An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria

Study Overview
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Brief Summary
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With the new reimbursement criteria, we want: To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year. To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment

Detailed Description
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100 patients will be followed for at least 1 year

Official Title
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An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study

Conditions
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Plaque Psoriasis Patients

Intervention / Treatment
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* Other: Enbrel treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria Patients ≥18 year Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plaque psoriasis patients<br>Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria | Other: Enbrel treatment<br>* Enbrel SC 50mg once weekly or 25mg twice weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Weeks of Etanercept Treatment | Average duration of time in weeks for treatment with etanercept was reported. | Baseline up to end of study (90 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Weeks of Off-Treatment | Total duration of time in weeks for which participants discontinued etanercept treatment was reported. | Baseline up to end of study (90 weeks) | 
| Psoriasis Area and Severity Index (PASI) Score | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. | Start and end of cycle 1, 2, 3 | 
| Percentage of Body Surface Area (BSA) Affected by Psoriasis | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. | Start and end of cycle 1, 2, 3 | 
| Number of Participants With Reasons for Treatmant Discontinuation | Number of participants who discontinued etanercept before completing the study was reported. | Baseline up to end of study (90 weeks) |