European Data Suggest Switching Patients to IgPro20 May Significantly Reduce Drug Administration Volume
King of Prussia, PA — 01 March 2010
Data from a European multicenter (non-IND study) showing that patients with PI who switched to IgPro20 from previously available SCIg formulations achieved comparable IgG trough levels without dosage adjustment, resulting in significantly less administration volume. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US.
The data were based on a sub-analysis of a multicenter study of 51 patients with PID switched from their previous treatment to an equivalent dose of weekly subcutaneous infusions of IgPro20. Nineteen patients were switched from other SCIg therapies, including 16% subcutaneous immunoglobulin (n=13), as well as Subcuvia (n=4) and Gammanorm (n=2), two formulations not approved in the US. The study took place over a 17-week period, with IgG trough levels evaluated at baseline, and Weeks 4, 8, 12, 13, 14, 15, 16 and 17. Trough levels were compared with pre-study levels. No apparent difference in trough levels between IgPro20 and previous 16 percent SCIg were found.
“There are currently little data available on switching from one SCIg to another,” said Dr. Stephen Jolles, Consultant Clinical Immunologist, University Hospital of Wales, U.K. “Our study suggests that the majority of patients can be switched to IgPro20 without dose adjustment, resulting in significantly less administration volume, providing reassuring evidence for physicians whose patients may require a change in treatment.”
Primary immunodeficiencies (PIs) are a group of nearly 100 types of disorder that result from the defective development and maturation of the immune system. The clinical hallmark of these disorders is increased susceptibility to infection. Immunoglobulin replacement therapy is indicated for patients who suffer from recurrent infections due to a lack of protective antibodies. Repeated infections can lead to organ damage, which over time can become life-threatening. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, can even result in death. Most types of PI are inherited, but in some cases the cause is unknown.
No single treatment works for all types of PI. Infusions of replacement antibodies (immunoglobulins) can help supplement the immune system to prevent infection in the nearly three-quarters of people living with PI whose disease is due to an antibody deficiency.
IgPro20 is currently being reviewed by the FDA for use as weekly immunoglobulin replacement therapy in patients with PI. If approved, it will represent a new treatment option for patients who want the freedom and convenience of self-administering their replacement therapy.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke, Director,
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