Evidence map›Paper›PMID 34402887›Full record

Trial reportJournal of Crohn's & colitis2022

Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial.

Séverine Vermeire, Geert D'Haens, Filip Baert, Silvio Danese, Taku Kobayashi, Edward V Loftus, Siddharth Bhatia, Christian Agboton, Maria Rosario, Chunlin Chen and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 12 pooled it
21.0field-weighted citation impact, top 1% of its field
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

81 citing papers in PubMed, 12 syntheses or guidelines pooled it, 163 citations in OpenAlex.

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  10. Vedolizumab for induction and maintenance of remission in Crohn's disease.The Cochrane database of systematic reviews · 2023
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  13. Trial
  14. Biosimilars: A Virtuous Cycle of Sustainability and Innovation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
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  16. Practical guidelines on medical management of adults with moderate-to-severe inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
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  18. Observational
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21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 6 countries.

Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Geert D'HaensDepartment of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Filip BaertDepartment of Gastroenterology, AZ Delta, Roeselare, Belgium.
Silvio DaneseHumanitas Clinical and Research Center - IRCCS, and Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Edward V LoftusDivision of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.
Siddharth BhatiaTakeda, Cambridge, MA, USA.
Christian AgbotonTakeda, Zurich, Switzerland.
Maria RosarioTakeda, Cambridge, MA, USA.
Chunlin ChenTakeda, Cambridge, MA, USA.
Wenwen ZhangTakeda, Cambridge, MA, USA.
Krisztina KisfalviTakeda, Cambridge, MA, USA.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Takeda (United States) · USAmsterdam University Medical Centers · NLAZ Delta · BEIstituti di Ricovero e Cura a Carattere Scientifico · ITKitasato University · JPKU Leuven · BEMayo Clinic in Arizona · USTakeda (Switzerland) · CHUniversity of California, San Diego · US

Funding

San Diego Digestive Diseases Research CenterP30DK120515 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LARS ECKMANN, Bernd G. Schnabl · 2019 to 2026
$10.8M
NIDDK NIH HHS P30 DK120515Takeda Foundation
6 · The paper itself

Abstract

BACKGROUND AND

aimsTo report results from VISIBLE 2, a randomised, double-blind, placebo-controlled, phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn's disease [CD].

methodsFollowing open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI ≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety.

resultsFollowing vedolizumab intravenous induction, 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p = 0.008]. Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p = 0.167]. At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%].

conclusionsVedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy.

Indexed as

Administration, IntravenousAdultAntibodies, Monoclonal, HumanizedCrohn DiseaseDouble-Blind MethodFemaleGastrointestinal AgentsHumansInjections, SubcutaneousMaintenance ChemotherapyMaleQuality of LifeRemission InductionAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabCrohn’s diseaseimmunotherapysubcutaneous

Identifiers

PMID34402887
PMCPMC8797168
OpenAlexW3195954854

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.