39
Figure 18 – Patient-reported Time to
Onset of Symptom Relief by Site of HAE Attack
(Berinert
®
20 IU/kg Body Weight) –
Per-patient and Per-attack Analysis
Median Time to Onset of Symptom Relief by Site of HAE Attack
in I.M.P.A.C.T.2
50
30
10
20
40
0
Time to Onset of Symptom Relief (min) (95% CI)
Per-patient Analysis
Per-attack Analysis
19.2
23.4
24.0
30.0
25.8
15.0
26.4
28.8
Abdominal
Facial
Peripheral
Laryngeal
n=51
n=21
n=30
n=16
n=747
n=51
n=235
n=48
n=Number of patients or attacks; CI=Confidence interval.
Figure 18. Patient-reported Time to Onset of Symptom Relief
by Site of HAE Attack (Berinert
®
20 IU/kg Body Weight) –
Per-patient and Per-attack Analysis
Figure 19 – Patient-reported Time to
Complete Resolution by Site of HAE Attack
(Berinert
®
20 IU/kg Body Weight) –
Per-patient and Per-attack Analysis
n=Number of patients or attacks; CI=Confidence interval.
Median Time to Complete Resolution of Symptoms
in I.M.P.A.C.T.2
48
36
24
12
0
Time to Complete Resolution (hours) (95% CI)
Per-patient Analysis
Per-attack Analysis
12.8
10.5
26.6
22.7 23.5
8.4
28.3
5.8
Abdominal
Facial
Peripheral
Laryngeal
n=51
n=21
n=30
n=16
n=747
n=51
n=235
n=48
n=Number of patients or attacks; CI=Confidence interval.
Figure 19. Patient-reported Time to Complete Resolution
by Site of HAE Attack (Berinert
®
20 IU/kg Body Weight) –
Per-patient and Per-attack Analysis
5.3 Consistent Efficacy of Berinert
®
After Repeated Administration for Attacks
at All Body Locations in I.M.P.A.C.T.2
80
Efficacy
5.31 Efficacious Regardless of
Anatomical Site of Attack
Using the identical primary endpoint as the pivotal study and
dosing of 20 IU/kg body weight, the I.M.P.A.C.T.2 extension
study demonstrated consistent efficacy for attacks at all body
locations. Themedian time to onset of symptom relief ranged
between 15 minutes for laryngeal attacks and 30 minutes
for peripheral attacks in the per-attack analysis, and between
23 minutes for abdominal attacks and 29 minutes for facial
attacks in the per-patient analysis (Figure 18).
The median time to complete resolution ranged between
8.4 hours for laryngeal attacks and 28.3 hours for facial
attacks in the per-attack analysis and between 5.8 hours
for laryngeal attacks and 26.6 hours for facial attacks in the
per-patient analysis (Figure 19).
5.32 Single Dose of 20 IU/kg Berinert
®
Sufficient to Effectively Treat Attacks
Only 1 hour after treatment with Berinert
®
, approximately
90% of patients had reported onset of symptom relief;
4 hours after treatment, onset of symptom relief was
reported by 97% of patients. Reliable symptom relief after
treatment with 20 IU/kg Berinert
®
was also attested by the
low number of redosing needed. For 99% of all attacks, a
single dose was sufficient for effective treatment. Worsening
of symptoms after treatment that required redosing was
experienced after only 0.37% of the 1,085 attacks treated
in I.M.P.A.C.T.2.
