Journal Of Clinical Immunology Data Show Privigen™ Demonstrates Effectiveness And Tolerability In Patients With Primary Immunodeficiencies

Main Category: Immune System / Vaccines
Also Included In: Pediatrics / Children's Health;  Clinical Trials / Drug Trials
Article Date: 26 Sep 2008 - 5:00 PST

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Data published online in the current edition of Journal of Clinical Immunology demonstrates that Privigen™, the new liquid immune globulin intravenous (human) 10 percent product from CSL Behring, is effective and well-tolerated in patients with Primary Immune Deficiencies (PI). PI is a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system, leaving patients susceptible to potentially life-threatening infections.

Privigen is a 10 percent liquid preparation of polyvalent human immunoglobulin (IgG) for intravenous administration. Stabilization with L-proline at pH 4.8 is unique in that it minimizes the formation of IgG dimers, and preserves IgG functional activity without refrigeration. High amounts of IgG dimers have been shown to reduce the tolerability of intravenous immunoglobulin (IVIg) administraton.

The published data derive from a phase III, open-label, single-arm investigational study that aimed to assess the tolerability and safety of replacement therapy with Privigen in patients with PI. The primary end point of the study was the number of acute serious bacterial infections (aSBIs). Eighty participants (aged between three and 69 years) with the common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA) received Privigen infusions at three or four week intervals over a 12-month period. Dose and dosing intervals were consistent with patients' pre-study treatment, with a maximum infusion rate of up to 8.0mg/kg min.

The annual rate of aSBIs with Privigen, which included pneumonia, bacteremia /septicaemia, osteomyelitits/septic arthritis, bacterials meningitis, or visceral abscess, was 0.08. That rate is well below the annual rate of one case aSBI per patient per year, which is recognised by the United States Food and Drug Administration as being indicative of efficacy for IgG substitution. It is also comparable to the rates observed in recent studies with other IVIg preparations in patients with PI, as is the annual rate of any infection (3.55, including aSBI) in this study.

"These results are good news for patients with primary immune deficiency disorders," said Dr. Mark Stein, Immunologist at Allergy Associates of the Palm Beaches, FL, USA and lead author of the study. "Privigen provides a clinically proven combination of efficacy, tolerability and convenience of use due to room temperature storage, all of which can help reduce the burden of this life-long disease and which may be advantageous to patients and healthcare professionals."

IVIgs are used to treat several conditions, including PI and autoimmune diseases. Privigen is approved in the United States, Canada, Switzerland and other countries in Europe as an IVIg for the treatment of patients diagnosed with PI and immune thrombocytopenic purpura.

About Primary Immune Deficiencies

This is a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by everyday germs. For individuals with PI - many of whom are children - infections may not improve with treatment as expected, and may keep returning. As a result, patients may face repeated rounds of antibiotics or be hospitalized for treatment. 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, may even result in death. Nearly 100 types of PIs exist. Most are inherited, but in some cases the cause is unknown.

No single treatment works for all the different types of PI. Infusions of replacement antibodies (immune globulins, i.e., Ig) can help supplement the immune system to prevent infection in nearly three-quarters of those people living with PI whose disease is tied to an antibody deficiency.

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 effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic disease in newborns, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia.

CSL Behring