Evidence map›Paper›PMID 39227642›Full record

Trial reportScientific reports2024

Induction and maintenance of mucosal healing in Crohn's disease with ustekinumab in clinical practice across all care levels in Germany (MUCUS).

Daniel C Baumgart, Andreas Stallmach, Philip Grunert, Stefan Schubert, Stefanie Howaldt, Ulrike von Arnim, Thomas Ochsenkühn, Jürgen Stein, Andreas Lügering, Daniel Schmidt and 2 more

Abstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Daniel C BaumgartMedizinische Klinik m.S. Hepatologie und Gastroenterologie, Charité-Universitätsmedizin Berlin, Berlin, Germany. daniel.baumgart@charite.de.
Andreas StallmachKlinik für Innere Medizin IV Gastroenterologie, Hepatologie, Infektiologie, Zentrale Endoskopie, Universitätsklinikum Jena, Jena, Germany.
Philip GrunertKlinik für Innere Medizin IV Gastroenterologie, Hepatologie, Infektiologie, Zentrale Endoskopie, Universitätsklinikum Jena, Jena, Germany.
Stefan SchubertGastroenterologie am Bayerischen Platz, Gastroenterologie, Berlin, Germany.
Stefanie HowaldtHamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen, Immunologie, Hamburg, Germany.
Ulrike von ArnimUniversitätsklinikum Magdeburg, Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie, Magdeburg, Germany.
Thomas OchsenkühnIsarklinikum, Klinik für Gastroenterologie, Hepatologie und Gastroenterologische Onkologie, München, Germany.
Jürgen SteinDGD Kliniken Frankfurt Sachsenhausen, Abteilung Gastroenterologie/Ernährungsmedizin, Frankfurt am Main, Germany.
Andreas LügeringMVZ Portal 10, Zentrum für Leber-, Magen- und Darmerkrankungen, Münster, Germany.
Daniel SchmidtMedizinische Klinik m.S. Hepatologie und Gastroenterologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Marten SchulzMedizinische Klinik m.S. Hepatologie und Gastroenterologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Andreas FischerMedizinische Klinik m.S. Hepatologie und Gastroenterologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The impact of ustekinumab (UST) on mucosal- and fistula healing and extraintestinal manifestations (EIM) in Crohn's disease (CD) were not fully elucidated in the registration trials. In this prospective, multicenter study (EudraCT number: 2017-005151-83) we evaluated the German label real-world-effectiveness of UST to achieve the primary endpoint of combined clinical and endoscopic response at week 52 and several secondary endpoints. Of 79 screened we enrolled 52 patients (female n = 28, bionaïve n = 13, biologic n = 39). At week 52 (per protocol analysis), 52% (n = 13/25) of patients achieved the primary endpoint [50% (n = 3/6) in the bionaïve, 45.5% (n = 5/11) biologic, 62.5% (n = 5/8 ) multiple biologics cohorts, respectively with age as independent predictor [OR 95% CI 0.933 (0.873, 0.998) p = 0.043], 60% (n = 15/25) achieved endoscopic response [50% (n = 3/6) in the bionaïve, 54.5% (n = 6/11) biologic, 75% (n = 6/8) multiple biologics cohorts, respectively], 36% (n = 9/25) achieved endoscopic remission [50% (n = 3/6) in the bionaïve, 27.3% (n = 3/11) biologic, 37.5% (n = 3/8) multiple biologics cohorts, respectively], 48% (n = 12/25) achieved mucosal healing [50% (n = 3/6) in the bionaïve, 36.4% (n = 4/11) biologic, 62.5% (n = 5/8) multiple biologics cohorts, respectively]. All achieved a fistula response and 33.3% (n = 1/3) in the multiple biologics group fistula remission at week 52. EIM decreased (week 0 28.2% vs. week 52 8%). CRP, FCP, PRO-2, EQ-5D-5L improved throughout. 36 patients (69.2%) experienced ≥ 1 treatment emergent adverse event, in 8 (15.4%) cases rated as severe and in 5 (9.6%) leading to UST discontinuation, but no very severe events or deaths. The effectiveness of UST was better than in the registration trials.

Indexed as

Crohn DiseaseIntestinal MucosaUstekinumabAdultFemaleGermanyHumansMaleMiddle AgedProspective StudiesTreatment OutcomeWound HealingUstekinumabCrohn’s diseaseExtraintestinal manifestationsInflammatory bowel diseaseMucosal healingQuality of lifeUstekinumab

Identifiers

PMID39227642
PMCPMC11371836

What OpenQuestion holds

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LicenceCC BY
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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.