Title
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
Phase
Phase 2Lead Sponsor
University of Medicine and Dentistry of New JerseyStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
PsoriasisIntervention/Treatment
acitretin ...Study Participants
10To 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.
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.
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
| Event Type | Organ System | Event Term | Etanercept With Acitretin |
|---|
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.
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.
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.
