Journal article
Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates
British Journal of Haematology, Vol.168(1), pp.113-123
2014
Abstract
Summary
In the phase 3 B-LONG [Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Subjects with Haemophilia B] study, rFIXFc dosed every 1–2 weeks was safe and efficacious in previously treated subjects with haemophilia B. To date, there are no evaluations of transitioning from conventional to long-acting factor IX (FIX) prophylaxis. This post-hoc analysis of B-LONG subjects compared prophylaxis with other FIX products and rFIXFc. Pre- and on-study data were analysed to assess dosing regimen, weekly FIX consumption and annualized bleeding rates (ABRs). Population pharmacokinetics models were used to generate FIX activity profiles with rFIXFc and recombinant FIX prophylaxis. Thirty-nine subjects, previously treated prophylactically, were evaluated. Prior to study, most subjects (69·2%) received twice-weekly FIX infusions; on study, subjects infused rFIXFc once every 1–2 weeks with c. 30–50% reductions in weekly consumption. On-study estimated mean ABRs were lower than pre-study estimated mean ABRs. Models predicted that rFIXFc administered 50 iu/kg weekly and 100 iu/kg every 10 d would maintain steady-state FIX trough levels ≥1 iu/dl in 95·4% and 89·2% of subjects, respectively. These results indicate that patients receiving rFIXFc prophylaxis can markedly reduce infusion frequency and FIX consumption, have a greater likelihood of maintaining FIX activity >1 iu/dl and experience fewer bleeding episodes compared with prior FIX prophylaxis.
Details
- Title
- Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates
- Authors/Creators
- J. Powell (Author/Creator) - University of California, DavisA. Shapiro (Author/Creator) - Indiana Hemophilia and Thrombosis CenterM. Ragni (Author/Creator) - Hemophilia Center of Western PennsylvaniaC. Negrier (Author/Creator) - Hôpital Edouard HerriotJ. Windyga (Author/Creator) - Institute of Haematology and Blood TransfusionM. Ozelo (Author/Creator) - Universidade Estadual de Campinas (UNICAMP)J. Pasi (Author/Creator) - Queen Mary University of LondonR. Baker (Author/Creator) - Murdoch UniversityJ. Potts (Author/Creator) - Biogen (United Kingdom)S. Li (Author/Creator) - Biogen (United States)B. Mei (Author/Creator) - Biogen (United States)G.F. Pierce (Author/Creator) - Biogen (United States)B. Robinson (Author/Creator) - Biogen (United States)
- Publication Details
- British Journal of Haematology, Vol.168(1), pp.113-123
- Publisher
- Blackwell Publishing Inc.
- Identifiers
- 991005544041007891
- Copyright
- © 2014 Biogen Idec.
- Murdoch Affiliation
- Murdoch University
- Language
- English
- Resource Type
- Journal article
UN Sustainable Development Goals (SDGs)
This output has contributed to the advancement of the following goals:
Source: InCites
Metrics
25 Record Views
InCites Highlights
These are selected metrics from InCites Benchmarking & Analytics tool, related to this output
- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.75 Blood Clotting
- 1.75.619 Bleeding Disorders
- Web Of Science research areas
- Hematology
- ESI research areas
- Clinical Medicine