40
Times to Onset of Symptom Relief and Complete Resolution
of Symptoms by Subgroup in I.M.P.A.C.T.2
Gender
Female (n=38)
Male (n=19)
Age group
17 to <65 years (n=50)
12 to <17 years (n=6)
Type of HAE
Type I (n=49)
Type II (n=7)
Intensity of attack
Severe (n=42)
Moderate (n=53)
Mild (n=21)
Time to treatment
>12 hours (n=38)
>6 to 12 hours (n=45)
>2 to 6 hours (n=48)
≤
2 hours (n=21)
Use of androgens
With (n=21)
Without (n=36)
Anti-C1-INH antibodies
With (n=19)
Without (n=38)
15.3
16.4
15.9
13.9
15.5
15.3
17.6
15.9
16.0
19.2
14.5
14.9
14.0
16.4
15.2
15.5
15.4
0.40
0.50
0.45
0.49
0.44
0.74
0.39
0.45
0.50
0.37
0.43
0.45
0.40
0.44
0.48
0.53
0.40
0 0.5
Time to Onset of
Symptom Relief (hours)
Time to Complete
Resolution (hours)
1 1.5 0 6 12 18 24 30 36
5.33 Efficacious Irrespective of Demographic
and Disease Characteristics
Subgroup analyses support the consistent efficacy and
safety of 20 IU/kg body weight Berinert
®
irrespective of
gender, age, type of HAE, intensity of attacks, time to start
of treatment, use of androgens, or presence of anti-C1-INH
antibodies (Figure 20).
5.34 Efficacious After Repeated Treatment
The effect of repeated administration of 20 IU/kg Berinert
®
was evaluated in a retrospective analysis of I.M.P.A.C.T.2.
81
In 18 patients treated for
≥
15 attacks each, the intensity
and distribution of body location of HAE attacks did not
change with an increasing number of attacks treated with
Berinert
®
. Also, none of the patients experienced statistically
significant changes in treatment response. The results of
this analysis suggest that the frequency of HAE attacks
(Figure 21), time to onset of symptom relief, and time to
complete resolution of HAE symptoms are not affected by
previous use of Berinert
®
.
Figure 20 – Median and 95% Confidence Intervals
of Times to Onset of Symptom Relief and Complete
Resolution of HAE Symptoms by Subgroups –
Per-patient Analysis
n=Number of patients.
Figure 21 – Time Between Consecutive HAE Attacks
Treated With Berinert
®
in Patients Treated for
≥
15
Attacks (n=18)
81
Attack Number
Time Between Consecutive Attacks in I.M.P.A.C.T.2
Time Between Attacks (days)
360
330
300
270
240
210
180
150
120
90
60
30
0
1 2
9 8 7 6 5 4 3
10 11
14
12
15
13
>15
