Observational Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 14, 2019; 25(38): 5862-5882
Published online Oct 14, 2019. doi: 10.3748/wjg.v25.i38.5862
Quality of life, work productivity impairment and healthcare resources in inflammatory bowel diseases in Brazil
Rogerio S Parra, Julio MF Chebli, Heda MBS Amarante, Cristina Flores, Jose ML Parente, Odery Ramos, Milene Fernandes, Jose JR Rocha, Marley R Feitosa, Omar Feres, Antonio S Scotton, Rodrigo B Nones, Murilo M Lima, Cyrla Zaltman, Carolina D Goncalves, Isabella M Guimaraes, Genoile O Santana, Ligia Y Sassaki, Rogerio S Hossne, Mauro Bafutto, Roberto LK Junior, Mikaell AG Faria, Sender J Miszputen, Tarcia NF Gomes, Wilson R Catapani, Anderson A Faria, Stella CS Souza, Rosana F Caratin, Juliana T Senra, Maria LA Ferrari
Rogerio S Parra, Jose JR Rocha, Marley R Feitosa, Omar Feres, Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, SP 14049-900, Brazil
Julio MF Chebli, Inflammatory Bowel Disease Center, Federal University of Juiz de Fora, Juiz de Fora, MG 36036-247, Brazil
Heda MBS Amarante, Hospital de Clinicas da Universidade Federal do Parana, Curitiba, PR 80060-900, Brazil
Cristina Flores, Hospital de Clinicas de Porto Alegre, Porto Alegre – RS 90035-007, Brazil
Jose ML Parente, Universidade Federal do Piaui, Teresina, PI 64073-500, Brazil
Odery Ramos, Hospital de Clínicas da Universidade Federal do Parana, Curitiba, PR 80060-900, Brazil
Milene Fernandes, CTI Clinical Trial & Consulting Services, Lisbon 1070-274, Portugal
Antonio S Scotton, CMIP Centro Mineiro de Pesquisa, Juiz de Fora, MG 36010-570, Brazil
Rodrigo B Nones, Hospital Nossa Senhora das Gracas, Curitiba, PR 80810-040, Brazil
Murilo M Lima, Hospital Universitario da Universidade Federal do Piaui, Teresina, PI 64049-550, Brazil
Cyrla Zaltman, Carolina D Gonçalves, Isabella M Guimaraes, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ 21941-913, Brazil
Genoile O Santana, Universidade do Estado da Bahia, - Salvador, BA 41150-000, Brazil
Ligia Y Sassaki, Rogerio S Hossne, Department of Internal Medicine, Botucatu Medical School at Sao Paulo State University (UNESP), Botucatu, SP 18618-687, Brazil
Mauro Bafutto, Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiania, GO 74535-170, Brazil
Roberto LK Junior, Mikaell AG Faria, Kaiser Clinica, Sao Jose do Rio Preto, SP 15015-110, Brazil
Sender J Miszputen, Escola Paulista de Medicina, Sao Paulo, SP 04023-900, Brazil
Tarcia NF Gomes, UNIFESP, Disciplina de Gastroenterologia, Sao Paulo, SP 04040-002, Brazil
Wilson R Catapani, Faculdade de Medicina do ABC, Santo Andre, SP 09060-870, Brazil
Anderson A Faria, Stella CS Souza, Maria LA Ferrari, Faculdade de Medicina UFMG, Belo Horizonte, MG, 30130-100, Brazil
Rosana F Caratin, Juliana T Senra, Takeda Pharmaceuticals Brazil, Sao Paulo, SP 04709-011, Brazil
Author contributions: Parra RS, Chebli J, Amarante HMBS, Flores C, Parente JML, Ramos O, Fernandes M, Scotton AS, Zaltman C, Santana GO, Sassaki LY, Bafutto M, Junior RLK, Miszputen SJ, Catapani WR and Ferrari ML provided substantial contributions to the concept and design of the study; Parra RS, Chebli J, Amarante HMBS, Flores C, Parente JML, Ramos O, Scotton AS, Zaltman C, Santana GO, Sassaki LY, Bafutto M, Junior RLK, Miszputen SJ, Catapani WR and Ferrari ML contributed for the acquisition of data; All authors contributed to the analysis and interpretation of data, revision of the manuscript for important intellectual content, granted final 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 participant centers.
Informed consent statement: All study participants provided written informed consent prior to study enrollment.
Conflict-of-interest statement: Parra RS has received fees for serving as a speaker and/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda. Saad-Hossne R has received fees for serving as a speaker for AbbVie, Janssen, Pfizer and Takeda. Miszputen S 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. Fernandes M is an employee of Eurotrials, now part of CTI, a CRO that provides services for pharmaceutical laboratories. Catapani WR has received fees for serving as a speaker and/or an advisory board member for Janssen and Takeda. Sassaki LY has received fees for serving as a speaker for AbbVie and Takeda. Gomes TNF has received research funding from Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES) and Takeda. She has received fees for serving as a speaker for Janssen. Chebli JMF has received fees for serving as a speaker for AbbVie, Janssen, UCB Pharma and Takeda. Senra JT and Caratin RF are employees of Takeda Pharmaceuticals Brazil. Nones RB has received fees for serving as a speaker for AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda. Parente JML has received fees for serving as a speaker for Takeda. Ferrari MLA has received fees for serving as a speaker and/or advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda. Santana GO has received fees for serving as a speaker for Takeda, AbbVie, Janssen, and UCB Pharma. She has received research funding from Celgene and Roche. She has received fees for serving as an advisory board member for Janssen. Rocha JJR has received fees for serving as a speaker for Nestle. Feitosa MR has received fees for serving as a speaker for AbbVie and Janssen. Scotton AS has received fees for serving as a speaker for Janssen, Novartis, AbbVie, MSD, and 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, and In Trials. Flores C has received fees for serving as a speaker for Janssen, Takeda, and AbbVie. She has received fees for serving as an advisory board member for Janssen. Zaltman C has received fees for serving as a speaker for UCB, Janssen, Takeda, and AbbVie. She has received research funding from AbbVie, Takeda, and Janssen. Bafutto M 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. No conflict-of-interest: Omar Feres, Murilo Moura Lima, Roberto Luiz Kaiser Junior, Carolina Dias Gonçalves, Stella Cristina Silva de Souza, Anderson Antonio de Faria, Isabella de Miranda Guimaraes, Heda Maria Barska dos Santos Amarante, Mikaell Alexandre Gouvea Faria, Odery Ramos Junior.
Data sharing statement: No additional data are available.
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 which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: Rogerio Serafim Parra, MD, PhD, Assistant Professor, Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, SP 14049-900, Brazil. rsparra@hcrp.usp.br
Telephone: +55-16-36022509
Received: June 12, 2019
Peer-review started: June 12, 2019
First decision: July 22, 2019
Revised: August 30, 2019
Accepted: September 13, 2019
Article in press: September 13, 2019
Published online: October 14, 2019
Processing time: 124 Days and 17.8 Hours
Abstract
BACKGROUND

Inflammatory bowel diseases (IBD) have been associated with a low quality of life (QoL) and a negative impact on work productivity compared to the general population. Information about disease control, patient-reported outcomes (PROs), treatment patterns and use of healthcare resources is relevant to optimizing IBD management.

AIM

To describe QoL and work productivity and activity impairment (WPAI), treatment patterns and use of healthcare resources among IBD patients in Brazil.

METHODS

A multicenter cross-sectional study included adult outpatients who were previously diagnosed with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC). At enrolment, active CD and UC were defined as having a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or calprotectin > 200 µg/g or previous colonoscopy results suggestive of inadequate control (per investigator criteria) and a 9-point partial Mayo score ≥ 5, respectively. The PRO assessment included the QoL questionnaires SF-36 and EQ-5D-5L, the Inflammatory Bowel Disease Questionnaire (IBDQ), and the WPAI questionnaire. Information about healthcare resources and treatment during the previous 3 years was collected from medical records. Chi-square, Fisher’s exact and Student’s t-/Mann-Whitney U tests were used to compare PROs, treatment patterns and the use of healthcare resources by disease activity (α = 0.05).

RESULTS

Of the 407 patients in this study (CD/UC: 64.9%/35.1%, mean age 42.9/45.9 years, 54.2%/56.6% female, 38.3%/37.1% employed), 44.7%/25.2% presented moderate-to-severe CD/UC activity, respectively, at baseline. Expressed in median values for CD/UC, respectively, the SF-36 physical component was 46.6/44.7 and the mental component was 45.2/44.2, the EQ-visual analog scale score was 80.0/70.0, and the IBDQ overall score was 164.0/165.0. Moderate to severe activity, female gender, being unemployed, a lower educational level and lower income were associated with lower QoL (P < 0.05). Median work productivity impairment was 20% and 5% for CD and UC patients, respectively, and activity impairment was 30%, the latter being higher among patients with moderate to severe disease activity compared to patients with mild or no disease activity (75.0% vs 10.0%, P < 0.001). For CD/UC patients, respectively, 25.4%/2.8% had at least one surgery, 38.3%/19.6% were hospitalized, and 70.7%/77.6% changed IBD treatment at least once during the last 3 years. The most common treatments at baseline were biologics (75.3%) and immunosuppressants (70.9%) for CD patients and 5-ASA compounds (77.5%) for UC patients.

CONCLUSION

Moderate to severe IBD activity, especially among CD patients, is associated with a substantial impact on QoL, work productivity impairment and an increased number of IBD surgeries and hospitalizations in Brazil.

Keywords: Inflammatory bowel disease; Crohn’s disease; Ulcerative colitis; Quality of life; Healthcare resources

Core tip: In a large multicenter sample of patients with ulcerative colitis or Crohn’s disease (CD), disease activity, female gender, unemployment, and lower education and income were associated with a poorer quality of life. Approximately one-third of patients had some work and activity impairment, the latter increasing with disease activity. CD patients used more health resources, with 25.4% having at least one surgery and 38.3% being hospitalized in the previous 3 years. Inflammatory bowel disease prevalence is increasing, and health services should be prepared to provide an adequate response, including optimal therapies, to manage the care of such patients.