Observational study of apremilast in patients with psoriasis in The NetherlandsAPRIL
Study Details
This is a multicenter, prospective, non-interventional, observational single arm study.
Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.
Protocol Summary
Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points
Timeframe: Up to approximately 12 months
Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points
Timeframe: Up to approximately 12 months
Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment
Timeframe: Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey
Timeframe: Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)
Timeframe: Up to approximately 12 months
Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)
Timeframe: Up to approximately 12 months
Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment
Timeframe: Up to approximately 2 months
Changes in body surface area (BSA)at 6 and 12 months treatment
Timeframe: Up to approximately 12 months
Changes in static physician global assessment (sPGA) at 6 and 12 months treatment
Timeframe: Up to approximately 12 months
Baseline characteristics of patients initiating apremilast treatment
Timeframe: Up to approximately 1 month
Reasons for discontinuation of apremilast
Timeframe: Up to approximately 12 months