ISTH Congress Abstracts

Official abstracts site for the ISTH Congress

MENU 

Interim Analysis from B-MORE, a 24-month Prospective, Multicentre, Non-interventional Study on Effectiveness and Usage of Recombinant Factor IX Fc (rFIXFc) in Haemophilia B

1Oslo University Hospital, Oslo, Oslo, Norway, 2Karolinska University Hospital, Stockholm, Stockholms Lan, Sweden, 3Hull University Teaching Hospital Trust And Centre for Atherothrombosis and Metabolic Disease, Hull, England, United Kingdom, 4AOU Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy, 5King Faisal Specialist Hospital and Research Centre, Riyadh, Ar Riyad, Saudi Arabia, 6Swedish Orphan Biovitrum AB, Stockholm, Stockholms Lan, Sweden, 7Sobi, Stockholm, Stockholms Lan, Sweden

Abstract Number: PB1153

Meeting: ISTH 2022 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical

Background: The extended half life rFIXFc has a well-established safety and efficacy profile demonstrated by phase 3 trials in patients with haemophilia B (HB; ≤2 IU/dL FIX) across all age-groups. The B-MORE study is prospectively evaluating real-world effectiveness and usage of rFIXFc in HB patients in Europe and Middle East.

Aims: To describe interim data for patients treated with rFIXFc in the ongoing B-MORE study.

Methods: This 24-month prospective, multicentre, non-interventional study includes patients prescribed with prophylactic or on-demand rFIXFc treatment prior to or at study enrolment. Baseline characteristics, 12-month retrospective data on previous FIX treatment prior to rFIXFc switch, rFIXFc prescribed dose and annualised bleeding rate (ABR) are reported.

Results: At interim data cut-off (22nd October 2021), 117 patients (2 female) from 25 centres were included in the effectiveness analysis. Baseline patient characteristics are shown in Table 1. Sixty patients were aged < 18 years (median 8.3, range 1-18 years). Patients with ≥6 months documented prophylaxis with standard half-life FIX prior to rFIXFc had a median (IQR) of 2.0 injections with FIX per week (2.0-2.0) (n=69), with a median (IQR) factor consumption of 74.9 (58.4-92.1) IU/kg/week (n=65) and a median (IQR) overall ABR of 1.0 (0.0-2.0) (n=69). Mean (range) overall duration of rFIXFc treatment from initiation to data cut-off was 824 (42-3650) and 457 (15-1207) days for prophylactically (n=106) and on-demand treated subjects (n=11), respectively. Dosing and ABR on rFIXFc prophylaxis are shown in Table 2.

Conclusion(s): Interim data from the ongoing B-MORE study indicate that rFIXFc prophylaxis can provide and maintain excellent bleed protection in this HB population including a large number of paediatric patients. These real-world data show a median ABR close to zero on rFIXFc prophylaxis with a low factor consumption mainly based on a once-weekly regimen.

Table 1. Baseline demographic data and characteristics, overall population

Table 1. Baseline demographic data and characteristics, overall population

Table 2. Prescribed prophylactic dosing and ABR on rFIXFc prophylaxis1

Table 2. Prescribed prophylactic dosing and ABR on rFIXFc prophylaxis1

To cite this abstract in AMA style:

Glosli H, Ranta S, Allsup D, Ricca I, Saleh M, Carlsheimer Å, Falk A, Santagostino E. Interim Analysis from B-MORE, a 24-month Prospective, Multicentre, Non-interventional Study on Effectiveness and Usage of Recombinant Factor IX Fc (rFIXFc) in Haemophilia B [abstract]. https://abstracts.isth.org/abstract/interim-analysis-from-b-more-a-24-month-prospective-multicentre-non-interventional-study-on-effectiveness-and-usage-of-recombinant-factor-ix-fc-rfixfc-in-haemophilia-b/. Accessed September 29, 2023.

« Back to ISTH 2022 Congress

ISTH Congress Abstracts - https://abstracts.isth.org/abstract/interim-analysis-from-b-more-a-24-month-prospective-multicentre-non-interventional-study-on-effectiveness-and-usage-of-recombinant-factor-ix-fc-rfixfc-in-haemophilia-b/