Description
Title: Flexibility in Prophylaxis Regimens for Sucrose-Formed Recombinant Factor VIII: Results from Postmarketing Surveillance Studies
Abstract: Objectives. Regimens for severe hemophilia A prophylaxis that permit more flexible dosing while maintaining efficacy may increase adherence and lower prophylaxis costs. Here, in a “real-world” practice setting, we compared the clinical efficacy of once- or twice-weekly prophylaxis with sucrose-formulated recombinant factor VIII (rFVIII-FS) versus 3 times weekly. Methods. Three postmarketing studies’ combined data were used. Patients with severe hemophilia A who received rFVIIIFS for 80% of a prophylaxis observation period (5 months) at a dose of 1 prophylaxis infusion/wk were included. Patients were divided into groups according to whether they received 1-2 prophylaxis injections per week (n = 63) or 3 prophylaxis injections per week (n = 76) of treatment. Annualized bleeding rates were determined using descriptive statistics (ABRs). Results. In the group receiving 1-2 prophylaxis injections/wk, the median (quartile 1; quartile 3) ABR for all bleeds was 2.0 (0; 4.0) and in the group receiving 3 prophylaxis injections/wk, it was 3.9 (1.5; 9.3). With 1-2 prophylaxis injections/wk, median ABRs for joint, spontaneous, and trauma-related bleeds were numerically lower. 63% of patients (3 prophylaxis injections/wk) to 84% of patients (1-2 prophylaxis injections/wk) had 4 annualized joint bleeds, which is an estimate of prophylaxis success. Conclusions. With rFVIII-FS, flexible dosing and effective prophylaxis were proven. Both once-twice-weekly and 3-times-weekly prophylaxis dosing regimens resulted in very good bleeding control.
Paper Quality: SCOPUS / Web of Science Level Research Paper
Subject: Medicine
Sub Category: Hematology
Writer Experience: 20+ Years
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