ArticleAdvances in therapy2025
Real-World Prophylaxis Outcomes with rIX-FP and rFIXFc for Males with Hemophilia B: Pooled Analysis of Medical Chart Data from Germany and Italy.
Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Extravascular distribution of factor IX-review of experimental and clinical evidence, and relevance for hemophilia B replacement therapy.Research and practice in thrombosis and haemostasis · 2026Review
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe current standard of care for people with severe hemophilia B is prophylaxis with factor IX (FIX) products. This analysis assessed the effectiveness of prophylaxis for people with hemophilia B (PwHB) receiving rIX-FP or rFIXFc prophylaxis in Germany and Italy.
methodsA retrospective, de-identified chart review included PwHB ≥ 12 years with severe/moderate hemophilia B from Germany or Italy, receiving prophylaxis with rIX-FP or rFIXFc for ≥ 12 months. The primary outcome was FIX consumption; the secondary outcomes were dosing interval, annualized bleeding rate (ABR), annualized spontaneous bleeding rate (AsBR), and annualized joint bleeding rate (AjBR). These outcomes were also explored in PwHB with pre- and post-rIX-FP switch data.
resultsOf 194 PwHB, 107 and 87 received rIX-FP and rFIXFc prophylaxis, respectively. The mean FIX consumption of rIX-FP was significantly lower compared to rFIXFc (42.4 vs. 65.2 IU/kg/week, p = 0.0001), with mean dosing intervals of 9.5 days (rIX-FP) and 7.9 days (rFIXFc). The mean bleeding rates for rIX-FP versus rFIXFc, respectively, were: ABR 0.7 versus 1.1 (p = 0.6704), AsBR 0.1 versus 0.3 (p = 0.3427), and AjBR 0.3 versus 0.4 (p = 0.5296). Subgroup analyses for PwHB with severe and moderate hemophilia B separately showed similar numerical patterns when comparing these outcomes. In the 18 patients with switch data, a significant reduction in FIX consumption was observed (median 51.7 to 33.3 IU/kg/week, p = 0.0069), and the mean dosing interval was extended (7.2-9.5 days). The ABR (median 1.6-0.0, p = 0.0172; n = 18) and AjBR (median 0.6-0.0, p = 0.0200; n = 14) decreased significantly, while the AsBR decreased but not significantly (median 0.2-0.0, p = 0.1460; n = 14).
conclusionrIX-FP prophylaxis was associated with reduced FIX consumption versus rFIXFc and offered equally effective or potentially improved bleed protection. Additionally, PwHB who switched to rIX-FP achieved significant decreases in FIX consumption, ABR, and AjBR compared with their prior FIX product.
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