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."