Observational Study of Apremilast in Patients With Psoriasis in The Netherlands

Study Overview
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Brief Summary
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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.

Detailed Description
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Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken. Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast. Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA)) Patients will be asked to complete the following questionnaires: DLQI TSQM EQ5D SF36- Itch Visual Analog Scale (VAS) WPAI Work Productivity and Activity Index Patient Benefit Index PBI End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented. AE monitoring All patients will be monitored for adverse events throughout the study. From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.

Official Title
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Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form. Patients starting treatment for psoriasis with apremilast in clinical practice. Exclusion Criteria: Refusal to participate in the study. Women who are pregnant or breast-feeding. Hypersensitivity to the active substance or to any of the excipients. Prior exposure to apremilast Psoriatic arthritis treated by a rheumatologist in the previous year

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 |
| --- | --- |
| Patients receiving Apremilast per daily clinical practice<br>Dutch patients receiving Apremilast according to daily clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points | The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions. | Up to approximately 12 months | 
| Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points | The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions. | Up to approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment | The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions. | Up to approximately 12 months | 
| Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey | The SF-36v2® Health Survey measures functional health and well-being from the patient's point of view. It can be used across age (18 and older), disease, and treatment group. | Up to approximately 12 months | 
| Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D) | EQ-5D is a standardized instrument for use as a measure of health outcome in a wide range of health conditions and treatment | Up to approximately 12 months | 
| Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS) | Itch VAS is a simple assessment of the itch severity using a visual analogue scale | Up to approximately 12 months | 
| Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment | PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and Severity Index). | Up to approximately 2 months | 
| Changes in body surface area (BSA)at 6 and 12 months treatment | BSA (Body Surface Area): severity is defined by how much of the body surface area is affected. | Up to approximately 12 months | 
| Changes in static physician global assessment (sPGA) at 6 and 12 months treatment | sPGA: assessment by physician to classify disease activity in a consistent manner | Up to approximately 12 months | 
| Baseline characteristics of patients initiating apremilast treatment | Characteristics at baseline of patient initiating apremilast treatment | Up to approximately 1 month | 
| Reasons for discontinuation of apremilast | Rate and reasons for discontinuation of apremilast within 12 months of start | Up to approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Observational, Apremilast, APRIL, Non-Interventional, The Netherlands