Dataset Information

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 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].

SUBMITTER: Sandborn WJ

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

REPOSITORIES: biostudies-literature

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Publications

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

Sandborn William J WJ Lewis James D JD Panes Julian J Loftus Edward V EV D'Haens Geert G Yu Zhuqing Z Huang Bidan B Lacerda Ana P AP Pangan Aileen L AL Feagan Brian G BG

Journal of Crohn's & colitis 20220301 3

<h4>Background and aims</h4>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.<h4>Methods</h4>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 includ ...[more]

PMID: 34546360

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Dataset Information

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

Background and aims

Methods

Results

Conclusions

Publications

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

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