Evidence map›Paper›PMID 27296941›Full record

Observational studyThe American journal of gastroenterology2016

The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium.

Parambir S Dulai, Siddharth Singh, Xiaoqian Jiang, Farhad Peerani, Neeraj Narula, Khadija Chaudrey, Diana Whitehead, David Hudesman, Dana Lukin, Arun Swaminath and 10 more

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in The American journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 140 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 8 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

140 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  14. Review
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80 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

20 authors.

Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Xiaoqian JiangDepartment of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
Farhad PeeraniDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Neeraj NarulaDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Khadija ChaudreyDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA.
Diana WhiteheadDivision of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
David HudesmanDivision of Gastroenterology, New York University (NYU), New York, New York, USA.
Dana LukinDivision of Gastroenterology, Montefiore Medical Center, New York, New York, USA.
Arun SwaminathDivision of Gastroenterology, NSLIJ Lenox Hill, New York, New York, USA.
Eugenia ShmidtDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Shuang WangDepartment of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
Brigid S BolandDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
John T ChangDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Sunanda KaneDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA.
Corey A SiegelDivision of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Edward V LoftusDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Bruce E SandsDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jean-Frederic ColombelDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Funding

iDASH: Integrating Data for Analysis, Anonymization, and SharingU54HL108460 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI OHNO-MACHADO, LUCILA · 2010 to 2015
$19.1M
UC San Diego Clinical and Translational Research InstituteKL2TR001444 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DEPP, COLIN A. · 2015 to 2024
$15.4M
San Diego Biomedical Informatics Education & Research (SABER)T15LM011271 · NLM · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SHAMIM NEMATI · 2012 to 2026
$9.7M
Training Grant in GastroenterologyT32DK007202 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GHOSH, PRADIPTA · 1985 to 2022
$7.7M
Protection of Records: Privacy (PReP) Technology for Medical ResearchR00LM011392 · NLM · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI JIANG, XIAOQIAN · 2013 to 2015
$650k
Protecting the pRivacy Of Genomes in REsearch StudieS (PROGRESS)R00HG008175 · NHGRI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI WANG, SHUANG · 2016 to 2018
$527k
Protect Privacy of Healthcare Data in the CloudR21LM012060 · NLM · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI JIANG, XIAOQIAN · 2014 to 2015
$376k
CIHRNHGRI NIH HHS R00 HG008175NHLBI NIH HHS U54 HL108460NIDDK NIH HHS T32 DK007202NLM NIH HHS R00 LM011392NLM NIH HHS R21 LM012060NLM NIH HHS T15 LM011271
6 · The paper itself

Abstract

objectivesWe assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD).

methodsRetrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively.

resultsWe included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF).

conclusionsVDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAnus DiseasesCohort StudiesCrohn DiseaseFemaleGastrointestinal AgentsHumansMaleMiddle AgedOptic NeuritisProportional Hazards ModelsRemission InductionRetrospective StudiesSeverity of Illness IndexSmokingAntibodies, Monoclonal, HumanizedGastrointestinal AgentsTumor Necrosis Factor-alphavedolizumab

Identifiers

PMID27296941

What OpenQuestion holds

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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.