41
5.4 Only Berinert
®
Has a Reliable Record of
More Than Half a Million Treatments Worldwide
Berinert
®
has a reliable record of proven efficacy and
safety in international clinical use in more than half a
million treatments in nearly 30 years of clinical use for the
treatment of HAE.
1
The data from I.M.P.A.C.T.1 and I.M.P.A.C.T.2 confirm
the observations and reports from Germany, Hungary,
Italy, Japan, Spain, and elsewhere that have demonstrated
that Berinert
®
is effective in the treatment of HAE attacks
(Figure 22).
30,35,39,62,82-88
For example, a retrospective analysis reported experience
with Berinert
®
in the treatment of cutaneous edema,
laryngeal edema, and abdominal symptoms in 61 patients
with HAE over a 10-year period. The study included
22 children and 4 pregnant women. Injection of 500 IU
fixed dose led to a substantial improvement within 15 to 60
minutes followed by a regression of the symptoms. Complete
regression of the clinical symptoms occurred within 12 to
48 hours. There was no reported progression of the
symptoms or rebound effect within 72 hours for any of
these patients.
85
5.41 Clinical Experience of Berinert
®
in Cutaneous Attacks
Furthermore, in a part-retrospective, part-prospective study,
Berinert
®
was used to treat 2,104 episodes of cutaneous
edema in 47 HAE-I and HAE-II patients compared to
9,046 untreated cutaneous attacks in the same patients
(Table 10).
35
•
Mean time to symptom improvement was 1.1 hours
(SD=1.4 hours) for Berinert
®
-treated attacks vs 50.4 hours
(SD=33.6 hours) for untreated attacks.
•
Skin swelling lasted 1.7 days (SD=1.3 days) in treated
attacks vs 3.2 days (SD=1.7 days) in untreated attacks
(p<0.001).
•
Facial edema regressed distinctly more slowly than
other sites of cutaneous edema.
•
In the episodes that were treated with Berinert
®
, no
rebound effect was observed within 48 hours.
Efficacy
Copyright: CSL Behring.
Figure 22 – 18-Year-old Patient Before (Left)
and After (Right) Treatment With Berinert
®
Number
of Patients
Site of Attack
Number
of Attacks
Mean Duration
of Attacks (days)
Face
Hands and/or arms
Feet and/or legs
Genitals
Trunk
Total
35
27
18
14
4
47
b
Untreated
628
5,084
2,692
505
137
9,046
Untreated
7.1
3.2
3.0
3.0
3.4
3.2
Treated
with
Berinert
®
483
831
638
123
29
2,104
Treated
with
Berinert
®
3.9
a
1.0
a
1.1
a
1.5
a
1.3
a
1.7
a
a
p<0.001.
b
Same patient may have had attacks at different sites at the same time.
Table 10 – Duration of 11,150 Episodes of
Cutaneous Swelling in 47 HAE Patients Left Untreated
or Treated With Berinert
®
C1-INH Therapy
35
