Trial reportJournal of Crohn's & colitis2025
Mirikizumab impact on disease clearance in patients with moderately to severely active ulcerative colitis: analysis of a pre-specified LUCENT trial endpoint.
Trial report in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
What it found
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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.
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.
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)
A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3
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)
Who cites it
1 citing paper in PubMed.
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
BACKGROUND AND
aimsConcurrent achievement of symptomatic, endoscopic, and histologic remission, known as disease clearance, has been proposed as a treatment target in ulcerative colitis. Mirikizumab, an anti-interleukin-23p19 antibody, has demonstrated long-term efficacy and safety, as reported in the LUCENT Phase 3 trials (NCT03518086, NCT03524092, and NCT03519945). The current analysis evaluates the impact of mirikizumab on disease clearance and its association with other clinical and patient-reported outcomes (PROs).
methodsLUCENT methods have previously been reported. The proportion of patients achieving disease clearance was determined through week (W)104. Association analyses were assessed between disease clearance and PROs (IBDQ, SF-36, WPAI: UC, PGRS, and PGRC), and early disease clearance and subsequent clinical outcomes (clinical, corticosteroid-free, endoscopic, histological, histologic-endoscopic, bowel urgency, stool frequency, and rectal bleeding).
resultsThe proportions of patients achieving disease clearance with mirikizumab at W12, W52, and W104 were 16.0%, 36.4%, and 51.3%, respectively. Mirikizumab-treated patients with disease clearance showed greater PRO improvements through W52 than those without. Early clearance at W12 was associated with significantly better clinical outcomes at later time points, except for bowel urgency remission at W52. This trend was repeated for clinical outcomes at W104 in patients who achieved disease clearance at W52.
conclusionsMirikizumab consistently demonstrated disease clearance across induction, maintenance, and long-term studies. The attainment of disease clearance was associated with greater improvement in PROs, and early achievement of disease clearance was associated with better long-term outcomes, including clinical remission, corticosteroid-free remission, endoscopic and histological outcomes, reduced stool frequency, and rectal bleeding.
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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.