Evidence map›Paper›PMID 34595983›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022

Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial.

Mary Rensel, Aram Zabeti, Maureen A Mealy, Daniel Cimbora, Dewei She, Jorn Drappa, Eliezer Katz

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

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07010302 (A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT07010302 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

TypeinterventionalSponsorMassachusetts General HospitalRan2026 to 2030Enrolled540ConditionsNMOSDArmsRituximab (R), Eculizumab (Soliris®), Ravulizumab, Satralizumab, Inebilizumab
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Sequelae of B-Cell Depleting Therapy: An Immunologist's Perspective.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    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

7 authors at 3 institutions in 1 country.

Mary RenselMellen Center for Multiple Sclerosis, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.ORCID 0000-0001-9613-8394
Aram ZabetiUniversity of Cincinnati, Cincinnati, OH, USA.
Maureen A MealyHorizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).ORCID 0000-0001-8967-6338
Daniel CimboraHorizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).
Dewei SheHorizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).
Jorn DrappaHorizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).
Eliezer KatzHorizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).
Horizon Therapeutics (United States) · USCleveland Clinic · USUniversity of Cincinnati · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEfficacy and safety of inebilizumab for treatment of neuromyelitis optica spectrum disorder in adults seropositive for aquaporin-4 (AQP4)-immunoglobulin (Ig) G were demonstrated in the 28-week randomized controlled period of the N-MOmentum study.

objectiveTo assess efficacy and safety of long-term inebilizumab treatment.

methodsPost hoc analysis was performed in 75 AQP4-IgG-seropositive participants receiving inebilizumab for ⩾4 years in the randomized controlled period and open-label extension of the N-MOmentum study.

resultsEighteen attacks occurred in 13 participants during inebilizumab treatment (annualized attack rate, 0.052 attacks/person-year). Twelve attacks occurred during the first year of treatment, and two each occurred in years 2-4. Disability scores remained stable throughout ⩾4 years of treatment. Inebilizumab was well tolerated, with two (2.7%) serious treatment-emergent adverse events related to inebilizumab and no deaths. Immunoglobulin G levels decreased over time; however, correlation between severe infections and low IgG levels could not be determined because of their small numbers.

conclusionThese results from the N-MOmentum study continue to support use of inebilizumab for treatment of neuromyelitis optica spectrum disorder. Furthermore, the findings suggest that efficacy of inebilizumab may be enhanced after the first year of treatment, warranting additional long-term investigation.

Indexed as

Antibodies, Monoclonal, HumanizedNeuromyelitis OpticaAdultAquaporin 4AutoantibodiesHumansImmunoglobulin GAntibodies, Monoclonal, HumanizedAquaporin 4AutoantibodiesImmunoglobulin GinebilizumabAnti-CD19 monoclonal antibodyneuromyelitis optica spectrum disorderoptic neuritistransverse myelitis

Identifiers

PMID34595983
PMCPMC9024030
OpenAlexW3202874702

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.