Study Demonstrates Relationship Between Subcutaneous IgG (SCIg) Dosage and Clinical Outcomes With Hizentra® Treatment in Patients With Primary Immunodeficiencies

KING OF PRUSSIA, Pa., March 21, 2011 /PRNewswire/ -- Data presented by CSL Behring today suggest that treatment with higher dose Hizentra® (IgPro 20) correlates with reduced risk of infection and missed school or work among patients with primary immunodeficiencies (PI). These data, presented at the 2011 American Academy of Allergy, Asthma and Immunology annual meeting, derived from two recent trials of Hizentra, one performed in the United States and one in the European Union, and aimed to show the relationship between subcutaneous IgG (SCIg) dosage and clinical outcomes. Earlier studies have shown that higher immunoglobulin G (IgG) doses by intravenous (IVIg) infusion result in higher serum IgG and therefore fewer infections.(1, 2) Hizentra is indicated for the treatment of patients with PI.

The study population comprised 46 patients—19 of whom were previously on SCIg—on a dose of 120 milligrams/kilogram body-weight (mg/kg bw) (mean of medians) and 38 patients on a dose of 208.2 mg/kg bw SCIg (mean of medians). Efficacy was assessed over 28 or 54 weeks.

Although both studies demonstrated clear evidence of effectiveness with zero acute serious bacterial infections (aSBIs), patients on the higher of the two doses of SCIg experienced a lower rate of infection (2.76 vs. 5.18 infections/patient/year) and fewer days missed from school/work (2.06 vs. 8.0 days/patient/year). Importantly, the lowest blood level of IgG following a dose increased by 23.8 percent in those patients on the higher dose of SCIg, compared to 8.6 percent in those on the lower dose of SCIg.

"These data suggest that the higher dose of Hizentra provides greater protection from infection and its consequences in patients with primary immunodeficiencies," said Dr. John Hagan, Assistant Professor of Medicine in the Divisions of Allergic Diseases and Primary Immunodeficiencies of the Mayo Clinic in Rochester, MN and lead author of the study. "A decrease in infection rate ultimately can reduce a patient's need for antibiotics, hospitalization and missed days from work or school."

"Along with these clinical benefits, Hizentra offers patients a concentrated subcutaneous Ig therapy that they can administer in any setting that is convenient for them," said Lynne Powell, CSL Behring Senior Vice President, North America Commercial Operations. "Hizentra is another example of the commitment CSL Behring has made to understand and respond to the needs of patients who have primary immune deficiency and certain other rare health conditions."

Local reactions to infusion and treatment-related adverse events were more commonly reported with the higher dose of SCIg, however, those reactions were primarily mild to moderate in severity. The potential for increased non-serious adverse events in patients taking the higher dose SCIg should be considered when individual treatment decisions are made.

About Primary Immunodeficiencies

Primary immunodeficiency (PI) is a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system.(3) In people with PI, the immune system is either absent or functioning inadequately, leaving them more susceptible to infection.(4) 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.(5) For more information on PI, please visit www.cslbehring.com or contact the leading PI patient advocate groups in the U.S., the Immune Deficiency Foundation and the Jeffrey Modell Foundation.

About Hizentra®

Hizentra (Immune Globulin Subcutaneous [Human]), the first and only 20 percent SCIg developed for subcutaneous use, is approved in the United States and is in registration in the EU and Switzerland. It is stable at 25 degrees C (77 degrees F) for 30 months due to formulation with L-proline. In the United States, Hizentra is indicated for the treatment of patients with primary immunodeficiency (PI), and contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. The most common drug-related adverse reactions, observed in 5 percent or more of subjects in the U.S. clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue. For more information, including full U.S. prescribing information, visit www.hizentra.com.

Hizentra is part of the immunoglobulin (Ig) franchise for CSL Behring. This comprehensive Ig product portfolio also includes the first U.S. FDA-approved subcutaneous immunoglobulin and the first proline-stabilized intravenous immunoglobulin. CSL Behring manufactures Hizentra at its state-of-the art facility in Bern, Switzerland, where advanced technologies are applied to further ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.

Important Safety Information

Hizentra, Immune Globulin Subcutaneous (Human), is indicated as replacement therapy for the treatment of patients with primary humoral immunodeficiency.

Hizentra is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. If anaphylactic reactions are suspected, administration should be discontinued immediately and the patient treated as medically appropriate. Because Hizentra contains the stabilizer L-proline, it is also contraindicated in patients with hyperprolinemia.

Hizentra should be administered subcutaneously only.

Hizentra is derived from human plasma. The risk of transmission of infectious agents including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be eliminated completely.

The most common drug-related adverse reactions, observed in 5 percent or more of subjects in the clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue.

Monitor patients for reactions associated with IVIg treatment that might occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), hemolysis and transfusion-related acute lung injury (TRALI).

For full prescribing information, visit www.hizentra.com/consumer/prescribing-information.aspx.

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 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.

1)  Eljkhout HW, van der Meer JWM, Kallenberg CGM, et al. The Effect of Two Different Dosages of Intravenous Immunoglobulin on the Incidence of Recurrent Infections in Patients with Primary Hypogammaglobulinemia: A Randomized, Double-Blind, Multicenter Crossover Trial. Ann Int Med. 2001;135:165-174.

2) Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis. Clin. Immunol. 2010 Oct;137(1):21-30

3)  Immune Deficiency Foundation. About primary immunodeficiencies: What is a primary immunodeficiency? http://www.primaryimmune.org/about_pi/about_pi.htm. Accessed February 2011.

4)  National Institute of Child Health & Human Development. Primary Immunodeficiency: What is primary immunodeficiency? http://www.nichd.nih.gov/health/topics/Primary_Immunodeficiency.cfm. Accessed February 2011.

5)  Jeffrey Modell Foundation. Primary Immunodeficiency Resource Center. About PI. http://www.info4pi.org/aboutPI/index.cfm?section=aboutPI&CFID=36419223&CFTOKEN=3244. Accessed February 2011.

SOURCE CSL Behring