Evidence map›Paper›PMID 37057827›Full record

Trial reportJournal of Crohn's & colitis2023

Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes.

Fernando Magro, Rish K Pai, Taku Kobayashi, Vipul Jairath, Florian Rieder, Isabel Redondo, Trevor Lissoos, Nathan Morris, Mingyang Shan, Meekyong Park and 1 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2023. 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 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
10.6field-weighted citation impact, top 1% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  16. Disease Clearance in Ulcerative Colitis: A Narrative Review.United European gastroenterology journal · 2025
    Review
  17. Observational
  18. Novel outcomes in inflammatory bowel disease.Journal of Crohn's & colitis · 2025
    Review
  19. Review
  20. 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

11 authors at 7 institutions in 5 countries.

Fernando MagroDepartment of Gastroenterology, University Hospital São João, Porto, Portugal.ORCID 0000-0003-2634-9668
Rish K PaiDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, AZ, USA.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Minato-ku, Tokyo, Japan.ORCID 0000-0002-2073-4234
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.ORCID 0000-0001-8603-898X
Florian RiederDepartment of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
Isabel RedondoEli Lilly Portugal, Produtos Farmacêuticos Lda., Lisbon, Portugal.
Trevor LissoosEli Lilly and Company, Indianapolis, IN, USA.
Nathan MorrisEli Lilly and Company, Indianapolis, IN, USA.
Mingyang ShanEli Lilly and Company, Indianapolis, IN, USA.
Meekyong ParkTechData Service Company LLC, Philadelphia, PA, USA.
Laurent Peyrin-BirouletUniversity of Lorraine, Inserm, NGERE, Nancy, and Groupe Hospitalier Privé Ambroise Paré - Hartmann, Paris IBD Center, Neuilly sur Seine, France.
Eli Lilly (United States) · USCleveland Clinic · USInserm · FRKitasato Institute Hospital · JPMayo Clinic in Arizona · USUniversidade do Porto · PTWestern University · CA

Funding

Septins in intestinal fibrosisR01DK132038 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI Andrei Ivanovich Ivanov, Florian Rieder · 2023 to 2026
$2.5M
Creeping fat and Crohn's disease associated stricturesR01DK123233 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI RIEDER, FLORIAN · 2020 to 2024
$1.9M
NIDDK NIH HHS R01 DK123233NIDDK NIH HHS R01 DK132038
6 · The paper itself

Abstract

BACKGROUND AND

aimsTo evaluate the effect of mirikizumab, a p19-targeted anti-interleukin-23, on histological and/or endoscopic outcomes in moderately-to-severely active ulcerative colitis [UC].

methodsEndoscopic remission [ER], histological improvement [HI], histological remission [HR], histological-endoscopic mucosal improvement [HEMI], and histological-endoscopic mucosal remission [HEMR] were assessed at Week [W]12 [LUCENT-1: N = 1162, induction] and W40 [LUCENT-2: N = 544, maintenance] for patients randomised to mirikizumab or placebo. Analyses were performed to evaluate predictors of: HEMI at W12 with mirikizumab and HEMR at W40 in patients re-randomised to subcutaneous [SC] mirikizumab; associations between W12 histological/endoscopic endpoints and W40 outcomes in mirikizumab responders re-randomised to mirikizumab SC; and associations between W40 endoscopic normalisation [EN] with/without HR.

resultsSignificantly more patients treated with mirikizumab achieved HI, HR, ER, HEMI, and HEMR vs placebo [p <0.001], irrespective of prior biologic/tofacitinib failure [p <0.05]. Lower clinical baseline disease activity, female sex, no baseline immunomodulator use, and no prior biologic/tofacitinib failure were predictors of HEMI at W12 [p <0.05]. Corticosteroid use and longer disease duration were negative predictors of achieving HEMR at W40 [p <0.05]. W12 HI, HR, or ER was associated with W40 HEMI or HEMR [p <0.05]; ER at W12 was associated with clinical remission [CR] [p <0.05] and corticosteroid-free remission [CSFR] at W40 [p = 0.052]. HR and HEMR at W12 were associated with CSFR, CR, and symptomatic remission at W40. Alternate HEMR [EN + HR] at W40 was associated with bowel urgency remission at W40 [p <0.05].

conclusionsEarly resolution of endoscopic and histological inflammation with mirikizumab is associated with better UC outcomes. Clinicaltrials.gov: LUCENT-1, NCT03518086; LUCENT-2, NCT03524092.

Indexed as

Antibodies, Monoclonal, HumanizedBiological ProductsColitis, UlcerativeSulfonamidesAdrenal Cortex HormonesFemaleHumansInflammationRemission InductionAdrenal Cortex HormonesAntibodies, Monoclonal, HumanizedBiological ProductsmirikizumabSulfonamidesW 12Histological remissionmirikizumabulcerative colitis

Identifiers

PMID37057827
PMCPMC10588772
OpenAlexW4365483305

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.