Evidence map›Paper›PMID 30203005›Full record

Trial reportJournal of Crohn's & colitis2019

Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials.

Brian G Feagan, William J Sandborn, Jean-Frédéric Colombel, Sharon O' Byrne, Javaria M Khalid, Christian Kempf, Parnia Geransar, Fatima Bhayat, David T Rubin

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 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.

NCT00783692 phase3completednot on this map

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

TypeinterventionalSponsorMillennium Pharmaceuticals, Inc.Ran2008 to 2012Enrolled1,116ConditionsCrohn's DiseaseArmsvedolizumab, Placebo
NCT00783718 phase3completednot on this map

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

TypeinterventionalSponsorMillennium Pharmaceuticals, Inc.Ran2009 to 2012Enrolled895ConditionsUlcerative ColitisArmsvedolizumab, Placebo
NCT01224171 phase3completednot on this map

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

TypeinterventionalSponsorMillennium Pharmaceuticals, Inc.Ran2010 to 2012Enrolled416ConditionsCrohn's DiseaseArmsvedolizumab, Placebo
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  3. Long-term safety of vedolizumab for inflammatory bowel disease.Alimentary pharmacology & therapeutics · 2020
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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

9 authors.

Brian G FeaganRobarts Research Institute, University of Western Ontario, London, ON, Canada.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Jean-Frédéric ColombelIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Sharon O' ByrneTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Javaria M KhalidTakeda International - UK Branch, London, UK.
Christian KempfTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Parnia GeransarTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Fatima BhayatTakeda Pharmaceuticals International Co., Cambridge, MA, USA.
David T RubinUniversity of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.

Funding

ULTRASTRUCTURE AND CYTOMORPHOLOGY COREP30DK042086 · NIDDK · UNIVERSITY OF CHICAGO · PI LIU, CAMBRIAN YANGSHAO · 1990 to 2025
$29.8M
NIDDK NIH HHS P30 DK042086
6 · The paper itself

Abstract

BACKGROUND AND

aimsExtraintestinal manifestations [EIMs] such as arthritis/arthralgia are common in inflammatory bowel disease. We performed post hoc analyses of data from the GEMINI studies to evaluate the effect of vedolizumab, a gut-selective anti-trafficking agent, on arthritis/arthralgia.

methodsSustained resolution of baseline arthritis/arthralgia, worsening of baseline arthritis/arthralgia, the occurrence of new arthritis/arthralgia, and the composite of new/worsening arthritis/arthralgia were evaluated. Cox modelling was used for time-to-event analysis. The influence of corticosteroid-tapering was also investigated.

resultsIn Crohn's disease [CD] patients, vedolizumab was significantly less likely than placebo to be associated with new/worsening arthritis/arthralgia (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.44-0.89). Similar incidences of sustained resolution of arthritis/arthralgia occurred with vedolizumab and placebo. In CD patients on corticosteroids at baseline, a decrease in corticosteroid dose increased the risk of new/worsening arthritis/arthralgia (odds ratio [OR], 7.49; 95% CI, 3.50-15.97) regardless of treatment; and in those achieving corticosteroid-free status, arthritis/arthralgia was less likely with vedolizumab than with placebo [HR, 0.14; 95% CI, 0.05-0.35]. In ulcerative colitis [UC] patients, vedolizumab and placebo showed a similar incidence of new/worsening of arthritis/arthralgia. In UC patients on corticosteroid at baseline, arthritis/arthralgia was more likely in those achieving corticosteroid-free status than in those continuing corticosteroids (HR 2.63 [95% CI 1.13-6.11]); and in those achieving corticosteroid-free status, the incidence of arthritis/arthralgia was similar with vedolizumab and placebo.

conclusionsVedolizumab therapy was associated with a reduced likelihood of new/worsening arthritis/arthralgia in CD and no increased incidence of these events in UC. STUDIES INCLUDED [CLINCIALTRIALS.GOV, NUMBER]: GEMINI 1 [NCT00783718]; GEMINI 2 [NCT00783692]; GEMINI 3 [NCT01224171].

Indexed as

Adrenal Cortex HormonesAntibodies, Monoclonal, HumanizedArthralgiaArthritisColitis, UlcerativeCrohn DiseaseDisease ProgressionGastrointestinal AgentsHumansIncidenceAdrenal Cortex HormonesAntibodies, Monoclonal, HumanizedGastrointestinal Agentsvedolizumab

Identifiers

PMID30203005
PMCPMC6302953

What OpenQuestion holds

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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.