Evidence map›Paper›PMID 30267385›Full record

ArticleCNS drugs2018

Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential.

Alexander Klistorner, Yi Chai, Letizia Leocani, Philipp Albrecht, Orhan Aktas, Helmut Butzkueven, Tjalf Ziemssen, Focke Ziemssen, Jette Frederiksen, Lei Xu and 2 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01721161 (A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
6.1field-weighted citation impact, top 3% 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.

NCT01721161 phase2completednot on this map

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis

TypeinterventionalSponsorBiogenRan2012 to 2014Enrolled82ConditionsAcute Optic NeuritisArmsBIIB033 (anti-LINGO-1 mAb), Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 49 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Observational
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Antibody Therapies for Progressive Multiple Sclerosis and for Promoting Repair.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  13. Review
  14. Article
  15. Remyelination Trials: Are We Expecting the Unexpected?Neurology(R) neuroimmunology & neuroinflammation · 2021
    Review
  16. Review
  17. Review
  18. Article
  19. Myelin Repair: From Animal Models to Humans.Frontiers in cellular neuroscience · 2021
    Review
  20. 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

12 authors at 8 institutions in 5 countries.

Alexander KlistornerDepartment of Ophthalmology, University of Sydney, Sydney, NSW, Australia.
Yi ChaiBiogen, Cambridge, MA, USA.
Letizia LeocaniNeurological Department and Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE), University Hospital-IRCCS San Raffaele, Milan, Italy.
Philipp AlbrechtDepartment of Neurology, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.
Orhan AktasDepartment of Neurology, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.
Helmut ButzkuevenDepartment of Neuroscience, Central Clinical School, Monash University Alfred Campus, Melbourne, VIC, Australia.
Tjalf ZiemssenMS Center Dresden, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden University of Technology, Dresden, Germany.
Focke ZiemssenCenter for Ophthalmology, Eberhard Karls University of Tübingen, Tübingen, Germany.
Jette FrederiksenDepartment of Neurology, Rigshospitalet Glostrup and University of Copenhagen, Copenhagen, Denmark.
Lei XuBiogen, Cambridge, MA, USA.
Diego CadavidBiogen, Cambridge, MA, USA. cadavid.diego@gmail.com.
RENEW MF-VEP Investigators
Heinrich Heine University Düsseldorf · DEBiogen (United States) · USMonash University · AUUniversity Hospital Carl Gustav Carus · DEUniversity of Copenhagen · DKThe University of Sydney · AUUniversity of Tübingen · DEVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultifocal visual evoked potential (MF-VEP) assesses a wider visual field than full-field VEP (FF-VEP) and potentially offers a more precise analysis of optic nerve injury and repair following optic neuritis. MF-VEP may offer advantages over FF-VEP as an endpoint in clinical trials of remyelinating therapies.

objectiveMF-VEP testing was used to study changes in visual pathways in 48% of RENEW [phase II, opicinumab (anti-LINGO-1; BIIB033) vs. placebo after first acute unilateral optic neuritis] participants.

methodsThis exploratory MF-VEP RENEW substudy compared mean outcomes at weeks 24 and 32 among participants in the intent-to-treat (ITT; n = 39; 72% female; mean age: 32.3 years) and per-protocol (PP; n = 31; 71% female; mean age: 32.2 years) populations in affected and fellow eye latency from fellow eye baseline latency and affected and fellow eye amplitude from their own baselines. Treatment differences were evaluated using analysis of covariance (week 24) and a mixed-effect model of repeated measures (week 32). Last observation carried forward was used to impute missing data at week 24.

resultsA trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32. Both treatment groups in the ITT population experienced partial recovery of amplitude in the affected eye at week 32. Notably, the mean change in fellow eye amplitude at weeks 24 and 32 was - 17.57 and - 31.41 nanovolts (nV) in placebo but only - 0.59 and 1.93 nV in the opicinumab group [differences at weeks 24 and 32: 16.98 nV (p = 0.050) and 33.33 nV (p < 0.01), respectively].

conclusionResults from this substudy showed advantages of MF-VEP over FF-VEP in multicenter studies of central nervous system reparative therapies and provide novel evidence that fellow eye visual pathway amplitude loss occurs after optic neuritis but can potentially be prevented by opicinumab treatment. REGISTRATION: ClinicalTrials.gov identifier NCT01721161.

Indexed as

Acute DiseaseAdultAntibodies, MonoclonalEvoked Potentials, VisualFemaleHumansImmunologic FactorsMaleOptic NeuritisPhotic StimulationTime FactorsVisual FieldsVisual PerceptionYoung AdultAntibodies, MonoclonalImmunologic Factorsopicinumab

Identifiers

PMID30267385
PMCPMC6280853
OpenAlexW2892802169

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.