Evidence map›Paper›PMID 38271613›Full record

Trial reportInflammatory bowel diseases2024

Extended Induction and Prognostic Indicators of Response in Patients Treated with Mirikizumab with Moderately to Severely Active Ulcerative Colitis in the LUCENT Trials.

Geert D'Haens, Peter D R Higgins, Laurent Peyrin-Biroulet, Bruce E Sands, Scott Lee, Richard E Moses, Isabel Redondo, Rodrigo Escobar, Theresa Hunter Gibble, Anthony Keohane and 4 more

Open 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. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
8.8field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Article
  10. 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
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Key Interleukins in Inflammatory Bowel Disease-A Review of Recent Studies.International journal of molecular sciences · 2024
    Review
  17. Mirikizumab in Moderately to Severely Active Colitis.Gastroenterology & hepatology · 2023
    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

14 authors at 10 institutions in 9 countries.

Geert D'HaensDepartment of Gastroenterology, Inflammatory Bowel Disease Centre, Amsterdam University Medical Center, Meibergdreef 9, C2-208, 1105 AZ Amsterdam, the Netherlands.ORCID 0000-0003-2784-4046
Peter D R HigginsGastroenterology Clinic, Taubman Center, 1500 E Medical Center Dr, University of Michigan, Ann Arbor, MI, USA.
Laurent Peyrin-BirouletDepartment of Gastroenterology, University of Lorraine, CHRU-Nancy, France.
Bruce E SandsDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Scott LeeDigestive Health Center, University of Washington Medical Center, Seattle, WA, USA.
Richard E MosesEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Isabel RedondoEli Lilly Portugal, Rua Galileu Galilei 2 Lisboa 1500-392, Portugal.
Rodrigo EscobarLilly S.A, Avenida de la Industria, 30. 28108, Alcobendas, SpainMadrid.
Theresa Hunter GibbleEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.ORCID 0000-0001-8412-9175
Anthony KeohaneHaaPACS GmbH, Statistics Europe, France.
Nathan MorrisEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Xin ZhangEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Vipin AroraEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642, Japan.ORCID 0000-0002-2073-4234
Eli Lilly (United States) · USEli Lilly (Spain) · ESESCP Business School · DEIcahn School of Medicine at Mount Sinai · USInserm · FRIstituto Nazionale di Fisica Nucleare, Galileo Galilei Institute for Theoretical Physics · ITKitasato Institute Hospital · JPUniversity Medical Center · USUniversity of Michigan · USUniversity of Washington Medical Center · US

Funding

Nonlinear Ultrasound: an Imaging Biomarker of Intestinal Fibrosis in Crohn's DiseaseR01DK109032 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI DILLMAN, JONATHAN RUSSELL, HIGGINS, PETER D.R. · 2016 to 2019
$2.4M
Eli Lilly and CompanyNIDDK NIH HHS R01 DK109032
6 · The paper itself

Abstract

backgroundEfficacy and safety of mirikizumab, a p19-targeted anti-interleukin-23 monoclonal antibody, for moderately to severely active ulcerative colitis was demonstrated previously. We evaluated clinical response, baseline characteristics, and clinical status in patients not responding by 12 weeks (W) of induction who then received extended induction treatment.

methodPatients unresponsive to 300 mg of intravenous (IV) mirikizumab every 4 weeks by W12 received 3 additional 300 mg IV doses every 4 weeks. Week-4 responders received 200 mg mirikizumab every 4 weeks subcutaneously until W52. Patients responding by W12 but subsequently losing response received rescue therapy with 300 mg IV for 3 doses every 4 weeks. Logistic regression modelling was performed for patients not achieving W12 clinical response to assess baseline characteristics and W12 efficacy parameters and potential prognostic factors of clinical response at W24.

resultsOf patients not achieving clinical response during induction, 53.7% achieved response following extended induction. After 52W, 72.2%, 43.1%, and 36.1% of patients achieved clinical response, endoscopic, and clinical remission, respectively. Of induction responders who subsequently lost response, 63.2% and 36.8% achieved symptomatic response and remission, respectively, after receiving rescue therapy No prior biologic or tofacitinib treatment, no immunomodulators at baseline, age older than 40 years, and W12 modified Mayo Score improvement were positively associated with a response to extended induction. The safety profile was similar to initial induction, with 38.3% treatment emergent adverse events, mostly mild.

conclusionWith "extended induction," total of 80.3% mirikizumab-treated patients achieved clinical response by W24. Potential prognostic factors determining response include disease severity, disease phenotype, C-reactive protein, and previous biologic therapy.

Indexed as

Colitis, UlcerativeSeverity of Illness IndexAdultAntibodies, Monoclonal, HumanizedFemaleHumansInduction ChemotherapyInterleukin-23 Subunit p19MaleMiddle AgedPrognosisRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedInterleukin-23 Subunit p19extended inductionIL-23 antibodiesmirikizumabulcerative colitis

Identifiers

PMID38271613
PMCPMC11630349
OpenAlexW4391215023

What OpenQuestion holds

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Registered trials

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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.