The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis

Phase 4

• Conditions: Psoriasis; Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Interventions: Drug: Adalimumab treatment arm; Drug: Fumaric acid esters treatment group; Other: Narrow band UVB radiation

• Registration Number: NCT01088165
• Lead Sponsor: Medical University of Vienna

Brief Summary

Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a central role in the pathogenesis of associated comorbidities such as diabetes and cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha which not only plays a central role in the pathogenesis of psoriasis but has also been linked to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have investigated the positive effects of TNF alpha blockers on associated cardiovascular disease in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic agents in patients with moderate to severe chronic plaque psoriasis.

The present study aims at determining the effects of adalimumab, a potent and frequently prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation. The effects of adalimumab will be compared with those of fumaric acids, which represent an established traditional systemic treatment option for moderate to severe psoriasis.

Study hypothesis:

Therapy with adalimumab will lead to an improvement of several parameters that reflect the risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids, hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid intima-media thickness will be secondary outcomes.

Aim:

If adalimumab and/or fumaric acids will show a significant impact on the above mentioned parameters, these findings would offer a new perspective for the long term management of psoriatic patients and their comorbidities.

Study design: Randomized, prospective, controlled, parallel group study

Study population: 66 patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Study Start: 2010-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-20
• Primary Completion: 2013-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Chronic severe plaque type psoriasis (PASI <10) requiring systemic treatment. Non-response or contraindication to previous systemic and/or light treatment
• PASI ≥ 10, BSA ≥ 10
• Age 18 - 80 years

Exclusion Criteria

• Women of childbearing potential not taking contraceptive measures
• Pregnant or breastfeeding women
• Patients with a history or ongoing malignancy, chronic infections or autoimmune disease
• Patients with severe impairment of their general health
• Patients who are unable to understand or comply with the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab treatment group	Adalimumab treatment arm	-
Adalimumab treatment group	Narrow band UVB radiation	-
Fumaric acid esters treatment group	Fumaric acid esters treatment group	-
Fumaric acid esters treatment group	Narrow band UVB radiation	-

Primary Outcome Measures

Name	Time	Method
The influence of adalimumab treatment in comparison to treatment with fumaric acid esters on the functional integrity of the endothelium will be monitored by flow mediated dilatation (FMD)	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
The measurement of carotid artery intima-media thickness (IMT) by ultrasound will serve as a morphological substrate for evaluating the potential effect of adalimumab on signs of atherosclerosis within the vessel wall	3 and 6 months
Influence of adalimumab in comparison to fumaric acid esters on biochemical cardiovascular and metabolic risk factors	3 and 6 months

Trial Locations

Locations (1)

Medical University Vienna Dpt. of Dermatology; 🇦🇹 Vienna, Austria