Late breaking Abstracts Article Swipe
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· 2020
· Open Access
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· DOI: https://doi.org/10.1111/hae.14142
· OA: W4285673059
Background: Damoctocog alfa pegol (BAY 94-9027, Jivi ® ) and rurioctocog alfa pegol (BAX 855, Adynovi ® ) are PEGylated, extended half-life, recombinant factor VIII (FVIII) products, indicated for use in patients ≥ 12 years of age with haemophilia A. Here, we present results from the first head-to-head comparative pharmacokinetic (PK) study of damoctocog alfa pegol and rurioctocog alfa pegol in adult patients with severe haemophilia A. Methods: In this single-centre, open-label, crossover study (ClinicalTrials.govidentifier: NCT04015492), previously FVIIItreated patients (≥150 exposure days) aged 18-65, with severe haemophilia A (FVIII < 1 IU/dL) were randomized to receive a single infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol (50 IU/kg each, nominal potency), or vice versa, with ≥ 7-day wash-out between doses.Serial PK samples were collected and PK parameters were estimated.Population PK models were developed to simulate times to 1, 5 and 10 IU/dL FVIII.Results: Patients (N = 18; mean age, 34.2 years) received actual administered doses of 54.3 IU/kg damoctocog alfa pegol and 61.4 IU/ kg rurioctocog alfa pegol.The geometric mean [%CV] AUC(0-t last ) was numerically higher for damoctocog alfa pegol (2311 IU•h/dL [44.0%]) versus rurioctocog alfa pegol (2150 IU•h/dL [39.6%]) for ~10% lower actual dose of damoctocog alfa pegol versus rurioctocog alfa pegol.Damoctocog alfa pegol had a superior PK profile based on actual dosing, vs rurioctocog alfa pegol, with improvement in most patients: 22% increase in AUC norm (95%CI 1.11-1.33,P = 0.0004), 18% slower clearance (95%CI 0.75-0.90,P = 0.0004) and longer halflife (17.0 h vs 16.0 h, respectively, P = 0.0064, Table ).Based on a
