Evidence map›Paper›PMID 42104877›Full record

Trial reportUnited European gastroenterology journal2026

Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis.

Ailsa Hart, Seyedehsan Navabi, Geert D'Haens, Katsuyoshi Matsuoka, María Dolores Martín-Arranz, Raja Atreya, Karen Hamrick Samaan, Endip Dhesi, Isabel Redondo, Baojin Zhu and 6 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in United European gastroenterology journal, 2026. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. A Practical Guide to the Use of Mirikizumab.The American journal of gastroenterology · 2024
    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

16 authors.

Ailsa HartSt Mark's Hospital & Imperial College London, London, UK.
Seyedehsan NavabiUnited Medical Doctors, Long Beach, California, USA.ORCID https://orcid.org/0000-0002-6777-4372
Geert D'HaensDepartment of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.
Katsuyoshi MatsuokaToho University Sakura Medical Center, Sakura, Japan.
María Dolores Martín-ArranzDepartment of Gastroenterology of La Paz University Hospital, School of Medicine, Universidad Autónoma de Madrid, Hospital La Paz Institute for Health Research, La Paz Hospital, Madrid, Spain.ORCID https://orcid.org/0000-0002-1872-0917
Raja AtreyaFirst Department of Medicine, University Hospital Erlangen, University of Erlangen-Nürnberg, Erlangen, Germany.ORCID https://orcid.org/0000-0002-8556-8433
Karen Hamrick SamaanEli Lilly and Company, Indianapolis, Indiana, USA.
Endip DhesiEli Lilly and Company, Basingstoke, UK.
Isabel RedondoEli Lilly and Company, Indianapolis, Indiana, USA.
Baojin ZhuEli Lilly and Company, Indianapolis, Indiana, USA.
Jerome PaulissenSyneos Health, Morrisville, North Carolina, USA.
Liliana Zaremba-PechmannHaaPACS GmbH, Schriesheim, Germany.
Simin BayganiEli Lilly and Company, Indianapolis, Indiana, USA.
Jimmy LimdiDepartment of Gastroenterology, Northern Care Alliance NHS Trust, Manchester, UK.
David LaharieCentre Hospitalier Universitaire de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et Oncologie Digestive, Université de Bordeaux, Bordeaux, France.ORCID https://orcid.org/0000-0002-4753-6676
Silvio DaneseGastroenterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgroundMirikizumab demonstrated efficacy in moderately-to-severely active ulcerative colitis, including in patients with prior advanced therapy failure (PATF) (Phase 3: LUCENT-1 [NCT03518086], LUCENT-2 [NCT03524092]). This post hoc analysis evaluates mirikizumab efficacy by number/mechanism of PATF.

methodsLUCENT-1 patients received 300 mg mirikizumab or placebo; mirikizumab induction responders entered LUCENT-2 and received 200 mg mirikizumab or placebo until week (W)52. Mirikizumab induction non-responders received extended induction with open-label 300 mg mirikizumab between W12 and W24. Extended induction responders received open-label 200 mg mirikizumab between W24 and W52. In each population, efficacy was analyzed by subgroups based on PATF number (0, 1, ≥ 2 [2-3]) and mechanism (including difficult-to-treat [DTT]: anti-TNF plus tofacitinib and/or vedolizumab).

resultsAt baseline, 479/1162 patients (41.2%) had (≥ 1) PATF, of which 177 (37.0%) had DTT. Among mirikizumab-treated patients (n = 868), W12 clinical response was achieved by 69.8%, 63.9%, 45.3%, and 41.9% of the 0-PATF, 1-PATF, ≥ 2-PATF, and DTT subgroups, respectively. 42.1% (365/868) continued with maintenance treatment. Among W12 responders, 51.9% (0-PATF), 44.2% (1-PATF), 49.0% (≥ 2-PATF), and 42.9% (DTT) achieved clinical remission at W52. Over half of the patients (54.0% [147/272]) in the extended induction population had PATF; 51.0% (75/147) were DTT. At W24, clinical response was achieved by 62.4%, 41.4%, 49.5%, and 49.3% of the 0-PATF, 1-PATF, ≥ 2-PATF, and DTT subgroups. Of this 49.3% of the DTT subgroup (extended induction responders), 38.9% (14/36) achieved W52 clinical remission.

conclusionsMirikizumab induction and maintenance is efficacious in moderately-to-severely active ulcerative colitis with or without prior failure of advanced therapy, including difficult-to-treat disease. TRAIL REGISTRATION: LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeEndoscopy, GastrointestinalGastrointestinal AgentsInduction ChemotherapyMaintenance ChemotherapyAdultDouble-Blind MethodFemaleHumansIntention to Treat AnalysisMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal Agentsmirikizumabadvanced therapybiologicdifficult‐to‐treatmirikizumabulcerative colitis

Identifiers

PMID42104877
PMCPMC13156813

What OpenQuestion holds

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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.