Evidence map›Paper›PMID 38459910›Full record

Trial reportInflammatory bowel diseases2024

Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.

Bruce E Sands, Geert D'Haens, David B Clemow, Peter M Irving, Jordan T Johns, Theresa Hunter Gibble, Maria T Abreu, Scott Lee, Tadakazu Hisamatsu, Taku Kobayashi and 9 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Inflammatory bowel diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06864403 (Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
25.3field-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.

NCT06864403 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2025 to 2027Enrolled25ConditionsPouchitis, Pouches, Ileoanal, Pouch, IlealArmsMirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Trial
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  10. Review
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  12. Article
  13. 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
    Article
  14. Interleukin-23 Inhibitors in Inflammatory Bowel Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. New Kids on the Block: IL-23 Inhibitors in IBD Management.Current gastroenterology reports · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 13 institutions in 8 countries.

Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Geert D'HaensAmsterdam University Medical Centers, Amsterdam, the Netherlands.ORCID 0000-0003-2784-4046
David B ClemowEli Lilly and Company, Indianapolis, IN, USA.ORCID 0000-0002-5328-8285
Peter M IrvingGuy's and St. Thomas' NHS Foundation Trust, King's College London, London, United Kingdom.
Jordan T JohnsEli Lilly and Company, Indianapolis, IN, USA.
Theresa Hunter GibbleEli Lilly and Company, Indianapolis, IN, USA.
Maria T AbreuUHealth Crohn's and Colitis Center, University of Miami Miller School of Medicine, Miami, FL, USA.ORCID 0000-0002-7294-0574
Scott LeeDigestive Health Center, University of Washington Medical Center, Seattle, WA, USA.
Tadakazu HisamatsuDepartment of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.ORCID 0000-0002-1178-3536
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.ORCID 0000-0002-2073-4234
Marla C DubinskyIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Severine VermeireDepartment of Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium.ORCID 0000-0001-9942-3019
Corey A SiegelDartmouth Hitchcock Medical Center, Lebanon, NH, USA.
Laurent Peyrin-BirouletDepartment of Gastroenterology, INFINY Institute, FHU-CURE, French Institute of Health and Medical Research Nutrition-Genetics and Exposure to Environmental Risks Research Unit, Nancy University Hospital, Nancy, France.
Richard E MosesEli Lilly and Company, Indianapolis, IN, USA.
Joe MilataEli Lilly and Company, Indianapolis, IN, USA.
Vipin AroraEli Lilly and Company, Indianapolis, IN, USA.
Remo PanaccioneInflammatory Bowel Disease Group, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-5247-940X
Axel DignassDepartment of Medicine I, Agaplesion Markus Krankenhaus, Frankfurt, Germany.
Eli Lilly (United States) · USIcahn School of Medicine at Mount Sinai · USAgaplesion Markus Hospital · DEAmsterdam University Medical Centers · NLDartmouth–Hitchcock Medical Center · USKing's College London · GBKitasato Institute Hospital · JPKyorin University · JPMcGill University Health Centre · CAUniversitair Ziekenhuis Leuven · BEUniversity of Calgary · CAUniversity of Miami · USUniversity of Washington Medical Center · US

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgroundMirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical remission at week 12 (W12) and maintaining clinical remission at W52 in patients with moderately to severely active ulcerative colitis. Results are presented from the open-label extension study through W104.

methodsClinical, symptomatic, quality-of-life, and adverse event outcomes are reported for mirikizumab induction responders and extended induction responders, including biologic-failed patients, who entered LUCENT-3, with data shown for W52 maintenance responders or remitters. Discontinuations or missing data were handled by nonresponder imputation (NRI), modified NRI (mNRI), and observed case (OC).

resultsAmong W52 mirikizumab responders, clinical response at W104 was 74.5%, 87.2%, and 96.7% and clinical remission was 54.0%, 62.8%, and 70.1% for NRI, mNRI, and OC, respectively. Among W52 mirikizumab remitters, clinical response at W104 was 76.6%, 89.0%, and 98.3% and clinical remission was 65.6%, 76.1%, and 84.2%. Using mNRI, remission rates at W104 for W52 clinical remitters were 74.7% corticosteroid-free, 79.5% endoscopic, 63.9% histologic-endoscopic mucosal remission, 85.9% symptomatic, 59.8% bowel urgency, 80.5% Inflammatory Bowel Disease Questionnaire (using NRI), 71.2% histologic-endoscopic mucosal improvement, and 77.5% bowel urgency improvement. Previous biologic-failed vs not-biologic-failed patient data were generally similar. Extended induction mNRI clinical response was 81.9%. Serious adverse events were reported in 5.2% of patients; 2.8% discontinued treatment due to adverse events.

conclusionsEndoscopic, histologic, symptomatic, and quality-of-life outcomes support the long-term benefit of mirikizumab treatment up to 104 weeks in patients with ulcerative colitis, including biologic-failed patients, with no new safety concerns.

Indexed as

Colitis, UlcerativeQuality of LifeRemission InductionAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedFemaleHumansInterleukin-23 Subunit p19MaleMiddle AgedTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedInterleukin-23 Subunit p19mirikizumabIL-23 p19 antibodylong-term extensionmirikizumabulcerative colitisweek 104 results

Identifiers

PMID38459910
PMCPMC11630283
OpenAlexW4392615010

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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.