PB1161 - Retrospective analysis of treatment individualization on hemophilia B patients from two Spanish centers who switched from SHL-FIX products to rIX-FP

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Albert Tugues

Hematologist
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Trombosis y Hemostasia, Servicio de Hematología y Hemoterapia.
Lleida, Catalonia, Spain

Co-Author(s)

EV

Eva Vicente

Hematologist
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Trombosis y Hemostasia, Servicio de Hematología y Hemoterapia.
Lleida, Catalonia, Spain
RS

Raquel Santoja

Resident
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
Lleida, Catalonia, Spain
AM

Ana Marco

Hematologist
University General Hospital Dr. Balmis, Alicante, Spain
Alicante, Comunidad Valenciana, Spain
PM

Pascual Marco Vera

Hematologist
Departmentof Clinical Medicine, Miguel Hernández University, Alicante, Spain
Alicante, Comunidad Valenciana, Spain
MG

Marta Gilabert

Pharmacist
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Farmacia
Lleida, Catalonia, Spain
JR

Judith Rius

Pharmacist
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Farmacia
Lleida, Catalonia, Spain
IM

Irene Mangues

Pharmacist
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Farmacia
Lleida, Catalonia, Spain
ID

Izarbe Delgado

Resident
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
Lleida, Catalonia, Spain
AR

Anaïs Ruiz

Resident
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
lleida, Catalonia, Spain
AG

Antonio Garcia

Hematologyst
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
lleida, Catalonia, Spain
CC

Carlos Chávez

Hematologyst
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
lleida, Catalonia, Spain
MT

Montserrat Teixidó

Hematologyst
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Trombosis y Hemostasia, Servicio de Hematología y Hemoterapia.
lleida, Catalonia, Spain
ER

Eugenia Rivero

Hematologist
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
Lleida, Catalonia, Spain
AL

Armando Luaña

Hematologyst
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Trombosis y Hemostasia, Servicio de Hematología y Hemoterapia.
lleida, Catalonia, Spain
AF

Ainara Ferrero

Hematologist
Hospital Universitari Arnau de Vilanova de Lleida, Servicio de Hematología y Hemoterapia.
Lleida, Catalonia, Spain
TG

Tomas Garcia

Hematologyst
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Trombosis y Hemostasia, Servicio de Hematología y Hemoterapia.
lleida, Catalonia, Spain
CM

Cristina Marzo

Hematologyst
Hospital Universitari Arnau de Vilanova de Lleida, Departamento de Trombosis y Hemostasia, Servicio de Hematología y Hemoterapia.
Lérida, Catalonia, Spain

Background: rIX-FP is an extended half-life (EHL-rFIX) fusion protein of coagulation factor IX with recombinant human albumin, indicated for on-demand and prophylactic treatment in patients with hemophilia B (PWHB) of all ages. EHL-rFIX products allow PWHB for prolonged dosing intervals, individualize their treatment and so reduce their treatment burden.

Aims: Analyse the switch to rIX-FP from 4 PHWB and their treatment individualization.

Methods: Retrospective data was collected for 4 patients from two Spanish centers who switched from SHL-FIX products to rIX-FP
Patient demographic data, pharmacokinetics,,adherence and consumption have been compiled.
A pharmacokinetic (PK) analysis was done with the WAPPS-Hemo platform.

Results: Four PWHB, two pediatric (ages 5,7) and two adults (17,49) with severe haemophilia B, began prophylaxis with rIX-FP.
Both pediatric were previously treated on 1x/week prophylaxis with recombinant FIX (2000 and 1500 UI weigh adjusted ) and switch to rIX-FP with same dose every 10 days and further extended dosing to 14 days given mean trough levels > 8,5% at day 10 days post-administration.
The adult patients were on 2x/week prophylaxis with plasma-derived FIX and switch to rIX-FP every 7 days for 2 months and extended the dosing interval to 10 ( teenager) and 14 days (adult) with mean FIX levels at day 7 post-infusion of 13,9% and 19,7% respectively (based on balanced prediction).
This treatment individualization has allowed reduction on 28,7 - 78,61 % number of infusions/Year and consumption by 54% ( 34-75 %) from 1500UI -18.000UI/month

No bleeding or adverse events were reported following the switch to rIX-FP

Conclusion(s): In summary, rIX-FP is an excellent choice for the prophylactic treatment of any PWHB and allows treatment individualization to the patient needs, providing benefits in terms of efficacy, adherence and quality of life.