38
5.22 Low Incidence of Progression of Symptoms
or Rebound Angioedema
The proportion of patients with increased intensity of
clinical HAE symptoms between 2 and 4 hours after the
start of treatment with 20 IU/kg Berinert
®
compared to
baseline was very low, 4.7% compared with 20.5% with
10 IU/kg Berinert
®
and 31% with placebo (p=0.0014). In
addition, the number of vomiting episodes within 4 hours
after administration of Berinert
®
was dramatically reduced
as was the proportion of patients receiving Berinert
®
who
reported the occurrence of any new HAE symptom not
present before treatment.
No patient treated with Berinert
®
at 20 IU/kg body weight
reported worsening of symptoms at 4 hours after adminis-
tration of study medication compared to baseline.
The placebo-controlled conditions of the I.M.P.A.C.T.1
study provide convincing evidence that a 20 IU/kg dose
of Berinert
®
prevents rebound angioedema, because no
patients in the 20 IU/kg group experienced any treatment-
related worsening of symptoms that required redosing.
5.23 Long-lasting Complete Relief From Pain
and Swelling of Attacks in Clinical Trials
As illustrated in Figure 17, the median time to complete
resolution of HAE symptoms in I.M.P.A.C.T.1was significantly
lower (p=0.0237) in the Berinert
®
20 IU/kg body weight
group (4.9 hours) than in the placebo group (7.8 hours).
9
8
7
6
5
4
3
2
1
0
Time to Complete Resolution (hours)
Placebo Group
20 IU/kg Group
4.9
a
7.8
Berinert
®
20 IU/kg Body Weight (n=43)
Placebo (n=42)
Median Time to Complete Resolution of Symptoms in I.M.P.A.C.T.1
Figure 17 – Median Time to Complete Resolution
of Symptoms (Berinert
®
20 IU/kg Body Weight vs
Placebo) in I.M.P.A.C.T.1
78
a
p=0.0237.
