Landmark study demonstrates Gamunex improves health-related quality of life in patients with CIDP.
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.
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.
Reference: 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).