Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials

Introduction: Lebrikizumab significantly reduced itch and itch interference on sleep in patients with moderate-to-severe atopic dermatitis (AD) at week 16 in two phase 3 trials. We investigated itch reduction and the efficacy of improving itch interference on sleep in lebrikizumab-treated patients o...

Descripción completa

Detalles Bibliográficos
Autores: Yosipovitch, Gil|||0000-0001-6303-1822, Lio, Peter|||0000-0001-7600-0152, Rosmarin, David, Serra Baldrich, Esther|||0000-0001-7603-0300, Carrascosa, José Manuel|||0000-0003-4266-0771, Crane, Heidi, Casillas, Marta|||0000-0002-6339-5279, Pierce, Evangeline|||0000-0002-8287-2835, Elmaraghy, Hany, Ständer, Sonja|||0000-0003-3612-7786, Legat, Franz Josef|||0000-0002-7785-4739, Bardolet, Laia, Zhong, Jinglin
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:dnet:uabarcelona_::0034c2fe8e1233c26c2578dcf8dfb6ad
Acceso en línea:https://ddd.uab.cat/record/328738
https://dx.doi.org/urn:doi:10.1159/000547142
Access Level:acceso abierto
Palabra clave:Atopic dermatitis
Itch
Patient-reported outcomes
Sleep loss
id ES_6a647ee3f86e269eb74dc1148cd9eeca
oai_identifier_str oai:dnet:uabarcelona_::0034c2fe8e1233c26c2578dcf8dfb6ad
network_acronym_str ES
network_name_str España
repository_id_str
spelling Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 TrialsYosipovitch, Gil|||0000-0001-6303-1822Lio, Peter|||0000-0001-7600-0152Rosmarin, DavidSerra Baldrich, Esther|||0000-0001-7603-0300Carrascosa, José Manuel|||0000-0003-4266-0771Crane, HeidiCasillas, Marta|||0000-0002-6339-5279Pierce, Evangeline|||0000-0002-8287-2835Elmaraghy, HanyStänder, Sonja|||0000-0003-3612-7786Legat, Franz Josef|||0000-0002-7785-4739Bardolet, LaiaZhong, JinglinAtopic dermatitisItchPatient-reported outcomesSleep lossIntroduction: Lebrikizumab significantly reduced itch and itch interference on sleep in patients with moderate-to-severe atopic dermatitis (AD) at week 16 in two phase 3 trials. We investigated itch reduction and the efficacy of improving itch interference on sleep in lebrikizumab-treated patients over 52 weeks. Methods: At week 16 in ADvocate1 and ADvocate2, patients who met protocol-defined response criteria to lebrikizumab 250 mg every 2 weeks (Q2W) were re-randomized 2:2:1 to lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W), or placebo Q2W to week 52; patients who did not achieve protocol-defined response continued open-label lebrikizumab Q2W. The Pruritus Numeric Rating Scale (NRS) evaluated the worst itch intensity over the previous 24 h in daily electronic diaries; the Sleep-Loss Scale measured the interference of itch on sleep over the last night. For week 16 responders, data after systemic rescue medication or discontinuation due to lack of efficacy were imputed with non-responder imputation; data after topical corticosteroid usage and discontinuation due to other reasons were set as missing; all missing data were imputed with multiple imputation. Descriptive statistics using observed data are reported for week 16 by non-responders. Results: At week 52 among patients who met week-16 protocol-defined response criteria, 73.4% and 71.8% receiving lebrikizumab Q4W and Q2W, respectively, reported ≥3-point improvement in the Pruritus NRS. Mean percent improvement from baseline to week 52 in the Pruritus NRS was 59.9% and 59.6% with lebrikizumab Q4W and Q2W, respectively. For patients who did not achieve a week-16 protocol-defined response, 73.3% achieved ≥3-point improvement on the Pruritus NRS at week 52, with mean percent improvement from baseline to week 52 of 59.2%. At week 52 in responders, ≥1-point improvement in the Sleep-Loss Scale was achieved by 77.9% and 78.9% of patients receiving lebrikizumab Q4W and Q2W, respectively, with a mean percent improvement from baseline to week 52 of 64.4% and 65.9%. For week-16 non-responders, 86.1% of patients achieved ≥1-point improvement in the Sleep-Loss Scale at week 52, with a mean percent improvement of 74.9%. Conclusion: These findings indicate that lebrikizumab is an effective AD treatment to reduce itch and improve sleep loss due to itch over the long term for both patients who did and did not meet protocol-defined response criteria at week 16.Universitat Autònoma de Barcelona. Departament de Medicina 22025-01-0120252025-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/328738https://dx.doi.org/urn:doi:10.1159/000547142reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:dnet:uabarcelona_::0034c2fe8e1233c26c2578dcf8dfb6ad2026-06-06T12:50:31Z
dc.title.none.fl_str_mv Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
title Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
spellingShingle Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
Yosipovitch, Gil|||0000-0001-6303-1822
Atopic dermatitis
Itch
Patient-reported outcomes
Sleep loss
title_short Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
title_full Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
title_fullStr Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
title_full_unstemmed Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
title_sort Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
dc.creator.none.fl_str_mv Yosipovitch, Gil|||0000-0001-6303-1822
Lio, Peter|||0000-0001-7600-0152
Rosmarin, David
Serra Baldrich, Esther|||0000-0001-7603-0300
Carrascosa, José Manuel|||0000-0003-4266-0771
Crane, Heidi
Casillas, Marta|||0000-0002-6339-5279
Pierce, Evangeline|||0000-0002-8287-2835
Elmaraghy, Hany
Ständer, Sonja|||0000-0003-3612-7786
Legat, Franz Josef|||0000-0002-7785-4739
Bardolet, Laia
Zhong, Jinglin
author Yosipovitch, Gil|||0000-0001-6303-1822
author_facet Yosipovitch, Gil|||0000-0001-6303-1822
Lio, Peter|||0000-0001-7600-0152
Rosmarin, David
Serra Baldrich, Esther|||0000-0001-7603-0300
Carrascosa, José Manuel|||0000-0003-4266-0771
Crane, Heidi
Casillas, Marta|||0000-0002-6339-5279
Pierce, Evangeline|||0000-0002-8287-2835
Elmaraghy, Hany
Ständer, Sonja|||0000-0003-3612-7786
Legat, Franz Josef|||0000-0002-7785-4739
Bardolet, Laia
Zhong, Jinglin
author_role author
author2 Lio, Peter|||0000-0001-7600-0152
Rosmarin, David
Serra Baldrich, Esther|||0000-0001-7603-0300
Carrascosa, José Manuel|||0000-0003-4266-0771
Crane, Heidi
Casillas, Marta|||0000-0002-6339-5279
Pierce, Evangeline|||0000-0002-8287-2835
Elmaraghy, Hany
Ständer, Sonja|||0000-0003-3612-7786
Legat, Franz Josef|||0000-0002-7785-4739
Bardolet, Laia
Zhong, Jinglin
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona. Departament de Medicina
dc.subject.none.fl_str_mv Atopic dermatitis
Itch
Patient-reported outcomes
Sleep loss
topic Atopic dermatitis
Itch
Patient-reported outcomes
Sleep loss
description Introduction: Lebrikizumab significantly reduced itch and itch interference on sleep in patients with moderate-to-severe atopic dermatitis (AD) at week 16 in two phase 3 trials. We investigated itch reduction and the efficacy of improving itch interference on sleep in lebrikizumab-treated patients over 52 weeks. Methods: At week 16 in ADvocate1 and ADvocate2, patients who met protocol-defined response criteria to lebrikizumab 250 mg every 2 weeks (Q2W) were re-randomized 2:2:1 to lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W), or placebo Q2W to week 52; patients who did not achieve protocol-defined response continued open-label lebrikizumab Q2W. The Pruritus Numeric Rating Scale (NRS) evaluated the worst itch intensity over the previous 24 h in daily electronic diaries; the Sleep-Loss Scale measured the interference of itch on sleep over the last night. For week 16 responders, data after systemic rescue medication or discontinuation due to lack of efficacy were imputed with non-responder imputation; data after topical corticosteroid usage and discontinuation due to other reasons were set as missing; all missing data were imputed with multiple imputation. Descriptive statistics using observed data are reported for week 16 by non-responders. Results: At week 52 among patients who met week-16 protocol-defined response criteria, 73.4% and 71.8% receiving lebrikizumab Q4W and Q2W, respectively, reported ≥3-point improvement in the Pruritus NRS. Mean percent improvement from baseline to week 52 in the Pruritus NRS was 59.9% and 59.6% with lebrikizumab Q4W and Q2W, respectively. For patients who did not achieve a week-16 protocol-defined response, 73.3% achieved ≥3-point improvement on the Pruritus NRS at week 52, with mean percent improvement from baseline to week 52 of 59.2%. At week 52 in responders, ≥1-point improvement in the Sleep-Loss Scale was achieved by 77.9% and 78.9% of patients receiving lebrikizumab Q4W and Q2W, respectively, with a mean percent improvement from baseline to week 52 of 64.4% and 65.9%. For week-16 non-responders, 86.1% of patients achieved ≥1-point improvement in the Sleep-Loss Scale at week 52, with a mean percent improvement of 74.9%. Conclusion: These findings indicate that lebrikizumab is an effective AD treatment to reduce itch and improve sleep loss due to itch over the long term for both patients who did and did not meet protocol-defined response criteria at week 16.
publishDate 2025
dc.date.none.fl_str_mv 2
2025-01-01
2025
2025-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/328738
https://dx.doi.org/urn:doi:10.1159/000547142
url https://ddd.uab.cat/record/328738
https://dx.doi.org/urn:doi:10.1159/000547142
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869410108679651328
score 15,812429

Similares en LA Referencia