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Study Demonstrates Safety and Efficacy of Subcutaneous Vivaglobin® as First-Line Therapy for Primary Immunodeficiency

Wed, 10/06/2010 - 11:31pm
Bio-Medicine.Org

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 treat

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