Evidence map›Paper›PMID 31667469›Full record

ArticleCrohn's & colitis 3602019

The Early Experience With Vedolizumab in the United States.

Bharati Kochar, Yue Jiang, Aaron Winn, Edward L Barnes, Christopher F Martin, Millie D Long, Michael D Kappelman

Open access · goldAbstract read
In one paragraph

Article in Crohn's & colitis 360, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
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 2 institutions in 1 country.

Bharati KocharMultidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Yue JiangDepartment of Biostatistics, Gillings School of Global Public Health, Chapel Hill, NC.
Aaron WinnDepartment of Clinical Sciences, Medical College of Wisconsin School of Pharmacy, Milwaukee, WI.
Edward L BarnesMultidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Christopher F MartinCenter for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Millie D LongMultidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michael D KappelmanMultidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC.
University of North Carolina at Chapel Hill · USMedical College of Wisconsin · US

Funding

PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT S. SANDLER · 1985 to 2026
$30.5M
NIDDK NIH HHS P30 DK034987
6 · The paper itself

Abstract

backgroundPost-marketing studies of new inflammatory bowel disease (IBD) therapies are needed to establish clinical effectiveness and safety in clinical practice. We aimed to describe the U.S. experience with vedolizumab in a commercially insured population.

methodsWe conducted a retrospective cohort study in Quintiles-IMS Legacy PharMetrics Adjudicated Claims Database from May 2014 to June 2016. We included new vedolizumab users with Crohn disease (CD) and ulcerative colitis (UC) between 18 and 64 years with ≥12 months of continuous enrollment prior to initiating vedolizumab. Outcomes included treatment persistence >14 weeks, late steroid use, IBD-related surgery and infections associated with hospitalization. We built multivariable regression models to identify predictors of treatment persistence and late steroid use.

resultsWe identified 269 CD and 187 UC vedolizumab initiators. Only 60% of CD patients and 56% of UC patients remained on vedolizumab after 14 weeks without IBD-related hospitalization, surgery, and corticosteroid use. There were no significant predictors of treatment persistence. Steroid use in the first 2 months of vedolizumab initiation was a significant predictor of late steroid use in CD (odds ratio: 23.34; 95% confidence interval: 5.10-153.89). In the 6 months after vedolizumab initiation, 1.9% of CD and 5.9% of UC patients had an IBD-related surgery. Serious infections were <4%.

conclusionsThese data reflect the early U.S. experience with vedolizumab. The population-level response to vedolizumab therapy is just >50%. Steroids at the time of vedolizumab initiation is the strongest predictor of late steroid use in CD. Rates of surgery and serious infections are low.

Indexed as

Crohn diseaseulcerative colitisvedolizumab

Identifiers

PMID31667469
PMCPMC6798787
OpenAlexW2971242491

What OpenQuestion holds

Textmetadata
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.