Abstract Number: VPB0692
Meeting: ISTH 2022 Congress
Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical
Background: BAY81-8973(Kovaltry,Bayer,US) was reported with enhanced pharmacokinetic(PK) profiles compared with some other standard half-life(SHL) FVIII concentrates. Limited head-to-head comparative studies were conducted in a real-world setting.
Aims: To make head-to-head comparisons of PK and clinical outcomes between Kovaltry and the other three SHL FVIII concentrates.
Methods: Forty-seven hemophiliac boys were enrolled and divided into three groups according to their previously used FVIII concentrates (Kogenate FS, Nf22; Advate, Nf14; GreenMono, Nf11). Two separate PK tests were conducted in each patient with a five-point assay during the study period from 6 months pre-switch to 6 months post-switch. FVIII levels were detected by one-stage assay and PK profiles were calculated by Non-Compartment Assay. Annualized bleeding rates were collected through patients’ bleeds logs during the one-year study period.
Results: Longer half-life time (t1/2)[Kogenate FS group:14.36±1.92 vs. 11.92±2.41h,P < 0.0001); Advate group(13.41±1.44 vs. 9.67±1.74h,P < 0.0001); GreenMono group(15.07±3.36 vs. 10.70±1.66h,P < 0.001)] and lower clearance[Kogenate FS group:3.26±1.06 vs. 3.92±1.16ml/kg/h, P < 0.01; Advate group:3.70±1.20 vs. 5.91±2.22ml/kg/h,P < 0.01; GreenMono group, 3.02±1.24 vs. 5.07±1.55ml/kg/h,P < 0.01] were observed in Kovaltry as well as longer mean residential time(P < 0.01) and higher area under curve(P < 0.01). No statistical difference was found in in-vivo recovery between Kovaltry and other FVIII products. Patients with higher VWF:Ag levels or blood group non-O had a longer augment of t1/2 during the switch in all three groups. Significantly reduced annualized bleeding rates(ABR) were observed in all three groups(P < 0.05) as well as improved annualized joint bleeding rates(AJBR) and annualized spontaneous bleeding rates(ASBR) in the Advate group and GreenMono group. Despite the P-values did not reach a statistical difference in the Kogenate FS group, the decreased mean value of AJBR(1.55 vs. 2.18) and ASBR(0.86 vs. 1.54) indicated the improvements.
Conclusion(s): Compared with Kogenate FS, Advate, and GreenMono, Kovaltry have enhanced PK profiles, which contributed to later-observed reduced bleeding rates.
Figure
Trough FVIII levels and bleeding rates of each patient during the switch.
Table
Comparative pharmacokinetics of three FVIII concentrate groups during the switch.
To cite this abstract in AMA style:
Huang K, Zhen Y, Li G, Wu X, Chen Z, Wu R. Enhanced pharmacokinetics and improved clinical outcomes in young hemophiliac boys after the switch to BAY 81-8973 from other standard half-life FVIII concentrates [abstract]. https://abstracts.isth.org/abstract/enhanced-pharmacokinetics-and-improved-clinical-outcomes-in-young-hemophiliac-boys-after-the-switch-to-bay-81-8973-from-other-standard-half-life-fviii-concentrates/. Accessed September 21, 2023.« Back to ISTH 2022 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/enhanced-pharmacokinetics-and-improved-clinical-outcomes-in-young-hemophiliac-boys-after-the-switch-to-bay-81-8973-from-other-standard-half-life-fviii-concentrates/