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

Autor: Roberto Luiz Kaiser Junior, José Joaquim Ribeiro da Rocha, Omar Féres, Murilo Moura Lima, Maria das Graças Pimenta Sanna, Rosana Fusaro Caratin, Isabella Guimarães, Marley Ribeiro Feitosa, Rodrigo Bremer Nones, Odery Ramos, Julio Pinheiro Baima, Hagata S Ramos, Rogério Serafim Parra, Maria de Lourdes Abreu Ferrari, Heda Maria Barska dos Santos Amarante, Mauro Bafutto, Cyrla Zaltman, Juliana Senra, Sender Jankiel Miszputen, Cristina Flores, Wilson Roberto Catapani, Carolina Gonçalves, Julia Faria Campos, Ligia Yukie Sassaki, Genoile Oliveira Santana, Mikaell Alexandre Gouvea Faria, Julio Maria Fonseca Chebli, José Miguel Luz Parente, António S Scotton
Přispěvatelé: Universidade Estadual Paulista (UNESP), São Paulo, Kaiser Day Hospital, Santo Andre, Faculdade de Medicina, Juiz de Fora, Rio de Janeiro, Porto Alegre, Universidade Federal do Paraná (UFPR), Curitiba, Teresina, University of Juiz de Fora, Universidade Federal de Minas Gerais (UFMG), Universidade de São Paulo (USP), Takeda Pharmaceuticals Brazil, Universidade Federal da Bahia (UFBA)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Scopus
Repositório Institucional da UNESP
Universidade Estadual Paulista (UNESP)
instacron:UNESP
World Journal of Gastroenterology
Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual)
Universidade de São Paulo (USP)
instacron:USP
Popis: Made available in DSpace on 2022-04-29T08:30:04Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-06-21 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. Department of Internal Medicine Botucatu Medical School at Sao Paulo State University (UNESP) Botucatu Department of Gastroenterology Escola Paulista de Medicina Sao Paulo São Paulo Department of Proctology Kaiser Day Hospital, São Jose do Rio Preto Department of Gastroenterology Faculdade de Medicina do ABC Santo Andre Department of Gastroenterology Faculdade de Medicina, Goiania 74535-170 Department of Gastroenterology CMIP Centro Mineiro de Pesquisa Juiz de Fora Department of Internal Medicine Federal University of Rio de Janeiro Rio de Janeiro Department of Gastroenterology Escola Paulista de Medicina São Paulo Hospital de Clínicas de Porto Alegre Hospital de Clínicas de Porto Alegre Porto Alegre Hospital de Clinicas da Universidade Federal do Paraná Hospital de Clinicas da Universidade Federal do Paraná Gastroenterology Department Hospital Nossa Senhora das Graças Curitiba Department of General Medicine Universidade Federal do Piauí Teresina Gastroenterology Hospital Universitario da Universidade Federal do Piaui Teresina Department of Medicine University Hospital of Federal University of Juiz de Fora, Juiz de Fora, Juiz de Fora Department of Clinical Medicine Universidade Federal de Minas Gerais, Belo Horizonte Hospital de Clinicas da Universidade Federal do Paraná Hospital de Clinicas da Universidade Federal do Paraná, Curitiba Department of Surgery and Anatomy Ribeirao Preto Medical School University of Sao Paulo, Ribeirão Preto Scientific Affairs Takeda Pharmaceuticals Brazil Clinical Research Takeda Pharmaceuticals São Paulo IBD Unit Federal University of Bahia, Salvador Department of Internal Medicine Botucatu Medical School at Sao Paulo State University (UNESP) Botucatu
Databáze: OpenAIRE
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