Evidence map›Paper›PMID 34107013›Full record

Trial reportJournal of Crohn's & colitis2021

Upadacitinib Treatment Improves Symptoms of Bowel Urgency and Abdominal Pain, and Correlates With Quality of Life Improvements in Patients With Moderate to Severe Ulcerative Colitis.

Subrata Ghosh, Yuri Sanchez Gonzalez, Wen Zhou, Ryan Clark, Wangang Xie, Edouard Louis, Edward V Loftus, Julian Panes, Silvio Danese

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Trial
  5. Trial
  6. Review
  7. Article
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  9. Article
  10. Novel outcomes in inflammatory bowel disease.Journal of Crohn's & colitis · 2025
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Assessing anorectal function in patients with recurrent ulcerative colitis.International journal of colorectal disease · 2024
    Article
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 5 countries.

Subrata GhoshCollege of Medicine and Health, University College Cork, Cork, Ireland.
Yuri Sanchez GonzalezDepartment of Health Economics and Outcomes Research, AbbVie Inc., North Chicago, IL, USA.
Wen ZhouDepartment of Clinical Development, AbbVie Inc., North Chicago, IL, USA.
Ryan ClarkDepartment of Health Economics and Outcomes Research, AbbVie Inc., North Chicago, IL, USA.
Wangang XieDepartment of Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
Edouard LouisDepartment of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium.
Edward V LoftusDivision of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.
Julian PanesDepartment of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.ORCID 0000-0002-4971-6902
Silvio DaneseDepartment of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy.
AbbVie (United States) · USCentre Hospitalier Universitaire de Liège · BEFondazione Humanitas per la Ricerca · ITHospital Clínic de Barcelona · ESMayo Clinic in Arizona · USUniversity College Cork · IE

Funding

AbbVie Inc.
6 · The paper itself

Abstract

BACKGROUND AND

aimsBowel urgency and abdominal pain are impactful, yet under-appreciated ulcerative colitis symptoms and not commonly assessed in clinical trials. We evaluated how these symptoms may improve with upadacitinib treatment and correlate with clinical and health-related quality of life [HRQOL] outcomes in the phase 2b U-ACHIEVE study.

methodsPatients aged 18-75 years, with moderately to severely active ulcerative colitis, were randomised to receive placebo or upadacitinib (7.5, 15, 30, or 45 mg once daily [QD]). Bowel urgency and abdominal pain were evaluated at baseline and Weeks 2, 4, 6, and 8. Week 8 correlations were evaluated between bowel urgency/abdominal pain with clinical [Mayo subscores and high-sensitivity C-reactive protein and faecal calprotectin measurements] and HRQOL outcomes [Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey scores].

resultsA greater proportion of patients [n = 250] reported no bowel urgency and less abdominal pain with upadacitinib treatment compared with placebo, with improvements observed as early as 2 weeks. At Week 8, patients receiving the 45-mg QD dose had the greatest improvements versus placebo, with 46% reporting no bowel urgency [vs 9%; p ≤ 0.001] and 38% reporting no abdominal pain [vs 13%; p = 0.015]. At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes.

conclusionsInduction treatment with upadacitinib demonstrated significant reductions in bowel urgency and abdominal pain compared with placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.

Indexed as

Severity of Illness IndexAbdominal PainAdolescentAdultAgedColitis, UlcerativeFecal IncontinenceFemaleGastrointestinal AgentsHeterocyclic Compounds, 3-RingHumansMaleMiddle AgedQuality of LifeSurveys and QuestionnairesTreatment OutcomeGastrointestinal AgentsHeterocyclic Compounds, 3-RingupadacitinibAbdominal painbowel urgencyupadacitinib

Identifiers

PMID34107013
PMCPMC8684481
OpenAlexW3168130233

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.