Evidence map›Paper›PMID 36777368›Full record

ArticleCrohn's & colitis 3602023

Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission.

Marla C Dubinsky, David B Clemow, Theresa Hunter Gibble, Xingyuan Li, Severine Vermeire, Tadakazu Hisamatsu, Simon P L Travis

2 registry-linked trialsAbstract read
In one paragraph

Article in Crohn's & colitis 360, 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.

0numbers the graph read from it
0cells of the map it votes in
24citing 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.

NCT06696014 recruitingnot on this mapstarted 2025, after this paper: background citation

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry

Typeobservational_patient_registrySponsorUniversity of North Carolina, Chapel HillRan2025 to 2030Enrolled100ConditionsUlcerative Colitis
NCT07237516 recruitingnot on this mapstarted 2025, after this paper: background citation

Zymfentra (Infliximab-dyyb) REal World Cohort STudy

Typeobservational_patient_registrySponsorUniversity of North Carolina, Chapel HillRan2025 to 2028Enrolled200ConditionsUlcerative Colitis (UC), Crohn's Disease (CD), Indeterminate Colitis, Inflammatory Bowel Disease (IBD)
3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

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  19. Raising the bar in ulcerative colitis management.Therapeutic advances in gastroenterology · 2024
    Review
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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

7 authors.

Marla C DubinskyMount Sinai Kravis Children's Hospital, Mount Sinai, New York, USA.ORCID https://orcid.org/0000-0003-4968-5795
David B ClemowEli Lilly and Company, Indianapolis, USA.ORCID https://orcid.org/0000-0002-5328-8285
Theresa Hunter GibbleEli Lilly and Company, Indianapolis, USA.
Xingyuan LiEli Lilly and Company, Indianapolis, USA.
Severine VermeireUniversity Hospitals, Leuven, Belgium.ORCID https://orcid.org/0000-0001-9942-3019
Tadakazu HisamatsuKyorin University School of Medicine, Mitaka, Japan.ORCID https://orcid.org/0000-0002-1178-3536
Simon P L TravisUniversity of Oxford, Oxford, UK.ORCID https://orcid.org/0000-0002-2690-4361

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Bowel urgency reduces ulcerative colitis patients' quality of life. Mirikizumab, a p19-directed anti-IL-23 antibody, demonstrates ulcerative colitis efficacy. Mirikizumab efficacy to reduce bowel urgency and bowel urgency association with other endpoints were analyzed in 2 Phase 3 trials. Methods: LUCENT-1 (Induction): 1162 patients randomized 3:1 to intravenous 300 mg mirikizumab or placebo every 4 weeks for 12 weeks. LUCENT-2 (Maintenance): 544 mirikizumab responders during induction were re-randomized 2:1 to subcutaneous mirikizumab 200 mg or placebo every 4 weeks for 40 weeks (52 weeks of continuous treatment). Bowel urgency was measured using the Urgency Numeric Rating Scale (0-10); for patients with LUCENT-1 baseline score ≥3, bowel urgency clinically meaningful improvement (≥3-point decrease) and remission (score ≤1) rates in mirikizumab versus placebo groups were compared at Weeks 12 and 52. Associations between bowel urgency and other efficacy endpoints were assessed at Weeks 12 and 52. Results: A significantly higher proportion of mirikizumab patients versus placebo achieved clinically meaningful improvement in bowel urgency and remission at Weeks 12 and 52. Significantly higher percentages of patients achieving bowel urgency clinically meaningful improvement or remission, compared with those who did not, also achieved endpoints for clinical, corticosteroid-free, endoscopic, and symptomatic remission; clinical response; normalized fecal calprotectin and C-reactive protein; and improved quality of life. Conclusions: In patients with ulcerative colitis, bowel urgency improvement was associated with better clinical outcomes than in patients without improvement during induction and maintenance. A greater proportion of mirikizumab patients achieved sustainable bowel urgency improvement and remission compared to placebo patients.

Indexed as

bowel urgencyimprovementmirikizumabremissionulcerative colitis

Identifiers

PMID36777368
PMCPMC9802448

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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.