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

Autor:	Sassaki LY; Department of Internal Medicine, Botucatu Medical School at Sao Paulo State University (UNESP), Botucatu 18618-687, São Paulo, Brazil. ligiasassaki@gmail.com., Miszputen SJ; Department of Gastroenterology, Escola Paulista de Medicina, Sao Paulo, São Paulo 18618-687, São Paulo, Brazil., Kaiser Junior RL; Department of Proctology, Kaiser Day Hospital, São Jose do Rio Preto 15015-110, São Paulo, Brazil., Catapani WR; Department of Gastroenterology, Faculdade de Medicina do ABC, Santo Andre 09060-870, São Paulo, Brazil., Bafutto M; Department of Gastroenterology, Faculdade de Medicina, Goiania 74535-170, Goiás, Brazil., Scotton AS; Department of Gastroenterology, CMIP Centro Mineiro de Pesquisa, Juiz de Fora 36010-570, Minas Gerais, Brazil., Zaltman C; Department of Internal Medicine, Federal University of Rio de Janeiro, Rio de Janeiro 21941-913, Rio de Janeiro, Brazil., Baima JP; Department of Internal Medicine, Botucatu Medical School at Sao Paulo State University (UNESP), Botucatu 18618-687, São Paulo, Brazil., Ramos HS; Department of Gastroenterology, Escola Paulista de Medicina, São Paulo 04023-900, São Paulo, Brazil., Faria MAG; Department of Proctology, Kaiser Day Hospital, São Jose do Rio Preto 15015-110, São Paulo, Brazil., Gonçalves CD; Department of Internal Medicine, Federal University of Rio de Janeiro, Rio de Janeiro 21941-913, Rio de Janeiro, Brazil., Guimaraes IM; Department of Internal Medicine, Federal University of Rio de Janeiro, Rio de Janeiro 21941-913, Rio de Janeiro, Brazil., Flores C; Hospital de Clínicas de Porto Alegre, Hospital de Clínicas de Porto Alegre, Porto Alegre 90035-903, Rio Grande do Sul, Brazil., Amarante HMBS; Hospital de Clinicas da Universidade Federal do Paraná, Hospital de Clinicas da Universidade Federal do Paraná, Curitiba Paraná, Paraná, Brazil., Nones RB; Gastroenterology Department, Hospital Nossa Senhora das Graças, Curitiba 80810-040, Paraná, Brazil., Parente JML; Department of General Medicine, Universidade Federal do Piauí, Teresina 64049-550, Piauí, Brazil., Lima MM; Gastroenterology, Hospital Universitario da Universidade Federal do Piaui, Teresina 64049-550, Piauí, Brazil., Chebli JM; Department of Medicine, University Hospital of Federal University of Juiz de Fora, Juiz de Fora, Juiz de Fora 36036-247, Minas Gerais, Brazil., Ferrari MLA; Department of Clinical Medicine, Universidade Federal de Minas Gerais, Belo Horizonte 30130-100, Minas Gerais, Brazil., Campos JF; Department of Clinical Medicine, Universidade Federal de Minas Gerais, Belo Horizonte 30130-100, Minas Gerais, Brazil., Sanna MGP; Department of Clinical Medicine, Universidade Federal de Minas Gerais, Belo Horizonte 30130-100, Minas Gerais, Brazil., Ramos O; Hospital de Clinicas da Universidade Federal do Paraná, Hospital de Clinicas da Universidade Federal do Paraná, Curitiba 80060-900, Paraná, Brazil., Parra RS; Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto 14048-900, São Paulo, Brazil., da Rocha JJR; Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto 14048-900, São Paulo, Brazil., Feres O; Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto 14048-900, São Paulo, Brazil., Feitosa MR; Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto 14048-900, São Paulo, Brazil., Caratin RF; Scientific Affairs, Takeda Pharmaceuticals Brazil, Sao Paulo 04709-011, Brazil., Senra JT; Clinical Research, Takeda Pharmaceuticals, São Paulo 04709-011, São Paulo, Brazil., Santana GO; IBD Unit, Federal University of Bahia, Salvador 41150-000, Bahia, Brazil.
Jazyk:	angličtina
Zdroj:	World journal of gastroenterology [World J Gastroenterol] 2021 Jun 21; Vol. 27 (23), pp. 3396-3412.
DOI:	10.3748/wjg.v27.i23.3396
Abstrakt:	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. Competing Interests: Conflict-of-interest statement: Ligia Yukie Sassaki has received fees for serving as a speaker for AbbVie and Takeda. Sender Jankiel Miszputen has received fees for serving as a speaker and/or a consultant for Farmoquimica, Janssen and Marjan. He has received research funding from Ache, Roche and Takeda. Wilson Roberto Catapani has received fees for serving as a speaker and/or an advisory board member for Janssen and Takeda. Mauro Bafutto has received fees for serving as a speaker for Takeda, AbbVie, Janssen, UCB and Farmoquimica. He has received fees for serving as an advisory board member for AbbVie and Janssen. Antonio Scafuto Scotton has received fees for serving as a speaker for Janssen, Novartis, AbbVie, MSD, EMS. He has received research funding from Janssen, Novartis, AbbVie, Roche, Pfizer, Bristol, Lilly, Novo Nordisk, Anthera, AstraZeneca, GSK, UCB, Sanofi, Takeda, Parexel, IQVIA, PPD, PRA, ICON, INP Research, Covance, In Trials. Cyrla Zaltman has received fees for serving as a speaker for UCB, Janssen, Takeda, AbbVie. She has received research funding from AbbVie, Takeda, Janssen. Julio Pinheiro Baima has received fees for serving as a speaker for Janssen and Takeda. Cristina Flores has received fees for serving as a speaker for Janssen, Takeda, AbbVie. She has received fees for serving as an advisory board member for Janssen. Rodrigo Bremer Nones has received fees for serving as a speaker for AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda. Jose Miguel Luz Parente has received fees for serving as a speaker for Takeda. Julio Maria Fonseca Chebli has received fees for serving as a speaker for AbbVie, Janssen, UCB Pharma and Takeda. Maria de Lourdes de Abreu Ferrari has received fees for serving as a speaker and/or advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda. Rogerio Serafim Parra has received fees for serving as a speaker and/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda. Jose Joaquim Ribeiro da Rocha has received fees for serving as a speaker for Nestle. Marley Ribeiro Feitosa has received fees for serving as a speaker for AbbVie and Janssen. Rosana Fusaro Caratin was an employee of Takeda Pharmaceuticals Brazil at the time the manuscript was developed. Juliana Tosta Senra is an employee of Takeda Pharmaceuticals Brazil. Genoile Oliveira Santana has received fees for serving as a speaker for Takeda, AbbVie, Janssen, UCB Pharma. She has received research funding from Celgene and Roche. She has received fees for serving as an advisory board member for Janssen. No conflict of interest: Roberto Luiz Kaiser Junior, Mikaell Alexandre Gouvea Faria, Carolina Dias Goncalves, Isabella de Miranda Guimaraes, Heda Maria Barska dos Santos Amarante, Murilo Moura Lima, Odery Ramos, Omar Feres, Hagata Souza Ramos, Julia Faria Campos, and Maria das Gracas Pimenta Sanna. (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)
Databáze:	MEDLINE
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