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Evidence presented at the 16th Biennial Meeting of the European Society for Immunodeficiencies (ESID) Supports Individualized Dosing with Hizentra®

Presentations focus on Hizentra flexible dosing regimens and push administration

PRAGUE — 30 October 2014

The goal of individualized therapy in the treatment of primary immunodeficiency (PI), a serious, life-threatening and lifelong condition, is to provide patients with the best clinical outcome. Individualized therapy is now possible thanks to recent advances in the field of IgG replacement therapy, which offer increased flexibility for physicians and patients.

Data evaluating flexible and individualized dosing and administration of Hizentra® (Immune Globulin Subcutaneous [Human]) for the treatment of primary and secondary immunodeficiencies (PI and SID) were presented by CSL Behring at the 16th Biennial Meeting of the European Society for Immunodeficiencies (ESID). The presentations include clinical observations and research that aim to investigate and advance the individualization of Hizentra therapeutic approaches.

Data from a clinical study and from clinical practice evaluating the investigational, manual push administration of Hizentra therapy were presented at an official satellite symposium of ESID sponsored by CSL Behring:

  • Interim analysis of a phase IV observational, non-interventional, prospective study (CHHINSTRAP) to assess patient satisfaction with an investigational “rapid* (manual) push” administration of Hizentra, was presented by Professor Anna Šedivá, Deputy Director for Science, Research and Innovation and Vice-Head of the Department of Immunology at Motol University Hospital, Prague, Czech Republic and President of the 16th ESID Biennial meeting. The interim results as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) showed overall improvement over baseline with the manual push administration technique in all four dimensions for evaluation (effectiveness, side effects, convenience, and overall satisfaction).

    *Note: The highest approved infusion rate for Hizentra is 25/ml/hour/site.

    “Having different IgG treatment and administration options that fit the individual needs and lifestyles of people living with immunodeficiencies is extremely important, as PI is a condition requiring lifelong, continual therapy to prevent frequent and recurring infections,” said Professor Šedivá. “This new research evaluating the potential of different Hizentra dosing and administration approaches represents exciting progress towards delivering a truly individualized IgG therapy regimen to each immunodeficiency patient.”

  • In addition, Dr. Alex Richter, Clinical Immunology Consultant at University Hospitals Birmingham NHS Foundation Trust and Clinical Senior lecturer at the University of Birmingham, Birmingham, UK presented learnings from a case series in a clinical practice setting that highlighted the simplicity and flexibility of manual push administration.

Frequent manual push is one alternative to the “classical” weekly subcutaneous immunoglobulin infusion; however, everyone’s lifestyle and medical needs are different. Therefore, offering alternative dosing options provides an opportunity to enhance clinical outcomes.

Additional Hizentra Posters Presented at ESID

In the poster, Subcutaneous Immunoglobulin Replacement Therapy – Flexible Dosing (abstract 250), a retrospective analysis of 92 PI patients, Dr. Sai S. Duraisingham and colleagues from Barts Health NHS Trust, London, UK, observed no difference in clinical outcomes between “classical” weekly dosing or 10-14 day subcutaneous administration of IgG replacement therapy (SCIg); adding to the current data supporting the protective effects of Hizentra for up to 14 days, an important finding for patients who choose to extend their time between infusions.

In an additional poster: Patient-Reported Overall Well-Being as a Measure Of Wear-Off Effect In IVIG-Treated Patients with Primary Immune Deficiency (abstract 198) – data were presented from two prospective, phase III, open-label studies of 86 patients, which showed that overall well-being based on patient’s self-perception decreased during the last week of three- or four-week dosing cycles of intravenous administration of IgG replacement therapy (IVIg) in approximately half of patients.

“Clinicians have long been concerned that the protective effects of IVIG may ‘wear off’ by the end of three- or four-week dosing interval, as IgG levels decline and patients become more susceptible to infections,” said Dr. Mikhail Rojavin, CSL Behring, Global Clinical Program Director and one of the authors of the open-label Phase III study. “One potential solution to minimize wear-off could be to increase the frequency of administration as well as to switch to subcutaneous replacement therapy based upon the individual needs of the patient.”

The data presented by CSL Behring at ESID today supports the use of Hizentra in dosing regimens that are flexible and allow physicians and patients to individualize therapy for optimal treatment outcomes.

About Primary and Secondary Immunodeficiencies

Immunodeficiencies constitute a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system. In people with primary or secondary immunodeficiency, certain components of the immune system are either absent or functioning inadequately, leaving them more susceptible to infection. In children, especially, infections may not improve with treatment as expected and may keep returning. As a result, patients may face repeated rounds of antibiotics and hospitalization for treatment. Repeated infections can lead to organ damage, which, over time, can become life threatening.

About Hizentra

Hizentra (Immune Globulin Subcutaneous [Human]), the first and only 20 percent SCIg developed for subcutaneous use, is approved in North America, Europe and Japan. In the United States, Hizentra is indicated for the treatment of patients with primary immunodeficiency, 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. For more information, including full U.S. prescribing information, visit http://www.hizentra.com/. In all 29 European/European Economic Area member states and Japan, Hizentra is authorized for treating patients diagnosed with PI as well as secondary immunodeficiencies.

For more information, including full Summary of Product Characteristics, visit http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002127/human_med_001440.jsp&mid=WC0b01ac058001d124.

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 used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a global biopharmaceutical company and a member of the CSL Group of companies. The parent company, CSL Limited (ASX:CSL), is headquartered in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.

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