37
As shown in Figure 16, patients treated with 20 IU/kg
body weight Berinert
®
experienced significant reduction
(p=0.0025) in time to onset of relief from symptoms of an
HAE attack as compared to placebo. The median time to
onset of symptom relief for the Berinert
®
20 IU/kg body
weight group was 30 minutes, compared with 85 minutes
for the placebo group.
80
The study demonstrated that the
20 IU/kg dose of Berinert
®
was significantly more efficacious
than the 10 IU/kg dose or placebo. Additionally, the dose
of 10 IU/kg body weight was superior to placebo, but not
statistically significant. Berinert
®
was also shown to be
effective irrespective of attack severity (moderate or severe).
As shown in Table 9, stratified analysis revealed that
Berinert
®
was effective, irrespective of body location (face
or abdomen). The placebo-controlled conditions of the
I.M.P.A.C.T.1 study provided convincing evidence for the
efficacy of 20 IU/kg C1-INH.
Efficacy
Figure 16 – Median Time to Onset of Symptom Relief
by Severity of Attack (Berinert
®
20 IU/kg Body Weight
vs Placebo) in I.M.P.A.C.T.1
78
900
800
700
600
500
400
300
200
100
0
Time to Onset of Symptom Relief (min)
All
Severe
Moderate
30
a
30
b
90 47
b
80
810
Severity of Attack
Berinert
®
20 IU/kg Body Weight (n=43)
Placebo (n=42)
Median Time to Onset of Symptom Relief by
Severity of Attack in I.M.P.A.C.T.1
n=Number of attacks.
a
p=0.0025.
b
Significance testing was applied only for primary endpoints and not for subgroup analyses.
Statistic
20 IU/kg Body Weight Berinert
®
Placebo
All Attacks
n=42
All Attacks
n=43
a
Abdominal
n=34
Facial
n=9
Time to Onset of Symptom Relief [hours]
b
Median (range)
0.50
(0.17–5.77)
0.50
(0.17–5.22)
0.92
(0.25–5.77)
1.42
(0.20–5.90)
Number (%) of patients with individual average time to onset of symptom relief of:
<1 hour
30 (69.8)
25 (73.5)
5 (55.6)
16 (38.1)
<4 hours
37 (86.0)
30 (88.2)
7 (77.8)
26 (61.9)
Time to Complete Resolution of HAE Symptoms [hours]
c
Median (range)
4.92
(0.47–1,486)
3.56
(0.47–1,486)
35.17
(7.93–81.53)
7.79
(0.33–1,486)
Table 9 – Times to Onset of Symptom Relief and Complete Resolution by Body Location in I.M.P.A.C.T.1
80
n=Number of patients.
a
Based on actual values recorded, see 78. No imputation was used for the time to onset of symptom relief.
b
Data for time to onset of symptom relief is missing for 1 patient.
c
Missing values of time to complete resolution were imputed with the maximum value of 1,486 hours.
