PRAGUE, Oct. 31, 2014 /PRNewswire/ -- 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 Sediva, 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 Sediva. "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/.
Media Contact:
Sandra
Ruckstuhl
Communications
Office: +41 31 344 1124
Sandra.Ruckstuhl@cslbehring.com
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