Evidence map›Paper›PMID 26288002›Full record

ArticleInflammatory bowel diseases2015

Efficacy of Vedolizumab as Induction Therapy in Refractory IBD Patients: A Multicenter Cohort.

Edward Shelton, Jessica R Allegretti, Betsy Stevens, Matthew Lucci, Hamed Khalili, Deanna D Nguyen, Jenny Sauk, Cosmas Giallourakis, John Garber, Matthew J Hamilton and 9 more

Abstract readMulticenter Study
In one paragraph

Article in Inflammatory bowel diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 3 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.

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

85 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
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  8. Article
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  11. Observational
  12. Review
  13. Article
  14. Review
  15. Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024
    Review
  16. Article
  17. Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023
    Review
  18. Article
  19. Article
  20. Article

25 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

19 authors.

Edward Shelton*Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts; †Harvard Medical School, Boston, Massachusetts; and ‡Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts.
Jessica R Allegretti
Betsy Stevens
Matthew Lucci
Hamed Khalili
Deanna D Nguyen
Jenny Sauk
Cosmas Giallourakis
John Garber
Matthew J Hamilton
Michal Tomczak
Fredrick Makrauer
Robert B Burakoff
Jonathan Levine
Punyaganie de Silva
Sonia Friedman
Ashwin Ananthakrishnan
Joshua R Korzenik
Vijay Yajnik

Funding

Pilot & Feasibility ProgramP30DK043351 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Curtis Huttenhower · 1991 to 2026
$35.3M
Oral Contraceptives in the Etiopathogenesis of Crohn's DiseaseK23DK099681 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI KHALILI, HAMED · 2013 to 2017
$946k
Genetic predictors of anti-TNF treatment response and infections in IBDK23DK097142 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI ANANTHAKRISHNAN, ASHWIN N · 2012 to 2016
$846k
An in depth study of mast cell tryptase as a novel mediator in colitisK08DK094971 · NIDDK · BRIGHAM AND WOMEN'S HOSPITAL · PI HAMILTON, MATTHEW J · 2012 to 2016
$786k
NIDDK NIH HHS K08 DK094971NIDDK NIH HHS K23 DK097142NIDDK NIH HHS K23 DK099681NIDDK NIH HHS P30 DK043351
6 · The paper itself

Abstract

backgroundVedolizumab (VDZ) demonstrated efficacy in Crohn's disease (CD) and ulcerative colitis (UC) in the GEMINI trials. Our aim was to evaluate the efficacy of VDZ at week 14 in inflammatory bowel disease in a multicenter cohort of patients.

methodsPatients at Massachusetts General Hospital and Brigham and Women's Hospital were considered for inclusion. VDZ (300 mg) was administered at weeks 0, 2, 6, and 14. Efficacy was assessed using the Harvey-Bradshaw index for CD, the simple clinical colitis activity index for UC and physician assessment, along with C-reactive protein and decrease of corticosteroid therapy. Clinical response was defined as decrease in Harvey-Bradshaw index ≥3 and simple clinical colitis activity index ≥3 and remission as Harvey-Bradshaw index ≤4, simple clinical colitis activity index ≤2 and physician assessment of response and remission.

resultsOur study included 172 patients (107 CD, 59 UC, 6 inflammatory bowel disease-unclassified, men 48.3%, mean age 40 years and disease duration 14 years). Fourteen patients had ostomy and 9 ileoanal pouch, and only 35.5% fulfilled eligibility for the GEMINI trials. Previous treatment failures with ≥ 2 anti-TNFs occurred in 70.9%, one-third were on an immunomodulator and 46% systemic steroids at baseline. In CD, 48.9% and 23.9% and in UC, 53.9% and 29.3% had clinical response and clinical remission at week 14, respectively. Adverse events occurred in 10.5%.

conclusionsVDZ is safe and well tolerated in refractory inflammatory bowel disease patients in a clinical practice with efficacy in UC and CD with responses similar to what was seen in clinical trials.

Indexed as

Adrenal Cortex HormonesAdultAntibodies, Monoclonal, HumanizedCohort StudiesColitis, UlcerativeC-Reactive ProteinCrohn DiseaseFemaleGastrointestinal AgentsHumansImmunologic FactorsInduction ChemotherapyMaleMiddle AgedSeverity of Illness IndexTreatment FailureAdrenal Cortex HormonesAntibodies, Monoclonal, HumanizedC-Reactive ProteinGastrointestinal AgentsImmunologic FactorsTNF protein, humanTumor Necrosis Factor-alphavedolizumab

Identifiers

PMID26288002
PMCPMC4745906

What OpenQuestion holds

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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.