Abstract

Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review

United European Gastroenterol J. 2022 Oct;10(8):854-867.doi: 10.1002/ueg2.12283. Epub 2022 Aug 27.

 

Bénédicte Caron 1Vipul Jairath 2 3 4Ferdinando D'Amico 5 6Kristine Paridaens 7Fernando Magro 8 9 10Silvio Danese 5Laurent Peyrin-Biroulet 1

 
     

Author information

1Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Nancy, France.

2Department of Medicine, Western University, London, Ontario, Canada.

3Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.

4Alimentiv Inc, London, Ontario, Canada.

5Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele Milano, Milan, Italy.

6Department of Biomedical Sciences, Humanitas University, Milan, Italy.

7Ferring International Center, Saint-Prex, Switzerland.

8Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal.

9Department of Clinical Pharmacology, São João University Hospital Center (CHUSJ), Porto, Portugal.

10Faculty of Medicine, University of Porto, Center for Health Technology and Services Research (CINTESIS), Porto, Portugal.

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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