Indirect comparisons of efficacy and weekly factor consumption during continuous prophylaxis with recombinant factor VIII Fc fusion protein and conventional recombinant factor VIII products

Haemophilia ◽  
2017 ◽  
Vol 23 (3) ◽  
pp. 408-416 ◽  
Author(s):  
A. Iorio ◽  
S. Krishnan ◽  
K.J. Myrén ◽  
S. Lethagen ◽  
N. McCormick ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Fc Fusion Protein ◽  
Indirect Comparisons

scholarly journals Long‐term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A

Haemophilia ◽  
2015 ◽  
Vol 22 (1) ◽  
pp. 72-80 ◽  
Author(s):  
B. Nolan ◽  
J. Mahlangu ◽  
D. Perry ◽  
G. Young ◽  
R. Liesner ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Safety And Efficacy ◽  
Fc Fusion Protein

Pharmacokinetics, Safety, and Efficacy of Recombinant Factor VIII Fc Fusion Protein

2017 ◽  
Vol 40 (1) ◽  
pp. 65-75 ◽  
Author(s):  
Kim Schafer ◽  
James Munn ◽  
Kate Khair ◽  
Neelam Thukral ◽  
Angela Tom ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Safety And Efficacy ◽  
Fc Fusion Protein

scholarly journals FcRn Rescues Recombinant Factor VIII Fc Fusion Protein from a VWF Independent FVIII Clearance Pathway in Mouse Hepatocytes

PLoS ONE ◽  
2015 ◽  
Vol 10 (4) ◽  
pp. e0124930 ◽  
Author(s):  
Arjan van der Flier ◽  
Zhan Liu ◽  
Siyuan Tan ◽  
Kai Chen ◽  
Douglas Drager ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Fc Fusion Protein ◽  
Mouse Hepatocytes

scholarly journals CLINICAL EFFICACY OF RECOMBINANT FACTOR VIII FC FUSION PROTEIN IN HAEMOPHILIA A PATIENT RECEIVING ON DEMAND TREATMENT ONLY

2021 ◽  
Vol 71 (1) ◽  
pp. 62-66
Author(s):  
Saima Zahir ◽  
Tahira Zafar ◽  
Altaf Hussain ◽  
Hamid Saeed Malik ◽  
Pervez Ahmed ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Armed Forces ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
On Demand ◽  
Group I ◽  
Fc Fusion Protein ◽  
Male Patients ◽  
Group Ii

Objective: To evaluate the efficacy of recombinant factor VIII FC fusion protein in haemophilia A patientreceiving on demand treatment only. Study Design: Comparative cross sectional study. Place and Duration of Study: Department of Hematology, Armed Forces Institute of Pathology and PakistanHemophilia Welfare Society, Rawalpindi, from Jun to Dec 2017. Methodology: Eighty-nine male patients of Hemophilia A already receiving recombinant factor VIII (20-30 Units/kg) on demand, with no history of inhibitors were included in study. Patients were divided as per age into paediatric and adult group and also on the basis of their basal factor VIII levels into severe, moderate and mild groups. Same patients were switched to recombinant factor VIII FC fusion protein (20-30 Units/kg) and its efficacy was measured and compared with recombinant Factor VIII in terms of dose requirement, injections, bleeds in six month period, presence of inhibitors and side effects. Results: Eighty nine male patients were studied. There was significant reduction in dose from median value of5750 units for group I to 4000 units for group II. Number of bleed in six month period were reduced from 5.3 ingroup I to 4.5 in group II. Number of injections were reduced on average to 1-2 injection per bleed in group II. No inhibitors were detected in group II. Conclusion: rFVIII Fc fusion protein has prolong activity and results in reduction of total dose, number of bleed,dose per bleed and has reduced antigenecity.

scholarly journals Prolonged activity of a recombinant factor VIII-Fc fusion protein in hemophilia A mice and dogs

Blood ◽  
2012 ◽  
Vol 119 (13) ◽  
pp. 3024-3030 ◽  
Author(s):  
Jennifer A. Dumont ◽  
Tongyao Liu ◽  
Susan C. Low ◽  
Xin Zhang ◽  
George Kamphaus ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Half Life ◽  
Hemophilia A ◽  
Specific Activity ◽  
Recombinant Factor Viii ◽  
Prophylactic Efficacy ◽  
Reduced Frequency ◽  
Fc Fusion Protein ◽  
Partial Correction

Abstract Despite proven benefits, prophylactic treatment for hemophilia A is hampered by the short half-life of factor VIII. A recombinant factor VIII-Fc fusion protein (rFVIIIFc) was constructed to determine the potential for reduced frequency of dosing. rFVIIIFc has an ∼ 2-fold longer half-life than rFVIII in hemophilia A (HemA) mice and dogs. The extension of rFVIIIFc half-life requires interaction of Fc with the neonatal Fc receptor (FcRn). In FcRn knockout mice, the extension of rFVIIIFc half-life is abrogated, and is restored in human FcRn transgenic mice. The Fc fusion has no impact on FVIII-specific activity. rFVIIIFc has comparable acute efficacy as rFVIII in treating tail clip injury in HemA mice, and fully corrects whole blood clotting time (WBCT) in HemA dogs immediately after dosing. Furthermore, consistent with prolonged half-life, rFVIIIFc shows 2-fold longer prophylactic efficacy in protecting HemA mice from tail vein transection bleeding induced 24-48 hours after dosing. In HemA dogs, rFVIIIFc also sustains partial correction of WBCT 1.5- to 2-fold longer than rFVIII. rFVIIIFc was well tolerated in both species. Thus, the rescue of FVIII by Fc fusion to provide prolonged protection presents a novel pathway for FVIII catabolism, and warrants further investigation.

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