Prospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 21, 2021; 27(23): 3396-3412
Published online Jun 21, 2021. doi: 10.3748/wjg.v27.i23.3396
Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil
Ligia Yukie Sassaki, Sender J Miszputen, Roberto Luiz Kaiser Junior, Wilson R Catapani, Mauro Bafutto, António S Scotton, Cyrla Zaltman, Julio Pinheiro Baima, Hagata S Ramos, Mikaell Alexandre Gouvea Faria, Carolina D Gonçalves, Isabella Miranda Guimaraes, Cristina Flores, Heda M B S Amarante, Rodrigo Bremer Nones, José Miguel Luz Parente, Murilo Moura Lima, Júlio Maria Chebli, Maria de Lourdes Abreu Ferrari, Julia F Campos, Maria G P Sanna, Odery Ramos, Rogério Serafim Parra, Jose J R da Rocha, Omar Feres, Marley R Feitosa, Rosana Fusaro Caratin, Juliana Tosta Senra, Genoile Oliveira Santana
Ligia Yukie Sassaki, Julio Pinheiro Baima, Department of Internal Medicine, Botucatu Medical School at Sao Paulo State University (UNESP), Botucatu 18618-687, São Paulo, Brazil
Sender J Miszputen, Department of Gastroenterology, Escola Paulista de Medicina, Sao Paulo, São Paulo 18618-687, São Paulo, Brazil
Roberto Luiz Kaiser Junior, Mikaell Alexandre Gouvea Faria, Department of Proctology, Kaiser Day Hospital, São Jose do Rio Preto 15015-110, São Paulo, Brazil
Wilson R Catapani, Department of Gastroenterology, Faculdade de Medicina do ABC, Santo Andre 09060-870, São Paulo, Brazil
Mauro Bafutto, Department of Gastroenterology, Faculdade de Medicina, Goiania 74535-170, Goiás, Brazil
António S Scotton, Department of Gastroenterology, CMIP Centro Mineiro de Pesquisa, Juiz de Fora 36010-570, Minas Gerais, Brazil
Cyrla Zaltman, Carolina D Gonçalves, Isabella Miranda Guimaraes, Department of Internal Medicine, Federal University of Rio de Janeiro, Rio de Janeiro 21941-913, Rio de Janeiro, Brazil
Hagata S Ramos, Department of Gastroenterology, Escola Paulista de Medicina, São Paulo 04023-900, São Paulo, Brazil
Cristina Flores, Hospital de Clínicas de Porto Alegre, Hospital de Clínicas de Porto Alegre, Porto Alegre 90035-903, Rio Grande do Sul, Brazil
Heda M B S Amarante, Hospital de Clinicas da Universidade Federal do Paraná, Hospital de Clinicas da Universidade Federal do Paraná, Curitiba Paraná, Paraná, Brazil
Rodrigo Bremer Nones, Gastroenterology Department, Hospital Nossa Senhora das Graças, Curitiba 80810-040, Paraná, Brazil
José Miguel Luz Parente, Department of General Medicine, Universidade Federal do Piauí, Teresina 64049-550, Piauí, Brazil
Murilo Moura Lima, Gastroenterology, Hospital Universitario da Universidade Federal do Piaui, Teresina 64049-550, Piauí, Brazil
Júlio Maria Chebli, Department of Medicine, University Hospital of Federal University of Juiz de Fora, Juiz de Fora, Juiz de Fora 36036-247, Minas Gerais, Brazil
Maria de Lourdes Abreu Ferrari, Julia F Campos, Maria G P Sanna, Department of Clinical Medicine, Universidade Federal de Minas Gerais, Belo Horizonte 30130-100, Minas Gerais, Brazil
Odery Ramos, Hospital de Clinicas da Universidade Federal do Paraná, Hospital de Clinicas da Universidade Federal do Paraná, Curitiba 80060-900, Paraná, Brazil
Rogério Serafim Parra, Jose J R da Rocha, Omar Feres, Marley R Feitosa, Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto 14048-900, São Paulo, Brazil
Rosana Fusaro Caratin, Scientific Affairs, Takeda Pharmaceuticals Brazil, Sao Paulo 04709-011, Brazil
Juliana Tosta Senra, Clinical Research, Takeda Pharmaceuticals, São Paulo 04709-011, São Paulo, Brazil
Genoile Oliveira Santana, IBD Unit, Federal University of Bahia, Salvador 41150-000, Bahia, Brazil
Author contributions: Sassaki LY, Miszputen SJ, Kaiser Junior RL, Catapani WR, Bafutto M, Scotton AS, Zaltman C, Baima JP, Ramos HS, Faria MAG, Gonçalves CD, Guimaraes IM, Flores C, Amarante HMBS, Nones RB, Parente JML, Lima MM, Chebli JM, Ferrari MLA, Campos JF, Sanna MGP, Ramos O, Parra RS, da Rocha JJR, Feres O, Feitosa MR, Caratin RF, Senra JT, and Santana GO substantially contributed to (1) the conception and design of the study, acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be submitted.
Supported by Takeda Pharmaceuticals Brazil.
Institutional review board statement: The study protocol was reviewed and approved by the Ethics Committees of the participant centers.
Clinical trial registration statement: The clinical trial is registered with ClinicalTrials.gov using identifier NCT02822235. Details can be found at https://clinicaltrials.gov/ct2/show/NCT02822235.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
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.
Data sharing statement: The data underlying this article will be shared on reasonable request to the corresponding author.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ligia Yukie Sassaki, PhD, Doctor, Department of Internal Medicine, Botucatu Medical School at Sao Paulo State University (UNESP), Avenida Professor Mário Rubens Guimarães Montenegro, Botucatu 18618-687, São Paulo, Brazil. ligiasassaki@gmail.com
Received: March 8, 2021
Peer-review started: March 8, 2021
First decision: March 27, 2021
Revised: April 17, 2021
Accepted: May 27, 2021
Article in press: May 27, 2021
Published online: June 21, 2021
Processing time: 102 Days and 3.5 Hours
Core Tip

Core Tip: This was a prospective, noninterventional study of 118 adult patients with active Crohn’s disease (CD) and 36 with active ulcerative colitis (UC). The aim was to describe the 12-mo disease evolution and treatment patterns of active moderate-to-severe inflammatory bowel disease (IBD) patients in Brazil. 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. A marked proportion of active IBD patients achieved disease control within one year, which is considered a long time to achieve the goal of reducing inflammation.