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- Title
Head-to-head comparison of the pharmacokinetic profiles of a high-purity factor IX concentrate (AlphaNine<sup>®</sup>) and a recombinant factor IX (BeneFIX<sup>®</sup>) in patients with severe haemophilia B.
- Authors
Lissitchkov, T.; Matysiak, M.; Zavilska, K.; Laguna, P.; Gercheva, L.; Antonov, A.; Moret, A.; Caunedo, P.; Aznar, J. A.; Woodward, M. K.; Páez, A.
- Abstract
Head-on comparative studies of factor IX (FIX) concentrates performed under standardized conditions are rarely conducted regardless of being a valuable instrument guiding health care providers towards better informed and cost-effective decisions. This study is an extension of a multicentre study that assessed the efficacy, safety and pharmacokinetics ( PK) of AlphaNine® in 25 previously treated patients with severe haemophilia B (FIX:C ≤ 2%). After a washout period ≥7 days following the last PK performed with AlphaNine® after a dose of 65-75 IU kg−1, an identical PK study was performed with BeneFIX® on 22 of the same patients. Venous blood samples for analysis were taken at baseline and at 0.25, 0.5, 1, 3, 6, 9, 24, 48, 72 and 74 h post infusion. The outcomes of the comparison of the PK parameters were as follows: Mean (± SD) in vivo recovery ( IVR) was 1.3 ± 0.4 IU dL−1 per IU kg−1 for AlphaNine® and 1.0 ± 0.3 IU dL−1 per IU kg−1 for BeneFIX® ( P < 0.01). Mean terminal half-life, mean residence time, area under the curve, clearance and volume of distribution of BeneFIX® were 36.0 ± 12.8 h, 39.3 ± 13.9 h, 1631 ± 467 IU h dL−1, 0.046 ± 0.01 dL kg−1 min−1 and 1.75 ± 0.52 mL kg−1 respectively. These values were not significantly different to those observed in AlphaNine®, although BeneFIX® displayed higher than expected IVR values and lower than expected clearance values. In conclusion, AlphaNine® showed a comparable half-life, but an IVR significantly higher than that of BeneFIX®. This dissimilarity may have implications on dosing requirements for on-demand treatment regimes affecting optimal resource allocation.
- Subjects
PHARMACOKINETICS; BLOOD coagulation factor IX; BLOOD coagulation factors; HEMOPHILIA treatment; BLOOD coagulation disorders; BLOOD disease treatment; THERAPEUTICS
- Publication
Haemophilia, 2013, Vol 19, Issue 5, p674
- ISSN
1351-8216
- Publication type
Article
- DOI
10.1111/hae.12148