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

Pfizer140 enrolled

Overview

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

100 patients will be followed for at least 1 year

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Plaque Psoriasis Patients

Interventions

Enbrel treatmentOTHER

Enbrel SC 50mg once weekly or 25mg twice weekly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Herestraat 49

Leuven, Belgium

Outcomes

Primary Outcomes

Number of Weeks of Etanercept Treatment

Average duration of time in weeks for treatment with etanercept was reported.

Time frame: Baseline up to end of study (90 weeks)

Secondary Outcomes

Number of Weeks of Off-Treatment

Total duration of time in weeks for which participants discontinued etanercept treatment was reported.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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