Evidence map›Paper›PMID 28070861›Full record

Trial reportAdvances in therapy2017

Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn's Disease Patients Stratified by Age.

Vijay Yajnik, Nabeel Khan, Marla Dubinsky, Jeffrey Axler, Alexandra James, Brihad Abhyankar, Karen Lasch

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
9.0field-weighted citation impact, top 2% 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

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 92 citations in OpenAlex.

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  10. [Risks of Cancer Associated with Therapeutic Drugs for Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024
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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

7 authors at 6 institutions in 3 countries.

Vijay YajnikMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA. VYAJNIK@mgh.harvard.edu.
Nabeel KhanPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Marla DubinskyMount Sinai Hospital, New York, NY, USA.
Jeffrey AxlerToronto Digestive Disease Associates, University of Toronto, Toronto, Canada.
Alexandra JamesTakeda Development Centre Europe Ltd, London, UK.
Brihad AbhyankarTakeda Development Centre Europe Ltd, London, UK.
Karen LaschTakeda Pharmaceuticals U.S.A. Inc, Deerfield, IL, USA.
Takeda (United Kingdom) · GBHarvard University · USMount Sinai Hospital · USTakeda (United States) · USUniversity of Pennsylvania · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe efficacy and safety of vedolizumab, a gut-selective α

methodsSafety and efficacy, including clinical response, clinical remission, and corticosteroid-free remission, at week 6 and/or 52 were determined post hoc in patients aged <35, 35 to <55, and ≥55 years.

resultsAt baseline, 353, 412, and 130 ulcerative colitis (UC) and 582, 443, and 90 Crohn's disease (CD) patients were aged <35, 35 to <55, and ≥55. Of these patients, 56 were aged ≥65 years (UC: 33, CD: 23). Trends favoring vedolizumab over placebo were observed for most efficacy endpoints irrespective of patient age; some variability between subgroups was observed. Safety profiles of vedolizumab and placebo were similar in all age groups. Vedolizumab-treated patients aged ≥55 had the lowest incidence of serious infections (0.9 per 100 person-years) and adverse events leading to hospitalization (14.8 per 100 person-years). There were no age-related differences in the incidence of adverse hematological events, malignancy, or death.

conclusionsThe safety and efficacy of vedolizumab in patients with UC or CD were similar for all age groups. The number of patients in the oldest age group in these analyses was small; thus further studies of vedolizumab in larger cohorts of elderly patients are warranted.

fundingMillennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.).

Indexed as

Antibodies, Monoclonal, HumanizedAdultAgedAge FactorsColitis, UlcerativeCrohn DiseaseDrug MonitoringGastrointestinal AgentsHumansIntegrinsMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal Agentsintegrin alpha4beta7IntegrinsvedolizumabCrohn’s diseaseUlcerative colitisVedolizumab

Identifiers

PMID28070861
PMCPMC5331094
OpenAlexW2569887051

What OpenQuestion holds

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LicenceCC BY-NC
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.