Acitretin and Etanercept in Psoriasis

University of Medicine and Dentistry of New Jersey10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

acitretinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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