Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review
Abstract
We performed a systematic review to investigate the definition of mild to moderate active ulcerative colitis (UC), and to describe predictors of good response to treatment in clinical trials assessing 5-ASA and/or budesonide. Thirty-nine randomized controlled trials were included. The UC Disease Activity Index (UCDAI) was the most frequent score used for defining mild to moderate active UC (16 studies, 41%), followed by Clinical Activity Index in 11 studies (28.2%). Four different cut-offs were used to define mild to moderate active UC using the UCDAI. The most frequently reported predictors of good response to treatment was a mild and moderate disease activity. There is heterogeneity in the definition of mild to moderate active UC in randomized clinical trials. A standardized definition of mild to moderate active UC used for inclusion of patients in clinical trials is needed.
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BibTeX
@article{caron2026definition,
title = {{Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review}},
author = {Bénédicte Caron and Vipul Jairath and Ferdinando D’amico and Kristine Paridaens and Fernando Magro and Silvio Danese and Laurent Peyrin-Biroulet},
journal = {United European Gastroenterology Journal},
year = {2026},
month = sep,
doi = {10.1002/ueg2.12283},
url = {https://hal.univ-lorraine.fr/hal-04167999v1},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review
AU - Bénédicte Caron
AU - Vipul Jairath
AU - Ferdinando D’amico
AU - Kristine Paridaens
AU - Fernando Magro
AU - Silvio Danese
AU - Laurent Peyrin-Biroulet
PY - 2026
DA - 2026/09/17
JO - United European Gastroenterology Journal
DO - 10.1002/ueg2.12283
UR - https://hal.univ-lorraine.fr/hal-04167999v1
AB - We performed a systematic review to investigate the definition of mild to moderate active ulcerative colitis (UC), and to describe predictors of good response to treatment in clinical trials assessing 5-ASA and/or budesonide. Thirty-nine randomized controlled trials were included. The UC Disease Activity Index (UCDAI) was the most frequent score used for defining mild to moderate active UC (16 studies, 41%), followed by Clinical Activity Index in 11 studies (28.2%). Four different cut-offs were used to define mild to moderate active UC using the UCDAI. The most frequently reported predictors of good response to treatment was a mild and moderate disease activity. There is heterogeneity in the definition of mild to moderate active UC in randomized clinical trials. A standardized definition of mild to moderate active UC used for inclusion of patients in clinical trials is needed.
SN - 2050-6406
SN - 2050-6414
ER -