Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 14, 2021; 27(2): 208-223
Published online Jan 14, 2021. doi: 10.3748/wjg.v27.i2.208
Real-world disease activity and sociodemographic, clinical and treatment characteristics of moderate-to-severe inflammatory bowel disease in Brazil
Cyrla Zaltman, Rogério Serafim Parra, Ligia Yukie Sassaki, Genoile Oliveira Santana, Maria de Lourdes Abreu Ferrari, Sender J Miszputen, Heda M B S Amarante, Roberto Luiz Kaiser Junior, Cristina Flores, Wilson R Catapani, José Miguel Luz Parente, Mauro Bafutto, Odery Ramos, Carolina D Gonçalves, Isabella Miranda Guimaraes, Jose J R da Rocha, Marley R Feitosa, Omar Feres, Rogerio Saad-Hossne, Francisco Guilherme Cancela Penna, Pedro Ferrari Sales Cunha, Tarcia NF Gomes, Rodrigo Bremer Nones, Mikaell Alexandre Gouvea Faria, Mírian Perpétua Palha Dias Parente, António S Scotton, Rosana Fusaro Caratin, Juliana Senra, Júlio Maria Chebli
Cyrla Zaltman, Carolina D Gonçalves, Isabella Miranda Guimaraes, Department of Internal Medicine, Federal University of Rio de Janeiro, Rio de Janeiro 21941-913, Brazil
Rogério Serafim Parra, Jose J R da Rocha, Marley R Feitosa, Omar Feres, Department of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto 14049-900, São Paulo, Brazil
Ligia Yukie Sassaki, Department of Internal Medicine, São Paulo State University (UNESP), Medical School, Botucatu 18618-687, São Paulo, Brazil
Genoile Oliveira Santana, IBD Unit, Federal University of Bahia, Salvador 41150-000, Bahia, Brazil
Maria de Lourdes Abreu Ferrari, Francisco Guilherme Cancela Penna, Pedro Ferrari Sales Cunha, Department of Clinical Medicine, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte 30130-100, Minas Gerais, Brazil
Sender J Miszputen, Department of Gastroenterology, Escola Paulista de Medicina, São Paulo 04023-900, Brazil
Heda M B S Amarante, Odery Ramos, Hospital de Clinicas, Universidade Federal do Parana, Curitiba 80060-900, Parana, Brazil
Roberto Luiz Kaiser Junior, Department of Proctology, Beneficencia Portuguesa Hospital/Kaiser Day Hospital, Sao Jose do Rio Preto 15015110, São Paulo, Brazil
Cristina Flores, Department of Gastroenterology and Hepatology Sciences, Hospital de Clínicas, Universidade Federal do Rio Grande do Sul, Porto Alegre 90560002, Rio Grande do Sul, Brazil
Wilson R Catapani, Department of Gastroenterology, Faculdade de Medicina do ABC, Santo Andre 09060-870, São Paulo, Brazil
José Miguel Luz Parente, Department of General Medicine, Gastroenterology Unit, University Hospital, Federal University of Piaui, Teresina 64049-550, Piauí, Brazil
Mauro Bafutto, Department of Gastroenterology, Faculdade de Medicina, Universidade Federal de Goiás, Goiania 74535-170, Goias, Brazil
Rogerio Saad-Hossne, Department of Surgery, Botucatu Medical School at São Paulo State University (UNESP), Botucatu 18618687, São Paulo, Brazil
Tarcia NF Gomes, Department of Gastroenterology, UNIFESP, São Paulo 04040-002, Brazil
Rodrigo Bremer Nones, IBD unit, Gastroenterology Department, Hospital Nossa Senhora das Graças, Curitiba 80810-040, Parana, Brazil
Mikaell Alexandre Gouvea Faria, Department of Proctology, Kaiser Hospital Dia, Sao Jose do Rio Preto 15015-110, São Paulo, Brazil
Mírian Perpétua Palha Dias Parente, Health Sciences Center, Epidemiology Unit, State University of Piaui, Teresina 64001-280, Piauí, Brazil
António S Scotton, Department of Gastroenterology, CMIP Centro Mineiro de Pesquisa, Juiz de Fora 36010-570, Minas Gerais, Brazil
Rosana Fusaro Caratin, Scientific Affairs, Takeda Pharmaceuticals Brazil, São Paulo 04709-011, Brazil
Juliana Senra, Clinical Research, Takeda Pharmaceuticals Brazil, São Paulo 04709-011, Brazil
Júlio Maria Chebli, Department of Medicine, University Hospital of Federal University of Juiz de Fora, Juiz de Fora 36036-247, Minas Gerais, Brazil
Author contributions: Zaltman C, Parra RS, Sassaki LY, Santana GO, Ferrari MLA, Miszputen SJ, Amarante HMBS, Junior RLK, Flores C, Catapani WR, Parente JML, Bafutto M, Ramos O, Scotton AS and Chebli JM provided substantial contributions to the concept and design, acquisition of data, and analysis and interpretation of data; Gonçalves CD, Guimaraes IM, da Rocha JJR, Feitosa MR, Feres O, Saad-Hossne R, Penna FGC, Cunha PFS, Gomes TNF, Nones RB, Faria MAG, Parente MPPD, Caratin RF and Senra J contributed to the analysis and interpretation of data; all authors contributed to the editing of the manuscript, revised it critically for important intellectual content, granted approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Supported by Takeda Pharmaceuticals Brazil.
Institutional review board statement: The study protocol was reviewed and approved by the ethics committees of the participating centers.
Informed consent statement: All study participants provided written informed consent prior to study enrollment.
Conflict-of-interest statement: Cyrla Zaltman has received speaker fees from AbbVie, Janssen, Pfizer, UCB Pharma and Takeda, and received research funding from AbbVie, Takeda, and Janssen; Rogerio Serafim Parra has received fees for serving as speaker or as an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda; Ligia Yukie Sassaki has received speaker fees from AbbVie and Takeda; Genoile Oliveira Santana has received speaker fees from AbbVie, Janssen, Takeda and UCB Pharma; and received research funding from Celgene, Roche and Takeda; Maria de Lourdes Abreu Ferrari has received fees for serving as a speaker or as an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda; Sender Jankiel Miszputen has received fees for serving as speaker or as a consultant for Farmoquimica, Janssen and Marjan, and received research funding from Ache, Roche and Takeda; Cristina Flores has received speaker fees from Janssen, Takeda, and AbbVie; and received fees for serving as an advisory board member for Janssen; Wilson Roberto Catapani has received fees for serving as a speaker or as an advisory board member for Janssen and Takeda; Jose Miguel Luz Parente has received speaker fees from Takeda; Mauro Bafutto has received speaker fees from Takeda, AbbVie, Janssen, UCB and Farmoquimica; and received fees for serving as an advisory board member for AbbVie and Janssen; Jose Joaquim Ribeiro da Rocha has received speaker fees from Nestle; Marley Ribeiro Feitosa has received speaker fees from Janssen and Nestle, and fees for scientific congresses’ support by Janssen, AbbVie, Takeda, Ferring and Nestle and was a subinvestigator in scientific studies sponsored by Janssen, AbbVie and Takeda; Rogerio Saad Hossne has received speaker fees from AbbVie, Janssen, Pfizer and Takeda; Francisco Guilherme Cancela e Penna has received speaker fees from Janssen, Takeda, AbbVie and UCB; Tarcia Nogueira Ferreira Gomes has received research funding from Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior and Takeda; and has received speaker fees from Janssen; Rodrigo Bremer Nones has received speaker fees from AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda; Antonio Scafuto Scotton has received speaker fees from Janssen, Novartis, AbbVie, MSD, and EMS, and 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, and In Trials; Rosana Fusaro Caratin was an employee at Takeda Pharmaceuticals Brazil at the time of the study and when this manuscript was written; Juliana Tosta Senra is an employee at Takeda Pharmaceuticals Brazil; Julio Maria Fonseca Chebli has received speaker fees from AbbVie, Janssen, UCB Pharma and Takeda; Heda Maria Barska dos Santos Amarante, Roberto Kaiser Junior, Odery Ramos, Carolina Dias Gonçalves, Isabella de Miranda Guimaraes, Omar Feres, Mikaell Alexandre Gouvea Faria, Pedro Ferrari Sales da Cunha, Mírian Perpétua Palha Dias Parente declare that they have no conflict of interest
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
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: Cyrla Zaltman, MD, PhD, Associate Professor, Internal Medicine, Federal University of Rio de Janeiro, Hospital Universitario Clementino Fraga Filho - Rua Prof. Rodolpho Paulo Rocco 255 - 4 andar - Ilha do Fundao, Rio de Janeiro 21941-913, Brazil. c.zaltman@gmail.com
Received: October 26, 2020
Peer-review started: October 26, 2020
First decision: December 3, 2020
Revised: December 17, 2020
Accepted: December 28, 2020
Article in press: December 28, 2020
Published online: January 14, 2021
Processing time: 77 Days and 2.4 Hours
ARTICLE HIGHLIGHTS
Research background

Inflammatory bowel diseases (IBD) incidence and prevalence has been consistently increasing in Latin American countries. Brazil is the largest country in South America, with regional sociodemographic and heath care disparities that can impact IBD epidemiology and treatment.

Research motivation

IBD incidence and prevalence have been increasing in Brazil but the information about IBD epidemiology and setting is still scarce in this continent-sized country. On the other hand, multiple treatments are currently available but some constraints on the access to biologic drugs have been reported. A real-world characterization of the IBD patient profile, disease activity and uptake of IBD treatments in Brazil is required to support the optimization of IBD management.

Research objectives

This study aimed to describe the sociodemographic, clinical and therapeutic characteristics of IBD outpatients in Brazil, overall and by three major geographical regions of Brazil: The Southeast (SE), South and Northeast/Midwest (NE/MW).

Research methods

A multicenter, cross-sectional study with a 3-year retrospective chart review component was conducted in 14 Brazilian IBD reference centers. Adult patients with moderate-to-severe Crohn’s disease (CD) or ulcerative colitis (UC) were consecutively enrolled between October 2016 and February 2017, during routinely scheduled in-office appointments. Active IBD at enrolment was defined as presenting, for CD patients, Harvey Bradshaw Index ≥ 8, Crohn’s Disease Activity Index ≥ 220, calprotectin level > 200 μg/g or an active result based on colonoscopy suggestive of inadequate control during the previous year, and, for UC patients, presenting a partial Mayo score ≥ 5. Descriptive statistics were used to analyze study variables, overall and by geographical region.

Research results

We observed that, in Brazil, CD was more frequent than UC, overall and by region. Almost half of CD patients and one quarter of UC patients presented active disease at enrolment and, while CD patients were commonly treated with biologic drugs, UC patients were mostly treated with 5-Aminosalicylic acid (5-ASA) derivates and immunosuppressors. CD patients showed a worse phenotype, namely ileocolonic disease and stricturing disease, and one-quarter had undergone CD-related surgery in the past 3 years. In the South, IBD patients were mostly men, had higher education and employment rates and were more likely to be followed up in the private setting than patients in the other regions. In the NE/MW region, the majority of IBD patients had a lower educational level and lower employment status. In this region, more UC patients had active disease compared to the SE and South regions, but the proportion of biologics users was much lower than that in the other regions.

Research conclusions

In Brazil, CD frequency, activity and severity outweighs those of UC. Nevertheless, one-quarter of UC patients have active disease, and most are receiving 5-ASA treatment. Regional variations in IBD management were observed, with the NE/MW region presenting more UC patients with active disease and less treated.

Research perspectives

Findings from this study can elucidate about differences in clinical practice across Brazilian regions, thus promoting discussion among specialists regarding the optimal management of IBD patients.