Evidence map›Paper›PMID 23667063›Full record

Trial reportNeurology2013

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

Jean-Marc Léger, Karine Viala, Guillaume Nicolas, Alain Créange, Jean-Michel Vallat, Jean Pouget, Pierre Clavelou, Christophe Vial, Andreas Steck, Lucile Musset and 2 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 5 pooled it
12.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 5 syntheses or guidelines pooled it, 198 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Frequency and Relevance of MYD88European journal of neurology · 2025
    Article
  14. Update on paraproteinemic neuropathy.Current neurology and neuroscience reports · 2025
    Review
  15. Article
  16. Article
  17. The Role of Complement Activation in IgM M-Protein-Associated Neuropathies.Neurology(R) neuroimmunology & neuroinflammation · 2025
    Article
  18. Article
  19. Monoclonal Gammopathy-Associated Neuropathy.Current hematologic malignancy reports · 2024
    Review
  20. Neurological manifestations of MGUS.Hematology. American Society of Hematology. Education Program · 2024
    Review

7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 2 countries.

Jean-Marc LégerDepartment of Neurology, University Hospital Pitié-Salpêtrière, Paris, France. jean-marc.leger@psl.aphp.fr
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)
Université Clermont Auvergne · FRUniversité d'Angers · FRHôpital de la Timone · FRHôpital Dupuytren · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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).

methodsFifty-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.

resultsTwenty-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.

conclusionsAlthough 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.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedDemyelinating DiseasesDouble-Blind MethodFemaleFollow-Up StudiesHumansImmunoglobulin MMaleMiddle AgedMyelin-Associated GlycoproteinPolyneuropathiesRituximabAntibodies, Monoclonal, Murine-DerivedImmunoglobulin MMyelin-Associated GlycoproteinRituximab

Identifiers

PMID23667063
PMCPMC3721095
OpenAlexW1998990397

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.