Page 14 - Roche Hemlibra Non-inhibitors - Product Monograph

JOINT BLEEDS WITH FVIII PROPHYLAXIS

Patients with hemophilia A experience permanent joint damage. This is because many
patients with hemophilia A without FVIII inhibitors still have breakthrough bleeds despite
FVIII prophylaxis.
• AHEAD Study

About 42% of patients on prophylaxis vs 12% of patients on on-demand therapy had zero
AJBR (Khair K et al. 2018).
• THUNDER Study

AJBR increased with age in both the prophylaxis and on demand groups (Figure 5) (Scott MJ,
et al. 2019).

18 n = 1
Non-inhibitor Inhibitor
Median annualized joint bleed rate
16
n = 4
14
12
n = 43
10

8

6

4 n = 153 n = 45 n = 2 n = 123
n = 130 n = 59 n = 10
2 n = 20 n = 7 n = 1 n = 6 n = 3 n = 0

0
Prophylaxis On - demand Prophylaxis On - demand Prophylaxis On - demand Prophylaxis On - demand
0-11 12-18 19-39 40+
Age Group

Figure 5: Median AJBR for Haemtrack compliant patients with severe haemophilia A using
prophylaxis and on demand treatment, categorized according to age and inhibitor status

The median (IQR) AJBR in patients with SHA on prophylaxis was 1.0 (0.0 4.0) and on demand
was 3.5 (0.0 12.8). Among patients with SHA, around 38% patients in the prophylaxis groups
and 28% in the on-demand group were joint bleed free.
Median hemophilia joint health score (HJHS) (n = 453) increased with age in SHA and MHA.
The median (IQR) HJHS in patients treated on demand was 0.0 (0.0 0.0), 0 18 years and 56.5
(53.0 60.0), aged >60 years (Figure 6) (Scott MJ, et al. 2019).

HEMLIBRA Monograph-Non-inhibitors | 12
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