The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients
Open accessAbstract
Current factor VIII (FVIII) products display a half-life (t1/2) of ∼ 8-12 hours, requiring frequent intravenous injections for prophylaxis and treatment of patients with hemophilia A. rFVIIIFc is a recombinant fusion protein composed of a single molecule of FVIII covalently linked to the Fc domain of human IgG1 to extend circulating rFVIII t1/2. This first-in-human study in previously treated subjects with severe hemophilia A investigated safety and pharmacokinetics of rFVIIIFc. Sixteen subjects received a single dose of rFVIII at 25 or 65 IU/kg followed by an equal dose of rFVIIIFc. Most adverse events were unrelated to study drug. None of the study subjects developed anti-rFVIIIFc antibodies or inhibitors. Across dose levels, compared with rFVIII, rFVIIIFc showed 1.54- to 1.70-fold longer elimination t1/2, 1.49- to 1.56-fold lower clearance, and 1.48- to 1.56-fold higher total systemic exposure. rFVIII and rFVIIIFc had comparable dose-dependent peak plasma concentrations and recoveries. Time to 1% FVIII activity above baseline was ∼ 1.53- to 1.68-fold longer than rFVIII across dose levels. Each subject showed prolonged exposure to rFVIIIFc relative to rFVIII. Thus, rFVIIIFc may offer a viable therapeutic approach to achieve prolonged hemostatic protection and less frequent dosing in patients with hemophilia A. This trial was registered at www.clinicaltrials.gov as NCT01027377.
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Cites
FcRn: the neonatal Fc receptor comes of age
Roopenian, D. C., & Akilesh, S. (2007) · Nature Reviews Immunology · doi:10.1038/nri2155 · Cited by 2,346
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 2×
“on primary prophylaxis after their first joint bleed had significantly fewer bleeds and less joint damage than children treated on-demand.(3) Compared to on-demand treatment, prophylactic therapy also decreases disability, hospitalization rate, and time lost from school or work;(6,17) and improves quality of life for…”
BackgroundThe hemophilias--from royal genes to gene therapy
Mannucci, P. M., & Tuddenham, E. G. D. (2001) · New England Journal of Medicine · doi:10.1056/nejm200106073442307 · Cited by 1,110 · cited 1×
“3 Introduction Hemophilia A is an inherited bleeding disorder that results in frequent spontaneous and traumatic bleeding into the joints and soft tissues.(1) When inadequately treated, this bleeding leads to chronic arthropathy, disability, and increased risk of death.”
Background
Cited by
Kitazawa, T., Igawa, T., Sampei, Z., Muto, A., Kojima, T., Soeda, T., Yoshihashi, K., Okuyama-Nishida, Y., Saito, H., Tsunoda, H., et al. (2012) · Nature Medicine · doi:10.1038/nm.2942 · Cited by 507
Human cell lines for biopharmaceutical manufacturing: history, status, and future perspectives
Dumont, J., Euwart, D., Mei, B., Estes, S., & Kshirsagar, R. (2016) · Critical Reviews in Biotechnology · doi:10.3109/07388551.2015.1084266 · Cited by 483
Self-citationRecent advances in (therapeutic protein) drug development
Lagassé, H. A. D., Alexaki, A., Simhadri, V. L., Katagiri, N. H., Jankowski, W., Sauna, Z. E., & Kimchi-Sarfaty, C. (2017) · F1000Research · doi:10.12688/f1000research.9970.1 · Cited by 481
Fusion Proteins for Half-Life Extension of Biologics as a Strategy to Make Biobetters
Strohl, W. R. (2015) · BioDrugs · doi:10.1007/s40259-015-0133-6 · Cited by 461
Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A
Mahlangu, J., Powell, J. S., Ragni, M. V., Chowdary, P., Josephson, N. C., Pabinger, I., Hanabusa, H., Gupta, N., Kulkarni, R., Fogarty, P., et al. (2014) · Blood · doi:10.1182/blood-2013-10-529974 · Cited by 454
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Metadata
- Authors
- Powell, J. S., Josephson, N. C., Quon, D., Ragni, M. V., Cheng, G., Li, E., Jiang, H., Li, L., Dumont, J. A., Goyal, J., Zhang, X., Sommer, J., McCue, J., Barbetti, M., Luk, A., & Pierce, G. F.
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2012-03-29
- Volume
- 119
- Issue
- 13
- Pages
- 3031-3037
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- OpenAlex
- W1968800426
- Cited by
- 240
- References
- 3
- FWCI
- 15.75
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Powell, J. S., Josephson, N. C., Quon, D., Ragni, M. V., Cheng, G., Li, E., Jiang, H., Li, L., Dumont, J. A., Goyal, J., Zhang, X., Sommer, J., McCue, J., Barbetti, M., Luk, A., & Pierce, G. F. (2012). Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients. Blood. https://doi.org/10.1182/blood-2011-09-382846
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