PK analysis shows benefit for rFVIII product in hemophilia A

Switching from the sucrose‐formulated recombinant factor VIII replacement therapy rFVIII‐FS (Kogenate) to the rFVIII product BAY 81‐8973 (Kovaltry) resulted in a longer half-life and improved bleeding rates in patients with hemophilia A, according to a recent report.

Juan Eduardo Megías‐Vericat, PharmD, of the Hospital Universitari i Politècnic La Fe, Valencia, Spain, and his colleagues conducted a comparative, cross‐sectional, pharmacokinetic analysis of switching from rFVIII‐FS to BAY 81‐8973 in patients with hemophilia A. The results of the analysis were reported in a letter to the editor published in Haemophilia.

“All the patients of this cohort were switched in a short period of time, while maintaining the same dose and frequency of infusions,” the researchers wrote.

The study included 14 patients who had moderate (n = 3) or severe (n = 11) hemophilia A and received pharmacokinetic-guided prophylaxis with rFVIII. The median weekly doses were 60.6 IU/kg and 61.6 IU/kg for rFVIII‐FS and BAY 81‐8973, respectively.

After analysis, the researchers found that the half-life of BAY 81‐8973 was significantly longer than rFVIII‐FS (median half-life, 16.9 hours vs. 15.4 hours; P = .001), with a median improvement of 3.0 hours (range, 1.5-4.0 hours). No significant differences were seen in any other pharmacokinetic factors.

With respect to bleeding, significant reductions were seen in annualized joint bleeding rate (P = .021), annualized bleeding rate (P = .038), and the number of spontaneous bleeds (P = .028) after the switch to BAY 81-8973.

The researchers acknowledged that the external validity of the study was a key limitation. As a result, Dr. Megías‐Vericat and his colleagues recommended that the findings be interpreted with discretion.

“The results of this study should be validated with an independent and larger cohort of patients, analyzing also the differences between adult and pediatric patients,” they concluded.

The study was partially funded by an unrestricted grant from Bayer. The authors reported having no conflicts of interest.

SOURCE: Megías-Vericat JE et al. Haemophilia. 2019 Mar 13. doi: 10.1111/hae.13733.

Switching from the sucrose‐formulated recombinant factor VIII replacement therapy rFVIII‐FS (Kogenate) to the rFVIII product BAY 81‐8973 (Kovaltry) resulted in a longer half-life and improved bleeding rates in patients with hemophilia A, according to a recent report.

Juan Eduardo Megías‐Vericat, PharmD, of the Hospital Universitari i Politècnic La Fe, Valencia, Spain, and his colleagues conducted a comparative, cross‐sectional, pharmacokinetic analysis of switching from rFVIII‐FS to BAY 81‐8973 in patients with hemophilia A. The results of the analysis were reported in a letter to the editor published in Haemophilia.

“All the patients of this cohort were switched in a short period of time, while maintaining the same dose and frequency of infusions,” the researchers wrote.

The study included 14 patients who had moderate (n = 3) or severe (n = 11) hemophilia A and received pharmacokinetic-guided prophylaxis with rFVIII. The median weekly doses were 60.6 IU/kg and 61.6 IU/kg for rFVIII‐FS and BAY 81‐8973, respectively.

After analysis, the researchers found that the half-life of BAY 81‐8973 was significantly longer than rFVIII‐FS (median half-life, 16.9 hours vs. 15.4 hours; P = .001), with a median improvement of 3.0 hours (range, 1.5-4.0 hours). No significant differences were seen in any other pharmacokinetic factors.

With respect to bleeding, significant reductions were seen in annualized joint bleeding rate (P = .021), annualized bleeding rate (P = .038), and the number of spontaneous bleeds (P = .028) after the switch to BAY 81-8973.

The researchers acknowledged that the external validity of the study was a key limitation. As a result, Dr. Megías‐Vericat and his colleagues recommended that the findings be interpreted with discretion.

“The results of this study should be validated with an independent and larger cohort of patients, analyzing also the differences between adult and pediatric patients,” they concluded.

The study was partially funded by an unrestricted grant from Bayer. The authors reported having no conflicts of interest.

SOURCE: Megías-Vericat JE et al. Haemophilia. 2019 Mar 13. doi: 10.1111/hae.13733.

Switching from the sucrose‐formulated recombinant factor VIII replacement therapy rFVIII‐FS (Kogenate) to the rFVIII product BAY 81‐8973 (Kovaltry) resulted in a longer half-life and improved bleeding rates in patients with hemophilia A, according to a recent report.

Juan Eduardo Megías‐Vericat, PharmD, of the Hospital Universitari i Politècnic La Fe, Valencia, Spain, and his colleagues conducted a comparative, cross‐sectional, pharmacokinetic analysis of switching from rFVIII‐FS to BAY 81‐8973 in patients with hemophilia A. The results of the analysis were reported in a letter to the editor published in Haemophilia.

“All the patients of this cohort were switched in a short period of time, while maintaining the same dose and frequency of infusions,” the researchers wrote.

The study included 14 patients who had moderate (n = 3) or severe (n = 11) hemophilia A and received pharmacokinetic-guided prophylaxis with rFVIII. The median weekly doses were 60.6 IU/kg and 61.6 IU/kg for rFVIII‐FS and BAY 81‐8973, respectively.

After analysis, the researchers found that the half-life of BAY 81‐8973 was significantly longer than rFVIII‐FS (median half-life, 16.9 hours vs. 15.4 hours; P = .001), with a median improvement of 3.0 hours (range, 1.5-4.0 hours). No significant differences were seen in any other pharmacokinetic factors.

With respect to bleeding, significant reductions were seen in annualized joint bleeding rate (P = .021), annualized bleeding rate (P = .038), and the number of spontaneous bleeds (P = .028) after the switch to BAY 81-8973.

The researchers acknowledged that the external validity of the study was a key limitation. As a result, Dr. Megías‐Vericat and his colleagues recommended that the findings be interpreted with discretion.

“The results of this study should be validated with an independent and larger cohort of patients, analyzing also the differences between adult and pediatric patients,” they concluded.

The study was partially funded by an unrestricted grant from Bayer. The authors reported having no conflicts of interest.

SOURCE: Megías-Vericat JE et al. Haemophilia. 2019 Mar 13. doi: 10.1111/hae.13733.