Evidence map›Paper›PMID 37282545›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2023

Attack adjudication in neuromyelitis optica spectrum disorder: Substantiation of criteria by magnetic resonance imaging and biomarkers in N-MOmentum.

Brian G Weinshenker, Dean M Wingerchuk, Ari J Green, Jeffrey L Bennett, Ho Jin Kim, Sean J Pittock, Kazuo Fujihara, Friedemann Paul, Gary Cutter, Romain Marignier and 9 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. 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 13 institutions in 7 countries.

Brian G WeinshenkerDepartment of Neurology, University of Virginia, Charlottesville, VA, USA.
Dean M WingerchukDepartment of Neurology, Mayo Clinic, Scottsdale, AZ, USA.
Ari J GreenUCSF Weill Institute for Neurosciences, Department of Neurology and Department of Ophthalmology, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0001-9275-3066
Jeffrey L BennettDepartments of Neurology and Ophthalmology, Programs in Neuroscience and Immunology, School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
Ho Jin KimDepartment of Neurology, Research Institute and Hospital of National Cancer Center, Goyang, South Korea.ORCID 0000-0002-8672-8419
Sean J PittockDepartment of Neurology, Center for Multiple Sclerosis and Autoimmune Neurology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-8387-6491
Kazuo FujiharaDepartment of Multiple Sclerosis Therapeutics, Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan.
Friedemann PaulClinical Neuroimmunology Department, Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Berlin, Germany.
Gary CutterDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Romain MarignierService de Neurologie Sclérose en Plaques, Pathologies de La Myéline et Neuro-Inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon, France.ORCID 0000-0002-5967-2800
Orhan AktasDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany/Brain and Mind Center, University of Sydney, Sydney, NSW, Australia/ Department of Neurology, Medical University Vienna, Vienna, Austria/ Department of Neurology, Palacký University Olomouc, Olomouc, Czech Republic.
Dewei SheHorizon Therapeutics plc, Gaithersburg, MD, USA.
Michael SmithHorizon Therapeutics plc, Gaithersburg, MD, USA.
William ReesHorizon Therapeutics plc, Gaithersburg, MD, USA.
Kristina PattersonHorizon Therapeutics plc, Gaithersburg, MD, USA.
Daniel CimboraHorizon Therapeutics plc, Gaithersburg, MD, USA.
Eliezer KatzHorizon Therapeutics plc, Gaithersburg, MD, USA.
Bruce Ac CreeDepartment of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0001-7689-2533
Horizon Therapeutics (United States) · USUniversity of California, San Francisco · USFukushima Medical University · JPHeinrich Heine University Düsseldorf · DEHospices Civils de Lyon · FRMax Delbrück Center · DEMayo Clinic · USMayo Clinic in Arizona · USNational Cancer Center · KRThe University of Sydney · AUUniversity of Alabama at Birmingham · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe N-MOmentum trial investigated safety and efficacy of inebilizumab in participants with neuromyelitis optica spectrum disorder (NMOSD).

objectiveEvaluate the attack identification process and adjudication committee (AC) performance in N-MOmentum.

methodsAdults (

resultsA total of 64 participant-reported neurological events occurred; 51 (80%) were investigator-determined to be attacks. The AC confirmed 43 of the investigator-determined attacks (84%). There was high inter- and intra-AC-member agreement. In 25/64 events (39%) and 14/43 AC-adjudicated attacks (33%), MRI was reviewed during adjudication. Retrospective analysis revealed new domain-specific T1 and T2 MRI lesions in 90% of adjudicated attacks. Increased mean sGFAP concentrations (>2-fold change) from baseline were observed in 56% of adjudicated attacks versus 14% of investigator-determined attacks rejected by the AC and 31% of participant-reported events determined not to be attacks.

conclusionAC adjudication of NMOSD attacks according to predefined criteria appears robust. MRI lesion correlates and sGFAP elevations were found in most adjudicated attacks.

Indexed as

Antibodies, Monoclonal, HumanizedNeuromyelitis OpticaBiomarkersGlial Fibrillary Acidic ProteinHumansMagnetic Resonance ImagingRetrospective StudiesAntibodies, Monoclonal, HumanizedBiomarkersGlial Fibrillary Acidic ProteininebilizumabBiomarkersGFAPinebilizumabmagnetic resonance imagingmyelitisneuromyelitis optica spectrum disorderoptic neuritisserum glial fibrillary acidic protein

Identifiers

PMID37282545
PMCPMC10338695
OpenAlexW4379599724

What OpenQuestion holds

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LicenceCC BY-NC
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.