Evidence map›Paper›PMID 33203339›Full record

Observational studyUnited European gastroenterology journal2021

Factors influencing the outcome of vedolizumab treatment: Real-life data with objective outcome measurements.

Orla Mader, Pascal Juillerat, Luc Biedermann, Pierre Michetti, Petr Hruz, Valerie Pittet, Gerhard Rogler, Nadine Zahnd-Straumann, Frank Seibold

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in United European gastroenterology journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 20% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023
    Review
  10. Positioning biologics in the treatment of IBD: A practical guideCurrent research in pharmacology and drug discovery · 2022
    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

9 authors at 7 institutions in 2 countries.

Orla MaderCrohn-Colitis Centre, Bern, Switzerland.ORCID 0000-0002-9777-3506
Pascal JuilleratDepartment of Gastroenterology, Clinic for Visceral Surgery and Medicine, Bern University Hospital, Bern, Switzerland.ORCID 0000-0002-0947-5235
Luc BiedermannDepartment of Gastroenterology, Zürich University Hospital, Zürich, Switzerland.
Pierre MichettiClinique de la Source, Lausanne, Switzerland.
Petr HruzUniversity Centre for Gastrointestinal and Liver Diseases, Clarunis, St Clara Hospital and University Hospital Basel, Basel, Switzerland.
Valerie PittetUniversity of Lausanne, Institute of Social and Preventive Medicine, Lausanne, Switzerland.ORCID 0000-0003-2208-966X
Gerhard RoglerDepartment of Gastroenterology, Zürich University Hospital, Zürich, Switzerland.
Nadine Zahnd-StraumannCenterview GmbH and Swiss IBDnet, Zürich, Switzerland.
Frank SeiboldCrohn-Colitis Centre, Bern, Switzerland.
Crohn's and Colitis UK · GBUniversity Hospital of Zurich · CHClinique de La Source · CHInstitute of Social and Preventive Medicine · CHSwiss Data Science Center · CHUniversity Hospital of Basel · CHUniversity of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVedolizumab (VDZ), a humanised monoclonal antibody against a4ß7-integrin, has shown efficacy in inflammatory bowel disease (IBD). It is of importance to assess the mid-to long-term efficacy of VDZ using real-life data.

objectiveOur study aimed to determine the efficacy of VDZ in patients with IBD with and without prior exposure to anti-tumour necrosis factor (TNF) treatments in a real-life setting. Furthermore, we investigated confounding factors influencing the remission to VDZ.

methodsPatients participating in the Swiss IBD Cohort Study were included in this study. Remission was defined as calprotectin less than 200 mg/kg stool and/or mucosal healing determined by endoscopy. End points were determined between Months 4 and 8 (T1) and between Months 12 and 16 (T2) after VDZ induction.

resultsRemission was reported in 50.5% (110/218) of patients in T1 (48.7% Crohn's disease [CD] and 52.5% ulcerative colitis [UC]) and 46.8% (102/218) in T2 (47% CD and 46.5% UC). In UC patients, a significantly higher remission rate was achieved in T2 among anti-TNF-naive patients (57.7%) compared to anti-TNF-experienced patients (34.7%; p = 0.02; odds ratio = 0.39, 95% confidence interval: 0.17-0.87). In patients with CD, no difference could be seen in either evaluation interval. Multivariable analysis showed that disease duration significantly influenced remission rates among UC patients. A late response to VDZ therapy with an achievement of remission in T2 was seen in a fifth of all patients (CD: 21.7%, UC: 20.8%). VDZ treatment was stopped in a third of all patients (31.8%) due to nonresponse, adverse events or aggravation of extra-intestinal manifestations.

conclusionIn a real-life national cohort setting, VDZ induced remission in more than half of IBD patients. Previous treatment with anti-TNF agents was associated with a significant lower efficacy of VDZ in UC but not in CD patients.

Indexed as

AdultAntibodies, Monoclonal, HumanizedBiomarkersCohort StudiesColitis, UlcerativeCrohn DiseaseFemaleGastrointestinal AgentsHumansInflammatory Bowel DiseasesLeukocyte L1 Antigen ComplexMaleOdds RatioOutcome Assessment, Health CareRemission InductionSteroidsAntibodies, Monoclonal, HumanizedBiomarkersGastrointestinal AgentsLeukocyte L1 Antigen ComplexSteroidsTumor Necrosis Factor Inhibitorsvedolizumabadverse eventsanti-TNF experiencedanti-TNF naiveCrohn's diseaseinflammatory bowel diseasereal-life dataremissionsafetyulcerative colitisvedolizumab

Identifiers

PMID33203339
PMCPMC8259282
OpenAlexW3103332779

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.