ISTH Congress Abstracts

Official abstracts site for the ISTH Congress

MENU 

Pharmacokinetics-adjusted Dosing of Rurioctocog Alfa Pegol (Adynovi) in Adult Patients with Haemophilia A

1Department of Haemostasis and Haemostatic Disorders, Medical University of Łódź, Łódź, Poland, 2Department of Haematology and Transplantology, Medical University of Gdańsk, Gdański, Poland, 3Department of Haematology and Internal Medicine MSWA Hospital of Poznań, Poznań, Poland, 4Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation, Medical University of Wrocław, Wrocław, Poland

Abstract Number: PB0614

Meeting: ISTH 2021 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical

Background: Rurioctocog alfa pegol (Adynovi) is a recombinant factor VIII (FVIII) concentrate conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Due to large interindividual variability in pharmacokinetics (PK) of FVIII products treatment optimization may require PK-adjusted dose and schedule personalization. myPKFiT app was designed to allow PK evaluation in hemophilia A (HA) patients treated with Adynovi.

Aims: Evaluation of PK-adjusted dosing of Adynovi in adult HA patients.

Methods: Ten adult HA patients (median age 38 years) from four centers in Poland who participated in BAX855 trial and were treated with Adynovi as a part of Named Patient Access were included. All participants received prophylaxis with Adynovi in PK-adjusted doses and were followed up for 30 months. In each patient, PK parameters (T1/2, time to 1%, through level) were established using myPKFiT software. All bleeding episodes during the follow-up period were recorded. Informed consent has been obtained from all participants.

Results: PK-adjusted dosing allowed to decrease Adynovi dose in all patients (mean 4870 IU vs 3386 IU). In 6 out of 10 patients, injection frequency was significantly lowered, and the time between injections was extended from 48 hrs to 72 hrs (n=3), 84 hrs (n=2) or 96 hrs (n=1). During 30 months of follow-up, median annual bleeding rate dropped from 30 (on demand) to 0 (prophylaxis), and 6 out of 10 patients did not experience any bleeds during the study period. The median through level of factor VIII was 2.5% (range 2.0 % to 6.5%).

Conclusions: Our results confirmed the efficacy of prophylactic treatment with Adynovi in heavily burdened adult HA population. The PK-adjusted dosing allows injection frequency reduction without compromising treatment efficacy and myPKFiT app is an accurately and conveniently designed tool allowing dosage personalization in patients treated with Adynovi. Low bleeding rate resulted from increased through level of factor VIII.

To cite this abstract in AMA style:

Treliński J, Chojnowski K, Robak M, Mital A, Zarzycka E, Bober M, Dziamska J, Woźny T, Urbaniak-Kujda D, Prajs I, Podolak-Dawidziak M. Pharmacokinetics-adjusted Dosing of Rurioctocog Alfa Pegol (Adynovi) in Adult Patients with Haemophilia A [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/pharmacokinetics-adjusted-dosing-of-rurioctocog-alfa-pegol-adynovi-in-adult-patients-with-haemophilia-a/. Accessed September 27, 2023.

« Back to ISTH 2021 Congress

ISTH Congress Abstracts - https://abstracts.isth.org/abstract/pharmacokinetics-adjusted-dosing-of-rurioctocog-alfa-pegol-adynovi-in-adult-patients-with-haemophilia-a/