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, MN, 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.
HAE 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.
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 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, 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.
Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Communications