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Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy: the ICE trial.
Expert Rev Neurother. 2009 Jun;9(6):789-95.
Hughes RA.
Department
of Clinical Neuroscience, Institute of Psychiatry, King's College
London, London SE5 8AF, UK.
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Chronic
inflammatory demyelinating polyradiculoneuropathy (CIDP) is a
potentially disabling autoimmune disease causing progressive or
relapsing-remitting weakness with or without sensory loss. Previous
small trials demonstrated short-term benefit from intravenous
immunoglobulin (IVIg), and international guidelines recommend IVIg as
an option. However, evidence had been insufficient to persuade
authorities to approve IVIg for use in CIDP.
This article aims to
review the Immune Globulin Intravenous CIDP Efficacy (ICE) trial, which
was a randomized, double-blind, placebo-controlled,
response-conditional crossover trial of Gamunex (intravenous
immunoglobulin, 10% caprylate/chromatography purified). With 117
participants, it is the largest treatment trial ever conducted in CIDP.
The results showed unequivocal short- and long-term benefit from IVIg
in confirmation of previous reports. The trial also showed for the
first time that continued IVIg infusion 1 g/kg every 3 weeks protected
participants from relapse. Adverse events were mostly mild and serious
adverse events were not more common with IVIg than with placebo. The
results persuaded the US FDA and Health Canada to approve Gamunex for
use in CIDP.
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