Perelman School of Medicine at the University of Pennsylvania

Gelfand Clinical Research Lab

Research

Vascular Inflammation in Psoriasis (VIP) Trials

PI: Joel M. Gelfand, MD, MSCE

In 2006 Gelfand and his team were the first to demonstrate that psoriasis, especially when severe, may be an independent risk factor for myocardial infarction. The purpose of the VIP trials is to determine the impact of psoriasis treatment on key markers of cardiovascular risk such as lipid metabolism (HDL function) and aortic inflammation measured by 18-FDG-PET/CT. 

A Trial to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease

The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis.

This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.

This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis. 

To learn more about the VIP study, please refer to this link


Vascular Inflammation in Psoriasis Extension Trial

Vascular Inflammation in Psoriasis - Extension Study (VIP-E)

VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen. 

To learn more about the VIP-E study, please refer to this link.


A Phase IV, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ustekinumab on Vascular Inflammation in Psoriasis

Vascular Inflammation in Psoriasis - Ustekinumab (VIP-U)

The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis.

This study will look for systemic vascular inflammation in study participants with a test called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in blood samples, including markers of high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.

The study will also examine the effects of ustekinumab compared to placebo on psoriasis activity, severity and safety.

To learn more about the VIP-U Study, please refer to this link.


A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers in Adult Subjects with Moderate to Severe Chronic Plaque-Type Psoriasis

Vascular Inflammation in Psoriasis - Secukinumab (VIP-S)

The VIP-S Study is a clinical trial designed to investigate the effect of secukinumab (Cosentyx) and placebo on reducing aortic vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis.

The purpose of this study is to see if the use of secukinumab has an effect on inflammation, specifically of the blood vessels, and on cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis. This study will also look at blood tests, or “markers”, that could help to identify risk for heart disease and metabolic diseases like diabetes, or “cardiometabolic disease”.

The effect of secukinumab on psoriasis activity and severity will also be examined.

To learn more about the VIP-S Study, please refer to this link.


A Phase IV, Open Label Study of the Effects of Apremilast on Vascular Inflammation and Cardiometabolic function in Psoriasis

Vascular Inflammation in Psoriasis - Apremilast (VIP-A)

The purpose of this study is to assess the effect of apremilast (Otezla), an FDA-approved medication for the treatment of psoriasis, on systemic inflammation and cardiovascular disease risk factors in people diagnosed with moderate to severe psoriasis.

This study will look for systemic vascular inflammation with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). A description of an FDG-PET/CT scan is included below. The study will also look for cardiometabolic (heart disease and metabolic factors such as types of blood fats) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.

This study will also compare subject-reported outcomes with a questionnaire that will assess quality-of-life for people living with psoriasis.

To learn more about the VIP-A Study, please refer to this link.



Selected Publications

High-density lipoprotein cholesterol function improves after successful treatment of psoriasis: a step forward in the right direction.

Mehta NNGelfand JM.

J Invest Dermatol. 2014 Mar;134(3):592-5. doi: 10.1038/jid.2013.447.

PMID: 23925466

Abnormal lipoprotein particles and cholesterol efflux capacity in patients with psoriasis.

Mehta NN, Li R, Krishnamoorthy P, Yu Y, Farver W, Rodrigues A, Raper A, Wilcox M, Baer A, DerOhannesian S, Wolfe M, Reilly MP, Rader DJ, VanVoorhees A, Gelfand JM

Atherosclerosis. 2012 Sep;224(1):218-21. doi: 10.1016/j.atherosclerosis.2012.06.068. Epub 2012 Jul 21.

PMID: 22858285

Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study.

Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM.

Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.

PMID: 21576552

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The Cutaneous Microbiota of Psoriasis: Lesional Variation and a Phase IV, Interventional Study of its Response to Phototherapy

PI: Junko Takeshita, MD, PhD

Psoriasis Microbiome and Phototherapy

The study is a phase IV, interventional, 9-week clinical trial to investigate the cutaneous microbiota of psoriasis and its response to phototherapy. 

The primary objectives of this study are to characterize the bacterial microbiota within psoriatic plaques compared with unaffected skin in patients with plaque psoriasis and to determine the effect of narrow-band ultraviolet B phototherapy on the cutaneous bacterial microbiota of lesional and non-lesional skin among patients with plaque psoriasis. 

To learn more about the Psoriasis Microbiome and Phototherapy study, please refer to this link

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Dermatology Clinical Effectiveness Research Network

DCERN

This innovative NIH funded network’s study assesses the comparative effectiveness of therapies for moderate to severe psoriasis as currently used in routine care. The study’s goal is to determine and compare the current effectiveness of therapies for moderate to severe psoriasis that patients are receiving at the time of their routine dermatologic evaluation.  

An innovative multi-center research structure, called DCERN (pronounced “Dee-Sirn”), the acronym for the Dermatology Clinical Effectiveness Research Network, was created to rigorously study the comparative effectiveness of treatments for psoriasis. Data from a large and diverse population of psoriasis patients from academic practice, private practice, and patient members of the National Psoriasis Foundation from across the United States was captured.  This aim addresses a major barrier to the conduct of comparative effectiveness studies in psoriasis as such studies can only be conducted through multi-disciplinary collaborative groups, and such an infrastructure in the dermatology field does not exist in United States. 

Another aim is to determine and compare the current effectiveness of therapies for moderate to severe psoriasis that patients are receiving at the time of their routine dermatologic evaluation. A series of cross-sectional studies was performed in a large and diverse patient population to evaluate comparative effectiveness during a one year time period of existing therapies for moderate to severe psoriasis such as phototherapy, acitretin, methotrexate, cyclosporine, alefacept, etanercept, adalimumab, and infliximab (and other biologics that are approved for use during the time of this study). This aim determines how these therapies currently perform with respect to patient and physician reported outcomes in various subgroups of patients treated in routine clinical practice at a given point in time.  

 

To learn more about DCERN, please refer to this link



Dermatologist preferences for first-line therapy of moderate to severe psoriasis in healthy adult patients.

Wan J, Abuabara K, Troxel AB, Shin DB, Van Voorhees AS, Bebo BF Jr, Krueger GG, Callis Duffin K,Gelfand JM.

J Am Acad Dermatol. 2012 Mar;66(3):376-86. doi: 10.1016/j.jaad.2011.03.012. Epub 2011 Aug 19.

PMID:21856040

Comparative effectiveness of commonly used systemic treatments or phototherapy for moderate to severe plaque psoriasis in the clinical practice setting.

Gelfand JM, Wan J, Callis Duffin K, Krueger GG, Kalb RE, Weisman JD, Sperber BR, Stierstorfer MB, Brod BA, Schleicher SM, Bebo BF Jr, Troxel AB, Shin DB, Steinemann JM, Goldfarb J, Yeung H, Van Voorhees AS.

Arch Dermatol. 2012 Apr;148(4):487-94. doi: 10.1001/archdermatol.2012.370.

PMID:22508874

Patient-reported outcomes for psoriasis patients with clear versus almost clear skin in the clinical setting.

Takeshita J, Callis Duffin K, Shin DB, Krueger GG, Robertson AD, Troxel AB, Van Voorhees AS,Gelfand JM.

J Am Acad Dermatol. 2014 Oct;71(4):633-41. doi: 10.1016/j.jaad.2014.05.001. Epub 2014 Jun 11.

PMID:24928705

Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis.

Yeung H, Wan J, Van Voorhees AS, Callis Duffin K, Krueger GG, Kalb RE, Weisman JD, Sperber BR, Brod BA, Schleicher SM, Bebo BF Jr, Shin DB, Troxel AB, Gelfand JM.

J Am Acad Dermatol. 2013 Jan;68(1):64-72. doi: 10.1016/j.jaad.2012.06.035. Epub 2012 Jul 28.

PMID: 22846688

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Incident Health Outcomes and Psoriasis Events

iHOPE

A population-based, cross sectional study using The Health Improvement Network (THIN), a large (7.5 million patients from 415 general practices) electronic medical records database maintained by general practitioners (GPs), broadly representative of the United Kingdom (UK) was conducted. 



Effect of psoriasis severity on hypertension control: a population-based study in the United Kingdom.

Takeshita J, Wang S, Shin DB, Mehta NN, Kimmel SE, Margolis DJ, Troxel AB, Gelfand JM.

JAMA Dermatol. 2015 Feb;151(2):161-9. doi: 10.1001/jamadermatol.2014.2094.

PMID: 25322196

Risk of moderate to advanced kidney disease in patients with psoriasis: population based cohort study.

Wan J, Wang S, Haynes K, Denburg MR, Shin DB, Gelfand JM.

BMJ. 2013 Oct 15;347:f5961. doi: 10.1136/bmj.f5961.

PMID: 24129480

Psoriasis severity and the prevalence of major medical comorbidity: a population-based study.

Yeung H, Takeshita J, Mehta NN, Kimmel SE, Ogdie A, Margolis DJ, Shin DB, Attor R, Troxel AB,Gelfand JM.

JAMA Dermatol. 2013 Oct;149(10):1173-9. doi: 10.1001/jamadermatol.2013.5015.

PMID: 23925466

Prevalence of metabolic syndrome in patients with psoriasis: a population-based study in the United Kingdom.

Langan SM, Seminara NM, Shin DB, Troxel AB, Kimmel SE, Mehta NN, Margolis DJ, Gelfand JM.

J Invest Dermatol. 2012 Mar;132(3 Pt 1):556-62. doi: 10.1038/jid.2011.365. Epub 2011 Nov 24.

PMID: 22113483

The risk of fracture among patients with psoriatic arthritis and psoriasis: a population-based study

Alexis Ogdie, Lauren Harter, Daniel Shin, Joshua Baker, Junko Takeshita, Hyon K Choi, Thorvardur Jon Love, Joel M Gelfand.

Ann Rheum Dis. 2017 Jan 16. pii: annrheumdis-2016-210441. doi: 10.1136/annrheumdis-2016-210441.

PMID: 28093419

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LITE Study

Lite Treatment Effectiveness Study

PI: Dr. Joel M. Gelfand, MD, MSCE

 

The LITE Study is a joint effort of academic investigators(PI: Dr. Joel Gelfand and Co-PI Dr. Kristina Callis Duffin) and the National Psoriasis Foundation with input and active involvement by patients, dermatologists, health insurance providers/payers, and other stakeholders.

For more information please visit the PCORI website

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