Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.

BACKGROUND: Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy. OBJECTIVE: To evaluate the long-term safety and efficacy of risankizumab in patients with psoriasis. METHODS: LIMMitless is an ongoing phase 3, open-label extension study evaluating the long-term safety...

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Autores: Papp KA, Blauvelt A, Puig L, Ohtsuki M, Beissert S, Gooderham M, Amin AZ, Liu J, Wu T, Azam T, Stakias V, Espaillat R, Sinvhal R, Soliman AM, Pang Y, Chen MM, Lebwohl MG
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2023
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositório:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p17062
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17062
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85170410016&doi=10.1016%2fj.jaad.2023.07.1024&partnerID=40&md5=e7dcf6cafb2ea775fd57470c3ed80bdc
Access Level:Acceso aberto
Palavra-chave:interleukin 23
plaque psoriasis
psoriasis
risankizumab
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spelling Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.Papp KABlauvelt APuig LOhtsuki MBeissert SGooderham MAmin AZLiu JWu TAzam TStakias VEspaillat RSinvhal RSoliman AMPang YChen MMLebwohl MGinterleukin 23plaque psoriasispsoriasisrisankizumabBACKGROUND: Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy. OBJECTIVE: To evaluate the long-term safety and efficacy of risankizumab in patients with psoriasis. METHODS: LIMMitless is an ongoing phase 3, open-label extension study evaluating the long-term safety and efficacy of continuous risankizumab 150 mg every 12 weeks for adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. This interim analysis assessed safety (ie, monitored treatment-emergent adverse events [TEAEs]) through 304 weeks. Efficacy assessments included determining the proportion of patients who achieved =90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90/100), static Physician's Global Assessment of clear/almost clear (sPGA 0/1), and Dermatology Life Quality Index of no effect on patient's life (DLQI 0/1) through 256 weeks. RESULTS: Among 897 patients randomized to risankizumab in the base studies, 706 were still ongoing at data cutoff. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low. At week 256, 85.1%/52.3% of patients achieved PASI 90/100, respectively, 85.8% achieved sPGA 0/1, and 76.4% achieved DLQI 0/1. LIMITATIONS: Open-label study with no placebo or active-comparator group. CONCLUSIONS: Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.MOSBY-ELSEVIER2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17062https://www.scopus.com/inward/record.uri?eid=2-s2.0-85170410016&doi=10.1016%2fj.jaad.2023.07.1024&partnerID=40&md5=e7dcf6cafb2ea775fd57470c3ed80bdcJOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGYISSN: 01909622ISSNe: 10976787reponame: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:p170622026-06-14T12:41:47Z
dc.title.none.fl_str_mv Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
title Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
spellingShingle Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
Papp KA
interleukin 23
plaque psoriasis
psoriasis
risankizumab
title_short Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
title_full Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
title_fullStr Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
title_full_unstemmed Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
title_sort Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
dc.creator.none.fl_str_mv Papp KA
Blauvelt A
Puig L
Ohtsuki M
Beissert S
Gooderham M
Amin AZ
Liu J
Wu T
Azam T
Stakias V
Espaillat R
Sinvhal R
Soliman AM
Pang Y
Chen MM
Lebwohl MG
author Papp KA
author_facet Papp KA
Blauvelt A
Puig L
Ohtsuki M
Beissert S
Gooderham M
Amin AZ
Liu J
Wu T
Azam T
Stakias V
Espaillat R
Sinvhal R
Soliman AM
Pang Y
Chen MM
Lebwohl MG
author_role author
author2 Blauvelt A
Puig L
Ohtsuki M
Beissert S
Gooderham M
Amin AZ
Liu J
Wu T
Azam T
Stakias V
Espaillat R
Sinvhal R
Soliman AM
Pang Y
Chen MM
Lebwohl MG
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv interleukin 23
plaque psoriasis
psoriasis
risankizumab
topic interleukin 23
plaque psoriasis
psoriasis
risankizumab
description BACKGROUND: Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy. OBJECTIVE: To evaluate the long-term safety and efficacy of risankizumab in patients with psoriasis. METHODS: LIMMitless is an ongoing phase 3, open-label extension study evaluating the long-term safety and efficacy of continuous risankizumab 150 mg every 12 weeks for adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. This interim analysis assessed safety (ie, monitored treatment-emergent adverse events [TEAEs]) through 304 weeks. Efficacy assessments included determining the proportion of patients who achieved =90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90/100), static Physician's Global Assessment of clear/almost clear (sPGA 0/1), and Dermatology Life Quality Index of no effect on patient's life (DLQI 0/1) through 256 weeks. RESULTS: Among 897 patients randomized to risankizumab in the base studies, 706 were still ongoing at data cutoff. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low. At week 256, 85.1%/52.3% of patients achieved PASI 90/100, respectively, 85.8% achieved sPGA 0/1, and 76.4% achieved DLQI 0/1. LIMITATIONS: Open-label study with no placebo or active-comparator group. CONCLUSIONS: Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.
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://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17062
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85170410016&doi=10.1016%2fj.jaad.2023.07.1024&partnerID=40&md5=e7dcf6cafb2ea775fd57470c3ed80bdc
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17062
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85170410016&doi=10.1016%2fj.jaad.2023.07.1024&partnerID=40&md5=e7dcf6cafb2ea775fd57470c3ed80bdc
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 MOSBY-ELSEVIER
publisher.none.fl_str_mv MOSBY-ELSEVIER
dc.source.none.fl_str_mv JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
ISSN: 01909622
ISSNe: 10976787
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
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repository.mail.fl_str_mv
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