34
5.0 Berinert
®
Usage and Efficacy
Chapter 5 Highlights
•
In Europe, Berinert
®
is currently approved
for the treatment and pre-procedure
prevention of acute angioedema attacks.
•
Efficacy and safety of Berinert
®
for the
treatment of acute attacks have been
demonstrated in the I.M.P.A.C.T. clinical
research program, the largest clinical trials
program of HAE ever conducted.
•
I.M.P.A.C.T.1, a placebo-controlled trial of
2 doses of the C1-INH concentrate Berinert
®
in patients with HAE, was completed in
2007. I.M.P.A.C.T.2 was the open-label
extension of I.M.P.A.C.T.1 to evaluate the
efficacy and safety of long-term treatment
with 20 IU/kg C1-INH for acute HAE attacks
at any body location.
•
During the I.M.P.A.C.T. trials, Berinert
®
demonstrated a fast onset of action, quickly
reducing symptoms of pain and swelling;
the median onset of relief in I.M.P.A.C.T.1
was 30.0 minutes after a single dose of
20 IU/kg body weight. In I.M.P.A.C.T.2, the
median time to onset of symptom relief
was 27.6 minutes.
•
Berinert
®
offered reliable relief – with
minimal risk of rebound angioedema –
continuously relieving the pain and
swelling of HAE. In I.M.P.A.C.T.2, the
number of redosing for recurrent angio-
edema symptoms was minimal (<1%).
Berinert
®
provided reliable relief regard-
less of severity or location of attack.
•
These data support earlier observations
and reports in Europe and Japan that
demonstrated that Berinert
®
is effective
in the treatment of HAE attacks.
•
Worldwide, Berinert
®
is the only C1-INH
therapy that has been used in more
than half a million treatments over
more than 30 years.
•
The ability of pre-procedure prophylaxis
with Berinert
®
to substantially reduce
the risk of peri-procedural HAE attacks
has been demonstrated in several case
reports and studies.
•
In clinical trials, the most common
adverse reactions were headache,
nausea, and nasopharyngitis.
