Advertisement

Topics

The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis

2014-08-27 03:15:10 | BioPortfolio

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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Psoriasis

Intervention

Adalimumab treatment arm, Fumaric acid esters treatment group, Narrow band UVB radiation

Location

Medical University Vienna Department of Dermatology
Vienna
Austria
A-1090

Status

Not yet recruiting

Source

Medical University of Vienna

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:10-0400

Clinical Trials [2907 Associated Clinical Trials listed on BioPortfolio]

APremilast After FumaRic Acid Ester Treatment

Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment

A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis

The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who hav...

A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants wi...

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psorias...

Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides

The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate ...

PubMed Articles [39622 Associated PubMed Articles listed on BioPortfolio]

S3 Guideline for the treatment of psoriasis vulgaris, update - Short version part 1 - Systemic treatment.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a forma...

Evaluation of growth performance and gastro-intestinal parameters on the response of weaned piglets to dietary organic acids.

Two experiments (E) were carried out to evaluate the effects of fumaric acid and an acidifier blend [composed by calcium formate, calcium lactate and medium-chain fatty acids (capric and caprylic)] in...

Fumarates - far more than a dietary supplement.

Fumaric acid has an important role in the citric acid cycle. Its esters were first used by a German chemist to treat his own psoriasis, hypothesizing that the disease may be related to disturbances in...

Adalimumab treatment of anti-TNF-naïve patients with ulcerative colitis: Deep remission and response factors.

Adalimumab is the second tumour necrosis factor antagonist (anti-TNF) adopted for the treatment of ulcerative colitis. Clinical data from naïve patients are scarce.

Fumaric acid production using renewable resources from biodiesel and cane sugar production processes.

The microbial production of fumaric acid by Rhizopus arrhizus NRRL 2582 has been evaluated using soybean cake from biodiesel production processes and very high polarity (VHP) sugar from sugarcane mill...

Medical and Biotech [MESH] Definitions

Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

An enzyme that catalyzes the reversible hydration of fumaric acid to yield L-malic acid. It is one of the citric acid cycle enzymes. EC 4.2.1.2.

Refusal of the health professional to initiate or continue treatment of a patient or group of patients. The refusal can be based on any reason. The concept is differentiated from PATIENT REFUSAL OF TREATMENT see TREATMENT REFUSAL which originates with the patient and not the health professional.

A vasodilator that also has bronchodilatory action. It has been employed in the treatment of angina pectoris, in the treatment of asthma, and in conjunction with ultraviolet light A, has been tried in the treatment of vitiligo. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1024)

More From BioPortfolio on "The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzumab (Itolizumab)
Biocon Launches ALZUMAb™ - a ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India • ALZUMAb™-World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for th...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Psoriasis
Psoriasis is a common skin condition affecting 2-3% of the population of the United Kingdom, where the skins replacement process is sped taking 2-6 days instead of the usual 21 - 28 days for the replacement of skin cells. Patients experience an accumulat...


Searches Linking to this Trial