Abstract

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

J Crohns Colitis. 2022 Mar 14;16(3):444-451.doi: 10.1093/ecco-jcc/jjab161.

 

William J Sandborn 1James D Lewis 2Julian Panes 3Edward V Loftus 4Geert D'Haens 5Zhuqing Yu 6Bidan Huang 7 6Ana P Lacerda 7Aileen L Pangan 7Brian G Feagan 8

 
     

Author information

1University of California San Diego, La Jolla, CA, USA.

2University of Pennsylvania, Philadelphia, PA, USA.

3Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

4Mayo Clinic, Rochester, MN, USA.

5Amsterdam University Medical Centers, Amsterdam, Netherlands.

6AstraZeneca, Chicago, IL, USA.

7AbbVie Inc., North Chicago, IL, USA.

8Robarts Clinical Trials, London, ON, Canada.

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 well-being and clinical outcomes were evaluated using cumulative distribution function and probability density function curves.

Results: In total, 858 patients with CD were included [adalimumab, n = 695; upadacitinib, n = 163]. Patients who achieved clinical remission [SF ≤2.8, AP score ≤1.0, neither worse than baseline] were more likely than those not in clinical remission to report IBDQ item 10 response in the 6-7 group category but not IBDQ categories ≤5. Higher IBDQ score for item 10 [6-7] was associated with lower SF and AP score. Greater point increases in IBDQ item 10 were associated with a greater percentage decrease in clinical parameters; a ≥25-30% decrease in SF or AP was associated with a ≥1-point improvement in IBDQ.

Conclusions: An association between improvements in patient-reported general well-being and clinical remission/response was observed using outcomes of SF and AP, supporting the clinical remission/response endpoint definitions used in clinical studies of CD. Clinical Trial Registrations [ClinicalTrials.gov]: NCT00077779 [CHARM]; NCT00348283 [EXTEND]; NCT02365649 [CELEST].

 

 

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