Evidence map›Paper›PMID 40641824›Full record

ArticleCrohn's & colitis 3602025

Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naïve Patients With Early or Late Crohn's Disease: Results From the EVOLVE Expansion Study.

Britt Christensen, Michael Scharl, Brian Bressler, Zaeem Khan, Yuliya Halchenko, Celine Gisler, Pravin Kamble, Shashi Adsul, Zeinab Farhat, Marc Ferrante

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Crohn's & colitis 360, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05056441 (ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05056441 completednot on this map

ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study

TypeobservationalSponsorTakedaRan2021 to 2022Enrolled623ConditionsCrohn Disease
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Britt ChristensenDepartment of Gastroenterology, The Royal Melbourne Hospital, Melbourne, VIC, Australia.ORCID https://orcid.org/0000-0002-8746-4275
Michael ScharlDepartment of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Brian BresslerDepartment of Medicine, Division of Gastroenterology, St. Paul's Hospital, Vancouver, BC, Canada.ORCID https://orcid.org/0000-0003-4740-8209
Zaeem KhanEpidemiology and Scientific Affairs, PPD, Part of Thermo Fisher Scientific, Montreal, QC, Canada.
Yuliya HalchenkoEpidemiology and Scientific Affairs, PPD, Part of Thermo Fisher Scientific, Montreal, QC, Canada.
Celine GislerDepartment of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Pravin KambleGlobal Evidence and Outcomes, Takeda, Cambridge, MA, United States.ORCID https://orcid.org/0000-0003-0395-4494
Shashi AdsulGlobal Evidence and Outcomes, Takeda, Cambridge, MA, United States.
Zeinab FarhatGlobal Evidence and Outcomes, Takeda, Cambridge, MA, United States.
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0003-1492-0716

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: We evaluated the real-world effectiveness and safety of vedolizumab and ustekinumab as first-line biologics in patients with Crohn's disease (CD), by disease duration. Methods: EVOLVE Expansion (ClinicalTrials.gov, NCT05056441) was a retrospective medical chart review study in Australia, Belgium, and Switzerland. Biologic-naïve patients with CD (≥18 years old) initiated first-line biologic treatment with vedolizumab or ustekinumab. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were assessed over 36 months. Outcomes were compared between patients with early (≤2 years) and late (>2 years) disease at biologic initiation. Serious adverse events (SAEs), serious infections (SIs), and healthcare resource use (HCRU) were evaluated. Results: In early ( Conclusions: Both vedolizumab and ustekinumab are effective treatment options for early- and late-stage CD. Over 36 months, mucosal healing rates in patients with early CD were significantly higher with vedolizumab than with ustekinumab.

Indexed as

biologicsCrohn’s diseasedisease durationeffectivenessinflammatory bowel disease

Identifiers

PMID40641824
PMCPMC12238940

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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.