Navigation Links
Landmark study demonstrates Gamunex improves health-related quality of life in patients with CIDP

RESEARCH TRIANGLE PARK, N.C. (April 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.

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.


Contact: Becky Levine
MedThink Communications

Related medicine news :

1. Document Security Systems (Amex: DMC) Invites You to a Landmark Event
2. Less than one-third of women aware of landmark hormone therapy study, Stanford researcher finds
3. Pathway to cell death redefined in landmark study
4. Pathway to cell death redefined in landmark study
5. UCLA to lead local study center in landmark government study of child health
6. Landmark Report: Excess Body Fat Causes Cancer
7. In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack
8. Landmark trial to evaluate cardioprotective properties of insulin
9. Safeway Inc. and the Prostate Cancer Foundation to Fund Landmark Prostate Cancer Research Collaboration
10. Yale launches landmark VIRGO study of young women with heart disease
11. Hospital Launches Landmark Project in Emergency Medicine
Post Your Comments:
(Date:11/28/2015)... ... November 28, 2015 , ... Trying to relax on a couch can ... "I conceived of this design due to personal experience with a bad back," he ... relaxation and convenience, as well as increases support. It also makes it easier to ...
(Date:11/27/2015)... Canada (PRWEB) , ... November 28, 2015 , ... There ... do we outperform our billings from last year? , This question has not been ... organizations are coming to the retirement age and the younger workforce don’t share the ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... According to ... are not changing the way that they are handling security in light of the ... and security presence in an attempt to stop an attack from reaching U.S. soil. ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from Hopkinsville, ... prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. , The ... medications. In doing so, it could help to prevent potential overdose situations. As ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... November 27th edition of USA Today in Atlanta, Dallas, New York, Minneapolis, South ... 750,000. The digital component is distributed nationally, through a vast social media strategy ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
(Date:11/25/2015)... 25, 2015 ... the "Global Brain Monitoring Devices Market ... --> ) has announced the ... Devices Market 2015-2019" report to their ... ( ) has announced the addition ...
Breaking Medicine Technology: