Acitretin and Etanercept in Psoriasis

Study Overview
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Brief Summary
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To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

Detailed Description
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This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.

Official Title
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Pilot, Single-Arm Study of the Effect of Adding Acitretin to Etanercept Therapy in Patients With Moderate to Severe Psoriasis Who Fail to Respond to Etanercept Monotherapy

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: acitretin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 [moderate] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept All patients on etanercept have been tested for TB before initiation of etanercept Exclusion Criteria: Patients < 18 years old or > 80 years old Patients who are not on etanercept 50 mg SQ once weekly Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation] or post-menopausal for at least 2 years, are eligible) Inability to understand consent or comply with study requirements Uncontrolled hypertriglyceridemia Patients with severely impaired hepatic function Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests Systemic psoriasis therapies or PUVA within the past 2 weeks UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week Patients with epilepsy or multiple sclerosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etanercept with acitretin<br>open-label | Drug: acitretin<br>* Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.<br>* Other names: Soriatane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy | Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy | Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease. | 6 months | 
| Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy | Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, etanercept, acitretin