Evidence map›Paper›PMID 22183938›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2012

Predictive nature of IgM anti-α-glucose serum biomarker for relapse activity and EDSS progression in CIS patients: a BENEFIT study analysis.

M S Freedman, C Metzig, L Kappos, C H Polman, G Edan, H-P Hartung, D H Miller, X Montalban, J Yarden, L Spector and 6 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00185211 (Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.8field-weighted citation impact, top 16% 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.

NCT00185211 phase3completednot on this map

Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.

TypeinterventionalSponsorBayerRan2002 to 2008Enrolled468ConditionsMultiple SclerosisArmsInterferon beta-1b (Betaseron, BAY86-5046)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 13 citations in OpenAlex.

  1. gMS-Classifier1 does not predict disability progression in multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2019
    Article
  2. Review
  3. Article
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

16 authors at 8 institutions in 7 countries.

M S FreedmanMultiple Sclerosis Research Clinic, The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada. mfreedman@toh.on.ca
C Metzig
L Kappos
C H Polman
G Edan
H-P Hartung
D H Miller
X Montalban
J Yarden
L Spector
E Fire
N Dotan
S Schwenke
V Lanius
R Sandbrink
C Pohl
Bayer (Germany) · DEHeinrich Heine University Düsseldorf · DEClinique de l'Yvette · FROttawa Hospital · CAUniversity College London · GBUniversity Hospital of Basel · CHVall d'Hebron Hospital Universitari · ESVrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigher serum levels of at least one of a panel of four α-glucose IgM antibodies (gMS-Classifier1) in clinically isolated syndrome (CIS) patients are associated with imminent early relapse within 2 years.

objectiveThe objective of this study was to determine the prognostic value of gMS-Classifier1 in a large study cohort of CIS patients.

methodsThe BEtaseron(®) in Newly Emerging multiple sclerosis For Initial Treatment (BENEFIT) 5-year study was designed to evaluate the impact of early versus delayed interferon-β-1b (IFNβ-1b; Betaseron(®)) treatment in patients with a first event suggestive of multiple sclerosis (MS). Patients (n = 258, 61% of total) with a minimum of 2 ml baseline serum were eligible for the biomarker study. gMS-Classifier1 antibodies' panel (anti-GAGA2, anti-GAGA3, anti-GAGA4 and anti-GAGA6) levels were measured blinded to clinical data. Subjects were classified as either 'positive' or 'negative' according to a classification rule.

resultsgMS-Classifier1 was not predictive for the time to clinically definite MS or time to MS according to the revised McDonald's criteria, but did significantly predict an increased risk for confirmed disability progression (log-rank test: p = 0.012).

conclusionsWe could not confirm previous results that gMS-Classifier1 can predict early conversion to MS in CIS. However, raised titres of these antibodies may predict early disability progression in this patient population.

Indexed as

AdolescentAdultAutoantibodiesAutoantigensBiomarkersDemyelinating DiseasesDisease ProgressionFemaleGlucoseHumansImmunoglobulin MImmunologic FactorsInterferon-betaMaleMiddle AgedPrognosisAutoantibodiesAutoantigensBiomarkersGlucoseImmunoglobulin MImmunologic FactorsInterferon-beta

Identifiers

PMID22183938
PMCPMC3546632
OpenAlexW2120619359

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.