Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose

Background: Dupilumab, a human monoclonal antibody, blocks the shared receptor component for interleukins-4/13, key and central drivers of type 2 inflammation. The TRAVERSE (NCT02134028) open-label extension study demonstrated the long-term safety and efficacy of dupilumab in patients >= 12 years...

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Autores: Pavord, ID, Bourdin, A, Papi, A, Domingo, C, Corren, J, Altincatal, A, Radwan, A, Pandit-Abid, N, Jacob-Nara, JA, Deniz, Y, Rowe, PJ, Laws, E, Lederer, DJ, Hardin, M
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p3703
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/3703
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85164700193&doi=10.1111%2fall.15792&partnerID=40&md5=a5648f344fc7070387791270cdd0a90a
Access Level:acceso abierto
Palabra clave:asthma control
exacerbations
inhaled corticosteroids
moderate-to-severe asthma
pre-bronchodilator FEV1
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spelling Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dosePavord, IDBourdin, APapi, ADomingo, CCorren, JAltincatal, ARadwan, APandit-Abid, NJacob-Nara, JADeniz, YRowe, PJLaws, ELederer, DJHardin, Masthma controlexacerbationsinhaled corticosteroidsmoderate-to-severe asthmapre-bronchodilator FEV1Background: Dupilumab, a human monoclonal antibody, blocks the shared receptor component for interleukins-4/13, key and central drivers of type 2 inflammation. The TRAVERSE (NCT02134028) open-label extension study demonstrated the long-term safety and efficacy of dupilumab in patients >= 12 years who completed a previous dupilumab asthma study. The safety profile was consistent with that observed in the parent studies. Here, we assess whether dupilumab sustains long-term efficacy in patients regardless of inhaled corticosteroid (ICS) dose at parent study baseline (PSBL). Methods: Patients from phase 2b (NCT01854047) or phase 3 (QUEST; NCT02414854) studies receiving high- or medium-dose ICS at PSBL and enrolled in TRAVERSE were included. We analyzed unadjusted annualized severe exacerbation rates, change from PSBL in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), 5-item asthma control questionnaire, and type 2 biomarkers in patients with type 2 asthma at baseline (blood eosinophils >= 150 cells/mu L or fractional exhaled nitric oxide [FeNO] >= 25 ppb), and subgroups defined by baseline blood eosinophils or FeNO. Results: Of patients with type 2 asthma (n = 1666), 891 (53.5%) were receiving high-dose ICS at PSBL. In this subgroup, unadjusted exacerbation rates for dupilumab versus placebo were 0.517 versus 1.883 (phase 2b) and 0.571 versus 1.300 (QUEST) over the parent study (52 weeks) and remained low throughout TRAVERSE (0.313-0.494). Improvements in pre-BD FEV1 were sustained throughout TRAVERSE. Similar clinical efficacy was observed among patients receiving medium-dose ICS at PSBL and biomarker subgroups. Conclusions: Dupilumab showed sustained efficacy for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 asthma on high-or medium-dose ICS.WILEY2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/3703https://www.scopus.com/inward/record.uri?eid=2-s2.0-85164700193&doi=10.1111%2fall.15792&partnerID=40&md5=a5648f344fc7070387791270cdd0a90aALLERGYISSN: 01054538ISSNe: 13989995reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p37032026-06-21T15:30:37Z
dc.title.none.fl_str_mv Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
title Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
spellingShingle Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
Pavord, ID
asthma control
exacerbations
inhaled corticosteroids
moderate-to-severe asthma
pre-bronchodilator FEV1
title_short Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
title_full Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
title_fullStr Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
title_full_unstemmed Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
title_sort Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
dc.creator.none.fl_str_mv Pavord, ID
Bourdin, A
Papi, A
Domingo, C
Corren, J
Altincatal, A
Radwan, A
Pandit-Abid, N
Jacob-Nara, JA
Deniz, Y
Rowe, PJ
Laws, E
Lederer, DJ
Hardin, M
author Pavord, ID
author_facet Pavord, ID
Bourdin, A
Papi, A
Domingo, C
Corren, J
Altincatal, A
Radwan, A
Pandit-Abid, N
Jacob-Nara, JA
Deniz, Y
Rowe, PJ
Laws, E
Lederer, DJ
Hardin, M
author_role author
author2 Bourdin, A
Papi, A
Domingo, C
Corren, J
Altincatal, A
Radwan, A
Pandit-Abid, N
Jacob-Nara, JA
Deniz, Y
Rowe, PJ
Laws, E
Lederer, DJ
Hardin, M
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv asthma control
exacerbations
inhaled corticosteroids
moderate-to-severe asthma
pre-bronchodilator FEV1
topic asthma control
exacerbations
inhaled corticosteroids
moderate-to-severe asthma
pre-bronchodilator FEV1
description Background: Dupilumab, a human monoclonal antibody, blocks the shared receptor component for interleukins-4/13, key and central drivers of type 2 inflammation. The TRAVERSE (NCT02134028) open-label extension study demonstrated the long-term safety and efficacy of dupilumab in patients >= 12 years who completed a previous dupilumab asthma study. The safety profile was consistent with that observed in the parent studies. Here, we assess whether dupilumab sustains long-term efficacy in patients regardless of inhaled corticosteroid (ICS) dose at parent study baseline (PSBL). Methods: Patients from phase 2b (NCT01854047) or phase 3 (QUEST; NCT02414854) studies receiving high- or medium-dose ICS at PSBL and enrolled in TRAVERSE were included. We analyzed unadjusted annualized severe exacerbation rates, change from PSBL in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), 5-item asthma control questionnaire, and type 2 biomarkers in patients with type 2 asthma at baseline (blood eosinophils >= 150 cells/mu L or fractional exhaled nitric oxide [FeNO] >= 25 ppb), and subgroups defined by baseline blood eosinophils or FeNO. Results: Of patients with type 2 asthma (n = 1666), 891 (53.5%) were receiving high-dose ICS at PSBL. In this subgroup, unadjusted exacerbation rates for dupilumab versus placebo were 0.517 versus 1.883 (phase 2b) and 0.571 versus 1.300 (QUEST) over the parent study (52 weeks) and remained low throughout TRAVERSE (0.313-0.494). Improvements in pre-BD FEV1 were sustained throughout TRAVERSE. Similar clinical efficacy was observed among patients receiving medium-dose ICS at PSBL and biomarker subgroups. Conclusions: Dupilumab showed sustained efficacy for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 asthma on high-or medium-dose ICS.
publishDate 2023
dc.date.none.fl_str_mv 2023
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://i3pt.portalinvestigacion.com/publicaciones/3703
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85164700193&doi=10.1111%2fall.15792&partnerID=40&md5=a5648f344fc7070387791270cdd0a90a
url https://i3pt.portalinvestigacion.com/publicaciones/3703
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85164700193&doi=10.1111%2fall.15792&partnerID=40&md5=a5648f344fc7070387791270cdd0a90a
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 ALLERGY
ISSN: 01054538
ISSNe: 13989995
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
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repository.mail.fl_str_mv
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