Page 12 - Roche Hemlibra Non-inhibitors - Product Monograph

BREAKTHROUGH BLEEDS AND BLEEDING EPISODES WITH FVIII PROPHYLAXIS
More than half of patients experience bleeds with FVIII prophylaxis:
Patients who comply with their prophylactic FVIII regimens may still experience a certain
number of bleeds per year and related morbidity (e.g., chronic arthropathy).

• 62% of 66 pediatric patients with severe hemophilia A still had bleeds over a period of 6
months (Mullins et al. 2017)

• Approximately 70% of 272 patients had bleeds over 1 year in routine clinical practice (Khair et
al. 2018)

Real-world data highlight the increase in ABR despite prophylaxis:

• Prospective non-interventional study (NIS)
Results from a prospective non-interventional study (NIS) in a real-world setting showed that
persons with hemophilia A (PwHA) without inhibitors continue to bleed on prophylaxis (Figure
3), and require treatment for breakthrough bleeds.

50
45 43.1
40
36.1
35
Mean ABR 30 23.8
25
20 19.8
15
10
5 6.2
05
0
Episodic Prophylactic All

Treated bleeds All bleeds

Figure 3: ABR in adult/adolescent PwHA without FVIII inhibitors

The study demonstrated the need for more efficacious hemostatic approaches (Kruse-Jarres
R et al. 2019).

• Advate Hemophilia A Outcome Database (AHEAD) cohort study
®
The global prospective long term AHEAD cohort study collected real world data from patients
with severe and moderate hemophilia. The cohort included 522 patients enrolled from 21
countries. The details of the median ABR in the prophylaxis group and on-demand group are
given in Table 1.

HEMLIBRA Monograph-Non-inhibitors | 10
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