Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil

Detalhes bibliográficos
Autor(a) principal: Sassaki, Ligia Yukie [UNESP]
Data de Publicação: 2021
Outros Autores: 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
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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spelling 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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