Evidence map›Paper›PMID 22703536›Full record

Trial reportJournal of neuroinflammation2012

Variability in detection and quantification of interferon β-1b-induced neutralizing antibodies.

Hans-Peter Hartung, Bernd Kieseier, Douglas S Goodin, Barry Gw Arnason, Giancarlo Comi, Stuart Cook, Massimo Filippi, Douglas R Jeffery, Ludwig Kappos, Timon Bogumil and 9 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of neuroinflammation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 17% 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

3 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  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

19 authors at 11 institutions in 6 countries.

Hans-Peter HartungHeinrich-Heine-Universität, Moorenstraße 5, Düsseldorf 40225, Germany. hans-peter.hartung@uni-duesseldorf.de
Bernd Kieseier
Douglas S Goodin
Barry Gw Arnason
Giancarlo Comi
Stuart Cook
Massimo Filippi
Douglas R Jeffery
Ludwig Kappos
Timon Bogumil
Brigitte Stemper
Rupert Sandbrink
Yukiko Nakada
Haruhiko Nakajima
Susanne Schwenke
Stephan Lehr
Jürgen Heubach
Christoph Pohl
Joachim Reischl
Bayer (Germany) · DEHeinrich Heine University Düsseldorf · DEMitsubishi Group (Japan) · JPSan Raffaele University of Rome · ITBayer (United States) · USBrain Research Foundation · USCornerstone University · USRutgers New Jersey Medical SchoolUniversity Hospital Bonn · DEUniversity Hospital of Basel · CHUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInterferon-beta (IFNB) therapy for multiple sclerosis can lead to the induction of neutralizing antibodies (NAbs) against IFNB. Various methods are used for detection and quantification of NAbs.

methodsBlood samples from 125 IFNB-1b-treated patients, which were tested NAb negative or NAb positive after conclusion of a clinical study, were retested three years after first being assessed in four different laboratories that offer routine NAb testing to practicing neurologists. The myxovirus protein A (MxA) induction assay, the cytopathic effect (CPE) assay (two laboratories), or the luciferase assay were used. Intra- and inter-laboratory agreement between assays with respect to NAb detection and NAb titer quantification were evaluated.

resultsHigh agreement for NAb detection (kappa coefficient, 0.86) and for titer levels was observed for the intra-laboratory comparison in the laboratory using the MxA induction assay performed three years ago and now. A similarly high agreement for NAb detection (kappa coefficient, 0.87) and for titer quantification was noted for the MxA assay of this laboratory with one of two laboratories using the CPE assay. All other inter-laboratory comparisons showed kappa values between 0.57 and 0.68 and remarkable differences in individual titer levels.

conclusionsThere are considerable differences in the detection and quantification of IFNB-induced NAbs among laboratories offering NAb testing for clinical practice using different assay methods. It is important that these differences are considered when interpreting NAb results for clinical decision-making and when developing general recommendations for potentially clinically meaningful NAb titer levels.

Indexed as

Adjuvants, ImmunologicAntibodies, NeutralizingClinical Laboratory TechniquesDose-Response Relationship, ImmunologicHumansInterferon-betaInterferon beta-1bObserver VariationAdjuvants, ImmunologicAntibodies, NeutralizingInterferon-betaInterferon beta-1b

Identifiers

PMID22703536
PMCPMC3403940
OpenAlexW2167187072

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Registered trials

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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.