Evidence map›Paper›PMID 32062041›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2020

Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis.

Parambir S Dulai, Siddharth Singh, Niels Vande Casteele, Joseph Meserve, Adam Winters, Shreya Chablaney, Satimai Aniwan, Preeti Shashi, Gursimran Kochhar, Aaron Weiss and 30 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00783718 (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), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
8.8field-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.

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
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 78 citations in OpenAlex.

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  16. [Old and New Biologics and Small Molecules in Inflammatory Bowel Disease: Anti Integrins].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

40 authors at 15 institutions in 2 countries.

Parambir S DulaiDivision of Gastroenterology, University of California, San Diego, La Jolla, California. Electronic address: pdulai@ucsd.edu.
Siddharth SinghDivision of Gastroenterology, University of California, San Diego, La Jolla, California.
Niels Vande CasteeleDivision of Gastroenterology, University of California, San Diego, La Jolla, California.
Joseph MeserveDivision of Gastroenterology, University of California, San Diego, La Jolla, California.
Adam WintersDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Shreya ChablaneyDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Satimai AniwanDivision of Gastroenterology, Mayo Clinic, Rochester, Minnesota.
Preeti ShashiDivision of Gastroenterology, Cleveland Clinic Foundation, Cleveland, Ohio.
Gursimran KochharDivision of Gastroenterology, Cleveland Clinic Foundation, Cleveland, Ohio.
Aaron WeissDivision of Gastroenterology, Montefiore Medical Center, Bronx, New York.
Jenna L Koliani-PaceDivision of Gastroenterology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Youran GaoDivision of Gastroenterology, North Shore University Hospital, Manhasset, New York.
Brigid S BolandDivision of Gastroenterology, University of California, San Diego, La Jolla, California.
John T ChangDivision of Gastroenterology, University of California, San Diego, La Jolla, California.
David FaleckDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Robert HirtenDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Ryan UngaroDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Dana LukinDivision of Gastroenterology, Montefiore Medical Center, Bronx, New York.
Keith SultanDivision of Gastroenterology, North Shore University Hospital, Manhasset, New York.
David HudesmanDivision of Gastroenterology, New York University, New York, New York.
Shannon ChangDivision of Gastroenterology, New York University, New York, New York.
Matthew BohmDivision of Gastroenterology, Indiana University, Indianapolis, Indiana.
Sashidhar VarmaDivision of Gastroenterology, Indiana University, Indianapolis, Indiana.
Monika FischerDivision of Gastroenterology, Indiana University, Indianapolis, Indiana.
Eugenia ShmidtDivision of Gastroenterology, University of Minnesota, Minneapolis, Minnesota.
Arun SwaminathDivision of Gastroenterology, Lenox Hill Hospital, New York, New York.
Nitin GuptaDivision of Gastroenterology, University of Mississippi, Jackson, Mississippi.
Maria RosarioTakeda Pharmaceuticals USA, Deerfield, Illinois.
Vipul JairathDivision of Gastroenterology, University of Western Ontario, London, Ontario, Canada.
Leonardo GuizzettiRobarts Clinical Trials, London, Ontario, Canada.
Brian G FeaganDivision of Gastroenterology, University of Western Ontario, London, Ontario, Canada.
Corey A SiegelDivision of Gastroenterology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Bo ShenDivision of Gastroenterology, Cleveland Clinic Foundation, Cleveland, Ohio.
Sunanda KaneDivision of Gastroenterology, Mayo Clinic, Rochester, Minnesota.
Edward V LoftusDivision of Gastroenterology, Mayo Clinic, Rochester, Minnesota.
William J SandbornDivision of Gastroenterology, University of California, San Diego, La Jolla, California.
Bruce E SandsDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Jean-Frederic ColombelDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Karen LaschTakeda Pharmaceuticals USA, Deerfield, Illinois.
Charlie CaoTakeda Pharmaceuticals USA, Deerfield, Illinois.
Icahn School of Medicine at Mount Sinai · USUniversity of California San Diego · USCleveland Clinic · USDeerfield (United States) · USIndiana University – Purdue University Indianapolis · USMayo Clinic · USDartmouth–Hitchcock Medical Center · USMontefiore Medical Center · USNew York University · USNorth Shore University Hospital · USWestern University · CALenox Hill Hospital · USRobarts Clinical Trials · CAUniversity of Minnesota · USUniversity of Mississippi · US

Funding

Training Grant in GastroenterologyT32DK007202 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GHOSH, PRADIPTA · 1985 to 2022
$7.7M
Evaluating a Prediction Tool and Decision Aid for Patients with Crohn's DiseaseR01HS021747 · AHRQ · DARTMOUTH COLLEGE · PI SIEGEL, COREY · 2012 to 2016
$2.3M
Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
AHRQ HHS R01 HS021747NIDDK NIH HHS K23 DK117058NIDDK NIH HHS T32 DK007202
6 · The paper itself

Abstract

BACKGROUND &

aimsWe created and validated a clinical decision support tool (CDST) to predict outcomes of vedolizumab therapy for ulcerative colitis (UC).

methodsWe performed logistic regression analyses of data from the GEMINI 1 trial, from 620 patients with UC who received vedolizumab induction and maintenance therapy (derivation cohort), to identify factors associated with corticosteroid-free remission (full Mayo score of 2 or less, no subscore above 1). We used these factors to develop a model to predict outcomes of treatment, which we called the vedolizumab CDST. We evaluated the correlation between exposure and efficacy. We validated the CDST in using data from 199 patients treated with vedolizumab in routine practice in the United States from May 2014 through December 2017.

resultsAbsence of exposure to a tumor necrosis factor (TNF) antagonist (+3 points), disease duration of 2 y or more (+3 points), baseline endoscopic activity (moderate vs severe) (+2 points), and baseline albumin concentration (+0.65 points per 1 g/L) were independently associated with corticosteroid-free remission during vedolizumab therapy. Patients in the derivation and validation cohorts were assigned to groups of low (CDST score, 26 points or less), intermediate (CDST score, 27-32 points), or high (CDST score, 33 points or more) probability of vedolizumab response. We observed a statistically significant linear relationship between probability group and efficacy (area under the receiver operating characteristic curve, 0.65), as well as drug exposure (P < .001) in the derivation cohort. In the validation cohort, a cutoff value of 26 points identified patients who did not respond to vedolizumab with high sensitivity (93%); only the low and intermediate probability groups benefited from reducing intervals of vedolizumab administration due to lack of response (P = .02). The vedolizumab CDST did not identify patients with corticosteroid-free remission during TNF antagonist therapy.

conclusionsWe used data from a trial of patients with UC to develop a scoring system, called the CDST, which identified patients most likely to enter corticosteroid-free remission during vedolizumab therapy, but not anti-TNF therapy. We validated the vedolizumab CDST in a separate cohort of patients in clinical practice. The CDST identified patients most likely to benefited from reducing intervals of vedolizumab administration due to lack of initial response. ClinicalTrials.gov no: NCT00783718.

Indexed as

Colitis, UlcerativeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsHumansRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabBiologicPersonalized MedicinePrognostic FactorResponse to Treatment

Identifiers

PMID32062041
PMCPMC7899124
OpenAlexW3005971833

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.