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IgPro20, the First 20 Percent Subcutaneous Immunoglobulin, Demonstrates Efficacy Against Infections While Maintaining Tolerability in Patients with Primary Immunodeficiency

Mon, 03/01/2010 - 6:21am
CSL Behring

Data presented today suggest that 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects patients with primary immunodeficiencies (PI) against infection. The 20 percent formulation, the highest Ig concentration currently available, was also shown to sustain serum IgG levels without causing unexpected rates of adverse events. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US.

The data were derived from a study of 49 patients (5-72 years) previously been treated with intravenous immunoglobulin (IVIG), who received weekly subcutaneous infusions of L-proline stabilized IgPro20. The study covered a 15-month period, including a 12-week wash-in/-out period and a 12-month efficacy period. The primary endpoint of the study was the annual rate of predefined serious bacterial infections (SBIs) per patient. No SBIs were reported during the study; 96 non-serious infections were identified.

Dr. Jordan Orange, Attending Physician, Division of Immunology, Children’s Hospital of Philadelphia stated: “These data suggest that IgPro20 provides PI patients with robust protection against infections, while the higher concentration may allow them to infuse the product more quickly thus potentially enhancing its convenience.”

The study also showed 99 percent of adverse events (AEs) reported with IgPro20 to be mild or moderate in intensity. The most common temporally associated AEs were injection site reactions. No serious IgPro20-related AEs were reported.

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.

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