Evidence map›Paper›PMID 37490069›Full record

Trial reportJournal of gastroenterology2023

Correlation of mucosal healing endpoints with long-term clinical and patient-reported outcomes in ulcerative colitis.

Gareth Parkes, Ryan C Ungaro, Silvio Danese, Maria T Abreu, Ethan Arenson, Wen Zhou, Dapo Ilo, F Stephen Laroux, Huiwen Deng, Yuri Sanchez Gonzalez and 1 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Journal of gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02819635 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
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.

NCT02819635 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorAbbVieRan2016 to 2021Enrolled1,302ConditionsUlcerative Colitis (UC)ArmsPlacebo, Upadacitinib
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Disease Clearance in Ulcerative Colitis: A Narrative Review.United European gastroenterology journal · 2025
    Review
  9. Article
  10. Novel outcomes in inflammatory bowel disease.Journal of Crohn's & colitis · 2025
    Review
  11. Article
  12. Article
  13. Article
  14. Treatment endpoints in ulcerative colitis: Does one size fit all?World journal of gastrointestinal pharmacology and therapeutics · 2024
    Article
  15. Article
  16. Article
  17. Article
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

11 authors.

Gareth ParkesDept of Gastroenterology, Royal London Hospital, Barts Health NHS Trust, London, UK. gareth.parkes@nhs.net.
Ryan C UngaroDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Silvio DaneseGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.
Maria T AbreuDivision of Gastroenterology, Crohn's and Colitis Center, University of Miami Miller School of Medicine, Miami, FL, USA.
Ethan ArensonAdelphi Values, Boston, MA, USA.
Wen ZhouAbbVie Inc., Chicago, IL, USA.
Dapo IloAbbVie Inc., Chicago, IL, USA.
F Stephen LarouxAbbVie Bioresearch Center, Worcester, MA, USA.
Huiwen DengAbbVie Inc., Chicago, IL, USA.
Yuri Sanchez GonzalezAbbVie Inc., Chicago, IL, USA.
Laurent Peyrin-BirouletUniversity Hospital of Nancy, Lorraine University, Vandoeuvre, France.

Funding

Assessing Predictors of Response to Anti-Tumor Necrosis Alpha Therapy in Early Crohns DiseaseK23DK111995 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI UNGARO, RYAN · 2019 to 2023
$948k
NIDDK NIH HHS K23 DK111995
6 · The paper itself

Abstract

backgroundWe evaluated the clinical relevance of achieving histologic endoscopic mucosal improvement (HEMI) and the more stringent target of histologic endoscopic mucosal remission (HEMR) in the phase 3 maintenance trial of upadacitinib for moderately to severely active ulcerative colitis.

methodsClinical and patient-reported outcomes were assessed in patients with clinical response after 8- or 16-week upadacitinib induction who received 52-week upadacitinib maintenance treatment. Cross-sectional and predictive analyses evaluated the relationship between HEMR or HEMI at Week 8/16 and Week 52, respectively, and outcomes at Week 52. Adjusted odds ratios (aOR) were derived from logistic regressions for patients achieving HEMR or HEMI without HEMR versus those not achieving HEMI.

resultsCross-sectional analyses showed that patients with HEMR had greater odds of achieving all clinical and patient-reported outcomes at Week 52 than those not achieving HEMI. In predictive analyses, patients with HEMR at Week 8/16 had significantly greater odds of achieving clinical remission (aOR = 3.6, p = 0.001) and endoscopic remission (aOR = 3.9, p < 0.001) at Week 52 than patients not achieving HEMI and HEMR. For patients achieving HEMI without HEMR, these odds were lower: clinical remission (aOR = 3.2, p < 0.001) and endoscopic remission (aOR = 2.4, p = 0.010). The odds of achieving clinically meaningful improvements in most patient-reported outcomes were directionally similar between HEMI and HEMR, but not statistically different to patients not achieving HEMI. No hospitalizations or surgeries were observed in patients with HEMR at Week 52.

conclusionsAchievement of HEMR or HEMI is clinically relevant with HEMR being associated with greater likelihood of improvement in long-term clinical and patient-reported outcomes. https://www. CLINICALTRIALS: gov NCT02819635.

Indexed as

Colitis, UlcerativeCross-Sectional StudiesEndoscopyHumansIntestinal MucosaRemission InductionSeverity of Illness IndexTreatment OutcomeHistologic endoscopic mucosal improvementHistologic endoscopic mucosal remissionInflammatory bowel disease

Identifiers

PMID37490069
PMCPMC10522527

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Registered trials

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.