Dataset Information

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

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.

SUBMITTER: Leger JM

PROVIDER: S-EPMC3721095 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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

Léger Jean-Marc JM Viala Karine K Nicolas Guillaume G Créange Alain A Vallat Jean-Michel JM Pouget Jean J Clavelou Pierre P Vial Christophe C Steck Andreas A Musset Lucile L Marin Benoit B

Neurology 20130510 24

<h4>Objective</h4>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).<h4>Methods</h4>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 ...[more]

PMID: 23667063

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Dataset Information

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

Publications

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

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