New Publication of Landmark Study Demonstrates Gamunex Improves Health-Related Quality of Life in Patients with CIDP
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Apr 23, 2009 - Talecris Biotherapeutics, Inc. today announced the publication of the health-related quality of life results from the largest clinical trial ever conducted in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the April 14, 2009 issue of Neurology. The data demonstrate that long-term treatment with Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) improves and maintains health-related quality of life in patients with CIDP. To access the abstract, click here.
The analysis of health-related quality-of-life endpoints showed that patients who received Gamunex experienced greater improvements in physical and mental component scores compared with placebo, as measured by the Short-Form-36 (SF-36) health survey, one of the most widely used measures of health-related quality of life. Improvements in all SF-36 domains favored Gamunex versus placebo, with physical functioning, role-physical, social functioning and mental health reaching significance.
“The data provide the rationale for administering maintenance doses of Gamunex every three weeks as a means of improving health-related quality of life and preventing relapse of symptoms,” according to Ingemar Merkies, M.D., Ph.D., Department of Neurology, Erasmus Medical Center, Rotterdam and Spaarne Hospital Hoofddorp, the Netherlands. The study was funded by Talecris Biotherapeutics.
CIDP is a debilitating nerve disease that results in progressive weakness in the arms and legs, causing significant disability for many individuals. Gamunex is the first and only FDA-approved product for the treatment of CIDP.
“Until now, there has been no FDA-approved dosing regimen for an effective course of intravenous immune globulin therapy to reduce neuromuscular disability and improve quality of life in patients with CIDP,” Merkies said. “Data from this trial provide an effective regimen with Gamunex to achieve improvements.”
“The improvement in health-related quality of life, social participation and activity supports the use of Gamunex in patients with CIDP who have responded to it in the past. It validates the benefits of every three week infusions of Gamunex.” said Dr. Peter Donofrio, professor of Neurology and Chief, Neuromuscular Section of the Department of Neurology, Vanderbilt University, Nashville, Tennessee.
Estelle Benson, executive director of the GBS/CIDP Foundation International, added “The Foundation is extremely grateful to Talecris for all they continue to do for our patient community.”
Study Design Details
Results from the current study were derived from the largest-ever clinical trial of patients with CIDP, titled, “Intravenous immune globulin [10% caprylate-chromatography purified] for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized, placebo-controlled trial.” The results of the trial were published in the February 2008 issue of The Lancet Neurology. To the access the abstract, click here.
In the ICE study, 117 patients with CIDP received Gamunex or placebo every three weeks for up to 24 weeks, switching from one treatment arm to the other if they failed to measurably improve on standard disability measures. Patients who improved were eligible for a 24-week extension for a total of 48 weeks of treatment. Moreover, the quality-of-life scores of those patients receiving Gamunex every three weeks for 48 weeks approached those of healthy individuals in the U.S.
There were zero discontinuations in the study due to Gamunex maintenance therapy, and 96 percent of the Gamunex infusions were free of drug-related headache. The most common drug-related adverse reactions observed at a rate of ‰¥ 5 percent were headache, fever, chills, hypertension, rash, nausea and asthenia. The most severe adverse reaction observed in patients receiving Gamunex was pulmonary embolism (PE) in one patient with a history of PE.
Chronic inflammatory demyelinating polyneuropathy 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, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human).
Immune Globulin Intravenous (Human) (IGIV) 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 [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.
Gamunex is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
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, hemostasis and neurology. 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 $1.4 billion in 2008, 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 our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
Contact: Talecris Biotherapeutics, Inc.
Wendy Wilson, 919-316-2430
Posted: April 2009