Evidence map›Paper›PMID 41517964›Full record

Trial reportMuscle & nerve2026

Post Hoc, Sex-Specific Subgroup Analysis of Efgartigimod in Patients With Generalized Myasthenia Gravis From the ADAPT Trial: A Sex and Gender Equity in Research (SAGER) Guidelines Approach.

Sarah Hoffmann, Sihui Zhao, Filip Callewaert, Silke Schoppe, Csilla Rózsa, Jennifer Spillane

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Muscle & nerve, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03669588 (A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT03669588 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

TypeinterventionalSponsorargenxRan2018 to 2020Enrolled167ConditionsGeneralized Myasthenia GravisArmsARGX-113, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Sarah HoffmannDepartment of Neurology, Neuroscience Clinical Research Center (NCRC) and Integrated Myasthenia Gravis Center, Charité-Universitätsmedizin, Berlin, Germany.ORCID https://orcid.org/0000-0001-9549-2594
Sihui ZhaoArgenx, Ghent, Belgium.
Filip CallewaertArgenx, Ghent, Belgium.
Silke SchoppeArgenx, Ghent, Belgium.
Csilla RózsaDepartment of Neurology, Jahn Ferenc Dél-Pesti Hospital, Budapest, Hungary.
Jennifer SpillaneCentre for Neuromuscular Disease, National Hospital for Neurology and Neurosurgery Queen Square, University College London Hospitals (UCLH) National Health Service (NHS) Foundation Trust, London, UK.

Funding

Argenx
6 · The paper itself

Abstract

INTRODUCTION/

aimsSex-specific differences in myasthenia gravis (MG) are widely acknowledged, yet data on sex-based outcomes of MG treatment are scarce. In accordance with Sex and Gender Equity in Research guidelines, this post hoc analysis assessed potential sex-specific differences in treatment outcomes in acetylcholine receptor antibody-positive (AChR-Ab+) generalized (g)MG participants in the Phase 3 ADAPT trial (NCT03669588).

methodsParticipants received four once-weekly efgartigimod infusions (10 mg/kg) or placebo per cycle. Endpoints (primary: proportion of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders (Cycle 1); secondary: proportion of Quantitative Myasthenia Gravis (QMG) and early (Cycle 1) MG-ADL responders, and time with clinically meaningful improvements in MG-ADL score; additional: quality of life outcomes, pharmacodynamics) were assessed according to sex.

resultsFemales were younger (mean age: 42.9 vs. 54.8 years), more likely to have undergone thymectomy (65.1% [56/86] vs. 44.2% [19/43]), and had higher baseline QMG scores (16.3 vs. 14.3) compared with males. Efgartigimod demonstrated homogeneous effects between sexes, with no significant difference in proportions of MG-ADL (p = 0.7014), early (Cycle 1) MG-ADL (p = 1.00), or QMG responders (p = 0.1595). Improvements in quality-of-life assessments, rates of minimal symptom expression, and mean total immunoglobulin G reductions (Cycle 1) were greater with efgartigimod verso placebo in females and males. Efgartigimod was well tolerated, with similar safety profiles across sexes. DISCUSSION: In ADAPT, efgartigimod-treated female and male AChR-Ab+ gMG patients had similar efficacy and safety outcomes. These data provide valuable insight for clinicians, given the established sex differences in MG disease course and treatment responses.

trial registrationThe ADAPT trial is registered on ClinicalTrials.gov (NCT03669588).

Indexed as

Myasthenia GravisSex CharacteristicsActivities of Daily LivingAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeReceptors, CholinergicSex FactorsTreatment Effect HeterogeneityTreatment OutcomeReceptors, Cholinergicautoantibodiesefgartigimod alfagendergeneralized myasthenia gravisPhase 3 clinical trialsex differencestherapeutic response

Identifiers

PMID41517964
PMCPMC12969971

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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.