Evidence map›Paper›PMID 33755884›Full record

Trial reportAdvances in therapy2021

Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease.

Laurent Peyrin-Biroulet, Edouard Louis, Edward V Loftus, Ana Lacerda, Qian Zhou, Yuri Sanchez Gonzalez, Subrata Ghosh

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02365649 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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.

NCT02365649 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled220ConditionsCrohn's DiseaseArmsPlacebo, ABT-494
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. [A case report of Crohn's disease in a child treated with upadacitinib].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026
    Article
  4. Article
  5. Review
  6. Article
  7. 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

7 authors at 5 institutions in 4 countries.

Laurent Peyrin-BirouletDepartment of Gastroenterology, Nancy University Hospital, Nancy, France. peyrinbiroulet@gmail.com.
Edouard LouisUniversity Hospital CHU of Liège, Liège, Belgium.
Edward V LoftusMayo Clinic College of Medicine, Rochester, MN, USA.
Ana LacerdaAbbVie Inc., North Chicago, IL, USA.
Qian ZhouAbbVie Inc., North Chicago, IL, USA.
Yuri Sanchez GonzalezAbbVie Inc., North Chicago, IL, USA.
Subrata GhoshUniversity of Birmingham, Birmingham, UK.
AbbVie (United States) · USCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire de Liège · BEMayo Clinic · USUniversity of Birmingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn the phase 2 CELEST study, positive efficacy results were obtained with the Janus kinase 1 inhibitor upadacitinib for adult patients with moderate to severe Crohn's disease. We present the health-related quality of life and work productivity improvement results with upadacitinib from CELEST.

methodsCELEST (NCT02365649) was a double-blind study where patients were randomized 1:1:1:1:1:1 in the 16-week induction period to placebo or upadacitinib 3 mg twice daily (BID), 6 mg BID, 12 mg BID, 24 mg BID, or 24 mg once daily (QD). Patients completing the induction period were re-randomized 1:1:1 to receive upadacitinib 3 mg BID, 12 mg BID, or 24 mg QD for 36 weeks or 3 mg BID, 6 mg BID, or 12 mg BID (after amendment). Inflammatory Bowel Disease Questionnaire (IBDQ), European Quality of Life-5 Dimensions visual analog scale (EQ-5D VAS), and Work Productivity and Activity Impairment (WPAI) questionnaire outcomes were assessed at baseline and Weeks 8, 16, and 52.

resultsAt Week 16, a significant percentage (P ≤ 0.05) of patients receiving upadacitinib 6-mg BID dose or higher achieved IBDQ response (IBDQ score change ≥ 16 points; 49%-57% for upadacitinib vs. 24% for placebo) and IBDQ remission, except 24 mg QD (IBDQ score ≥ 170; 26%-39% for upadacitinib vs. 11% for placebo). Greater improvements in IBDQ total score, EQ-5D VAS, and activity impairment from baseline (P ≤ 0.1) versus placebo were also observed. Larger improvements (P ≤ 0.1) in IBDQ response and total score and EQ-5D VAS were observed at Week 8 with 6 and 24 mg BID versus placebo, with improvements for all dosages maintained or greater at Week 52 for IBDQ, EQ-5D VAS, and WPAI endpoints, in particular for the 12-mg BID group.

conclusionImprovements in health-related quality of life and work productivity were achieved and sustained with upadacitinib in patients with moderate to severe Crohn's disease.

trial registrationClinicalTrials.gov identifier, NCT02365649.

Indexed as

Crohn DiseaseQuality of LifeAdultDouble-Blind MethodEfficiencyHeterocyclic Compounds, 3-RingHumansTreatment OutcomeHeterocyclic Compounds, 3-RingupadacitinibCELESTEuropean Quality of Life-5 Dimensions Visual Analog ScaleInflammatory Bowel Disease QuestionnaireJanus kinase 1Quality of lifeUpadacitinibWork Productivity and Activity Impairment Questionnaire

Identifiers

PMID33755884
PMCPMC8107073
OpenAlexW3136894032

What OpenQuestion 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 OpenQuestion graph.