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Study Demonstrates Safety and Efficacy of Subcutaneous Vivaglobin® as First-Line Therapy for Primary Immunodeficiency
Date:10/6/2010

ISTANBUL, Oct. 7 /PRNewswire/ -- Vivaglobin® (subcutaneous immunoglobulin [IgG]) (SCIg) is an effective and safe initial therapy for treatment-naive patients with primary immunodeficiency (PI) and may offer an attractive alternative to intravenous IgG (IVIg) therapy in the newly diagnosed, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies. The study found that IgG replacement therapy initiated with Vivaglobin in patients with PI provided adequate serum IgG levels, protected the patients from infections, and improved health-related quality of life, without raising safety concerns.

SCIg treatment, which is delivered directly under the skin, is an important treatment option for patients who do not easily tolerate administration by intravenous infusion because they have poor venous access or experience serious side effects. SCIg is self-administered, offering users convenience and reducing some of the need for healthcare resources associated with IVIg therapy. Additionally, because SCIg is infused weekly, it provides sustained serum IgG levels.

"Though SCIg treatment sustains IgG levels better than IVIg does, for the newly diagnosed patient, IVIg therapy has usually been the recommended first course of treatment," said Bruce Ritchie, MD, FRCPC, Associate Professor, Division of Hematology, Department of Medicine, University of Alberta, and study investigator. "Our findings challenge the practice of initiating replacement therapy using IVIg in people newly diagnosed with primary immunodeficiency disease. The findings also confirm the therapeutic benefits of administering SCIg as first-line treatment in this patient population."

Vivaglobin is approved in the European Union and Switzerland for treating PI as well as secondary immunodeficiency (SI) patients. In Canada and the United States, Vivaglobin is approved for treating PI.

Study DesignIn this study, 18 treatment-naïve patients were administered Vivaglobin 100 mg/kg for 5 consecutive days, followed by weekly infusion of 100 mg/kg (as 1-2 infusions per week) for 24 weeks. The primary endpoint was the proportion of patients achieving IgG trough levels of at least 5 g/L on day 12. Secondary endpoints included IgG increase from baseline to day 12, total Ig levels, rate of any infections, antibiotic use and health-related quality of life assessment (HRQoL).

Findings demonstrate that the proportion of patients achieving serum IgG levels of at least 5 g/L was 94.4 percent by day 12. The mean baseline IgG level of 3.56+/-1.28 g/L increased by 3.94+/-0.75 g/L on day 12, and remained stable throughout the study. Due to irregular attendance, one patient achieved only 3.39 g/L at day 12 and later withdrew informed consent. Thirty-four infection episodes were reported by 10 patients (annualized rate: 3.95/patient). Antibiotic use to treat infections totaled 267 days in 8 patients (annualized rate: 31 days/patient). HRQoL significantly improved from screening to completion visit (43.5 percent vs. 62.0 percent in general health). Nine patients experienced 58 adverse events (AE) at least possibly related to treatment (rate: 0.105/infusion), most frequently injection site swelling (4 patients), injection site erythema (3 patients), and headache (3 patients), all of mild intensity. Two patients had 7 serious AEs (rate: 0.013/infusion) which were considered not related to treatment. No AE led to withdrawal.

About Primary ImmunodeficiencyPrimary immunodeficiency (PI) is a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system. In people with PI, the immune system is either absent or functioning inadequately, leaving them more susceptible to infection. For individuals with PI -- many of them 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. Collectively, PIs affect an estimated 10 million people worldwide, and the incidence is estimated to be 1 in 10,000.

About Vivaglobin Vivaglobin is delivered directly under the skin via a small portable pump. In clinical trials, Vivaglobin was shown to be a safe and effective immunoglobulin replacement therapy for treating patients with PI.

As with all immunoglobulin products, Vivaglobin is contraindicated in individuals with a history of anaphylactic or severe systemic response to immunoglobulin preparations, in the US and Canada also and in persons with selective immunoglobulin A deficiency who have known antibody against IgA.

Vivaglobin is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents including viruses cannot be eliminated completely.

The most frequent adverse event reported in clinical trials was injection-site reaction, consisting of mild or moderate swelling, redness and itching. No serious local site reactions were observed and reactions tended to decrease substantially after repeated use. Other adverse events included headache, gastrointestinal disorder, fever, nausea, sore throat and rash. More information about Vivaglobin, including its full US prescribing information, is available at www.vivaglobin.com.

About CSL BehringCSL 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 and 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. Contact:Sheila A. BurkeDirector, Communications & Public RelationsWorldwide Commercial OperationsCSL BehringC: 484-919-2618 (US)O: 610-878-4209 (US)Sheila.Burke@cslbehring.com
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