Acitretin and Etanercept in Psoriasis

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: acitretin

Detailed Description

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
• Enrollment (Actual): 10
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: etanercept with acitretin; open-label	Drug: acitretin; 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.; Other Names: Soriatane

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: Connetics Corp.
• Investigators: Principal Investigator: Melissa A. Magliocco, MD, Rutgers, the State University of New Jersey

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 13, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: psoriasis; etanercept; acitretin
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Acitretin
• Other Study ID Numbers: 5487 (Old Duke IRB number)