Healthcare Industry News: Intravenous Immunoglobulin
News Release - June 27, 2012
PRIMA Study Shows Treatment with Privigen(R) Improved Function in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)ROTTERDAM, Netherlands, June 27, 2012 -- (Healthcare Sales & Marketing Network) -- Data presented today from the Privigen Impact on Mobility and Autonomy (PRIMA) trial at the Peripheral Nerve Society Inflammatory Neuropathy Consortium Meeting in Rotterdam, Netherlands, suggests that treatment with Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], an Intravenous Immunoglobulin (IVIg), may lead to improvement in function in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
PRIMA, a prospective, multicenter, open-label, single-arm study investigating the efficacy and safety of Privigen in previously IVIG-treated and untreated patients with CIDP achieved its primary efficacy endpoint, which was the percentage of patients responding—as measured by the Inflammatory Neuropathy Cause and Treatment (INCAT) scale—at study completion compared to baseline. The overall response rate was 60.7 percent. The 25-week treatment period permitted the observation that a response to IVIG can occur late (i.e., after more than 6 weeks of therapy). This finding may encourage some treating physicians to continue IVIG therapy longer in their CIDP patients before assessing whether or not the therapy is working.
"CIDP is a rare, progressive disease that may cause permanent nerve damage and studies show that current treatment options may not work for all patients," said Jean-Marc Leger, M.D., Hospital de la Salpetriere. "Finding new treatment options to slow the advancement of the disease is extremely important. The results from this study are promising as they suggest that Privigen may help decrease weakness and loss of motor function in people with CIDP."
Functional improvement was evaluated by the INCAT scale, which is used to measure a patients' ability to perform tasks (i.e., walking, motor hand tasks, etc.). On this scale, patient scores rise with increasing weakness and disability, whereas improvement in basic motor functions is indicated by a reduction in the score. Results presented today showed that mean overall INCAT score significantly improved from 3.7 at baseline to 2.3 at completion of treatment. Half of the responders achieved the clinically meaningful threshold by Week 4.
"As a leader in developing innovative Ig therapies, CSL Behring continually seeks to advance the understanding of medicines that address the treatment needs of patients with rare diseases such as CIDP," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D, at CSL Behring. "We are pleased that this study has shown Privigen to have promise in improving functional ability in patients with CIPD. We plan to continue our Ig research in this disease state with the goal of providing another important treatment option to patients with CIDP."
Privigen is approved in the European Union, Switzerland, Canada and the United States for treating patients diagnosed with primary immune deficiency (PID) and immune thrombocytopenic purpura (ITP). In Europe, Privigen is also approved for treating Guillain-Barre Syndrome and Kawasaki-Syndrome. Recently, CSL Behring submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen in CIDP.
About the Study
The Privigen Impact on Mobility and Autonomy (PRIMA) trial was a prospective, multicenter, open-label, single-arm study, assessing the efficacy and safety of Privigen in Intravenous Immunoglobulin (IVIG) untreated and IVIG-pre-treated patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Of the 31 patients screened, 28 were enrolled in the study (15 IVIG-untreated; 13 IVIG-pretreated). Patients received an induction dose of 2 g/kg body weight administered over 2–5 days, followed by seven infusions of 1 g/kg body weight at 3-week intervals (treatment duration 22 weeks).
About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
CIDP is a rare disorder of the peripheral nerves characterized by symmetrical weakness in the arms and legs that progressively worsens for longer than two months. CIDP is believed to be underdiagnosed and undertreated. Therefore, its prevalence is difficult to determine, with some estimates being as high as 8.9 per 100,000 adults. If left untreated, approximately 30 percent of CIDP patients will progress to wheelchair dependence. CIDP can occur at any age; typically, initial onset occurs between the ages of 30 and 60. Early recognition and treatment can help prevent disability and improve recovery from CIDP.
Privigen is part of the immunoglobulin (Ig) franchise of CSL Behring. CSL Behring manufactures Privigen at its state-of-the art facility in Bern, Switzerland where the most advanced technologies are applied to ensure product safety and supply. This facility represents the long-term commitment of CSL Behring to global Ig markets. Privigen is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. In Europe it is indicated for treating: primary immunodeficiency, primary immune thrombocytopenic purpura, Guillain-Barre syndrome, Kawasaki disease, replacement therapy in multiple myeloma or chronic lymphocytic leukemia with secondary hypogammaglobulinemia and recurrent infections, replacement therapy in children with congenital AIDS and recurrent infections, and allogeneic haematopoietic stem cell transplantation (HSCT) in patients with secondary hypogammaglobulinemia. For more information about Privigen, including full prescribing information, visit http://www.privigen.com/Professional/Prescribing-Information.aspx and for Europe http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000831/human_med_000993.jsp&jsenabled=true.
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, hereditary angioedema 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 (CSL.AX), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
Source: CSL Behring
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