Evidence map›Paper›PMID 38313767›Full record

ArticleCrohn's & colitis 3602024

Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies.

Millie D Long, Stefan Schreiber, Toshifumi Hibi, Theresa Hunter Gibble, Deborah A Fisher, Gina Park, Richard E Moses, Peter D R Higgins, James O Lindsay, Scott D Lee and 2 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Crohn's & colitis 360, 2024. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
5.5field-weighted citation impact, top 4% 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.

NCT03518086 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2024Enrolled1,281ConditionsUlcerative ColitisArmsMirikizumab, Placebo
NCT03524092 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2025Enrolled1,328ConditionsUlcerative ColitisArmsMirikizumab SC, Mirikizumab IV, Placebo SC
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

12 authors at 8 institutions in 5 countries.

Millie D LongDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.
Stefan SchreiberDepartment Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Toshifumi HibiKitasato Institute Hospital, Minato-ku, Center for Advanced IBD Research and Treatment, Tokyo, Japan.
Theresa Hunter GibbleEli Lilly and Company, Indianapolis, IN, USA.ORCID https://orcid.org/0000-0001-8412-9175
Deborah A FisherEli Lilly and Company, Indianapolis, IN, USA.
Gina ParkTechdata Services Company LLC, King of Prussia, PA, USA.
Richard E MosesEli Lilly and Company, Indianapolis, IN, USA.
Peter D R HigginsDepartment of Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.
James O LindsayBarts Health NHS Trust, London, UK.
Scott D LeeDivision of Gastroenterology, University of Washington Medical Center, Seattle, WA, USA.
Rodrigo EscobarEli Lilly and Company, Indianapolis, IN, USA.
Vipul JairathDepartment of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada.ORCID https://orcid.org/0000-0001-8603-898X
Eli Lilly (United States) · USBarts Health NHS Trust · GBChristian-Albrechts-Universität zu Kiel · DEKitasato Institute Hospital · JPUniversity of Michigan · USUniversity of North Carolina at Chapel Hill · USUniversity of Washington Medical Center · USWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality-of-life (QoL) outcomes. Methods: LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200 mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, the association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. Results: A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, Conclusions: In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies. Clinical Studies: LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.

Indexed as

bowel urgencyquality of lifeulcerative colitis

Identifiers

PMID38313767
PMCPMC10838132
OpenAlexW4390640897

What Socratic 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 Socratic graph.