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Landmark study demonstrates Gamunex improves health-related quality of life in patients with CIDP
Date:4/24/2009

ents."

"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 pu
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Contact: Becky Levine
blevine@medthink.com
919-786-4918
MedThink Communications
Source:Eurekalert

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