Evidence map›Paper›PMID 33538237›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2021

Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD.

Bruce Ac Cree, Jeffrey L Bennett, Ho Jin Kim, Brian G Weinshenker, Sean J Pittock, Dean Wingerchuk, Kazuo Fujihara, Friedemann Paul, Gary R Cutter, Romain Marignier and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02200770 (A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT02200770 phase2 / phase3completednot on this map

A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

TypeinterventionalSponsorMedImmune LLCRan2015 to 2020Enrolled231ConditionsNeuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersArmsInebilizumab, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis.International journal of molecular sciences · 2022
    Review
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

20 authors at 10 institutions in 6 countries.

Bruce Ac CreeDepartment of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0001-7689-2533
Jeffrey L BennettUniversity of Colorado School of Medicine, Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.
Ho Jin KimResearch Institute and Hospital of National Cancer Center, Goyang, South Korea.ORCID 0000-0002-8672-8419
Brian G WeinshenkerMayo Clinic, Rochester, MN, USA.
Sean J PittockMayo Clinic, Rochester, MN, USA.ORCID 0000-0002-8387-6491
Dean WingerchukMayo Clinic, Scottsdale, AZ, USA.
Kazuo FujiharaDepartment of Multiple Sclerosis Therapeutics, Fukushima Medical University, Fukushima, Japan/Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan.
Friedemann PaulExperimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine, Berlin, Germany/Charité-Universitätsmedizin Berlin, Berlin, Germany.
Gary R CutterUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Romain MarignierService de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuroinflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon, France.
Ari J GreenDepartment of Neurology and Department of Ophthalmology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.
Orhan AktasMedical Faculty, Heinrich Heine University, Düsseldorf, Germany.
Hans-Peter HartungMedical Faculty, Heinrich Heine University, Düsseldorf, Germany.
Ian M WilliamsOxford PharmaGenesis Ltd, Oxford, UK.
Jorn DrappaViela Bio, Gaithersburg, MD, USA.
Dewei SheViela Bio, Gaithersburg, MD, USA.
Daniel CimboraViela Bio, Gaithersburg, MD, USA.
William ReesViela Bio, Gaithersburg, MD, USA.
John N RatchfordViela Bio, Gaithersburg, MD, USA.
Eliezer KatzViela Bio, Gaithersburg, MD, USA.
Mayo Clinic in Arizona · USHeinrich Heine University Düsseldorf · DEUniversity of California, San Francisco · USFukushima Medical University · JPHospices Civils de Lyon · FRMax Delbrück Center · DENational Cancer Center · KROxford Instruments (United Kingdom) · GBUniversity of Alabama at Birmingham · USUniversity of Colorado Anschutz Medical Campus · US

Funding

Humoral Immunity, Astrocyte Injury, and Demyelination in Neuromyelitis OpticaR01EY022936 · NEI · UNIVERSITY OF COLORADO DENVER · PI BENNETT, JEFFREY L · 2013 to 2022
$3.8M
NEI NIH HHS R01 EY022936
6 · The paper itself

Abstract

backgroundIn the N-MOmentum trial, the risk of an adjudicated neuromyelitis optica spectrum disorder (NMOSD) attack was significantly reduced with inebilizumab compared with placebo.

objectiveTo demonstrate the robustness of this finding, using pre-specified sensitivity and subgroup analyses.

methodsN-MOmentum is a prospective, randomized, placebo-controlled, double-masked trial of inebilizumab, an anti-CD19 monoclonal B-cell-depleting antibody, in patients with NMOSD. Pre-planned and

resultsIn the N-MOmentum trial (ClinicalTrials.gov: NCT02200770), 174 participants received inebilizumab and 56 received placebo. Attack risk for inebilizumab versus placebo was consistently and significantly reduced, regardless of attack definition, type of attack, baseline disability, ethnicity, treatment history, or disease course (all with hazard ratios < 0.4 favoring inebilizumab,

conclusionN-MOmentum demonstrated that inebilizumab provides a robust reduction in the risk of NMOSD attacks regardless of attack evaluation method, attack type, patient demographics, or previous therapy.The N-MOmentum study is registered at ClinicalTrials.gov: NCT2200770.

Indexed as

Neuromyelitis OpticaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAquaporin 4HumansProspective StudiesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAquaporin 4inebilizumabAttack riskclinical trialDevic’s diseaseinebilizumabneuromyelitis opticaneuromyelitis optica spectrum disorderpatient demographicssensitivity analyses

Identifiers

PMID33538237
PMCPMC8564264
OpenAlexW3128929230

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.