Study Shows C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute, Successive Attacks of Hereditary Angioedema at All Body Sites
Additional data presented at the 2010 AAAAI Annual Meeting confirms long half-life of C1-INH protects HAE patients from rebound attacks
NEW ORLEANS, March 1 /PRNewswire/ -- C1-esterase inhibitor
(C1-INH) concentrate is an effective, well-tolerated therapy that
rapidly relieves acute swelling attacks and successive attacks at
any body location in patients with hereditary angioedema (HAE), a
rare and serious genetic disorder, according to data presented
today at the 2010 American Academy of Allergy, Asthma &
Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data
presented at the meeting confirms that C1-INH concentrate has a
longer half-life than other treatment options for HAE, which
protects patients from rebound attacks.
The latest results from the ongoing, prospective, open label
International Multi-center Prospective Angioedema C1-Inhibitor
Trial (I.M.P.A.C.T. 2) with C1-INH concentrate showed a median time
to the onset of symptom relief of 15 minutes for laryngeal attacks,
20 minutes for abdominal attacks, 28 minutes for facial attacks and
31 minutes for peripheral attacks, such as attacks in the hands and
feet. In total, 57 patients who experienced 975 HAE attacks in any
body location were studied.
"This study adds to the growing body of clinical evidence that
C1-INH replacement therapy should be considered the gold standard
for treating acute swelling attacks in hereditary angioedema," said
Timothy J. Craig, D.O., Professor of Medicine and Pediatrics at
Penn State University in Hershey, PA. "The new I.M.P.A.C.T. 2
results, which reflect the outcomes of 975 HAE attacks, show that
C1-INH concentrate is highly effective, safe and well-tolerated in
rapidly relieving symptoms of HAE at many different regions of the
body."
HAE is a genetic disorder caused by a deficiency of C1-INH and
is inherited in an autosomal dominant manner. Symptoms of HAE
include episodes of edema or swelling in the face and the abdomen.
Patients who have abdominal attacks of HAE can experience episodes
of severe pain, diarrhea, nausea, and vomiting caused by swelling
of the intestinal wall. HAE attacks that involve the face can cause
painful distortion and painful swelling. Diagnosis of HAE requires
a blood test to confirm low or abnormal levels of C1-INH. There are
estimates of 6,000 to 10,000 or more people with HAE in the
U.S.
Long Half-Life Confirmed
Researchers confirmed the long half-life of C1-INH concentrate
seen in previous studies by a population pharmacokinetics analysis
of I.M.P.A.C.T. 1 based on plasma samples from 97 patients with HAE
treated with 10 or 20 U/kg C1-INH concentrate as part of the
I.M.P.A.C.T. studies. Sampling was performed at initiation of
treatment, one hour and four hours after dosing and with some
patients extended up to 24 hours until their discharge from the
clinic.
"The long half-life of C1-INH concentrate effectively protects
patients with HAE from rebound attacks, an attack that occurs
before the complete resolution of a first attack," said Dr. Craig.
"In contrast to other treatment options with shorter half-lives,
C1-INH provides an extended period of efficacy that has a certain
prophylactic effect for patients with HAE."
About I.M.P.A.C.T. 1
I.M.P.A.C.T. was a study of 124 HAE patients with acute,
moderate, or severe abdominal or facial attacks. C1-INH concentrate
was administered at two different doses and compared with placebo.
The main study endpoints were time to onset of symptom relief from
HAE attacks, proportion of subjects with worsening clinical HAE
symptoms, and safety.
The I.M.P.A.C.T. study found that C1-inhibitor concentrate
(C1-INH) is effective and safe in rapidly treating acute abdominal
and facial skin swellings in adults and adolescents with HAE. The
study found that the median time to symptom relief was 30 minutes
after receiving C1-INH compared with 1.5 hours with a
placebo.
About I.M.P.A.C.T. 2
Findings of I.M.P.A.C.T. 2 were based on treatment with 20 U/kg
bodyweight of C1-INH in 975 episodes of HAE attacks at any body
location in 57 patients. The main study end-points were time to
onset of symptom relief, complete resolution of all symptoms, and
safety.
The median times to complete resolution of all symptoms were
reported as early as 8 hours for laryngeal attacks, followed by 10
hours for abdominal attacks, 24 hours for peripheral attacks and 31
hours for facial attacks. No drug-related serious adverse events
have been reported to date, nor were any rebound effects observed
following C1-INH administration.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics
industry. Committed to saving lives and improving the quality of
life for people with rare and serious diseases, the company
manufacturers and markets a range of plasma-derived and recombinant
therapies worldwide. CSL Behring therapies are indicated for the
treatment of coagulation disorders including hemophilia and von
Willebrand disease, primary immune deficiencies and inherited
respiratory disease. The company's products are also used in
cardiac surgery, organ transplantation, burn treatment and to
prevent hemolytic diseases in newborns. CSL Behring operates one of
the world's largest plasma collection networks, CSL Plasma. CSL
Behring is a subsidiary of CSL Limited , a biopharmaceutical
company headquartered in Melbourne, Australia. For more
information, visit www.cslbehring.com.
Contact: Sheila A. Burke, Director, Communications & Public Relations Worldwide Commercial Operations CSL Behring 610-878-4209 (o) 484-919-2618 (c) Sheila.Burke@cslbehring.com
Source: CSL Behring
CONTACT: Sheila A. Burke, Director, Communications & Public
Relations,
Worldwide Commercial Operations, CSL Behring, +1-610-878-4209
(o),
+1-484-919-2618 (c), Sheila.Burke@cslbehring.com
Web Site: http://www.cslbehring.com/
Posted: March 2010
