Evidence map›Paper›PMID 31326395›Full record

Trial reportThe Journal of investigative dermatology2020

A Phase IV, Randomized, Double-Blind, Placebo-Controlled Crossover Study of the Effects of Ustekinumab on Vascular Inflammation in Psoriasis (the VIP-U Trial).

Joel M Gelfand, Daniel B Shin, Abass Alavi, Drew A Torigian, Tom Werner, Maryte Papadopoulos, Junko Takeshita, Megan H Noe, Amit K Dey, Martin P Playford and 1 more

Abstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in The Journal of investigative dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 7 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

71 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  15. Gut-heart axis: cardiac remodeling and heart failure in the context of inflammatory bowel disease and dysbiosis.American journal of physiology. Gastrointestinal and liver physiology · 2025
    Review
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11 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

11 authors.

Joel M GelfandDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Electronic address: Joel.Gelfand@pennmedicine.upenn.edu.
Daniel B ShinDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Abass AlaviDepartment of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Drew A TorigianDepartment of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Tom WernerDepartment of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Maryte PapadopoulosDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Junko TakeshitaDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Megan H NoeDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Amit K DeySection of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.
Martin P PlayfordSection of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.
Nehal N MehtaSection of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.

Funding

Psoriasis and the Risk of DiabetesK24AR064310 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI GELFAND, JOEL M · 2013 to 2017
$870k
Respiratory infections and vaccination behaviors in patients with chronic inflammatory skin diseasesK23AR073932 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI NOE, MEGAN H · 2018 to 2022
$766k
Racial Disparities in the Treatment of Psoriasis: A Mixed Methods ApproachK23AR068433 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI TAKESHITA, JUNKO · 2015 to 2019
$726k
NIAMS NIH HHS K23 AR068433NIAMS NIH HHS K23 AR073932NIAMS NIH HHS K24 AR064310
6 · The paper itself

Abstract

Psoriasis is a T helper type 17 autoimmune disease associated with an increased risk cardiovascular events and mortality. Ustekinumab, an antibody to p40, blocks cytokines IL-12 and IL-23, and is a highly effective and safe treatment for psoriasis. We conducted a randomized double-blinded placebo-controlled trial to determine the effect of ustekinumab on aortic vascular inflammation (AVI) measured by imaging, and key biomarkers of inflammation, lipid, and glucose metabolism in the blood of patients with moderate-to-severe psoriasis. A total of 43 patients were randomized, and at week 12, ustekinumab-treated patients had a -18.65% (95% confidence interval = -29.45% to -7.85%) reduction in AVI, a reduction in inflammatory biomarkers, and an increase in apolipoprotein B lipoproteins compared with placebo. At week 12, placebo patients were crossed over such that all patients received ustekinumab for 52 weeks. At the end of 52 weeks of ustekinumab treatment, there was no change in AVI compared with baseline, inflammatory markers were reduced, and there were increases in selected measures of lipids and leptin. These results show that blockade of IL-12 and/or IL-23 may transiently reduce AVI, with more durable reduction in inflammatory cytokines associated with cardiovascular disease.

Indexed as

Anti-Inflammatory AgentsBiomarkersBlood VesselsCross-Over StudiesCytokinesDouble-Blind MethodFollow-Up StudiesHumansInflammationInflammation MediatorsInterleukin-12Interleukin-23PlacebosPsoriasisTh17 CellsUstekinumabAnti-Inflammatory AgentsBiomarkersCytokinesInflammation MediatorsInterleukin-12Interleukin-23PlacebosUstekinumab

Identifiers

PMID31326395
PMCPMC6926160

What OpenQuestion holds

Textmetadata
LicenceTDM
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.