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.
RCT Entities:
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.
Authors: Giancarlo Comi; Luisa Roveri; Antony Swan; Hugh Willison; Martin Bojar; Isabel Illa; Clementine Karageorgiou; Eduardo Nobile-Orazio; Peter van den Bergh; Tony Swan; Richard Hughes; Jaques Aubry; Nicole Baumann; Robert Hadden; Michael Lunn; Martin Knapp; Jean-Marc Léger; Pierre Bouche; Radim Mazanec; Nicoletta Meucci; Frans van der Meché; Klaus Toyka Journal: J Neurol Date: 2002-10 Impact factor: 4.849
Authors: R Hughes; S Bensa; H Willison; P Van den Bergh; G Comi; I Illa; E Nobile-Orazio; P van Doorn; M Dalakas; M Bojar; A Swan Journal: Ann Neurol Date: 2001-08 Impact factor: 10.422
Authors: A Pestronk; J Florence; T Miller; R Choksi; M T Al-Lozi; T D Levine Journal: J Neurol Neurosurg Psychiatry Date: 2003-04 Impact factor: 10.154
Authors: Meletios A Dimopoulos; Efstathios Kastritis; Roger G Owen; Robert A Kyle; Ola Landgren; Enrica Morra; Xavier Leleu; Ramón García-Sanz; Nikhil Munshi; Kenneth C Anderson; Evangelos Terpos; Irene M Ghobrial; Pierre Morel; David Maloney; Mathias Rummel; Véronique Leblond; Ranjana H Advani; Morie A Gertz; Charalampia Kyriakou; Sheeba K Thomas; Bart Barlogie; Stephanie A Gregory; Eva Kimby; Giampaolo Merlini; Steven P Treon Journal: Blood Date: 2014-07-15 Impact factor: 22.113