Evidence map›Paper›PMID 40205711›Full record

Observational studyAlimentary pharmacology & therapeutics2025

Real-World Effectiveness and Safety of Mirikizumab Induction Therapy in Patients With Ulcerative Colitis: A Multicentre Retrospective Observational Study.

Yasuhiro Takagi, Toshiyuki Sato, Takanori Nishiguchi, Akira Nogami, Masataka Igeta, Soichi Yagi, Maiko Ikenouchi, Mikio Kawai, Koji Kamikozuru, Yoko Yokoyama and 5 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–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.

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

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  6. Interleukin-23 Inhibitors in Inflammatory Bowel Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
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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

15 authors.

Yasuhiro TakagiDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.ORCID https://orcid.org/0009-0002-8310-9767
Toshiyuki SatoDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.ORCID https://orcid.org/0000-0001-8307-2445
Takanori NishiguchiCenter for Inflammatory Bowel Disease, Division of Gastroenterology, Department of Internal Medicine, Tokyo Yamate Medical Center, Tokyo, Japan.
Akira NogamiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.ORCID https://orcid.org/0009-0003-0706-0436
Masataka IgetaDepartment of Biostatistics, Hyogo Medical University, Nishinomiya, Hyogo, Japan.ORCID https://orcid.org/0000-0001-8706-4231
Soichi YagiDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
Maiko IkenouchiDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.ORCID https://orcid.org/0000-0001-5816-5789
Mikio KawaiDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
Koji KamikozuruDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
Yoko YokoyamaDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
Toshihiko TomitaDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
Hirokazu FukuiDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
Masayuki FukataCenter for Inflammatory Bowel Disease, Division of Gastroenterology, Department of Internal Medicine, Tokyo Yamate Medical Center, Tokyo, Japan.ORCID https://orcid.org/0000-0002-8539-1594
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-2073-4234
Shinichiro ShinzakiDepartment of Gastroenterology, School of Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.ORCID https://orcid.org/0000-0002-7051-618X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn randomised controlled trials, mirikizumab achieved clinical remission and improved outcomes of patients with moderate to severe ulcerative colitis (UC). However, there is currently no real-world evidence for mirikizumab.

aimTo evaluate the real-world effectiveness and safety of mirikizumab.

methodsIn a retrospective cohort study among three facilities, we included patients with UC who first received mirikizumab between June 2023 and April 2024. The primary outcome was the change in the partial Mayo score (PMS) from week 0 to 12. Secondary outcomes included changes in serum C-reactive protein (CRP) and leucine-rich α2-glycoprotein (LRG) levels from week 0 to 12; clinical remission rate (PMS < 2 with rectal bleeding subscore of 0), CRP remission rate (< 3.0 mg/L), and LRG remission rate (< 12.7 μg/mL) at week 12; and adverse events during induction therapy.

resultsWe included 52 patients. Median (interquartile range) PMS decreased from week 0 to 12 (5 [3-6] to 2 [0-3], p < 0.001). CRP and LRG levels also decreased (CRP: 3.8 [0.9-7.3] to 1.8 [0.5-4.0] mg/L, p = 0.015; LRG: 20.1 [16.3-23.2] to 15.9 [12.8-23.2] μg/mL, p = 0.014). Rates of clinical remission, CRP remission, and LRG remission at week 12 were 44.2%, 67.3%, and 27.3%, respectively. There were no adverse events leading to permanent discontinuation of mirikizumab or death.

conclusionThis real-world study demonstrated the short-term effectiveness and safety of mirikizumab in patients with UC.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeAdultC-Reactive ProteinFemaleHumansMaleMiddle AgedRemission InductionRetrospective StudiesSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedC-Reactive ProteinIL‐23mirikizumabulcerative colitisustekinumab

Identifiers

PMID40205711
PMCPMC12107223

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.