Evidence map›Paper›PMID 37103755›Full record

Trial reportJournal of neurology2023

Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension.

Andreas Meisel, Djillali Annane, Tuan Vu, Renato Mantegazza, Masahisa Katsuno, Rasha Aguzzi, Glen Frick, Laura Gault, James F Howard, CHAMPION MG Study Group

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03920293 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis), which is not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 2 pooled it
20.6field-weighted citation impact, top 1% 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.

NCT03920293 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2019 to 2023Enrolled175ConditionsGeneralized Myasthenia GravisArmsRavulizumab, Placebo
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 98 citations in OpenAlex.

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  14. 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
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5 more citing papers are in PubMed but not listed here.

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

10 authors at 7 institutions in 5 countries.

Andreas MeiselCharité Universitätsmedizin Berlin, Berlin, Germany. andreas.meisel@charite.de.ORCID http://orcid.org/0000-0001-7233-5342
Djillali AnnaneHôpital Raymond Poincaré, Garches, France.ORCID http://orcid.org/0000-0001-6805-8944
Tuan VuUniversity of South Florida Morsani College of Medicine, Tampa, FL, USA.ORCID http://orcid.org/0000-0003-0724-0210
Renato MantegazzaFondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.ORCID http://orcid.org/0000-0002-9810-5737
Masahisa KatsunoNagoya University Graduate School of Medicine, Nagoya, Japan.ORCID http://orcid.org/0000-0001-9453-9311
Rasha AguzziAlexion, AstraZeneca Rare Disease, Boston, MA, USA.ORCID http://orcid.org/0000-0002-8587-7105
Glen FrickAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
Laura GaultAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
James F HowardThe University of North Carolina, Chapel Hill, NC, USA.ORCID http://orcid.org/0000-0002-7136-8617
CHAMPION MG Study Group
Alexion Pharmaceuticals (United States) · USCharité - Universitätsmedizin Berlin · DEFondazione IRCCS Istituto Neurologico Carlo Besta · ITHôpital Raymond-Poincaré · FRNagoya University · JPUniversity of North Carolina at Chapel Hill · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRavulizumab demonstrated efficacy and an acceptable safety profile versus placebo in the randomized controlled period (RCP) of the phase 3 CHAMPION MG trial in patients with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis. We report an interim analysis of the ongoing open-label extension (OLE) designed to evaluate long-term treatment effects.

methodsFollowing completion of the 26-week RCP, patients could enter the OLE; patients who received ravulizumab in the RCP continued the drug; patients who previously received placebo switched to ravulizumab. Patients receive body-weight-based maintenance dosing of ravulizumab every 8 weeks. Efficacy endpoints up to 60 weeks included Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, with least-squares (LS) mean change and 95% confidence intervals (95% CI) reported.

resultsLong-term efficacy and safety in the OLE were analyzed in 161 and 169 patients, respectively. Improvements in all scores were maintained through 60 weeks in patients who received ravulizumab during the RCP; LS mean change from RCP baseline in MG-ADL score was - 4.0 (95% CI: - 4.8, - 3.1; p < 0.0001). Rapid (within 2 weeks) and sustained improvements occurred in patients previously receiving placebo; LS mean change in MG-ADL score from OLE baseline to Week 60 was - 1.7 (95% CI: - 2.7, - 0.8; p = 0.0007). Similar trends were seen in QMG scores. Ravulizumab treatment was associated with a decreased rate of clinical deterioration events compared with placebo. Ravulizumab was well tolerated; no meningococcal infections were reported.

conclusionFindings support the sustained efficacy and long-term safety of ravulizumab, administered every 8 weeks, in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis. CLINICALTRIALS: gov identifier: NCT03920293; EudraCT: 2018-003243-39.

Indexed as

Activities of Daily LivingMyasthenia GravisAdultAntibodies, Monoclonal, HumanizedAutoantibodiesHumansReceptors, CholinergicTreatment OutcomeAntibodies, Monoclonal, HumanizedAutoantibodiesravulizumabReceptors, CholinergicGeneralized myasthenia gravisLong-termOpen-labelRavulizumab

Identifiers

PMID37103755
PMCPMC10134722
OpenAlexW4367175027

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.