Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.3748/wjg.v27.i23.3396 http://hdl.handle.net/11449/229037 |
Resumo: | BACKGROUND Crohn’s disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBDs) with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden, especially in patients with moderate-to-severe disease. The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil (RISE BR) study was a noninterventional study designed to evaluate disease control, treatment patterns, disease burden and health-related quality of life in patients with moderate-to-severe active IBD. We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD. AIM To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil. METHODS This was a prospective, noninterventional study of adult patients with active Crohn’s disease (CD: Harvey-Bradshaw Index ≥ 8, CD Activity Index ≥ 220), inadequate CD control (i.e., calprotectin > 200 µg/g or colonoscopy previous results), or active ulcerative colitis (UC: Partial Mayo score ≥ 5). Enrollment occurred in 14 centers from October 2016 to February 2017. The proportion of active IBD patients after 9-12 mo of follow-up, Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation, discontinuation and dose changes were examined. RESULTS The study included 118 CD and 36 UC patients, with mean ± SD ages of 43.3 ± 12.6 and 44.9 ± 16.5 years, respectively. The most frequent drug classes at index were biologics for CD (62.7%) and 5-aminosalicylate derivates for UC patients (91.7%). During follow-up, 65.3% of CD and 86.1% of UC patients initiated a new treatment at least once. Discontinuations/dose changes occurred in 68.1% of CD patients [median 2.0 (IQR: 2-5)] and 94.3% of UC patients [median 4.0 (IQR: 3-7)]. On average, CD and UC patients had 4.4 ± 2.6 and 5.0 ± 3.3 outpatient visits, respectively. The median time to first mild or no activity was 319 (IQR: 239-358) d for CD and 320 (IQR: 288-358) d for UC patients. At 9-12 mo, 22.0% of CD and 20.0% of UC patients had active disease. CONCLUSION Although a marked proportion of active IBD patients achieved disease control within one year, the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting. |
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Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in BrazilCrohn’s diseaseInflammatory bowel diseasesProspective studyUlcerative colitisBACKGROUND Crohn’s disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBDs) with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden, especially in patients with moderate-to-severe disease. The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil (RISE BR) study was a noninterventional study designed to evaluate disease control, treatment patterns, disease burden and health-related quality of life in patients with moderate-to-severe active IBD. We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD. AIM To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil. METHODS This was a prospective, noninterventional study of adult patients with active Crohn’s disease (CD: Harvey-Bradshaw Index ≥ 8, CD Activity Index ≥ 220), inadequate CD control (i.e., calprotectin > 200 µg/g or colonoscopy previous results), or active ulcerative colitis (UC: Partial Mayo score ≥ 5). Enrollment occurred in 14 centers from October 2016 to February 2017. The proportion of active IBD patients after 9-12 mo of follow-up, Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation, discontinuation and dose changes were examined. RESULTS The study included 118 CD and 36 UC patients, with mean ± SD ages of 43.3 ± 12.6 and 44.9 ± 16.5 years, respectively. The most frequent drug classes at index were biologics for CD (62.7%) and 5-aminosalicylate derivates for UC patients (91.7%). During follow-up, 65.3% of CD and 86.1% of UC patients initiated a new treatment at least once. Discontinuations/dose changes occurred in 68.1% of CD patients [median 2.0 (IQR: 2-5)] and 94.3% of UC patients [median 4.0 (IQR: 3-7)]. On average, CD and UC patients had 4.4 ± 2.6 and 5.0 ± 3.3 outpatient visits, respectively. The median time to first mild or no activity was 319 (IQR: 239-358) d for CD and 320 (IQR: 288-358) d for UC patients. At 9-12 mo, 22.0% of CD and 20.0% of UC patients had active disease. CONCLUSION Although a marked proportion of active IBD patients achieved disease control within one year, the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting.Department of Internal Medicine Botucatu Medical School at Sao Paulo State University (UNESP) BotucatuDepartment of Gastroenterology Escola Paulista de Medicina Sao Paulo São PauloDepartment of Proctology Kaiser Day Hospital, São Jose do Rio PretoDepartment of Gastroenterology Faculdade de Medicina do ABC Santo AndreDepartment of Gastroenterology Faculdade de Medicina, Goiania 74535-170Department of Gastroenterology CMIP Centro Mineiro de Pesquisa Juiz de ForaDepartment of Internal Medicine Federal University of Rio de Janeiro Rio de JaneiroDepartment of Gastroenterology Escola Paulista de Medicina São PauloHospital de Clínicas de Porto Alegre Hospital de Clínicas de Porto Alegre Porto AlegreHospital de Clinicas da Universidade Federal do Paraná Hospital de Clinicas da Universidade Federal do ParanáGastroenterology Department Hospital Nossa Senhora das Graças CuritibaDepartment of General Medicine Universidade Federal do Piauí TeresinaGastroenterology Hospital Universitario da Universidade Federal do Piaui TeresinaDepartment of Medicine University Hospital of Federal University of Juiz de Fora, Juiz de Fora, Juiz de ForaDepartment of Clinical Medicine Universidade Federal de Minas Gerais, Belo HorizonteHospital de Clinicas da Universidade Federal do Paraná Hospital de Clinicas da Universidade Federal do Paraná, CuritibaDepartment of Surgery and Anatomy Ribeirao Preto Medical School University of Sao Paulo, Ribeirão PretoScientific Affairs Takeda Pharmaceuticals BrazilClinical Research Takeda Pharmaceuticals São PauloIBD Unit Federal University of Bahia, SalvadorDepartment of Internal Medicine Botucatu Medical School at Sao Paulo State University (UNESP) BotucatuUniversidade Estadual Paulista (UNESP)São PauloKaiser Day HospitalSanto AndreFaculdade de MedicinaJuiz de ForaRio de JaneiroPorto AlegreUniversidade Federal do Paraná (UFPR)CuritibaTeresinaUniversity of Juiz de ForaUniversidade Federal de Minas Gerais (UFMG)Universidade de São Paulo (USP)Takeda Pharmaceuticals BrazilUniversidade Federal da Bahia (UFBA)Sassaki, Ligia Yukie [UNESP]Baima, Julio Pinheiro [UNESP]Miszputen, Sender J.Junior, Roberto Luiz KaiserFaria, Mikaell Alexandre GouveaCatapani, Wilson R.Bafutto, MauroScotton, António S.Zaltman, CyrlaGonçalves, Carolina D.Guimaraes, Isabella MirandaRamos, Hagata S.Flores, CristinaAmarante, Heda M.B.S.Nones, Rodrigo BremerParente, José Miguel LuzLima, Murilo MouraChebli, Júlio Mariade Lourdes Abreu Ferrari, MariaCampos, Julia F.Sanna, Maria G.P.Ramos, OderyParra, Rogério Serafimda Rocha, Jose J.R.Feres, OmarFeitosa, Marley R.Caratin, Rosana FusaroSenra, Juliana TostaSantana, Genoile Oliveira2022-04-29T08:30:04Z2022-04-29T08:30:04Z2021-06-21info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article3396-3412http://dx.doi.org/10.3748/wjg.v27.i23.3396World Journal of Gastroenterology, v. 27, n. 23, p. 3396-3412, 2021.2219-28401007-9327http://hdl.handle.net/11449/22903710.3748/wjg.v27.i23.33962-s2.0-85108658110Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengWorld Journal of Gastroenterologyinfo:eu-repo/semantics/openAccess2024-08-14T17:22:48Zoai:repositorio.unesp.br:11449/229037Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-14T17:22:48Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
title |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
spellingShingle |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil Sassaki, Ligia Yukie [UNESP] Crohn’s disease Inflammatory bowel diseases Prospective study Ulcerative colitis |
title_short |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
title_full |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
title_fullStr |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
title_full_unstemmed |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
title_sort |
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil |
author |
Sassaki, Ligia Yukie [UNESP] |
author_facet |
Sassaki, Ligia Yukie [UNESP] Baima, Julio Pinheiro [UNESP] Miszputen, Sender J. Junior, Roberto Luiz Kaiser Faria, Mikaell Alexandre Gouvea Catapani, Wilson R. Bafutto, Mauro Scotton, António S. Zaltman, Cyrla Gonçalves, Carolina D. Guimaraes, Isabella Miranda Ramos, Hagata S. Flores, Cristina Amarante, Heda M.B.S. Nones, Rodrigo Bremer Parente, José Miguel Luz Lima, Murilo Moura Chebli, Júlio Maria de Lourdes Abreu Ferrari, Maria Campos, Julia F. Sanna, Maria G.P. Ramos, Odery Parra, Rogério Serafim da Rocha, Jose J.R. Feres, Omar Feitosa, Marley R. Caratin, Rosana Fusaro Senra, Juliana Tosta Santana, Genoile Oliveira |
author_role |
author |
author2 |
Baima, Julio Pinheiro [UNESP] Miszputen, Sender J. Junior, Roberto Luiz Kaiser Faria, Mikaell Alexandre Gouvea Catapani, Wilson R. Bafutto, Mauro Scotton, António S. Zaltman, Cyrla Gonçalves, Carolina D. Guimaraes, Isabella Miranda Ramos, Hagata S. Flores, Cristina Amarante, Heda M.B.S. Nones, Rodrigo Bremer Parente, José Miguel Luz Lima, Murilo Moura Chebli, Júlio Maria de Lourdes Abreu Ferrari, Maria Campos, Julia F. Sanna, Maria G.P. Ramos, Odery Parra, Rogério Serafim da Rocha, Jose J.R. Feres, Omar Feitosa, Marley R. Caratin, Rosana Fusaro Senra, Juliana Tosta Santana, Genoile Oliveira |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (UNESP) São Paulo Kaiser Day Hospital Santo Andre Faculdade de Medicina Juiz de Fora Rio de Janeiro Porto Alegre Universidade Federal do Paraná (UFPR) Curitiba Teresina University of Juiz de Fora Universidade Federal de Minas Gerais (UFMG) Universidade de São Paulo (USP) Takeda Pharmaceuticals Brazil Universidade Federal da Bahia (UFBA) |
dc.contributor.author.fl_str_mv |
Sassaki, Ligia Yukie [UNESP] Baima, Julio Pinheiro [UNESP] Miszputen, Sender J. Junior, Roberto Luiz Kaiser Faria, Mikaell Alexandre Gouvea Catapani, Wilson R. Bafutto, Mauro Scotton, António S. Zaltman, Cyrla Gonçalves, Carolina D. Guimaraes, Isabella Miranda Ramos, Hagata S. Flores, Cristina Amarante, Heda M.B.S. Nones, Rodrigo Bremer Parente, José Miguel Luz Lima, Murilo Moura Chebli, Júlio Maria de Lourdes Abreu Ferrari, Maria Campos, Julia F. Sanna, Maria G.P. Ramos, Odery Parra, Rogério Serafim da Rocha, Jose J.R. Feres, Omar Feitosa, Marley R. Caratin, Rosana Fusaro Senra, Juliana Tosta Santana, Genoile Oliveira |
dc.subject.por.fl_str_mv |
Crohn’s disease Inflammatory bowel diseases Prospective study Ulcerative colitis |
topic |
Crohn’s disease Inflammatory bowel diseases Prospective study Ulcerative colitis |
description |
BACKGROUND Crohn’s disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBDs) with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden, especially in patients with moderate-to-severe disease. The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil (RISE BR) study was a noninterventional study designed to evaluate disease control, treatment patterns, disease burden and health-related quality of life in patients with moderate-to-severe active IBD. We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD. AIM To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil. METHODS This was a prospective, noninterventional study of adult patients with active Crohn’s disease (CD: Harvey-Bradshaw Index ≥ 8, CD Activity Index ≥ 220), inadequate CD control (i.e., calprotectin > 200 µg/g or colonoscopy previous results), or active ulcerative colitis (UC: Partial Mayo score ≥ 5). Enrollment occurred in 14 centers from October 2016 to February 2017. The proportion of active IBD patients after 9-12 mo of follow-up, Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation, discontinuation and dose changes were examined. RESULTS The study included 118 CD and 36 UC patients, with mean ± SD ages of 43.3 ± 12.6 and 44.9 ± 16.5 years, respectively. The most frequent drug classes at index were biologics for CD (62.7%) and 5-aminosalicylate derivates for UC patients (91.7%). During follow-up, 65.3% of CD and 86.1% of UC patients initiated a new treatment at least once. Discontinuations/dose changes occurred in 68.1% of CD patients [median 2.0 (IQR: 2-5)] and 94.3% of UC patients [median 4.0 (IQR: 3-7)]. On average, CD and UC patients had 4.4 ± 2.6 and 5.0 ± 3.3 outpatient visits, respectively. The median time to first mild or no activity was 319 (IQR: 239-358) d for CD and 320 (IQR: 288-358) d for UC patients. At 9-12 mo, 22.0% of CD and 20.0% of UC patients had active disease. CONCLUSION Although a marked proportion of active IBD patients achieved disease control within one year, the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-06-21 2022-04-29T08:30:04Z 2022-04-29T08:30:04Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.3748/wjg.v27.i23.3396 World Journal of Gastroenterology, v. 27, n. 23, p. 3396-3412, 2021. 2219-2840 1007-9327 http://hdl.handle.net/11449/229037 10.3748/wjg.v27.i23.3396 2-s2.0-85108658110 |
url |
http://dx.doi.org/10.3748/wjg.v27.i23.3396 http://hdl.handle.net/11449/229037 |
identifier_str_mv |
World Journal of Gastroenterology, v. 27, n. 23, p. 3396-3412, 2021. 2219-2840 1007-9327 10.3748/wjg.v27.i23.3396 2-s2.0-85108658110 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
World Journal of Gastroenterology |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
3396-3412 |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
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1808128133699731456 |