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

• Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  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.
  
  

• PASI Area Under the Curve (AUC) Between Randomization and Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
  
  
• Change From Randomization in PGA Score to Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  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.
  
  
• Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  Relapse was defined as the loss of 50% improvement in PASI.
  
  
• Probability of Being Relapse Free During the 24 Weeks After Randomization [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
  
  
• Percent (%) Change of PASI Score From Randomization to Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  Percent improvement in PASI score was calculated from Week 6 to Week 24.
  
  
• Change From Randomization in DLQI to Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
  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).
  
  
• DLQI at Each Visit From Baseline [ Time Frame: Baseline to Week 24. ] [ Designated as safety issue: No ]
  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).
  
  
• Percentage of Rebound Effects [ Time Frame: Baseline to Week 24. ] [ Designated as safety issue: Yes ]
  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.
  
  

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.