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WFH guidelines

 

 

spontaneous bleeds

 

 

real world evidence
Refixia prophylaxis provides bleed free protection in children

  

 

 

(IQR: 0.00–0.98)**2

(IQR: 0.00–2.04)**2

(IQR: 0.00–4.00)**2

*With a 40 IU/kg once-weekly dose.7 As measured by ISTH target joint criteria at the end of paradigm4 clinical trial. The most recent definition of a target joint from the ISTH is ≥3 spontaneous bleeds into the joint within a consecutive 6-month period. When there have been ≤2 bleeds into the joint within a consecutive 12-month period, the joint is no longer considered a target joint.7 Patients had at least 150 exposure days to any FIX product prior to enrolment in the trial2

**Results from 29 patients (13–65 years) treated with 40 IU/kg once-weekly prophylaxis in the pivotal trial, paradigm22


 

ABR, annualised bleeding rate; IU, international unit; FIX, factor IX; IQR, interquartile range; ISTH, International Society on Thrombosis and Haemostasis

new target joint prevention for all patients 12 and under10

target joint resolution for children 7–1210

*Based on single-dose PK parameters of Refixia® 40 IU/kg15

**Mean steady-state pre-dose trough levels across the clinical trials for all previously treated children receiving Refixia® 40 IU/kg once weekly10,15



EHL, extended half-life; FIX, factor IX; IU, international unit; PK, pharmacokinetics; PTP, previously treated patient;
PUP, previously untreated patient

1.

World Federation of Hemophilia (WFH). Guidelines for management of hemophilia, 3rd edition. Available at: https://www1.wfh.org/publications/files/pdf-1863.pdf (Accessed April 2022).

 

 

2.

Collins PW et al. Blood 2014; 124:3880–3886.

3.

Collins PW. Haemophilia 2012; 18:131–135.

 

4.

Oldenburg J. Blood 2015; 125:2038–2044.

5.

van Keep M et al. J Comp Eff Res 2018; 7:39–48.

 

6.

iménez-Yuste V et al. Blood Transfus 2014; 12:314–319.

7.

Negrier C et al. Haemophilia 2016; 22:507–513.

 

8.

Lee A et al. Blood 2020; 136:37–38.

 

9.

Matino D et al. Res Pract Thromb Haemost 2022; 6:e12661.

 

10.

Refixia® Summary of Product Characteristics, 2023.

11.

Tiede A et al. Haemophilia 2017; 23:547–555.

12.

Young G et al. Thromb Res 2016; 141:69–76.

13.

Castaman G. Expert Rev Hematol 2018; 11:673–683

14.

Hansen JU et al. J Haem Pract 2022; 9:103–117

15.

Carcao M et al. J Thromb Haemost 2016; 14:1521–1529

16.

Chan AK et al. Res Pract Thromb Haemost 2020; 4:1101–1113.