Evidence map›Paper›PMID 39231444›Full record

Trial reportInflammatory bowel diseases2025

Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease.

Julian Panés, Edouard Louis, Peter Bossuyt, Namita Joshi, Wan-Ju Lee, Ana P Lacerda, Kristina Kligys, Si Xuan, Nidhi Shukla, Edward V Loftus

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03345823 phase3active not recruitingnot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

TypeinterventionalSponsorAbbVieRan2018 to 2027Enrolled747ConditionsCrohn's DiseaseArmsUpadacitinib, Placebo for Upadacitinib
NCT03345836 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

TypeinterventionalSponsorAbbVieRan2017 to 2021Enrolled624ConditionsCrohn's DiseaseArmsMatching Placebo for Upadacitinib, Upadacitinib
NCT03345849 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

TypeinterventionalSponsorAbbVieRan2017 to 2022Enrolled526ConditionsCrohn's DiseaseArmsUpadacitinib, Placebo for Upadacitinib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

10 authors.

Julian PanésHospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.ORCID 0000-0002-4971-6902
Edouard LouisDepartment of Clinical Sciences, University Hospital CHU of Liège, Liège, Belgium.
Peter BossuytImelda Gastrointestinal (GI) Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.ORCID 0000-0003-4027-7365
Namita JoshiHEOR, AbbVie Inc., North Chicago, IL, USA.
Wan-Ju LeeHEOR, AbbVie Inc., North Chicago, IL, USA.
Ana P LacerdaHEOR, AbbVie Inc., North Chicago, IL, USA.
Kristina KligysHEOR, AbbVie Inc., North Chicago, IL, USA.
Si XuanHEOR, AbbVie Inc., North Chicago, IL, USA.
Nidhi ShuklaHEOR, AbbVie Inc., North Chicago, IL, USA.
Edward V LoftusDivision of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe evaluated the association of achieving endoscopic outcomes at week 12 of induction with improvements in clinical outcomes and quality of life (QoL) at week 52 of maintenance in patients with moderately to severely active Crohn's disease (CD) treated with upadacitinib (UPA).

methodsThis post hoc analysis evaluated data from 2 phase 3 induction trials (NCT03345836 and NCT03345849) and 1 maintenance (NCT03345823) trial. Clinical responders to 12-week induction therapy with UPA who also received 52-week maintenance treatment with UPA were included. Endoscopic response, remission, healing, and ulcer-free endoscopy were assessed at week 12. Meaningful improvements in clinical and QoL outcomes were evaluated at week 52.

resultsA significantly greater proportion of patients who achieved an endoscopic response at the end of induction, compared with patients who did not, attained Crohn's Disease Activity Index (CDAI) remission (52.0% vs 34.6%; P ≤ .01), corticosteroid-free CDAI remission (50.0% vs 30.9%), Inflammatory Bowel Disease Questionnaire remission (52.6% vs 30.3%), and meaningful improvements in Functional Assessment of Chronic Illness Therapy-Fatigue response (46.7% vs 25.9%), overall work impairment (47.1% vs 26.5%), and daily activity impairment (53.3% vs 34.1%) (all P < .05) at week 52. Similar findings were observed for patients who achieved endoscopic remission, endoscopic healing, and ulcer-free endoscopy at the end of induction vs those who did not.

conclusionsEarly improvement in endoscopic outcomes after UPA induction treatment was associated with long-term meaningful improvements in clinical outcomes and QoL in patients with CD. CLINICAL REGISTRATION NUMBER: U-EXCEED induction trial (NCT03345836), U-EXCEL induction trial (NCT03345849), and U-ENDURE maintenance trial (NCT03345823).

Indexed as

Crohn DiseaseEndoscopy, GastrointestinalHeterocyclic Compounds, 3-RingQuality of LifeAdultFemaleHumansMaintenance ChemotherapyMaleMiddle AgedRemission InductionSeverity of Illness IndexTreatment OutcomeYoung AdultHeterocyclic Compounds, 3-Ringupadacitinibclinical trialsCrohn’s diseaseendoscopyquality of lifeupadacitinib

Identifiers

PMID39231444
PMCPMC11808569

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.