Page 26 - Roche Hemlibra Non-inhibitors - Product Monograph

HAVEN 1–4: mean ABRs over time

ABRs* over consecutive 24-week treatment intervals by study
10

9 1-24 weeks 25-48 weeks 49-72 weeks 73-96 weeks
8

7
Mean ABR * (95% CI) 5
6

4

3
2 3.1 1.8 2.1
1.5
1 0.9 0.9
0.6
0.4 0.4 0.4 0.3 0.3 0.1 0.2 NE † NE †
0
HAVEN 1 HAVEN 2 HAVEN 3 HAVEN 4
n 109 101 97 73 86 64 49 18 148 144 129 23 48 45 9 0

*Based on the calculated annualized bleed rate for bleeds treated with coagulation factors. †Only data for time intervals with
≥10 participants are reported.

There was a trend for decreasing ABR in each study over time.

With longer follow-up, the adult inhibitor/non-inhibitor ABRs decreased to be closer to the
rates of paediatric patients, who tend to have lower ABR due to less damaged joints.

HAVEN 1–4: zero bleeds over time

Proportion of participants with 0 or 1-3 bleeds over time

0 bleeds 1-3 bleeds
10 5.6
9 14.9 10.3 13.7 12.8 12.5 12.2 84.4 30.4 24.3 19.4 8.7 17.8
8 7 17.4 84.2 87.8 86.3 87.2 87.5 87.8 72.9 77.5 91.3 27.1 77.8
Percentage of participants 6 5 4 3 62.8 64.6
71.6

1 2
NE * NE *
0
1-24 25-48 49-72 73-96 1-24 25-48 49-72 73-96 1-24 25-48 49-72 73-96 1-24 25-48 49-72 73-96
HAVEN 1 HAVEN 2 HAVEN 3 HAVEN 4
n 109 101 97 73 86 64 49 18 148 144 129 23 48 45 9 0

* Only data for time intervals with ≥10 participants are reported.
† Bleeds treated with coagulation factors.

HEMLIBRA Monograph-Non-inhibitors | 24
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