Evidence map›Paper›PMID 40241307›Full record

Trial reportEuropean journal of neurology2025

Long-Term Efficacy and Safety of Ravulizumab in Adults With Anti-Acetylcholine Receptor Antibody-Positive Generalized Myasthenia Gravis: Final Results From the Phase 3 CHAMPION MG Open-Label Extension.

Tuan H Vu, Renato Mantegazza, Djillali Annane, Masahisa Katsuno, Andreas Meisel, Michael W Nicolle, Vera Bril, Rasha Aguzzi, Glen Frick, James F Howard and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 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

24 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  11. The role and mechanism of IL‑35 in myasthenia gravis (Review).International journal of molecular medicine · 2026
    Review
  12. Italian recommendations for the diagnosis and treatment of myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Article
  13. Review
  14. Review
  15. Article
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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

11 authors.

Tuan H VuUniversity of South Florida Morsani College of Medicine, Tampa, Florida, USA.
Renato MantegazzaFondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.
Djillali AnnaneHôpital Raymond Poincaré, Garches, University Paris Saclay-UVSQ, Garches, France.
Masahisa KatsunoNagoya University Graduate School of Medicine, Nagoya, Japan.ORCID https://orcid.org/0000-0001-9453-9311
Andreas MeiselCharité Universitätsmedizin Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0001-7233-5342
Michael W NicolleLondon Health Sciences Centre, London, Ontario, Canada.
Vera BrilEllen & Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-5805-4883
Rasha AguzziAlexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Glen FrickAlexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
James F HowardThe University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.ORCID https://orcid.org/0000-0002-7136-8617
CHAMPION MG Study Group

Funding

Alexion, AstraZeneca Rare Disease
6 · The paper itself

Abstract

backgroundRavulizumab, an anti-complement C5 monoclonal antibody, was efficacious with acceptable safety in the randomized controlled period (RCP) and interim open-label extension (OLE) periods of the CHAMPION MG phase 3 trial in adults with anti-acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis (gMG). Here, we report final results from the OLE.

methodsPatients who completed the 26-week RCP could enter the OLE and receive ravulizumab for up to 4 years. Efficacy and safety were assessed throughout the OLE.

resultsAmong all ravulizumab-treated patients (n = 169; median [range] ravulizumab treatment, 759.0 [14.0, 1265.0] days), 161 entered the OLE (ravulizumab-ravulizumab: n = 78; placebo-ravulizumab: n = 83). Sustained improvements were observed in Myasthenia Gravis Activities of Daily Living (MG-ADL) total scores (ravulizumab-ravulizumab, least squares mean [95% CI] change from RCP baseline at week 164: -4.0 [-5.3, -2.8]; p < 0.0001; placebo-ravulizumab, change from OLE baseline after 138 weeks of treatment: -2.1 [-3.3, -0.9]; p = 0.0005). One hundred and forty-one out of 160 (88.1%) patients achieved a ≥ 2-point improvement in MG-ADL total score, and 59/141 (41.8%) achieved a score of 0 or 1; once achieved, 32/59 (54.2%) sustained this status for > 50% of their remaining time in the study. Similar improvements were observed in Quantitative Myasthenia Gravis and Myasthenia Gravis Quality of Life-15 revised scores, and Neurological Quality of Life Fatigue subscale scores. Clinical deterioration event rates were reduced in the OLE versus placebo in the RCP. Corticosteroid usage was reduced in the OLE. Ravulizumab was well tolerated; no meningococcal infections were reported.

conclusionRavulizumab demonstrated clinically meaningful and durable efficacy and safety in adults with AChR-Ab+ gMG.

Indexed as

Antibodies, Monoclonal, HumanizedAutoantibodiesMyasthenia GravisReceptors, CholinergicAdultAgedClinical Trials, Phase III as TopicDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAutoantibodiesravulizumabReceptors, CholinergicC5ITeculizumabgeneralized myasthenia gravisgMGravulizumab

Identifiers

PMID40241307
PMCPMC12003558

What Socratic 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 Socratic graph.