Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy: the ICE trial

Abstract

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.

Keywords::

• chronic inflammatory demyelinating polyradiculoneuropathy
• intravenous immunoglobulin
• randomized, controlled trial

Financial & competing interests disclosure

Richard Hughes has received hospitality, honoraria for speaking and consultancy fees from Talecris, the company which produces Gamunex, and was a member of the steering committee of the trial reviewed in this article. Professor Hughes has also acted as a consultant or received hospitality and honororia for speaking for the following other companies which produce IVIg: Baxter, CSL Behring, Kedrion, LFB and Octapharma. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. The content of the paper was checked by staff employed by Talecris, the company which produces Gamunex which was the immunoglobulin product tested in the trial reviewed in this article.