Page 13 - Roche Hemlibra Non-inhibitors - Product Monograph

Median ABR in prophylaxis group Median ABR in ondemand group

Year 1 visit 1.7 8.9

Year 2 visit 1.6 13.0

Year 3 visit 2.2 10.3

Table 1: Median ABR in the prophylaxis group and on-demand group

The study concluded that though the goal of zero bleed is achievable, patients still bleed
(Khair K et al. 2018).

• THUNDER Study

The THUNDER study analyzed the treatment patterns and outcomes in UK patients with
severe or moderate hemophilia A (SHA/MHA) in 2015. Inhibitors were present in 159 (8.8%)
SHA patients and 34 (3.9%) MHA patients. Of 717 non inhibitor patients with SHA or MHA
reporting HT compliant data during the study period, 563 (78.5%) had SHA, and 154 (21.5%)
MHA. The median (IQR) ABR in patients with SHA on prophylaxis was 2.0 (0.0 7.0) and 6.5
(2.0 17.8) on demand. The study showed that the ABR increased with age in both the
prophylaxis and on demand groups (Figure 4) (Scott MJ, et al. 2019).

25 n = 1
n = 4
Non-inhibitor Inhibitor
Median annualized joint bleed rate 15 n = 6 n = 45 n = 2 n = 43
20

10

0 5 n = 130 n = 20 n = 7 n = 1 n = 59 n = 3 n = 0 n = 153 n = 10 n = 123
Prophylaxis On - demand Prophylaxis On - demand Prophylaxis On - demand Prophylaxis On - demand
0-11 12-18 19-39 40+

Age Group

Figure 4: Median ABR for Haemtrack compliant patients with severe haemophilia A using prophylaxis
and on demand treatment, categorized according to age and inhibitor status

HEMLIBRA Monograph-Non-inhibitors | 11
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