Evidence map›Paper›PMID 39093640›Full record

Trial reportInflammatory bowel diseases2025

Mirikizumab Sustained Impact on Fatigue in Patients with Moderately to Severely Active Crohn's Disease in the Phase 2 AMAG Study.

Miguel Regueiro, Monika Fischer, Peter Bossuyt, Kim McGinnis, Marijana Protic, Theresa Hunter Gibble, Tommaso Panni, Lai Shan Chan, Toshifumi Hibi, David T Rubin

Abstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. Pooled it
  2. Trial
  3. Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Trial
  4. Article
  5. Review
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

10 authors.

Miguel RegueiroDepartment of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-7681-8111
Monika FischerDivision of Gastroenterology and Hepatology, Indiana University, Indianapolis, IN, USA.
Peter BossuytImelda GI Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium.ORCID 0000-0003-4027-7365
Kim McGinnisEli Lilly and Company, Indianapolis, IN, USA.
Marijana ProticEli Lilly and Company, Indianapolis, IN, USA.
Theresa Hunter GibbleEli Lilly and Company, Indianapolis, IN, USA.ORCID 0000-0001-8412-9175
Tommaso PanniEli Lilly and Company, Indianapolis, IN, USA.
Lai Shan ChanEli Lilly and Company, Indianapolis, IN, USA.
Toshifumi HibiKitasato Institute Hospital Center for Advanced Inflammatory Bowel Disease Research and Treatment, Minato-ku, Tokyo, Japan.
David T RubinInflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgroundFatigue is a burdensome, under-recognized, multidimensional symptom experienced by patients with Crohn's disease (CD). We evaluated the impact of mirikizumab on fatigue and the association between changes in select patient-reported outcomes and clinical measures with changes in fatigue from baseline to week 104 (W104).

methodsPatients (N = 191) were randomized (2:1:1:2) to receive placebo (PBO), 200 mg, 600 mg, or 1000 mg of mirikizumab, administered intravenously (IV) every 4 weeks at W0, W4, and W8. Patients who achieved ≥1 point improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) and received mirikizumab at W12 (rerandomized maintenance cohort) were rerandomized to continue induction IV treatment assignment (IV-C) or received 300 mg of mirikizumab subcutaneously (SC) until W52. Nonrandomized maintenance cohort had endoscopic nonimprovers (1000 mg) and PBO patients (PBO/1000 mg) who received 1000 mg of mirikizumab until W52. Subjects from the maintenance period with clinical benefit received 300 mg SC Q4W from W52 to W104. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire was used to assess fatigue, and the FACIT-F associations were assessed using Pearson correlation coefficient.

resultsAt W12, mirikizumab groups reported improved FACIT-F scores compared with PBO, and improvement was maintained through W52 and W104. Changes in FACIT-F at W52 and W104 had strong correlations with changes at the same time point in quality of life (QoL) scores but lacked correlations with changes in inflammatory biomarkers.

conclusionsMirikizumab treatment significantly improved fatigue in patients with moderately to severely active CD, which was sustained to W104. The improvement in fatigue was correlated with improvement in clinical measures and was strongly correlated with improvement in QoL.

Indexed as

Antibodies, Monoclonal, HumanizedCrohn DiseaseFatigueAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresQuality of LifeSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedCrohn’s diseasefatiguequality of life

Identifiers

PMID39093640
PMCPMC11808575

What OpenQuestion holds

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LicenceCC BY-NC
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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.