Evidence map›Paper›PMID 39506903›Full record

Trial reportMuscle & nerve2025

Efficacy and safety of maintenance intravenous immunoglobulin in generalized myasthenia gravis patients with acetylcholine receptor antibodies: A multicenter, double-blind, placebo-controlled trial.

Vera Bril, Tomasz Berkowicz, Andrzej Szczudlik, Michael W Nicolle, Josef Bednarik, Petr Hon, Antanas Vaitkus, Tuan Vu, Csilla Rozsa, Tim Magnus and 15 more

Abstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Muscle & nerve, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Immunoglobulin for myasthenia gravis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. 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

25 authors.

Vera BrilToronto General Hospital, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-5805-4883
Tomasz BerkowiczIII Miejskie Centrum Medyczne im, Dr Karola Jonschera w Łodzi, Lodz, Poland.
Andrzej SzczudlikCentrum Neurologii Klinicznej, Krakow, Poland.
Michael W NicolleLondon Health Sciences Centre and Western University, London, Ontario, Canada.
Josef BednarikDepartment of Neurology, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Petr HonFakultni Nemocnice Ostrava, Neurologicka Klinika, Ostrava-Poruba, Czech Republic.
Antanas VaitkusDepartment of Neurology, Hospital of Lithuanian University of Health Sciences, Kaunas Clinics, Kaunas, Lithuania.
Tuan VuDepartment of Neurology, University of South Florida Morsani College of Medicine, Tampa, Florida, USA.ORCID https://orcid.org/0000-0003-0724-0210
Csilla RozsaJahn Ferenc Del-pesti Korhaz es Rendelointezet Neurologiai Osztaly, Budapest, Hungary.
Tim MagnusUniversitaetsklinikum Hamburg Eppendorf, Klinik und Poliklinik fuer Neurologie, Neurologische Studienzentrale, Hamburg, Germany.
Gyula PanczelDepartment of Neurology, Flór Ferenc County Hospital, Kistarcsa, Hungary.
Toomas ToomsooEast Tallinn Central Hospital, Tallinn, Estonia.
Mamatha PasnoorDepartment of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA.
Tahseen MozaffarUniversity of California, Irvine, Orange, California, USA.ORCID https://orcid.org/0000-0002-1230-0188
Miriam FreimerDepartment of Neurology, The Ohio State University, Columbus, Ohio, USA.
Ulrike ReunerDepartment of Neurology, University Clinic Dresden, Technische Universität Dresden, Dresden, Germany.
László VécseiDepartment of Neurology, Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged, Hungary.
Nizar SouayahDepartment of Neurology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.
Todd LevineHonor Health Neurology, Scottsdale, Arizona, USA.
Robert M PascuzziIndiana School of Medicine, Indianapolis, Indiana, USA.
Marinos C DalakasDepartment of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Michael RivnerNeurology/EMG Laboratory, Augusta University, Augusta, Georgia, USA.
Rhonda GriffinGrifols Bioscience Research Group, Research Triangle Park, North Carolina, USA.
Montse Querolt CollGrifols Bioscience Research Group, Sant Cugat, Spain.
Elsa MondouGrifols Bioscience Research Group, Research Triangle Park, North Carolina, USA.

Funding

Grifols Therapeutics LLC
6 · The paper itself

Abstract

INTRODUCTION/

aimsProspective, randomized, controlled trials of intravenous immunoglobulin (IVIG) maintenance therapy in myasthenia gravis (MG) are lacking. In this trial, we evaluated the safety and efficacy of caprylate/chromatography-purified IVIG; (IGIV-C) in patients with generalized MG undergoing standard care.

methodsSixty-two patients enrolled in this phase 2, multicenter, international, randomized trial (1:1 IGIV-C [2 g/kg loading dose; 1 g/kg every 3 weeks through week 21] or placebo). Efficacy was assessed by changes in Quantitative MG (QMG) score at week 24 versus baseline (primary endpoint) and percentage of patients with clinical improvement in QMG, MG Composite (MGC), and MG-Activities of Daily Living (MG-ADL) scores (secondary endpoints). Safety assessments reported all adverse events (AEs).

resultsThe change in QMG at 24 weeks was -5.1 for IGIV-C and -3.1 for placebo (p = .187). Seventy percent of patients in the IGIV-C group had improvement in MG-ADL (≥2-point decrease) versus 40.6% in the placebo group (p = .025). Patients showing clinical improvement in QMG and MGC (≥3-point decrease) were 70.0% for IGIV-C versus 59.4% for placebo (p = .442) and 60.0% for IGIV-C versus 53.1% for placebo (p = .610). IGIV-C was well tolerated; serious AEs were similar between arms. Three of four MG exacerbations requiring hospitalizations occurred in the IGIV-C arm with one death. DISCUSSION: Several efficacy parameters showed numerical results greater than those seen in the placebo group. This was a small study and may have been underpowered to see significant differences. Additional studies may be warranted to fully determine the efficacy of IVIG maintenance therapy in MG.

Indexed as

Immunoglobulins, IntravenousMyasthenia GravisReceptors, CholinergicActivities of Daily LivingAdultAgedAutoantibodiesDouble-Blind MethodFemaleHumansImmunologic FactorsMaleMiddle AgedProspective StudiesTreatment OutcomeAutoantibodiesImmunoglobulins, IntravenousImmunologic FactorsReceptors, Cholinergicautoimmune diseaseintravenous immunoglobulinmyasthenia gravisneuromuscular disease

Identifiers

PMID39506903
PMCPMC11632570

What OpenQuestion holds

Textmetadata
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.