-steady state in individual hemophilia A patients receiving emicizumab prophylaxis.

Yada K, Nogami K, Ogiwara K, et al. Int J Hematol 2019;110:419–430.    

Factor VIIIa-mimetic Cofactor Activity of a Bispecific Antibody to Factors IX/IXa and X/Xa, Emicizumab, Depends on Its Ability to Bridge the Antigens.

Kitazawa T, Esaki K, Tachibana T, et al. Thromb Haemost 2017;117:1348–1357.

Emicizumab improves the stability and structure of fibrin clot derived from factor VIII‐deficient plasma, similar to the addition of factor VIII

Shimonishi N, Nogami K, Ogiwara K, et al. Haemophilia. 2020;26(3):e97-e105.

Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study.

Pipe SW, Shima M, Lehle M, et al. Lancet Haematol 2019;6:e295–e305.

Emicizumab: A Review in Haemophilia A

Blair, H.A. Drugs 79, 1697–1707 (2019).

First report of emicizumab use in a female patient with severe hemophilia A

Verstraete G, Lambert C, Hermans C. Blood Adv. 2020;4(13):2950-2952.

Effects and Interferences of Emicizumab, a Humanised Bispecific Antibody Mimicking Activated Factor VIII Cofactor Function, on Coagulation Assays

Adamkewicz JI, Chen DC, Paz-Priel I. Thromb Haemost. 2019;119(7):1084-1093.

Effect of emicizumab on global coagulation assays for plasma supplemented with apixaban or argatroban

Tripodi A, Chantarangkul V, Padovan L, Clerici M, Scalambrino E, Peyvandi F. J Thromb Thrombolysis. 2020;49(3):413-419.

The Effect of Emicizumab Prophylaxis on Health-Related Outcomes in Persons With Haemophilia A With Inhibitors: HAVEN 1 Study.

Oldenburg J, Mahlangu J, Bujan W, et al. Haemophilia 2019;25:33–44.

Emicizumab for the prevention of bleeds in hemophilia A

Mahlangu J. Expert Opin Biol Ther. 2019;19(8):753-761.

Thromboprophylaxis in a patient with COVID‐19 and severe hemophilia A on emicizumab prophylaxis

Rivas-Pollmar MI, Álvarez-Román MT, Butta-Coll NV, Martín Salces M, García-Barcenilla S, Jiménez-Yuste V. [published online ahead of print, 2020 Jun 11]. J Thromb Haemost. 2020;10.1111/jth.14954.

Emicizumab-mediated haemostatic function in patients with haemophilia A is down-regulated by activated protein C through inactivation of activated factor V.

Yada K, Nogami K, Shinozawa K, et al. Br J Haematol 2018;183:257–266.

Laboratory Monitoring in Emicizumab-Treated Persons with Hemophilia A.

Müller J, Pekrul I, Pötzsch B, et al. Thromb Haemost 2019;119:1384–1393.

Emicizumab-mediated haemostatic function in patients with haemophilia A is down-regulated by activated protein C through inactivation of activated factor V.

Yada K, Nogami K, Shinozawa K, et al. Br J Haematol 2018;183:257–266.

Emicizumab, the bispecific antibody to factors IX/IXa and X/Xa, potentiates coagulation function in factor XI‐deficient plasma in vitro

Minami H, Nogami K, Yada K, et al. J Thromb Haemost. 2019;17(1):126-137.

Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers.

Kotani N, Yoneyama K, Kawakami N, et al. Clin Pharmacol Drug Dev 2019;8:702–712.

Emicizumab for the treatment of haemophilia A: a narrative review

Franchini M, Marano G, Pati I, et al. Blood Transfus. 2019;17(3):223-228.

A boy with joint pain associated with emicizumab treatment: The importance of plasma level measurement

Hooimeijer HL, Lukens MV, Verhagen MV, Meijer K, Stein-Wit MA, Tamminga RYJ. Haemophilia. 2020;26(3):e138-e140.

Routine measurements of factor VIII activity and inhibitor titer in the presence of emicizumab utilizing anti-idiotype monoclonal antibodies.

Nogami K, Soeda T, Matsumoto T, et al. J Thromb Haemost 2018;16:1383–1390.    

Emicizumab, the bispecific antibody to factors IX/IXa and X/Xa, potentiates coagulation function in factor XI-deficient plasma in vitro.

Minami H, Nogami K, Yada K, et al. J Thromb Haemost 2019;17:126–137.

Emicizumab‐mediated haemostatic function in patients with haemophilia A is down‐regulated by activated protein C through inactivation of activated factor V

Yada K, Nogami K, Shinozawa K, et al. Br J Haematol. 2018;183(2):257-266.

Emicizumab Prophylaxis in Patients Who Have Hemophilia A Without Inhibitors.

Mahlangu J, Oldenburg J, Paz-Priel I, et al. N Engl J Med 2018;379:811–822.

Emicizumab for hemophilia A without inhibitors

Cafuir L, Kruse-Jarres R, Mancuso ME, Kempton CL. Expert Rev Hematol. 2019;12(7):515-524

Total knee replacement with and without emicizumab: a unique comparison of perioperative management

Evans MS, Davis C, Eyster ME. Blood Adv. 2020;4(5):855-857.

A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors.

Shima M, Nogami K, Nagami S, et al. Haemophilia 2019;25:979–987.

Emicizumab Improves Ex Vivo Clotting Function in Patients with Mild/Moderate Hemophilia A.

Nakajima Y, Nogami K, Yada K, et al. Thromb Haemost 2020;120:968–976.

Modified clot waveform analysis to measure plasma coagulation potential in the presence of the anti-factor IXa/factor X bispecific antibody emicizumab.

Nogami K, Matsumoto T, Tabuchi Y, et al. J Thromb Haemost 2018;16:1078–1088.

Emicizumab, A Bispecific Antibody to Factors IX/IXa and X/Xa, Does Not Interfere with Antithrombin or TFPI Activity In Vitro

Noguchi-Sasaki M, Soeda T, Ueyama A, et al. TH Open. 2018;2(1):e96-e103.

Long-term safety and efficacy of emicizumab in a phase 1/2 study in patients with hemophilia A with or without inhibitors.

Shima M, Hanabusa H, Taki M, et al. Blood Adv 2017;1:1891–1899.

Emicizumab: Review of the literature and critical appraisal

Rodriguez-Merchan EC, Valentino LA. Haemophilia. 2019;25(1):11-20

Major surgery management in patients with haemophilia A and inhibitors on emicizumab prophylaxis without global coagulation monitoring

Biron-Andreani C, Diaz-Cau I, Ranc A, et al. Br J Haematol. 2020;189(3):e100-e103.

Emicizumab, a humanized bispecific antibody to coagulation factors IXa and X with a factor VIIIa-cofactor activity.

Kitazawa T and Shima M. Int J Hematol 2020;111:20–30.

A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A

Yoneyama K, Schmitt C, Kotani N, et al. Clin Pharmacokinet. 2018;57(9):1123-1134.

Emicizumab Prophylaxis in Hemophilia A with Inhibitors.

Oldenburg J, Mahlangu JN, Kim B, et al. N Engl J Med 2017;377:809–818.

Bispecific Antibody Emicizumab for Haemophilia A: A Breakthrough for Patients with Inhibitors

Mahlangu JN. BioDrugs. 2018;32(6):561-570.

Successful Perioperative Combination of High-Dose FVIII Therapy Followed by Emicizumab in a Patient with Hemophilia A with Inhibitors

Okamoto S, Suzuki N, Suzuki A, et al. TH Open. 2019;3(4):e364-e366.

Emicizumab improves the stability and structure of fibrin clot derived from factor VIII-deficient plasma, similar to the addition of factor VIII.

Shimonishi N, Nogami K, Ogiwara K, et al. Haemophilia 2020;26:e97–e105.

Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens

Kitazawa T, Esaki K, Tachibana T, et al. Thromb Haemost. 2017;117(7):1348-1357.

Factor VIII–Mimetic Function of Humanized Bispecific Antibody in Hemophilia A

Shima M, Hanabusa H, Taki M, et al. N Engl J Med. 2016;374(21):2044-2053.

Emicizumab, a humanized bispecific antibody to coagulation factors IXa and X with a factor VIIIa-cofactor activity

Kitazawa T, Shima M. Int J Hematol. 2020;111:20–30

ST‐Segment Elevation Myocardial Infarction (STEMI) and Pulmonary Embolism in a Hemophilia A Patient Receiving Emicizumab and recombinant Activated Factor VII

Gundabolu K, Goldsweig A, Bhatt VR, Koepsell SA, Harper JL. Haemophilia. 2020;26(1):e5-e8.

Non–antigen-contacting region of an asymmetric bispecific antibody to factors IXa/X significantly affects factor VIII-mimetic activity

Sampei Z, Igawa T, Soeda T, et al. MAbs. 2015;7(1):120-128.

A First-In-Human Phase 1 Study of ACE910, a Novel Factor VIII-mimetic Bispecific Antibody, in Healthy Subjects.

Uchida N, Sambe T, Yoneyama K, et al. Blood 2016;127:1633–41.

The role of emicizumab, a bispecific factor IXa- and factor X-directed antibody, for the prevention of bleeding episodes in patients with hemophilia A

Knight T, Callaghan MU. Therap Adv Hem. 2018;(Oct), 319–34

Rescue factor VIII replacement to secure hemostasis in a patient with hemophilia A and inhibitors on emicizumab prophylaxis undergoing hip replacement

Santagostino E, Mancuso ME, Novembrino C, Solimeno LP, Tripodi A, Peyvandi F. Haematologica. 2019;104(8):e380-e382.

Laboratory testing in hemophilia: impact of factor and non-factor replacement therapy on coagulation assays.

Peyvandi F, Kenet G, Pekrul I, et al. J Thromb Haemost 2020;18:1242–1255.

Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity

Sampei Z, Igawa T, Soeda T, et al. PLoS One. 2013;8(2):e57479.

Emicizumab for routine prophylaxis to prevent bleeding episodes in patients with hemophilia A

Díaz-Ricart M, Isola IM, Escolar G. Drugs Today (Barc). 2018;54(10):591-600.

Management of perioperative hemostasis in a severe hemophilia A patient with inhibitors on emicizumab using global hemostasis assays

Kizilocak H, Yukhtman CL, Marquez-Casas E, Lee J, Donkin J, Young G. Ther Adv Hematol. 2019;10:2040620719860025.

Emicizumab for hemophilia A with factor VIII inhibitors

Young G, Callaghan M, Dunn A, Kruse-Jarres R, Pipe S. Expert Rev Hematol. 2018;11(11):835-846.

Emicizumab use in major orthopedic surgery

Seaman CD, Ragni MV. Blood Adv. 2019;3(11):1722-1724.

Emicizumab-kxwh: First Global Approval

Scott LJ, Kim ES. Drugs. 2018;78(2):269-274.

Emicizumab prophylaxis to facilitate anticoagulant therapy for management of intra‐atrial thrombosis in severe haemophilia with an inhibitor

Weyand AC, Dorfman AL, Shavit JA, Pipe SW. Haemophilia. 2019;25(3):e203-e205.

Emicizumab, a bispecific antibody recognizing coagulation factors IX and X: how does it actually compare to factor VIII?

Lenting PJ, Denis CV, Christophe OD. Blood. 2017;130(23): 2463–2468.

Use of thrombin generation assay to personalize treatment of breakthrough bleeds in a patient with hemophilia and inhibitors receiving prophylaxis with emicizumab

Dargaud Y, Lienhart A, Janbain M, Le Quellec S, Enjolras N, Negrier C. Haematologica. 2018;103(4):e181-e183.

Prediction of the haemostatic effects of bypassing therapy using comprehensive coagulation assays in emicizumab prophylaxis-treated haemophilia A patients with inhibitors.

Furukawa S, Nogami K, Shimonishi N, et al. Br J Haematol 2020; DOI: 10.1111/bjh.16574 (ePub ahead of print).

A new era of treatment for patients with haemophilia A?

Klamroth R. Hamostaseologie. 2017;37(3):216-218

Bispecific antibody mimicking factor VIII

Nogami K. Thromb Research. 2016; 141:supp 2, S34-35

Effects and Interferences of Emicizumab, a Humanised Bispecific Antibody Mimicking Activated Factor VIII Cofactor Function, on Coagulation Assays.

Adamkewicz JI, Chen DC and Paz-Priel I. Thromb Haemost 2019;119:1084–1093.

Non-antigen-contacting region of an asymmetric bispecific antibody to factors IXa/X significantly affects factor VIII-mimetic activity.

Sampei Z, Igawa T, Soeda T, et al. MAbs 2015;7:120–8.