Portal de investigação
Defining mucosal healing in randomized controlled trials of inflammatory bowel disease: A systematic review and future perspective
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- Parigi, TL
- Solitano, V
- Armuzzi, A
- Acosta, MBD
- Begun, J
- Ben-Horin, S
- Biedermann, L
- Colombel, JF
- Dignass, A
- Fumery, M
- Ghosh, S
- Kobayashi, T
- Louis, E
- Panaccione, R
- Rausch, A
- Reinisch, W
- Selinger, C
- Jairath, V
- Danese, S
- Peyrin-Biroulet, L
Unidades de investigação
Abstract
Background: Mucosal healing (MH) is an established treatment goal in inflammatory bowel disease (IBD). However, various definitions of MH exist. We aimed to identify how MH is defined in randomized controlled trials (RCTs) in ulcerative colitis (UC) and Crohn's disease (CD). Methods: We searched MEDLINE, EMBASE, and the Cochrane library from inception to December 2023 for phase 2 and 3 RCTs of advanced therapies in IBD. Results: One hundred forty-four studies were included, 72 in UC and 72 in CD, published between 1997 and 2023. In UC, 64% (46/72) RCTs reported MH as an endpoint. 12 definitions of MH were found, from endoscopic assessment alone (35/46; 76%) to the more recent combination of histology and endoscopy (10/46; 22%). 96% (44/46) of studies used the Mayo Endoscopic Subscore. In CD, reporting of MH lagged behind UC, with only 12% (9/72) of trials specifically defining MH as an endpoint, 7 as "absence of ulceration," 2 as Simplified Endoscopic Score for CD score <= 2 or 0. Histological assessment was performed in 3 RCTs of CD. Centralized reading of endoscopy was used in 48% (35/72) of RCTs of UC and 22% (16/72) of CD. Only 1 RCT included transmural healing as an endpoint. Conclusions: A standard definition of MH in IBD is lacking. Definitions have evolved particularly in UC, which now includes the addition of histological evaluation. Transmural healing holds promise as a future target in CD. We support a greater standardization of definitions as we expect endpoints to become increasingly stringent and multimodal with computers automating the assessment.
Dados da publicação
- ISSN/ISSNe:
- 2050-6406, 2050-6414
- Tipo:
- Review
- Páginas:
- 1266-1279
- DOI:
- 10.1002/ueg2.12671
- Link para outro recurso:
- www.scopus.com
United European Gastroenterology Journal John Wiley & Sons Inc.
Citações Recebidas na Web of Science: 3
Citações Recebidas na Scopus: 4
Documentos
- Não há documentos
Filiações
Keywords
- clinical trials; Crohn's disease; deep remission; endoscopy; histologic healing; histological healing; IBD; neutrophils; pathology; ulcerative colitis
Financiamento
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Citar a publicação
Parigi TL,Solitano V,Armuzzi A,Acosta MBD,Begun J,Ben S,Biedermann L,Colombel JF,Dignass A,Fumery M,Ghosh S,Kobayashi T,Louis E,Magro F,Panaccione R,Rausch A,Reinisch W,Selinger C,Jairath V,Danese S,Peyrin L. Defining mucosal healing in randomized controlled trials of inflammatory bowel disease: A systematic review and future perspective. United Eur. Gastroenterol. J. 2024. 12(9):p. 1266-1279. IF:6,000. (1).
