Sub-Analysis of Phase III Suggests Long-Term Therapy May Improve Physical and Social Functioning In CIDP Patients
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sep 23, 2008 - Sub-analysis from a Phase III study of patients with a neurological disease, chronic inflammatory demyelinating polyneuropathy (CIDP), suggest that therapy with Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) may improve their physical and social functioning compared to placebo. Improvements in clinical symptoms also correlated with improvements in nerve function, according to the study funded by Talecris Biotherapeutics, Inc. The data were reported yesterday at the American Neurological Association meeting in Salt Lake City, Utah.
On September 12, the U.S. Food and Drug Administration (FDA) approved Gamunex(R) for the treatment of CIDP to improve neuromuscular disability and impairment, and for maintenance therapy to prevent relapse.
As reported in yesterday's poster session, the quality-of-life assessment suggested that patients experienced fewer limitations in their daily activities and reported improvements across a scale of physical and emotional measures, including social function and mental health, compared to patients taking placebo. IGIV-C treatment appeared to result in a larger improvement from baseline in SF-36 physical component score compared with placebo. IGIV-C treatment also appeared to result in a larger improvement from baseline in Rotterdam handicap scale (RHS) score compared with placebo treatment, with an improvement in the ability to perform daily activities in the IGIV-C group but worsening observed in the placebo group.
"Assessing quality of life in chronic conditions like CIDP is important because quality of life measures tend to parallel traditional assessments such as clinical symptoms and laboratory results," the study authors concluded.
CIDP is a debilitating disease that inflicts progressive damage on peripheral nerves in the arms and legs, causing muscle weakness and fatigue that limits daily activities such as climbing stairs or lifting household objects. In severe cases, patients become wheelchair bound.
While the cause is unknown, the immune-mediated disease attacks and destroys the myelin sheaths that cover and protect peripheral nerves, diminishing the patients' muscle strength, control and sensory function.
As nerve function is an essential measure of disease progression, the Phase III study also examined the correlations between nerve conduction and clinical efficacy assessments.
Results from the correlation analysis, also reported yesterday, suggest that improvements in clinical assessments, such as hand grip strength and INCAT (inflammatory neuropathy cause and treatment) disability score, were positively correlated with the strength and speed of nerve signals.
"Improvements in clinical measures of impairment and disability and of nerve conductions in patients with CIDP after treatment with Gamunex further support the administration of Gamunex as a first-line and maintenance therapy for treating patients with CIDP," said Norman Latov, M.D., head of the Peripheral Neuropathy Center at Cornell University in New York, NY.
The Gamunex data reported yesterday represent a sub-analysis derived from a large-scale, Phase III clinical trial published in the Feb. 2008 issue of The Lancet Neurology. The study, titled "Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized, placebo-controlled trial," demonstrated the long-term (up to one year) safety and efficacy of Gamunex in treating CIDP.
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a neurological disorder often characterized by progressive weakness and impaired sensory function in the legs and arms. This disorder is caused by damage to the myelin sheath (the fatty covering that wraps around and protects nerve fibers) of the peripheral nerves. Signs and symptoms -- which usually develop slowly over weeks and progress over several months -- may include weakness of the arms, legs and face; tingling and numbness in the arms and legs (often beginning in the fingers and toes); as well as muscle aches and fatigue.
CIDP, affecting two to seven individuals per 100,000 worldwide, can occur at any age and in both genders, although it is more common in young adults and in men.
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI), and as immunomodulatory therapy for both idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information. The package insert is currently being revised to incorporate the CIDP indication and supporting information.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,500 talented people worldwide.
To learn more about Talecris and how its employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
Wendy Wilson, 919-316-2430; Fax: 919-316-6377
Posted: September 2008