Evidence map›Paper›PMID 29869016›Full record

SynthesisJournal of gastroenterology2018

Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease.

Stefan Schreiber, Axel Dignass, Laurent Peyrin-Biroulet, Greg Hather, Dirk Demuth, Mahmoud Mosli, Rebecca Curtis, Javaria Mona Khalid, Edward Vincent Loftus

Registry-linked trialAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04362735 (Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy), which is not on this map. Cited by 96 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 4 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.

NCT04362735 unknown statusnot on this mapstarted 2020, after this paper: background citation

Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world Study

TypeobservationalSponsorPontifícia Universidade Católica do ParanáRan2020 to 2021Enrolled100ConditionsCrohn DiseaseArmsVedolizumab
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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36 more citing papers are in PubMed but not listed here.

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

9 authors.

Stefan SchreiberDepartment of Internal Medicine I and Institute of Clinical Molecular Biology, University-Hospital Schleswig-Holstein, Christian-Albrechts-University, Rosalind-Franklin-Strasse 12, 24105, Kiel, Germany. s.schreiber@mucosa.de.
Axel DignassDepartment of Medicine 1, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.
Laurent Peyrin-BirouletInserm U954 and Gastroenterology Department, Nancy University Hospital, Lorraine University, Vandoeuvre-lès-Nancy, France.
Greg HatherTakeda Oncology, Takeda Global Research and Development, Boston, MA, USA.
Dirk DemuthGlobal Medical Affairs, Takeda International-UK Branch, London, UK.
Mahmoud MosliDepartment of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
Rebecca CurtisGlobal Medical Affairs, Takeda International-UK Branch, London, UK.
Javaria Mona KhalidGlobal Medical Affairs, Takeda International-UK Branch, London, UK.
Edward Vincent LoftusDepartment of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSelective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness.

methodsA systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn's disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014-June 22, 2017. Response and remission rates were combined in random-effects meta-analyses.

resultsAt treatment week 14, 32% of UC patients [95% confidence interval (CI) 27-39%] and 30% of CD patients (95% CI 25-34%) were in remission; and at month 12, 46% for UC (95% CI 37-56%) and 30% for CD (95% CI 20-42%). For UC, the rates of corticosteroid-free remission were 26% at week 14 (95% CI 20-34%) and 42% at month 12 (95% CI 31-53%); for CD they were 25% at week 14 (95%, CI 20-31%) and 31% at month 12 (95%, CI 20-45%). At month 12, 33-77% of UC and 6-63% of CD patients had mucosal healing. Nine percent of patients reported serious adverse events.

conclusionsVedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit-risk profile of vedolizumab.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedGastrointestinal AgentsHumansInflammatory Bowel DiseasesIntestinal MucosaMiddle AgedRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabCrohn’s diseaseInflammatory bowel diseaseReal-world effectivenessUlcerative colitisVedolizumab

Identifiers

PMID29869016
PMCPMC6132930

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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.