Evidence map›Paper›PMID 38869019›Full record

Trial reportJournal of Crohn's & colitis2024

Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme.

Silvio Danese, Axel Dignass, Katsuyoshi Matsuoka, Marc Ferrante, Millie Long, Isabel Redondo, Richard Moses, Sebastian Maier, Theresa Hunter Gibble, Nathan Morris and 2 more

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

Trial report in Journal of Crohn's & colitis, 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Comparative effectiveness of mirikizumab and risankizumab in patients with ulcerative colitis: A propensity-matched cohort study.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
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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.

Silvio DaneseGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy.ORCID 0000-0001-7341-1351
Axel DignassDepartment of Medicine I, Agaplesion Markus Krankenhaus, Frankfurt, Germany.
Katsuyoshi MatsuokaToho University, Sakura Medical Center, Sakura, Japan.ORCID 0000-0002-2950-7660
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.ORCID 0000-0003-1492-0716
Millie LongDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.
Isabel RedondoEli Lilly and Company, Indianapolis, USA.
Richard MosesEli Lilly and Company, Indianapolis, USA.
Sebastian MaierEli Lilly and Company, Indianapolis, USA.
Theresa Hunter GibbleEli Lilly and Company, Indianapolis, USA.ORCID 0000-0001-8412-9175
Nathan MorrisEli Lilly and Company, Indianapolis, USA.
Catherine MilchEli Lilly and Company, Indianapolis, USA.
Maria T AbreuDivision of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

BACKGROUND AND

aimsUlcerative colitis [UC], a chronic inflammatory bowel disease, may manifest with symptoms of increased stool frequency [SF], rectal bleeding [RB], bowel urgency [BU], abdominal pain [AP], and fatigue. Mirikizumab, an anti-IL-23p19 antibody, demonstrated efficacy and safety in patients with moderately to severely active UC in the LUCENT Phase 3 trials. We evaluated mirikizumab's efficacy in achieving symptom control and time to symptom improvement during induction, maintenance of sustained symptom control, 'comprehensive symptom control', defined according to a combination of individual patient-reported outcomes, and prognostic baseline indicators of early symptomatic remission at Week 4.

methodsThe results of LUCENT-1/-2 have previously been reported. Treatment differences for symptomatic endpoints were compared over 52 weeks versus placebo [PBO] and comprehensive symptomatic endpoints at 12 and 52 weeks of continuous treatment. Subgroup analyses were conducted for prior biologic or tofacitinib treatment failure. Prognostic analyses were run using regression analysis.

resultsBy Week [W] 2, mirikizumab-treated patients achieved greater reductions in SF, RB, BU, and fatigue versus PBO. At W4, there was a higher rate of AP improvement. At W12, a greater proportion of mirikizumab-treated patients achieved symptomatic remission, RB remission, SF remission, and BU remission/clinically meaningful improvement. Mirikizumab-treated patients sustained symptom control versus placebo patients in maintenance until W52. This treatment effect was shown in patients regardless of prior biologic or tofacitinib failure. Additionally, mirikizumab achieved comprehensive symptom control versus PBO at W12 and W52.

conclusionsMirikizumab demonstrated efficacy in achieving and sustaining symptom control and comprehensive symptom control over 52 weeks [NCT03518086; NCT03524092].

Indexed as

Colitis, UlcerativeAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodFatigueFemaleHumansInterleukin-23 Subunit p19MaleMiddle AgedPatient Reported Outcome MeasuresPiperidinesRemission InductionSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedInterleukin-23 Subunit p19PiperidinesComprehensivesymptomulcerative colitis

Identifiers

PMID38869019
PMCPMC11532612

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.