Evidence map›Paper›PMID 40591171›Full record

Trial reportJournal of patient-reported outcomes2025

Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab.

David B Clemow, Marla C Dubinsky, Simin K Baygani, Bruce E Sands, Anthony Keohane, Silvio Danese, Stefan Schreiber, Alissa J Walsh, Toshifumi Hibi, Theresa Hunter Gibble and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of patient-reported outcomes, 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

12 authors.

David B ClemowEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. clemow_david_b@lilly.com.
Marla C Dubinsky, Mount Sinai Hospital, New York, NY, USA.
Simin K BayganiEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Anthony KeohaneHaaPACS GmbH, Statistics, Schriesheim, Germany.
Silvio DaneseIRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.
Stefan SchreiberUniversity Hospital Schleswig-Holstein, Kiel, Germany.
Alissa J WalshOxford University Hospitals NHS Foundation Trust, Oxford, UK.
Toshifumi HibiKitasato University, Kitasato Institute Hospital, Tokyo, Japan.
Theresa Hunter GibbleEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Richard E MosesEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Simon P L TravisKennedy Institute of Rheumatology, Translational Gastroenterology Unit, and Biomedical Research Centre, University of Oxford, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMirikizumab has demonstrated efficacy in moderately to severely active ulcerative colitis. A 1-2-point change in Urgency Numeric Rating Scale (NRS) score can be meaningful for patients. In these post-hoc analyses, we evaluated the efficacy of mirikizumab compared to placebo by baseline Urgency NRS score groups (0-3, 4-6, and 7-10) and its effect on bowel urgency severity over time. METHODOLOGY: Urgency NRS was measured as a secondary outcome at baseline, week 12, and week 52. Bowel urgency improvement was assessed for patients who achieved and did not achieve multiple efficacy endpoints. Data were analyzed using Fisher's exact test with nonresponder imputation.

resultsAt weeks 12 and 52, a significantly higher percentage of mirikizumab-treated patients achieved clinical response as well as clinical, endoscopic, and symptomatic remission compared to placebo-treated patients, regardless of baseline Urgency NRS score category (higher proportions versus placebo, delta 9%-45%). Improvement in Urgency NRS score category at weeks 12 and 52 for mirikizumab-treated patients was observed when other efficacy outcomes were achieved (13%-90%) and not achieved (12%-75%).

conclusionsA greater proportion of mirikizumab-treated patients with ulcerative colitis achieved symptomatic, clinical, and endoscopic remission endpoints compared to placebo-treated patients, regardless of baseline bowel urgency severity. After one year, bowel urgency was improved to a greater extent with mirikizumab than with placebo, even for patients who did not achieve other clinical outcomes. Small improvements in bowel urgency are associated with significant health-related quality-of-life improvements. Monitoring shifts in urgency severity over time using the Urgency NRS can aid in understanding patients' treatment outcomes.

trial registrationLUCENT-1 (NCT03518086) Registered 04 May 2018 https://clinicaltrials.gov/study/NCT03518086 . LUCENT-2 (NCT03524092) Registered 10 May 2018 https://clinicaltrials.gov/study/NCT03524092 .

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeGastrointestinal AgentsAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal Agents

Identifiers

PMID40591171
PMCPMC12214185

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.