How Berinert works
Hereditary angioedema is a rare condition observed in one in 10.000-50,000 people. It is caused by a mutation in the SERPING1 gene, resulting in insufficient levels of functional C1-INH in the blood. C1-INH controls three mechanisms in the body: the complement system, blood clotting (coagulation), and vasodilation (widening of blood vessels). In C1-INH’s absence, proper regulation of these mechanisms fails, resulting in extreme swelling due to fluid leakage into the deeper layers of the skin from the blood vessels.
Berinert is a concentrated C1-INH isolated from healthy blood donors and packaged as a single-use powder to be dissolved and injected into the bloodstream during an acute attack to restore functional C1-INH levels. Patients may start feeling symptom relief as quickly as a half-hour after treatment with Berinert.
Berinert in clinical trials
Several clinical studies were conducted to assess the safety and effectiveness of Berinert. The most important clinical trials that led to the approval of this therapy in several countries are the international Phase 2/3 study IMPACT-1 (NCT00168103) and its extension study IMPACT-2 (NCT00292981).
IMPACT-1 involved 126 participants and assessed the effect of Berinert in hereditary angioedema patients having acute facial or abdominal attacks. The results showed that the treatment led to rapid symptom relief in as little as 30 minutes.
IMPACT-2 was a study involving 57 patients and evaluating all possible symptoms in a long-term treatment setting. This study also reported a very quick median symptom relief of 26 minutes. One dose was sufficient to effectively treat 99 percent of patients experiencing symptoms.
More information About Berinert
Berinert is a generally safe and well-tolerated therapy. The most common side effects are headaches, dizziness, throat irritation, diarrhea, nausea, and tingling or numbness in the skin and limbs.
The U.S. Food and Drug Administration (FDA) approved Berinert in 2009 to be used for acute abdominal and facial attacks in adult and adolescent hereditary angioedema patients. In 2016, the approval was expanded to include the treatment of patients younger than 12 and older than 65 years of age. Since 2012, life-threatening laryngeal attacks are also included among the indications of Berinert.
Berinert is now approved for the treatment of acute hereditary angioedema attacks in over 30 countries. It is on the way to becoming the first-line therapy in treating hereditary angioedema patients. Berinert also can be used prior to surgical operations to prevent attacks during the procedure.
It also is possible to self-administer Berinert. However, patients or caregivers need training before they can correctly administer the injections.
Because C1 inhibitor controls blood clotting and vasodilation, Berinert may not be suitable for patients who have a history of blood clots, atherosclerosis, or heart and blood vessel diseases.
Some patients may experience an allergic reaction to Berinert. Healthcare providers should be alerted in case of symptoms such as hives, swelling, or difficulty breathing.
Berinert is obtained from the plasma of human blood donors. Although all donations are tested for infections and the risk of any disease transmission is very low, it cannot be completely excluded.
Angioedema News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.