Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil

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Autor(es): dc.contributorUniversidade Federal do Rio Grande do Sul-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorInstituto de Dermatologia e Estética do Rio de Janeiro-
Autor(es): dc.contributorHospital Moinhos de Vento-
Autor(es): dc.contributorPontifícia Universidade Católica do Paraná-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorSão José do Rio Preto-
Autor(es): dc.contributorHospital Universitário Evangélico Mackenzie de Curitiba-
Autor(es): dc.contributorAbbVie Inc.-
Autor(es): dc.contributorAbbVie Deutschland GmbH & Co. KG-
Autor(es): dc.contributorIn memoriam-
Autor(es): dc.contributorFaculdade de Medicina de ABC-
Autor(es): dc.creatorCestari, Tania F.-
Autor(es): dc.creatorSouza, Cacilda da Silva-
Autor(es): dc.creatorAzulay-Abulafia, Luna-
Autor(es): dc.creatorRomiti, Ricardo-
Autor(es): dc.creatorCarvalho, André V.E.-
Autor(es): dc.creatorSilva de Castro, Caio César-
Autor(es): dc.creatorMarques, Sílvio Alencar-
Autor(es): dc.creatorAntonio, João Roberto-
Autor(es): dc.creatorFabrício, Lincoln-
Autor(es): dc.creatorSoliman, Ahmed M.-
Autor(es): dc.creatorWu, Tianshuang-
Autor(es): dc.creatorSinvhal, Ranjeeta-
Autor(es): dc.creatorStakias, Vassilis-
Autor(es): dc.creatorSong, Alexandra P.-
Autor(es): dc.creatorKalabic, Jasmina-
Autor(es): dc.creatorMartin, Naomi-
Autor(es): dc.creatorOyafuso, Luiza Keiko Matsuka-
Data de aceite: dc.date.accessioned2025-08-21T22:52:49Z-
Data de disponibilização: dc.date.available2025-08-21T22:52:49Z-
Data de envio: dc.date.issued2025-04-29-
Data de envio: dc.date.issued2025-03-01-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1016/j.abd.2024.08.002-
Fonte completa do material: dc.identifierhttps://hdl.handle.net/11449/299697-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/299697-
Descrição: dc.descriptionBackground: Psoriasis, a chronic, inflammatory skin disease, requires long-term therapy. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. Objective: The authors assessed the efficacy and safety of risankizumab compared with methotrexate in adults with moderate-to-severe plaque psoriasis. Methods: IMMbrace was a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study. Patients received subcutaneous risankizumab 150 mg at weeks 0, 4, and 16 plus oral placebo weekly, or oral methotrexate 5 mg weekly (with dose escalation up to 25 mg based on response and tolerability) plus subcutaneous placebo at weeks 0, 4, and 16. Primary efficacy endpoints were the proportions of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90) and static Physician's Global Assessment of clear/almost clear (sPGA 0/1) at week 28. Safety was also assessed. Results: Among 98 patients randomized (risankizumab, n = 50; methotrexate, n = 48), 95 completed the double-blind period. At week 28, significantly higher proportions of patients treated with risankizumab versus methotrexate achieved PASI90 (84.0% vs. 35.4%; p < 0.001); sPGA 0/1 was achieved by 90.0% and 64.6% of patients in the risankizumab and methotrexate groups (p ≤ 0.001). Risankizumab efficacy was maintained throughout week 112. Adverse event rates were similar in the two groups. Study limitations: The sample size was small due to the difficulty of recruiting patients without methotrexate use. Conclusions: Risankizumab demonstrated superior efficacy over methotrexate at week 28; efficacy was maintained, and no new safety findings were observed through week 112.-
Descrição: dc.descriptionAbbVie-
Descrição: dc.descriptionDepartment of Dermatology Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande do Sul, RS-
Descrição: dc.descriptionDivision of Dermatology Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo, SP-
Descrição: dc.descriptionInstituto de Dermatologia e Estética do Rio de Janeiro-
Descrição: dc.descriptionDepartment of Dermatology Hospital das Clínicas Universidade de São Paulo, SP-
Descrição: dc.descriptionDepartment of Dermatology Hospital Moinhos de Vento, RS-
Descrição: dc.descriptionDiscipline of Dermatology Pontifícia Universidade Católica do Paraná, PR-
Descrição: dc.descriptionDepartment of Infectology Dermatology Imaging Diagnosis and Radiotherapy Faculty of Medicine Universidade Estadual Paulista, SP-
Descrição: dc.descriptionDiscipline of Dermatology Faculdade Estadual de Medicina de São José do Rio Preto São José do Rio Preto, SP-
Descrição: dc.descriptionDermaology Service Hospital Universitário Evangélico Mackenzie de Curitiba, PR-
Descrição: dc.descriptionAbbVie Inc.-
Descrição: dc.descriptionAbbVie Deutschland GmbH & Co. KG-
Descrição: dc.descriptionIn memoriam-
Descrição: dc.descriptionDepartment of Dermatology Faculdade de Medicina de ABC, SP-
Descrição: dc.descriptionDepartment of Infectology Dermatology Imaging Diagnosis and Radiotherapy Faculty of Medicine Universidade Estadual Paulista, SP-
Formato: dc.format260-271-
Idioma: dc.languageen-
Relação: dc.relationAnais Brasileiros de Dermatologia-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectMethotrexate-
Palavras-chave: dc.subjectPsoriasis-
Palavras-chave: dc.subjectRisankizumab-
Título: dc.titleEfficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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