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Randomized Controlled Trial
. 2013 Jun 11;80(24):2217-25.
doi: 10.1212/WNL.0b013e318296e92b. Epub 2013 May 10.

Placebo-controlled trial of rituximab in IgM anti-myelin-associated glycoprotein neuropathy

Jean-Marc Léger  1 , Karine Viala, Guillaume Nicolas, Alain Créange, Jean-Michel Vallat, Jean Pouget, Pierre Clavelou, Christophe Vial, Andreas Steck, Lucile Musset, Benoit Marin; RIMAG Study Group (France and Switzerland)
Collaborators, Affiliations
Randomized Controlled Trial

Placebo-controlled trial of rituximab in IgM anti-myelin-associated glycoprotein neuropathy

Jean-Marc Léger et al. Neurology. .

Abstract

Objective: To determine whether rituximab 375 mg/m(2) was efficacious in patients with immunoglobulin M (IgM) anti-myelin-associated glycoprotein antibody demyelinating neuropathy (IgM anti-MAG demyelinating neuropathy).

Methods: Fifty-four patients with IgM anti-MAG demyelinating neuropathy were enrolled in this randomized, double-blind, placebo-controlled trial. The inclusion criteria were inflammatory neuropathy cause and treatment (INCAT) sensory score (ISS) ≥4 and visual analog pain scale >4 or ataxia score ≥2. The primary outcome was mean change in ISS at 12 months.

Results: Twenty-six patients were randomized to a group receiving 4 weekly infusions of 375 mg/m(2) rituximab, and 28 patients to placebo. Intention-to-treat analysis, with imputation of missing ISS values by the last observation carried forward method, showed a lack of mean change in ISS at 12 months, 1.0 ± 2.7 in the rituximab group, and 1.0 ± 2.8 in the placebo group. However, changes were observed, in per protocol analysis at 12 months, for the number of patients with an improvement of at least 2 points in the INCAT disability scale (p = 0.027), the self-evaluation scale (p = 0.016), and 2 subscores of the Short Form-36 questionnaire.

Conclusions: Although primary outcome measures provide no evidence to support the use of rituximab in IgM anti-MAG demyelinating neuropathy, there were improvements in several secondary outcomes in per protocol analysis.

Level of evidence: This study provides Class I evidence that rituximab is ineffective in improving ISS in patients with IgM anti-MAG demyelinating neuropathy.

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Figures

Figure
Figure. Schematic design of the trial
See this image and copyright information in PMC

References

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