Evidence map›Paper›PMID 40488552›Full record

Trial reportJournal of Crohn's & colitis2025

Achievement of long-term treatment goals in upadacitinib-treated patients with moderately to severely active ulcerative colitis: a post hoc analysis of phase 3 trial data.

Julian Panés, Marla C Dubinsky, Yoh Ishiguro, Nidhi Shukla, Elena Dubcenco, Valencia Remple, Dolly Sharma, Remo Panaccione

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

Trial report in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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
NCT03653026 phase3completednot on this map

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

TypeinterventionalSponsorAbbVieRan2018 to 2021Enrolled522ConditionsUlcerative Colitis (UC)ArmsPlacebo, Upadacitinib
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Julian PanésHospital Clinic Barcelona, IDIPABS, CIBERehd, Barcelona, Spain.ORCID 0000-0002-4971-6902
Marla C DubinskySusan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, NY, United States.
Yoh IshiguroDepartment of Clinical Research, Hirosaki General Medical Center, National Hospital Organization, Hirosaki, Japan.
Nidhi ShuklaAbbVie Inc., Chicago, IL, United States.
Elena DubcencoAbbVie Inc., Chicago, IL, United States.
Valencia RempleAbbVie Inc., Chicago, IL, United States.
Dolly SharmaAbbVie Inc., Chicago, IL, United States.
Remo PanaccioneDepartment of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-5247-940X

Funding

AbbVie
6 · The paper itself

Abstract

BACKGROUND AND

aimsComprehensive disease control is an important yet elusive treatment goal in ulcerative colitis (UC). We evaluated the effect of upadacitinib induction and maintenance treatment on composite clinical endpoints and normalization of important health-related quality of life (HRQoL) outcomes.

methodsData from the U-ACHIEVE and U-ACCOMPLISH trials were analyzed. Clinical responders to upadacitinib 45 mg 8-week induction were re-randomized 1:1:1 to upadacitinib 30 mg, 15 mg, or placebo for 52 weeks of maintenance. The percentage of patients achieving a composite clinical endpoint (clinical remission, complete symptom resolution, and Inflammatory Bowel Disease Questionnaire [IBDQ] remission) and a composite endpoint for normalization of HRQoL outcomes (Functional Assessment of Chronic Illness Therapy-Fatigue, IBDQ remission, Work Productivity and Activity Impairment Questionnaire-Ulcerative Colitis, 36-item Short Form Survey Physical Component Summary and Mental Component Survey, and EuroQol 5-Dimension 5-Level scores) was evaluated.

resultsAt induction week 8, more patients treated with upadacitinib 45 mg achieved the composite clinical endpoint vs placebo (6.4% vs 0.9%, P ≤ .001) and normalization of the composite HRQoL endpoint (18.9% vs 5.5%, P ≤ .001). At maintenance week 52, the composite clinical endpoint was achieved by 18.3% and 13.1% of patients treated with upadacitinib 30 mg and 15 mg, respectively, vs 4.5% with placebo (P ≤ .001). Normalization of the composite HRQoL endpoint was achieved by 24.0% and 22.3% of patients treated with upadacitinib 30 mg and 15 mg, respectively, vs 8.7% for placebo (P ≤ .001).

conclusionsUpadacitinib may help patients with moderately to severely active UC achieve complete symptom resolution, endoscopic remission, and normalization of HRQoL. CLINICAL REGISTRATION NUMBERS: U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026).

Indexed as

Colitis, UlcerativeHeterocyclic Compounds, 3-RingAdultFemaleHumansMaintenance ChemotherapyMaleMiddle AgedQuality of LifeRemission InductionSeverity of Illness IndexTreatment OutcomeHeterocyclic Compounds, 3-Ringupadacitinibclinical trialsquality of lifesocio-economical and psychological endpoints

Identifiers

PMID40488552
PMCPMC12260494

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.