Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis

Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.

In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Dermatology Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must understand and voluntarily sign an informed consent form.
• Must be male or female and age 18-55 years at time of consent.
• Must be able to adhere to the study visit schedule and other protocol requirements
• Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
• Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
• Negative PPD at Screening or 3 months earlier.
• Have not used any biologic treatment for psoriasis in the past 12 months.

Exclusion Criteria:

• Inability to provide voluntary consent
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Pregnant, trying to become pregnant or breastfeeding
• Prior diagnosis of coronary artery disease (CAD) or heart disease.
• Systemic fungal infection
• History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
• History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
• Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
• Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
• History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
• Positive Hepatitis B Surface antigen at screening
• Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
• History of any demyelinating disorder such as multiple sclerosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adalimumab 40mg; Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months	Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]; 40mg subcutaneously, every other week for 6 months; Other Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Endothelial Function Compared to Baseline.	Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IL-6 Profile Compared to Baseline	IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.	6 months
Changes in Adiponectin Profile Compared to Baseline	Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.	24 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: AbbVie
• Investigators: Principal Investigator: Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: March 18, 2011
• First Posted (Estimate): March 22, 2011

Study Record Updates

• Last Update Posted (Estimate): December 26, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Moderate to Severe Chronic plaque type psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: ABBO-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan to share data