Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.

Detailed Description
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The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.

Official Title
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A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Etanercept
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between age 18 and 70 years Active and stable plaque psoriasis with a BSA≥10 or PASI≥10. Exclusion Criteria: Evidence of skin conditions other than psoriasis Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab Corticosteroid dose of prednisone >10 mg/day Serious infection Receipt of any live vaccine Abnormal hematology or chemistry Body mass index (BMI) > 38 Pregnancy or Breastfeeding Significant concurrent medical conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etanercept<br>Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. | Drug: Etanercept<br>* Etanercept 50 mg QW initiated during taper of ciclosporin<br>* Other names: Enbrel;|
| Placebo Comparator: placebo<br>Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. | Other: Placebo<br>* Randomized to placebo during taper of ciclosporin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) | PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline. | Randomization to Week 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI Area Under the Curve (AUC) Between Randomization and Week 24 | PASI AUC = Area under the curve from randomization (Week 6) to Week 24. | Randomization to Week 24. | 
| Change From Randomization in PGA Score to Week 24 | PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline. | Randomization to Week 24. | 
| Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization | Relapse was defined as the loss of 50% improvement in PASI. | Randomization to Week 24. | 
| Probability of Being Relapse Free During the 24 Weeks After Randomization | Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis. | Randomization to Week 24. | 
| Percent (%) Change of PASI Score From Randomization to Week 24 | Percent improvement in PASI score was calculated from Week 6 to Week 24. | Randomization to Week 24. | 
| Change From Randomization in DLQI to Week 24 | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Randomization to Week 24. | 
| DLQI at Each Visit From Baseline | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Baseline to Week 24. | 
| Percentage of Rebound Effects | Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy. | Baseline to Week 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis