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Overview
PUPs
PTPs
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On-demand treatment in PTPs of 1,796 bleeding episodes were resolved with only 1 infusion2 |
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On-demand treatment in PUPs of 997 bleeding episodes were resolved with only 1 infusion3 |
FIX: factor IX; PTP: previously treated patient; PUP: previously untreated patient.
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94.1% of responses were rated excellent or good in PUPs receiving an initial infusion of BeneFIX for on-demand treatment of hemophilia B2
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75% of bleeds were controlled after 1 infusion with BeneFIX (n = 748)2
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2 out of 63 PUPs developed high-titer (>5 BU/dL) inhibitors in clinical trials.2
Study description:
This is a multicenter, international, open-label, single-cohort study. Patients received rFIX for on-demand treatment or routine prophylaxis continued on the study for at least 2 years, up to a maximum of 5 years or 100 exposure days, whichever occurred first. Patients who completed the core phase were allowed to enter the extension phase to receive rFIX for up to 1 additional year, at the discretion of the investigator and after prior written authorization from the sponsor.2
*Study included 54 evaluable patients; median dose 62.7 IU/kg (range: 8.2-292 IU/kg).2
aEfficacy was rated by the patient/guardian or investigator using a 4-point scale of “excellent,” “good,” “moderate,” or “no response,” consistent with the rating scale used in the rFIX hemophilia clinical study of PTPs.2
FIX: factor IX; IU: international unit; pdFIX: plasma-derived factor IX; PTP: previously treated patient; PUP: previously untreated patient; rFIX: recombinant factor IX; SD: Standard Deviation.
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90.9% of responses were rated excellent or good in PTPs receiving an initial infusion of BeneFIX for on-demand treatment2
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80.9% of bleeds were controlled after 1 infusion with BeneFIX2
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1 out of 56 patients developed a low-titer transient inhibitor.2
Study description:
A 20-center international trial was conducted in PTPs with severe or moderate (<5 IU/dL factor IX activity) hemophilia B. Participants received rFIX for pharmacokinetic studies, treatment of or prophylaxis against hemorrhage, or surgical hemostasis, and were assessed at 3-month intervals for 2 years.2
*Bleed control rating scale: Efficacy was rated by the patient or investigator using a 4-point scale, based on a comparison with previously used pdFIX products for similar bleeds or procedures: excellent (as much and as rapid an improvement as the best pdFIX-related responses), good (as much and as rapid an improvement as most pdFIX-related responses), moderate (not as good as most pdFIX-related responses), or no response (no improvement).2
FIX: factor IX; IU: international unit; pdFIX: plasma-derived factor IX; PTP: previously treated patient; PUP: previously untreated patient; rFIX: recombinant factor IX.
Approval No. : BV0098A2259/032022
Invalidation Date: 17/02/2025 |
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