Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease.

ABSTRACT:

Background and aims

Patient-reported outcomes are recommended endpoints in Crohn's disease [CD] trials. The association between patient-reported general well-being relative to symptoms of diarrhoea and abdominal pain [AP] in patients with moderate to severe CD was explored.

Methods

Patients from three randomized, placebo-controlled, double-blind adalimumab or upadacitinib studies with average daily very soft/liquid stool frequency [SF] ≥4 and/or AP score ≥2 at baseline were included. Using electronic diaries, patients reported general well-being [seven-point Likert scale; 1 = worst; 7 = best] in item 10 of the Inflammatory Bowel Disease Questionnaire [IBDQ]. Changes in well-being and clinical outcomes of SF and AP from baseline to week 12 or 16, and the relationship between

SUBMITTER: Sandborn WJ 

PROVIDER: S-EPMC8919823 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature