Parra RS, Chebli JMF, Amarante HMBS, Flores C, Parente JML, Ramos O, Fernandes M, Rocha JJR, Feitosa MR, Feres O, Scotton AS, Nones RB, Lima MM, Zaltman C, Goncalves CD, Guimaraes IM, Santana GO, Sassaki LY, Hossne RS, Bafutto M, Junior RLK, Faria MAG, Miszputen SJ, Gomes TNF, Catapani WR, Faria AA, Souza SCS, Caratin RF, Senra JT, and Ferrari MLA
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., Competing Interests: 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., (©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.)