ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis

ObjectiveThis phase 3b, open-label, randomized ADAPT NXT study investigated the efficacy, safety, and tolerability of efgartigimod administered in either a fixed cycles dosing regimen (3 cycles of 4 once-weekly infusions, with 4 weeks between cycles) or a cycle followed by every-other-week (Q2W) dos...

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Autores: Habib, AA, Claeys, KG, Bril, V, Hussain, Y, Gwathmey, K, Sahagian, G, Cortés-Vicente, E, Brauer, E, Gelinas, D, Sumbul, A, Jimenez, RH, Hristova, D, Masschaele, D, Mantegazza, R, Meisel, A, Attarian, S
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p20008
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=20008
Access Level:acceso abierto
Palabra clave:efgartigimod
generalized myasthenia gravis
myasthenia gravis activities of daily living
neonatal Fc receptor
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spelling ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia GravisHabib, AAClaeys, KGBril, VHussain, YGwathmey, KSahagian, GCortés-Vicente, EBrauer, EGelinas, DSumbul, AJimenez, RHHristova, DMasschaele, DMantegazza, RMeisel, AAttarian, Sefgartigimodgeneralized myasthenia gravismyasthenia gravis activities of daily livingneonatal Fc receptorObjectiveThis phase 3b, open-label, randomized ADAPT NXT study investigated the efficacy, safety, and tolerability of efgartigimod administered in either a fixed cycles dosing regimen (3 cycles of 4 once-weekly infusions, with 4 weeks between cycles) or a cycle followed by every-other-week (Q2W) dosing.MethodsAdult participants with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG) were randomized 3:1 to Q2W or fixed cycles dosing of efgartigimod (10 mg/kg intravenously) for 21 weeks. The primary endpoint was the mean change from baseline in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score averaged across 21 weeks.ResultsSixty-nine participants were treated (fixed cycles, n = 17; Q2W, n = 52). Least squares (LS) mean (95% CI) of the change from baseline in MG-ADL total score from Weeks 1 to 21 was -5.1 (-6.5 to -3.8) in the fixed cycles arm and -4.6 (-5.4 to -3.8) in the Q2W arm. Clinical improvements were observed in MG-ADL total scores as early as Week 1 and were maintained throughout the study. Achievement of minimal symptom expression (MG-ADL: 0-1) from Weeks 1 to 21 occurred in 47.1% (n = 8/17) and 44.2% (n = 23/52) of participants in the fixed cycles and Q2W arms, respectively. Efgartigimod was well tolerated; COVID-19, headache, and upper respiratory tract infection were the most common treatment-emergent adverse events.InterpretationEfgartigimod administered as either fixed cycles or Q2W dosing results in rapid, robust, and sustained clinically meaningful improvement. These results build upon previous studies and provide additional efgartigimod dosing approaches to achieve and sustain clinical efficacy in patients with gMG.WILEY2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=20008Annals of Clinical and Translational NeurologyISSN: 23289503reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p200082026-06-14T12:41:47Z
dc.title.none.fl_str_mv ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
title ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
spellingShingle ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
Habib, AA
efgartigimod
generalized myasthenia gravis
myasthenia gravis activities of daily living
neonatal Fc receptor
title_short ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
title_full ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
title_fullStr ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
title_full_unstemmed ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
title_sort ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis
dc.creator.none.fl_str_mv Habib, AA
Claeys, KG
Bril, V
Hussain, Y
Gwathmey, K
Sahagian, G
Cortés-Vicente, E
Brauer, E
Gelinas, D
Sumbul, A
Jimenez, RH
Hristova, D
Masschaele, D
Mantegazza, R
Meisel, A
Attarian, S
author Habib, AA
author_facet Habib, AA
Claeys, KG
Bril, V
Hussain, Y
Gwathmey, K
Sahagian, G
Cortés-Vicente, E
Brauer, E
Gelinas, D
Sumbul, A
Jimenez, RH
Hristova, D
Masschaele, D
Mantegazza, R
Meisel, A
Attarian, S
author_role author
author2 Claeys, KG
Bril, V
Hussain, Y
Gwathmey, K
Sahagian, G
Cortés-Vicente, E
Brauer, E
Gelinas, D
Sumbul, A
Jimenez, RH
Hristova, D
Masschaele, D
Mantegazza, R
Meisel, A
Attarian, S
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv efgartigimod
generalized myasthenia gravis
myasthenia gravis activities of daily living
neonatal Fc receptor
topic efgartigimod
generalized myasthenia gravis
myasthenia gravis activities of daily living
neonatal Fc receptor
description ObjectiveThis phase 3b, open-label, randomized ADAPT NXT study investigated the efficacy, safety, and tolerability of efgartigimod administered in either a fixed cycles dosing regimen (3 cycles of 4 once-weekly infusions, with 4 weeks between cycles) or a cycle followed by every-other-week (Q2W) dosing.MethodsAdult participants with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG) were randomized 3:1 to Q2W or fixed cycles dosing of efgartigimod (10 mg/kg intravenously) for 21 weeks. The primary endpoint was the mean change from baseline in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score averaged across 21 weeks.ResultsSixty-nine participants were treated (fixed cycles, n = 17; Q2W, n = 52). Least squares (LS) mean (95% CI) of the change from baseline in MG-ADL total score from Weeks 1 to 21 was -5.1 (-6.5 to -3.8) in the fixed cycles arm and -4.6 (-5.4 to -3.8) in the Q2W arm. Clinical improvements were observed in MG-ADL total scores as early as Week 1 and were maintained throughout the study. Achievement of minimal symptom expression (MG-ADL: 0-1) from Weeks 1 to 21 occurred in 47.1% (n = 8/17) and 44.2% (n = 23/52) of participants in the fixed cycles and Q2W arms, respectively. Efgartigimod was well tolerated; COVID-19, headache, and upper respiratory tract infection were the most common treatment-emergent adverse events.InterpretationEfgartigimod administered as either fixed cycles or Q2W dosing results in rapid, robust, and sustained clinically meaningful improvement. These results build upon previous studies and provide additional efgartigimod dosing approaches to achieve and sustain clinical efficacy in patients with gMG.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=20008
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=20008
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv Annals of Clinical and Translational Neurology
ISSN: 23289503
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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