CSL Behring presents Hizentra study data against PI at AAAAI meeting

Mar 22 2011

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. 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.

SOURCE CSL Behring