Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2024 |
| Outros Autores: | , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
| Texto Completo: | http://hdl.handle.net/10451/63211 |
Resumo: | © © The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
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Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trialCrohn’s diseaseRisankizumabDurability© © The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.Background and aims: Durable clinical remission, endoscopic healing, and biomarker normalization are key treatment goals for Crohn's disease. The selective anti-interleukin-23 p19 inhibitor risankizumab has demonstrated efficacy and safety in moderately to severely active Crohn's disease. This post-hoc analysis of data from the pivotal risankizumab maintenance study assessed whether risankizumab maintenance therapy sustained the clinical and endoscopic outcomes achieved with risankizumab induction therapy. Methods: We evaluated 462 patients who achieved a clinical response to risankizumab intravenous induction treatment and were re-randomized to receive subcutaneous risankizumab 360 mg, subcutaneous risankizumab 180 mg, or placebo [withdrawal] every 8 weeks for 52 weeks in the randomized, controlled FORTIFY maintenance study. Maintenance of clinical, endoscopic, and biomarker endpoints at week 52 among patients who achieved these endpoints after 12 weeks of induction treatment was evaluated. Results: A significantly higher proportion of patients receiving maintenance treatment with risankizumab 360 or 180 mg compared with placebo [withdrawal] maintained Crohn's Disease Activity Index remission [68.6%, 70.8%, vs 56.3%; p < 0.05], stool frequency/abdominal pain remission [69.2%, 64.1%, vs 50.5%; p < 0.01], endoscopic response [70.2%, 68.2%, vs 38.4%; p < 0.001], endoscopic remission [74.4%, 45.5%, vs 23.9%; p < 0.05], and Simple Endoscopic Score for Crohn's Disease of 0-2 [65.5%, 36.7%, vs 21.9%]. Most patients [56.8-83.3%] who achieved normalized faecal calprotectin or C-reactive protein during induction sustained them with maintenance risankizumab. Conclusions: Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over 1 year in patients with moderately to severely active Crohn's disease. Clinical trial registration number: NCT03105102.This work was supported by AbbVie. AbbVie funded the research for this study and provided writing support. No honoraria or payments were made for authorship.Oxford University PressRepositório da Universidade de LisboaFerrante, MarcIrving, Peter M.Abreu, Maria T.Axler, JeffreyGao, XiangCao, QianFujii, ToshimitsuRausch, AstridTorres, JoanaNeimark, EzequielSong, AlexandraWallace, KoriKligys, KristinaBerg, SofieLiao, XiaomeiZhou, QingKalabic, JasminaFeagan, BrianPanaccione, Remo2024-03-06T11:42:19Z20242024-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/63211engJ Crohns Colitis. 2024 Mar 1;18(3):416-4231873-994610.1093/ecco-jcc/jjad1681876-4479info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-11-20T18:28:43Zoai:repositorio.ul.pt:10451/63211Portal AgregadorONGhttps://www.rcaap.pt/oai/openairemluisa.alvim@gmail.comopendoar:71602024-11-20T18:28:43Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
| dc.title.none.fl_str_mv |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| title |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| spellingShingle |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial Ferrante, Marc Crohn’s disease Risankizumab Durability |
| title_short |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| title_full |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| title_fullStr |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| title_full_unstemmed |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| title_sort |
Maintenance Risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3 trial |
| author |
Ferrante, Marc |
| author_facet |
Ferrante, Marc Irving, Peter M. Abreu, Maria T. Axler, Jeffrey Gao, Xiang Cao, Qian Fujii, Toshimitsu Rausch, Astrid Torres, Joana Neimark, Ezequiel Song, Alexandra Wallace, Kori Kligys, Kristina Berg, Sofie Liao, Xiaomei Zhou, Qing Kalabic, Jasmina Feagan, Brian Panaccione, Remo |
| author_role |
author |
| author2 |
Irving, Peter M. Abreu, Maria T. Axler, Jeffrey Gao, Xiang Cao, Qian Fujii, Toshimitsu Rausch, Astrid Torres, Joana Neimark, Ezequiel Song, Alexandra Wallace, Kori Kligys, Kristina Berg, Sofie Liao, Xiaomei Zhou, Qing Kalabic, Jasmina Feagan, Brian Panaccione, Remo |
| author2_role |
author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
| dc.contributor.author.fl_str_mv |
Ferrante, Marc Irving, Peter M. Abreu, Maria T. Axler, Jeffrey Gao, Xiang Cao, Qian Fujii, Toshimitsu Rausch, Astrid Torres, Joana Neimark, Ezequiel Song, Alexandra Wallace, Kori Kligys, Kristina Berg, Sofie Liao, Xiaomei Zhou, Qing Kalabic, Jasmina Feagan, Brian Panaccione, Remo |
| dc.subject.por.fl_str_mv |
Crohn’s disease Risankizumab Durability |
| topic |
Crohn’s disease Risankizumab Durability |
| description |
© © The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
| publishDate |
2024 |
| dc.date.none.fl_str_mv |
2024-03-06T11:42:19Z 2024 2024-01-01T00:00:00Z |
| dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
| dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10451/63211 |
| url |
http://hdl.handle.net/10451/63211 |
| dc.language.iso.fl_str_mv |
eng |
| language |
eng |
| dc.relation.none.fl_str_mv |
J Crohns Colitis. 2024 Mar 1;18(3):416-423 1873-9946 10.1093/ecco-jcc/jjad168 1876-4479 |
| dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
application/pdf |
| dc.publisher.none.fl_str_mv |
Oxford University Press |
| publisher.none.fl_str_mv |
Oxford University Press |
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reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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mluisa.alvim@gmail.com |
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1817549281322598400 |