Evidence map›Paper›PMID 32426038›Full record

ArticleTherapeutic advances in neurological disorders2020

Response to eculizumab in patients with myasthenia gravis recently treated with chronic IVIg: a subgroup analysis of REGAIN and its open-label extension study.

Saiju Jacob, Hiroyuki Murai, Kimiaki Utsugisawa, Richard J Nowak, Heinz Wiendl, Kenji P Fujita, Fanny O'Brien, James F Howard

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in neurological disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 15% 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.

NCT01997229 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2013 to 2016Enrolled125ConditionsRefractory Generalized Myasthenia GravisArmsEculizumab, Placebo
NCT02301624 phase3completednot on this map

A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2014 to 2019Enrolled117ConditionsRefractory Generalized Myasthenia GravisArmsEculizumab, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Novel Immunotherapies for Myasthenia Gravis.ImmunoTargets and therapy · 2023
    Review
  9. Role of complement in myasthenia gravis.Frontiers in neurology · 2023
    Review
  10. Anti-complement Agents for Autoimmune Neurological Disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  11. Review
  12. Review
  13. Eculizumab in myasthenia gravis: A review.Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological Society
    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

8 authors at 8 institutions in 4 countries.

Saiju JacobQueen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.ORCID https://orcid.org/0000-0003-0037-454X
Hiroyuki MuraiDepartment of Neurology, International University of Health and Welfare, Narita, Japan.
Kimiaki UtsugisawaDepartment of Neurology, Hanamaki General Hospital, Hanamaki, Japan.
Richard J NowakDepartment of Neurology, Yale University School of Medicine, New Haven, CT, USA.
Heinz WiendlDepartment of Neurology, University of Münster, Münster, Germany.ORCID https://orcid.org/0000-0003-4310-3432
Kenji P FujitaAlnylam Pharmaceuticals, Cambridge, MA, USA.
Fanny O'BrienAlexion Pharmaceuticals, Boston, MA, USA.
James F HowardDepartment of Neurology, University of North Carolina, Chapel Hill, NC, USA.
National Hospital Organization Hanamaki Hospital · JPInternational University of Health and Welfare · JPAlexion Pharmaceuticals (United States) · USAlnylam Pharmaceuticals (United States) · USUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Münster · DEUniversity of North Carolina at Chapel Hill · USYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase III eculizumab for refractory generalized myasthenia gravis REGAIN study [ClinicalTrials.gov identifier: NCT01997229] and its open-label extension (OLE) [ClinicalTrials.gov identifier: NCT02301624], patients with treatment-refractory antiacetylcholine receptor antibody-positive generalized myasthenia gravis had clinically meaningful improvements with eculizumab

methodsThe subgroup comprised patients who had received IVIg at least four times in 1 year, with at least one IVIg treatment cycle during the 6 months before the first REGAIN study dose. Data from REGAIN and the OLE were analyzed. Response to eculizumab

resultsThe subgroup had similar patient and disease characteristics as the overall REGAIN population. Clinical assessments showed sustained eculizumab efficacy during REGAIN and the OLE over 18 months. Patients receiving placebo in REGAIN experienced rapid improvements in assessment scores when treated with eculizumab in the OLE. There was a lower rate of disease exacerbations with eculizumab than with placebo during REGAIN, and eculizumab was well tolerated.

conclusionEculizumab treatment, compared with placebo, results in meaningful clinical improvements and fewer disease exacerbations for patients who previously received chronic IVIg.

trial registrationREGAIN [ClinicalTrials.gov identifier: NCT01997229]; REGAIN open-label extension [ClinicalTrials.gov identifier: NCT02301624].

Indexed as

eculizumabintravenous immunoglobulinIVIgmyasthenia gravisREGAIN

Identifiers

PMID32426038
PMCPMC7222230
OpenAlexW3021616230

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.