Navigation Links
CSL Behring Study Confirms Early Treatment with Berinert® Provides Faster Resolution of Acute Hereditary Angioedema Symptoms
Date:3/6/2012

ORLANDO, Fla., March 6, 2012 /PRNewswire/ --CSL Behring announced today that treatment with Berinert®, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster symptom relief than later treatment, according to data presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. While HAE patients treated within six hours of attack onset and those treated six hours or more after attack onset experienced a similar median time to onset of symptom relief, symptoms resolved considerably faster in patients who were treated earlier.

"For HAE patients, timely treatment is a key factor in limiting the severity of an attack," said Timothy J. Craig, D.O., Professor of Medicine and Pediatrics at Penn State University in Hershey, Pennsylvania, and one of the study's investigators. "While treatment with Berinert before or after six hours starts to provide patients with symptom relief, our results show that treating an HAE attack at the first sign of symptoms expedites the resolution of those symptoms."

According to an analysis of data from both the I.M.P.A.C.T. 1 and I.M.P.A.C.T. 2 studies, median times to onset of symptom relief after treatment with 20 U/kg Berinert were similar, regardless of treatment timing (30 and 25 minutes for treatment within 6 hours of attack onset versus 31 and 16 minutes for treatment at six hours or later), while median times to complete resolution were shorter if treatment was received within six hours (2.8 and 12.6 hours) rather than at six hours or later (7.9 and 14.4 hours). Additionally, with 20 U/kg Berinert versus placebo after treatment within 6 hours, median times to onset of symptom relief and complete resolution of symptoms were considerably faster (hazard ratios: 3.36 and 4.30). Treatment at six hours or later showed slightly less pronounced differences in median times to onset of symptom relief and complete resolution relative to placebo (hazard ratios: 1.18 and 1.61).

A second study presented at the meeting retrospectively analyzed patient outcomes associated with intravenous self-administration of C1 Esterase Inhibitor (C1-INH), a method that enables patients to treat themselves earlier, at home. The study, conducted over a period of more than 18 months, enrolled a total of 13 HAE patients who were shown how to self-administer. The study found that self-administration of intravenous C1-INH concentrate can be a good option for patients with HAE. Adverse events were rare in the study, and no complications related to home administration were reported.

"Given the importance of timely treatment, the idea of home-based therapy for HAE attacks has gained support in recent years," said Ralph Shapiro, M.D., of the Midwest Immunology Clinic in Plymouth, Minnesota, and the study's lead investigator. "Our findings suggest that self-administration of Berinert can provide patients with a new confidence in managing their HAE symptoms."Berinert is approved for on-demand treatment of acute abdominal, facial or laryngeal attacks of HAE in adults and adolescents, and is also approved for patient self-administration after proper training by a healthcare professional. Dr. Craig was an investigator for both the I.M.P.A.C.T. 1 and I.M.P.A.C.T. 2 studies which were funded by CSL Behring. Dr. Shapiro received an unrestricted grant from CSL Behring for his work analyzing patient outcomes associated with self-administration of Berinert.

About HAEHAE is a rare genetic disorder caused by a deficiency of C1-INH and inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in various locations, including the face, abdomen and larynx.  Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat 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 Berinert®Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered, plasma-derived intravenous therapy, treats acute facial, abdominal and laryngeal hereditary angioedema (HAE) symptoms by providing C1-INH deficient adult and adolescent patients with the missing human protein. Without C1-INH, people with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth, throat and abdomen. CSL Behring has marketed its pasteurized and nanofiltered C1-esterase inhibitor concentrate, Berinert, in Germany for more than 30 years. The product is approved and marketed in 23 other European countries, the United States, Australia, Canada, Israel, Argentina, Japan and South Korea.

The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is contraindicated in individuals with a history of life-threatening systemic reactions, to C1 esterase inhibitor preparations, including anaphylaxis. The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. In placebo-controlled clinical trial, dysgeusia was the most common adverse reaction reported in over 4 percent of subjects who received Berinert and more frequently than in placebo group. Thrombotic events have been reported in patients receiving C1 esterase inhibitor product, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses.

Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.  Please see full prescribing information for Berinert.

About CSL BehringCSL 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, hereditary angioedema, 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
O: 610-878-4209
Sheila.Burke at cslbehring.com 

Study authors 

J Bernstein 

D Hurewitz 

A Bewtra 

T Machnig 

H Keinecke 

T Craig 


'/>"/>

SOURCE CSL Behring
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Medical Experts Who Participated in CSL Behrings Key Issues Dialogue Prefer Albumin for Fluid Management
2. CSL Behring Awards LEAD Grant to Patient Organizations to Educate Constituents on State Insurance Exchanges
3. Overview of CSL Behring Innovations in Recombinant Technologies Presented at International Conference
4. CSL Behring Marks World Hemophilia Day by Announcing the Winners of the CSL Behring - Prof. Heimburger Award 2011
5. CSL Behring Awards Advocacy Grants to Patient Groups in Maryland, New England, the Midwest and Washington
6. ProFibrix and CSL Behring Enter Into Fibrinogen and Thrombin Supply Agreement
7. CSL Behrings Innovative HeliTrax(SM) System Helps Physicians Manage Hemophilia A Patients
8. Video: CSL Behring Provides $1.2M Grant for Worlds First Study of Postpartum Women with VWD, Common Bleeding Disorder
9. FirstMarks Landmark Clinical Study Successfully Completed that Fulfills the Unmet Need to Access the Risk of Near Term MI
10. New Study Building Framework to Bring Personalized Medicine to the Clinic
11. Argos Therapeutic Arcelis™ Immunotherapy AGS-003 in Combination With Sunitinib Shows Statistically Significant Correlation of Immune System Response to Overall Survival in Phase 2 Study in Patients with Advanced Renal Cell Carcinoma (RCC)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 /PRNewswire/ - FACIT has announced ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" ... commercialization of a portfolio of first-in-class WDR5 inhibitors ... such as WDR5 represent an exciting class of ... precision medicine for cancer patients. Substantial advances have ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm ... Mold) microbial test has received AOAC Research Institute approval 061601. , “This is ... last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. “The ...
(Date:6/23/2016)... 23, 2016   EpiBiome , a precision microbiome ... in debt financing from Silicon Valley Bank (SVB). The ... to advance its drug development efforts, as well as ... "SVB has been an incredible strategic partner to ... traditional bank would provide," said Dr. Aeron Tynes ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... In a ... Hospital in Denmark detail how a patient who developed lymphedema after being treated for ... The results could change the paradigm for dealing with this debilitating, frequent side effect ...
Breaking Biology Technology:
(Date:4/28/2016)... FRANCISCO and BANGALORE, India , ... of EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... provider, today announced a global partnership that will ... way to use mobile banking and payment services. ... is a key innovation area for financial services, but it ...
(Date:4/19/2016)... -- The new GEZE SecuLogic access control ... system solution for all door components. It can be ... interface with integration authorization management system, and thus fulfills ... dimensions of the access control and the optimum integration ... considerable freedom of design with regard to the doors. ...
(Date:4/13/2016)... -- IMPOWER physicians supporting Medicaid patients in Central ... in telehealth thanks to a new partnership with higi. ... patients can routinely track key health measurements, such as ... when they opt in, share them with IMPOWER clinicians ... retail location at no cost. By leveraging this data, ...
Breaking Biology News(10 mins):