Open AccessDefinition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review
Author(s) -
Caron Bénédicte,
Jairath Vipul,
D’Amico Ferdinando,
Paridaens Kristine,
Magro Fernando,
Danese Silvio,
PeyrinBiroulet Laurent
Publication year - 2022
Publication title -
united european gastroenterology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.667
H-Index - 35
eISSN - 2050-6414
pISSN - 2050-6406
DOI - 10.1002/ueg2.12283
Subject(s) - medicine , ulcerative colitis , clinical trial , budesonide , randomized controlled trial , disease , clinical practice , gastroenterology , physical therapy , corticosteroid
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.