Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis; Vascular Inflammation; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Psoriasis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to determine the effect of adalimumab on inflammation of blood vessels that
      could lead to heart attack in patients with psoriasis. Changes to the carotid artery and
      ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment)
      and compared against patients treated with a topical treatment that does not affect the
      entire body.
    

Detailed description: 
      Psoriasis and rheumatoid arthritis (RA) have been shown to be independent risk factors for
      myocardial infarction (MI). The risk is believed to be related in part to systemic
      inflammation associated with these diseases. Some studies have suggested that treatment of RA
      patients with anti-TNF alpha can decrease the risks of MI. However, we do not have data on
      the effect of anti-TNF alpha on coronary atherosclerosis. Adalimumab is probably the best
      anti-TNF alpha candidate to study for an effect on coronary atherosclerosis as it has more
      affinity for membrane bound TNF alpha than other anti-TNF alpha products such as etanercept
      and a higher global anti-TNF alpha activity in psoriasis patients.

      This study involves a comparison of adalimumab administered sub-cutaneously with a loading
      dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week thereafter for a total
      of 10 injections (two 40 mg injections at week 0 for a total dose of 80 mg, followed by
      single injections at weeks 1, 3, 5, 7, 9, 11, 13 and 15) with non systemic treatments for
      psoriasis (topical therapy and/or UVB therapy). Patients will be randomized (2:1) to either
      adalimumab or topical and/or UVB therapy for psoriasis.

      If this pilot study shows that adalimumab reduces vascular inflammation in patients with
      psoriasis, a larger study could be undertaken to study the effect of adalimumab on coronary
      atherosclerotic plaques.
    

Intervention name(s): adalimumab; UVB Phototherapy; Topical treatment
Intervention type(s): Biological; Device; Other
Intervention description(s): Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks); This intervention can be applied alone or in combination with topical treatment. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening.; This intervention can be applied alone or in combination with UVB phototherapy. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening. The investigator will prescribe to patients randomized in this arm a select topical product from the list:
Calcipotriol, Calcipotriene, Dovonex, Tazorac, Tazarotene Anthralin, Corticosteroids.
Other intervention name(s): Humira; Ultra violet light B
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: psoriasis; vascular inflammation; coronary atherosclerosis