Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis

Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) fo...

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Autores: Papp, Kim A.|||0000-0001-9557-3642, Lebwohl, Mark Gabriel, Puig Sanz, Lluís|||0000-0001-6083-0952, Ohtsuki, Mamitaro, Beissert, Stefan, Zeng, Jiewei, Rubant, Simone A., Sinvhal, Ranjeeta, Zhao, Yan, Soliman, Ahmed M.|||0009-0008-8632-1396, Alperovich, Gabriela, Leonardi, Craig L.
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:270201
Acceso en línea:https://ddd.uab.cat/record/270201
https://dx.doi.org/urn:doi:10.1111/bjd.20595
Access Level:acceso abierto
Palabra clave:Adult
Antibodies, Monoclonal
Double-Blind Method
Follow-Up Studies
Humans
Psoriasis
Quality of Life
Severity of Illness Index
Treatment Outcome
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spelling Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasisinterim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-upPapp, Kim A.|||0000-0001-9557-3642Lebwohl, Mark GabrielPuig Sanz, Lluís|||0000-0001-6083-0952Ohtsuki, MamitaroBeissert, StefanZeng, JieweiRubant, Simone A.Sinvhal, RanjeetaZhao, YanSoliman, Ahmed M.|||0009-0008-8632-1396Alperovich, GabrielaLeonardi, Craig L.AdultAntibodies, MonoclonalDouble-Blind MethodFollow-Up StudiesHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeBackground: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis. Methods: LIMMitless is an ongoing, phase III, open-label extension study evaluating the long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395). Results: Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable with those identified in the base studies. Conclusions: Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks. 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/270201https://dx.doi.org/urn:doi:10.1111/bjd.20595reponame: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:ddd.uab.cat:2702012026-06-06T12:50:31Z
dc.title.none.fl_str_mv Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up
title Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
spellingShingle Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
Papp, Kim A.|||0000-0001-9557-3642
Adult
Antibodies, Monoclonal
Double-Blind Method
Follow-Up Studies
Humans
Psoriasis
Quality of Life
Severity of Illness Index
Treatment Outcome
title_short Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
title_full Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
title_fullStr Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
title_full_unstemmed Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
title_sort Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
dc.creator.none.fl_str_mv Papp, Kim A.|||0000-0001-9557-3642
Lebwohl, Mark Gabriel
Puig Sanz, Lluís|||0000-0001-6083-0952
Ohtsuki, Mamitaro
Beissert, Stefan
Zeng, Jiewei
Rubant, Simone A.
Sinvhal, Ranjeeta
Zhao, Yan
Soliman, Ahmed M.|||0009-0008-8632-1396
Alperovich, Gabriela
Leonardi, Craig L.
author Papp, Kim A.|||0000-0001-9557-3642
author_facet Papp, Kim A.|||0000-0001-9557-3642
Lebwohl, Mark Gabriel
Puig Sanz, Lluís|||0000-0001-6083-0952
Ohtsuki, Mamitaro
Beissert, Stefan
Zeng, Jiewei
Rubant, Simone A.
Sinvhal, Ranjeeta
Zhao, Yan
Soliman, Ahmed M.|||0009-0008-8632-1396
Alperovich, Gabriela
Leonardi, Craig L.
author_role author
author2 Lebwohl, Mark Gabriel
Puig Sanz, Lluís|||0000-0001-6083-0952
Ohtsuki, Mamitaro
Beissert, Stefan
Zeng, Jiewei
Rubant, Simone A.
Sinvhal, Ranjeeta
Zhao, Yan
Soliman, Ahmed M.|||0009-0008-8632-1396
Alperovich, Gabriela
Leonardi, Craig L.
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Adult
Antibodies, Monoclonal
Double-Blind Method
Follow-Up Studies
Humans
Psoriasis
Quality of Life
Severity of Illness Index
Treatment Outcome
topic Adult
Antibodies, Monoclonal
Double-Blind Method
Follow-Up Studies
Humans
Psoriasis
Quality of Life
Severity of Illness Index
Treatment Outcome
description Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis. Methods: LIMMitless is an ongoing, phase III, open-label extension study evaluating the long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395). Results: Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable with those identified in the base studies. Conclusions: Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks.
publishDate 2021
dc.date.none.fl_str_mv 2
2021-01-01
2021
2021-01-01
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/270201
https://dx.doi.org/urn:doi:10.1111/bjd.20595
url https://ddd.uab.cat/record/270201
https://dx.doi.org/urn:doi:10.1111/bjd.20595
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
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