Prodromal Symptoms Warn of Hereditary Angioedema Attacks, Give Patients Time to Start Therapy and Decrease Morbidity

Sat Nov 7, 2009 7:00am EST
 
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Prodromal Symptoms Warn of Hereditary Angioedema Attacks, Give Patients Time
to Start Therapy and Decrease Morbidity


MIAMI BEACH, Fla., Nov. 7 /PRNewswire/ -- Most patients with hereditary
angioedema (HAE) have prodromal symptoms that signal an oncoming HAE attack
giving the patients sufficient time to initiate treatment and decrease the
morbidity associated with that attack, according to survey findings presented
today at the 2009 American College of Allergy, Asthma & Immunology (ACAAI)
Annual Meeting. Early recognition of symptoms such as fatigue and nausea,
which occur frequently before an acute HAE attack, can provide patients with
up to 24 hours to initiate treatment before further onset of the attack.  

Administered in parallel with the ongoing, open label International
Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 2), the
survey was designed to evaluate prodromal symptoms at the time of treatment of
HAE attacks. Thirty-one patients experiencing 253 attacks were treated with C1
esterase inhibitor concentrate (C1-INH).  Prodromal symptoms were reported
before 171 of these attacks (67.6 percent). The start of symptoms ranged from
20 minutes to 24 hours before the onset of HAE exacerbations, with a median
duration of 12 hours. The most commonly reported prodromal symptoms were
fatigue (41.9%), nausea (26.1%) and flu-like feelings (22.1%). Other prodromal
symptoms included urticaria-like skin eruptions (11.1%), non-itchy rash
(11.1%), bowel movement change (9.1%), abdominal rumbling (7.5%), and tingling
(4.0%). 

"For patients suffering from HAE, timely treatment is critical to effective
management of this debilitating and life-threatening disorder," said Timothy
J. Craig, D.O., Professor of Medicine and Pediatrics at Penn State University
in Hershey, PA., and one of the study's investigators. "Our study shows that
patients who recognize the warning signs of an HAE attack have adequate time
to initiate treatment and improve their outcomes."   

HAE is a genetic disorder affecting approximately 6,000 to 10,000 Americans
and is caused by a deficiency of C1-INH, which is inherited in an autosomal
dominant manner.  Patients who have abdominal attacks can experience episodes
of severe pain, diarrhea, nausea, and vomiting caused by swelling of the
intestinal wall. Attacks that involve the face and larynx can result in airway
closure, asphyxiation, and, if untreated, death. Diagnosis of HAE requires a
blood test to confirm low or abnormal levels of C1-INH.

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 640 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 time to the onset of symptom relief was 16 minutes for laryngeal
attacks, 23 minutes for abdominal attacks, 28 minutes for facial attacks and
31 minutes for peripheral attacks, such as attacks in the hands and feet.  The
median times to complete resolution of all symptoms were reported as early as
8 hours for laryngeal attacks, 11 hours for abdominal, 24 hours for facial and
25 hours for peripheral 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 global leader in the plasma protein biotherapeutics industry.
Passionate about improving the quality of patients' lives, CSL Behring
manufactures and markets a range of safe and effective plasma-derived and
recombinant products and related services. The company's therapies are used in
the treatment of immune deficiency disorders, hemophilia, von Willebrand
disease, other bleeding disorders and inherited emphysema. Other products are
used for the prevention of hemolytic diseases in the newborn, in cardiac
surgery, organ transplantation and in the treatment of burns. The company also
operates one of the world's largest plasma collection networks, CSL Plasma.
CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with
headquarters in Melbourne, Australia. For more information, visit
www.cslbehring.com. 

    Contact:
    Sheila A. Burke, Director, Communications & Public Relations
    Worldwide Commercial Operations
    CSL Behring
    C: 484-919-2618
    O: 610-878-4209
    Sheila.Burke@cslbehring.com


SOURCE  CSL Behring

Sheila A. Burke, Director, Communications & Public Relations, Worldwide
Commercial Operations, CSL Behring, Cell, +1-484-919-2618, Office,
+1-610-878-4209, Sheila.Burke@cslbehring.com

 

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