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. 2010;4(3):e154-66.
Epub 2010 Aug 24.

Intravenous immunoglobulin for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and meta-analysis

Kathryn Gaebel, Gord Blackhouse, Kaitryn Campbell, Diana Robertson, Feng Xie, Nazila Assasi, Colin Chalk, Mitchell Levine, Ron Goeree

Intravenous immunoglobulin for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and meta-analysis

Kathryn Gaebel et al. Open Med. 2010.

Abstract

Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired immune-mediated inflammatory disorder that targets the myelin sheaths of the peripheral nervous system. Intravenous immunoglobulin (IVIg) is a blood product containing immunoglobulin G pooled from many human donors. In fall 2008, CIDP became an approved indication for IVIg in the United States and Canada.

Objective: To evaluate the clinical effectiveness and safety of IVIg for the treatment of CIDP through a systematic review of published randomized controlled trials.

Methods: We searched the MEDLINE (1996-2009, including in-process and other non-indexed citations), Embase (1996-2009) and other databases through the Ovid interface. We applied a methodological filter to limit retrieval to controlled clinical trials, meta-analyses and systematic reviews, and health technology assessments. Retrieval was limited to studies involving humans, and no language restrictions were employed. We pooled extracted data to estimate the effect size of IVIg treatment based on the random-effects model.

Results: We identified 9 unique randomized controlled trials. Of these, 3 compared IVIg therapy with an active comparator (plasma exchange, plasma exchange using extracorporeal immunoadsorption, oral prednisolone, respectively); the other 6 trials had placebo controls. No incremental benefit was seen in terms of primary outcomes for comparisons of IVIg therapy and an active comparator. Data from 4 of the 6 placebo-controlled trials were included in a meta-analysis. A significant improvement in disability (i.e., reduction in disability score) was found, with a standardized mean difference of 0.65 (95% confidence interval [CI] 0.23 to 1.08) in favour of IVIg. A pooled analysis of the proportion of patients with a response to treatment, as defined by the investigators of each of the trials, resulted in a risk ratio of 2.74 (95% CI 1.80 to 4.15) favouring IVIg.

Interpretation: IVIg therapy was statistically superior to placebo in reducing disability and impairment among patients with CIDP. The effectiveness of IVIg was similar to that of the alternative treatment strategies of plasma exchange and oral prednisolone.

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Conflict of interest statement

Competing interests: Kathryn Gaebel has received funds from Abbott Laboratories Ltd. for a speaking engagement. Gord Blackhouse received funding from Eli Lilly Canada Inc. and GlaxoSmithKline Inc. for consulting. Colin Chalk received funding from Talecris Biotherapeutics Ltd., and he is the primary investigator in a multi-centre study funded by Baxter Canada. Mitchell Levine received funding from AstraZeneca Canada Inc., Eli Lilly Canada Inc., Pfizer Canada Inc. and Merck Frosst Canada Inc. He has acted as an expert witness for Novartis Pharmaceuticals Canada Inc. and for Wyeth Pharmaceuticals. He has also chaired the Expert Drug Committee for Health Canada. Ron Goeree was advisory board member to Janssen-Ortho Inc. and Hoffmann-La Roche Ltd. He has been a consultant for Eli Lilly Canada Inc.

Figures

Table 1
Table 1
Study characteristics
Figure 1
Figure 1
Flow diagram for reports selected for clinical review. RCT = randomized controlled trial
Figure 2
Figure 2
Forest plot showing the effect of intravenous immunoglobulin (IVIg) within each study and the overall pooled estimate, as standardized mean difference in disability score.
Figure 3
Figure 3
Forest plot for the pooled analysis of the proportion of patients with a response to treatment.
See this image and copyright information in PMC

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