Evidence map›Paper›PMID 30365009›Full record

ArticleInflammatory bowel diseases2019

Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis.

Brian G Feagan, Stefan Schreiber, Douglas C Wolf, Jeffrey L Axler, Arpeat Kaviya, Alexandra James, Rebecca I Curtis, Parnia Geransar, Andreas Stallmach, Robert Ehehalt and 3 more

Abstract read
In one paragraph

Article in Inflammatory bowel diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Observational
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  7. Review
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  10. Review of the Landmark VARSITY Trial.Gastroenterology & hepatology · 2021
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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

13 authors.

Brian G FeaganRobarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Stefan SchreiberDepartment of Internal Medicine I, Kiel University, Kiel, Germany.
Douglas C WolfAtlanta Gastroenterology Associates, Atlanta, Georgia, USA.
Jeffrey L AxlerToronto Digestive Disease Associates, University of Toronto, Toronto, Ontario, Canada.
Arpeat KaviyaTakeda International - UK Branch, London, United Kingdom.
Alexandra JamesTakeda International - UK Branch, London, United Kingdom.
Rebecca I CurtisTakeda International - UK Branch, London, United Kingdom.
Parnia GeransarTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Andreas StallmachDepartment of Internal Medicine IV, University Hospital Jena, Friedrich Schiller University of Jena, Jena, Germany.
Robert EhehaltGastroenterology Outpatient Clinic, Heidelberg, Germany.
Bernd BokemeyerGastroenterology Practice, Minden, Germany.
Javaria Mona KhalidTakeda International - UK Branch, London, United Kingdom.
Sharon O'ByrneTakeda Pharmaceuticals International AG, Zurich, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSustaining clinical remission is an important treatment goal in moderate-to-severe UC. This post hoc exploratory analysis assessed the long-term efficacy of vedolizumab in the subset of patients with UC in the GEMINI 1 study who were in clinical remission by week 14 after 3 induction doses, administered at weeks 0, 2, and 6.

methodsSustained clinical remission (primary endpoint) was evaluated using 2 definitions: (1) a partial Mayo Score (pMS) of ≤2 with no subscore >1 and (2) a rectal bleeding subscore (RBS) of 0 throughout weeks 14, 26, 38, and 52.

resultsThe proportion of patients in clinical remission at week 14 was significantly higher in patients receiving vedolizumab (n = 620) compared with placebo (n = 149) (pMS: 32.7% vs 20.1% [percentage-point difference (∆) 12.6%; 95% confidence interval [CI], 5.2-20.0]; RBS: 47.3% vs 28.9% [∆18.4%; 95% CI, 10.1-26.7]). Of patients in clinical remission at week 14, a significantly higher proportion of vedolizumab-treated patients achieved sustained clinical remission compared with placebo (pMS: 66.5% vs 26.7%; ∆39.8%; 95% CI, 22.7-56.9; RBS: 56.7% vs 20.9%; ∆35.7%; 95% CI, 22.3-49.1). Findings were consistent in tumor necrosis factor (TNF) antagonist-naive and antagonist-failure patients.

conclusionCompared with placebo, 35%-40% more patients receiving a full induction course of vedolizumab had sustained clinical remission after 52 weeks of therapy. This result was observed irrespective of TNF antagonist treatment history. Clinical remission at week 14 may therefore be a predictor for sustained clinical remission with vedolizumab.

Indexed as

Induction ChemotherapySeverity of Illness IndexAdultAntibodies, Monoclonal, HumanizedColitis, UlcerativeFemaleFollow-Up StudiesGastrointestinal AgentsHumansMalePrognosisRemission InductionAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabremissionTNF antagonistulcerative colitisvedolizumab

Identifiers

PMID30365009
PMCPMC6499937

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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.