- Eight posters including one oral presentation support ongoing research and clinical experience with Hizentra®, the first and only subcutaneous immunoglobulin (Ig) therapy approved to address the unique needs of CIDP patients.
- Presentations include new analysis from the PATH (Polyneuropathy and Treatment with Hizentra) study, the largest clinical trial in CIDP.
GENOA, Italy, June 20, 2019 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that it will support the presentation of eight scientific posters at the 2019 annual meeting of the Peripheral Nerve Society (PNS), to be held 22-26 June, in Genoa, Italy. Research to be presented includes new insights from the PATH trial extension, including long-term Quality of Life (QoL) and outcomes data analyses, and evaluation of IgG levels as a potential biomarker to predict treatment response in the treatment of CIDP. PATH is the largest clinical trial ever conducted with CIDP patients. An additional CSL Behring-supported presentation will assess the impact of CIDP diagnosis delay (after incident symptoms) on physical function (PF) using self-reported data from the GBS|CIDP Foundation International survey.
"PATH study data continues to guide healthcare providers and CIDP researchers in more fully understanding the clinical benefits of subcutaneous Ig treatment, Hizentra, which is already making a difference in helping us fulfill our promise to CIDP patients," said Andrew Koenig, D.O., F.A.C.R., Immunology and Neurology Therapeutic Area Lead, Medical Affairs, CSL Behring. "We are committed to further analysis based on the trial extension results to continue to advance patient care and deliver innovation that will improve quality of life for people living with CIDP."
In addition to the meeting presentations, CSL Behring will also host a symposium, "Navigating Diagnosis and Treatment Challenges in CIDP" (23 June, 7 p.m. CET) to review additional insights regarding the diagnosis and treatment of the commonly misdiagnosed condition. David Cornblath, M.D., Professor of Neurology, Johns Hopkins School of Medicine, will chair the discussion which will feature the following lectures: "Impact of over and under diagnosing CIDP," by Jeffrey A. Allen, M.D., Assistant Professor of Neurology, Feinberg School of Medicine, Northwestern University; "Finding the right treatment regimen for CIDP," by Pieter Van Doorn, M.D., Professor of Neuromuscular Disorders. Erasmus MC, University Medical Center, Rotterdam, the Netherlands; and "Optimising CIPD Guidelines," by Peter Van den Bergh, M.D., Director of the Neuromuscular Reference Centre, Cliniques Universitaires St. Luc in Brussels.
CSL Behring is the only company to offer a portfolio of biologics to address the unique needs of CIDP patients in several regions around the world – Hizentra®, the first and only subcutaneous immunoglobulin option for CIDP patients, while Privigen® is the first and only 10 percent, ready-to-use, room-temperature stored, liquid intravenous immunoglobulin stabilized with proline. Earlier this year, both Hizentra and Privigen were approved by Japan's Ministry of Health, Labour and Welfare for the treatment of patients with CIDP.
In CIDP, a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord), the myelin sheath, critical for impulse conductivity in nerve cells, is damaged. This may result in numbness or tingling, muscle weakness, fatigue, and other symptoms. CIDP effects can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. Approximately 30 percent of CIDP patients will progress to wheelchair dependence if not treated [i]. The incidence of CIDP each year is estimated to be between 1.5 and 3.6 million within the global population [ii].
Hizentra [Human normal immunoglobulin (SCIG)], the first 20 percent SCIG developed for subcutaneous use, is available in more than 45 countries to treat certain immune deficiencies and as a maintenance treatment for CIDP. Hizentra, the world's most prescribed SCIG, has a proven track record of safety, efficacy and tolerability and has over 6 million exposures worldwide since 2010.
Privigen [Human normal immunoglobulin (IVIG)] is a 10 percent, ready to use, liquid IVIG stabilized with proline. A naturally occurring amino acid, proline has been shown to reduce IgG aggregation and dimer formation. It is available in more than 60 countries around the world and is used as replacement therapy for patients with primary and secondary immunodeficiencies, and as an immunomodulatory therapy for patients with immune thrombocytopenia (ITP), Kawasaki disease, and neurological disorders such as CIDP, multifocal motor neuropathy (MMN) and Guillain-Barré syndrome.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary and secondary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs more than 22,000 people, and delivers its life-saving therapies to people in more than 60 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring.
[i] Laughlin R.S. et al. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology. 7;73(1):39-45.
[ii] American Association of Neuromuscular & Electrodiagnostic Medicine (2019). Chronic Inflammatory Demyelinating Polyneuropathy. Accessed May 2019.
View original content:http://www.prnewswire.com/news-releases/csl-behring-to-showcase-clinical-advances-and-insights-in-chronic-inflammatory-demyelinating-polyneuropathy-cidp-with-hizentra--human-normal-immunoglobulin-20-subcutaneous-at-the-2019-peripheral-nerve-society-annual-meeti-300871708.html