The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.
Factor VIII–Mimetic Function of Humanized Bispecific Antibody in Hemophilia A
Open accessAbstract
BACKGROUND: In patients with severe hemophilia A, standard treatment is regular prophylactic and episodic intravenous infusions of factor VIII. However, these treatments are burdensome, especially for children, and may lead to the formation of anti-factor VIII alloantibodies (factor VIII inhibitors). Emicizumab (ACE910), a humanized bispecific antibody mimicking the cofactor function of factor VIII, was developed to abate these problems. METHODS: We enrolled 18 Japanese patients with severe hemophilia A (with or without factor VIII inhibitors) in an open-label, nonrandomized, interindividual dose-escalation study of emicizumab. The patients received subcutaneous emicizumab weekly for 12 weeks at a dose of 0.3, 1.0, or 3.0 mg per kilogram of body weight (cohorts 1, 2, and 3, respectively). The end points were safety and pharmacokinetic and pharmacodynamic profiles. An additional, exploratory end point was the annualized bleeding rate, calculated as 365.25 times the number of bleeding episodes, divided by the number of days in the treatment period as compared with the 6 months before enrollment. RESULTS: Emicizumab was associated with neither serious adverse events nor clinically relevant coagulation abnormalities. Plasma concentrations of emicizumab increased in a dose-dependent manner. Activated partial-thromboplastin times remained short throughout the study. The median annualized bleeding rates in cohorts 1, 2, and 3 decreased from 32.5 to 4.4, 18.3 to 0.0, and 15.2 to 0.0, respectively. There was no bleeding in 8 of 11 patients with factor VIII inhibitors (73%) and in 5 of 7 patients without factor VIII inhibitors (71%). Episodic use of clotting factors to control bleeding was reduced. Antibodies to emicizumab did not develop. CONCLUSIONS: Once-weekly subcutaneous administration of emicizumab markedly decreased the bleeding rate in patients who had hemophilia A with or without factor VIII inhibitors. (Funded by Chugai Pharmaceutical; JapicCTI number, 121934.).
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Citations
Cites
Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia
Manco-Johnson, M. J., Abshire, T. C., Shapiro, A. D., Riske, B., Hacker, M. R., Kilcoyne, R., Ingram, J. D., Manco-Johnson, M. L., Funk, S., Jacobson, L., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa067659 · Cited by 1,950 · cited 4×
“Upper respiratory tract infection 0 1 0 1 (6)”
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Definitions in hemophilia: communication from the SSC of the ISTH
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Self-citationThe principal results of the International Immune Tolerance Study: a randomized dose comparison
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Immunogenicity of protein therapeutics: The key causes, consequences and challenges
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Cited by
Bispecific antibodies: a mechanistic review of the pipeline
Labrijn, A. F., Janmaat, M. L., Reichert, J. M., & Parren, P. W. H. I. (2019) · Nature Reviews Drug Discovery · doi:10.1038/s41573-019-0028-1 · Cited by 1,303
Emicizumab Prophylaxis in Hemophilia A with Inhibitors
Oldenburg, J., Mahlangu, J. N., Kim, B., Schmitt, C., Callaghan, M. U., Young, G., Santagostino, E., Kruse-Jarres, R., Negrier, C., Kessler, C., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1703068 · Cited by 1,121
Self-citationBispecific antibodies: design, therapy, perspectives
Sedykh, S., Prinz, V., Buneva, V., & Nevinsky, G. (2018) · Drug Design, Development and Therapy · doi:10.2147/dddt.s151282 · Cited by 292
Nathwani, A. C. (2019) · Hematology · doi:10.1182/hematology.2019000007 · Cited by 140
Protein-Engineered Coagulation Factors for Hemophilia Gene Therapy
Samelson-Jones, B. J., & Arruda, V. R. (2019) · Molecular Therapy - Methods & Clinical Development · doi:10.1016/j.omtm.2018.12.007 · Cited by 58
Metadata
- Authors
- Shima, M., Hanabusa, H., Taki, M., Matsushita, T., Sato, T., Fukutake, K., Fukazawa, N., Yoneyama, K., Yoshida, H., & Nogami, K.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-05-26
- Volume
- 374
- Issue
- 21
- Pages
- 2044-2053
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2400928773
- Cited by
- 478
- References
- 27
- FWCI
- 43.71
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Shima, M., Hanabusa, H., Taki, M., Matsushita, T., Sato, T., Fukutake, K., Fukazawa, N., Yoneyama, K., Yoshida, H., & Nogami, K. (2016). Factor VIII–Mimetic Function of Humanized Bispecific Antibody in Hemophilia A. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1511769
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