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Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain.
- Source :
-
BMJ case reports [BMJ Case Rep] 2020 Oct 13; Vol. 13 (10). Date of Electronic Publication: 2020 Oct 13. - Publication Year :
- 2020
-
Abstract
- Extended half-life of factor IX (FIX) demonstrated clinical benefit and lower treatment burden than standard half-life FIX products in clinical trials. We analysed the impact in efficacy, pharmacokinetics (PKs) and costs of the switch from nonacog alfa (rFIX) to albutrepenonacog alfa (rFIX-FP) in the first patient with haemophilia B (HB) treated in Spain outside clinical trials. A 7-year-old boy presented with HB with poor venous access and repetition infections using rFIX, which was switched to rFIX-FP. Prophylaxis was adjusted by PKs using WAPPS-Hemo tailoring from 100 IU/kg/week of rFIX to 80 IU/kg/3 weeks of rFIX-FP. Comparing 6 months before, rFIX-FP reduced 68.5% FIX consumption/kg and 58.3% infusion frequency, but total costs/weight showed a slight increase. Ratio of half-life between rFIX and rFIX-FP was 3.4-3.7. This case report revealed that switch to rFIX-FP decreased frequency and FIX consumption, without adverse events and bleeds.<br />Competing Interests: Competing interests: None declared.<br /> (© BMJ Publishing Group Limited 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
- Subjects :
- Blood Coagulation Tests
Child
Drug Costs
Drug Substitution economics
Factor IX economics
Factor IX pharmacokinetics
Half-Life
Hemophilia B complications
Hemophilia B diagnosis
Hemophilia B economics
Hemorrhage economics
Hemorrhage etiology
Humans
Male
Recombinant Fusion Proteins economics
Recombinant Fusion Proteins pharmacokinetics
Serum Albumin economics
Serum Albumin pharmacokinetics
Severity of Illness Index
Factor IX administration & dosage
Hemophilia B drug therapy
Hemorrhage prevention & control
Recombinant Fusion Proteins administration & dosage
Serum Albumin administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1757-790X
- Volume :
- 13
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- BMJ case reports
- Publication Type :
- Academic Journal
- Accession number :
- 33051199
- Full Text :
- https://doi.org/10.1136/bcr-2019-234142