A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice

Study Overview
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Brief Summary
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The DARWIN study is an Italian multicenter, observational, cross-sectional study involving both a primary data collection (at enrollment visit) and secondary use of data (retrospective observation period). DARWIN will describe patients' characteristics in Italian routine clinical practice as well as the medication utilization patterns, including needs and benefits form the patient's perspective.

Detailed Description
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The DARWIN study is anticipated to enroll 375 participants from 24 Italian dermatologic departments and recruitment is expected to take approximately 20 months. Participants must have started apremilast treatment 6 (±1) months prior enrollment in order to be considered eligible. The decision to prescribe apremilast falls within current practice according to the current decision-making process in the Italian routine clinical practice and according to AIFA prescribing information. No extra-procedures (diagnostic or monitoring) will be implemented and the assessment schedule reflects the routine clinical practice for psoriatic patients treated with apremilast. Patients will be consecutively enrolled in the study and information will be collected as recorded in the medical chart before starting apremilast (as close as possible to the apremilast start date/index date), and/or directly observed during the enrolment visit. The study variables will describe patient disease and characteristics, apremilast utilization patterns, psoriasis severity a, extent and impact on patient wellbeing, apremilast safety profile and apremilast satisfaction.

Official Title
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DARWIN: Description of Apremilast Real World Italian Psoriasis Network - a Multicenter, Observational, Cross-sectional Study to Describe Patient Characteristics and Treatment Pattern

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have understood and voluntarily signed the informed consent and privacy form. Age ≥ 18 years at the time of signing the informed consent and privacy form. Patients with available hospital medical chart since the start of apremilast treatment ('index date'). Diagnosis of plaque psoriasis. Treatment with apremilast for plaque psoriasis, according to Summary of Product Characteristics (SmPC), started 6 (±1) months before enrollment. Patients who interrupted apremilast treatment before enrollment will also be included. Ability to understand (read & write) the Italian language and to follow the study instructions. Exclusion Criteria: Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial. Started apremilast as part of a clinical trial, or previous apremilast use (prior to the index date).

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

| Intervention/Treatment |
| --- |
|Drug: Apremilast|Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean age of the patients treated with apremilast | Age at treatment initiation (years) | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment) | 
| Gender frequency of the patients treated with apremilast | Gender (male/female); frequency in % | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean body weight of the patients treated with apremilast | Body weight in kg | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean body mass index of the patients treated with apremilast | BMI (combined outcome of weight and height in the form of kg/m^2) | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean blood pressure of the patients treated with apremilast | Blood pressure in mmHg | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean duration of psoriatic disease of the patients treated with apremilast | Duration in years | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean Psoriasis area severity index score of the patients treated with apremilast | Psoriasis area severity index score (PASI) | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean Body surface area of the patients treated with apremilast | Psoriasis-involved body surface area (BSA) in % | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Mean Physician global assessment (PGA) score of the patients treated with apremilast | Physician global assessment (PGA) | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Frequency of previous antipsoriatic treatments in the patients treated with apremilast | Previous treatments classes in % | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 
| Reasons for discontinuation of previous antipsoriatic treatments in the patients treated with apremilast | Frequency distribution of reasons in % | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants receiving apremilast at enrollment visit | Persistence on apremilast treatment will be measured up to approximately 7 months after treatment initiation | Up to approximately 7 months after treatment initiation | 
| Apremilast treatment duration | Apremilast treatment duration is defined as the difference between the start date and the end date of apremilast treatment. | Up to approximately 7 months after treatment initiation | 
| Change from baseline in Body Surface Area (BSA) | BSA is measurement of the body area involved in relation to the whole body surface. | Up to approximately 7 months after treatment initiation | 
| Change from baseline in the Physician Global Assessment (PGA) Score | A 4 to 6-point scoring system used to assess plaque psoriasis disease severity | Up to approximately 7 months after treatment initiation | 
| Change from baseline in the Dermatology Life Quality Index (DLQI) score | DLQI is 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. | Up to approximately 7 months after treatment initiation | 
| Proportions of patients achieving PGA score 0 or 1 | The Physician's Global Assessment is a measurement of overall involvement by the investigator at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions. | Up to approximately 7 months after treatment initiation | 
| Proportions of patients achieving DLQI score ≤5 | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. | Up to approximately 7 months after treatment initiation | 
| Proportions of patients achieving ≥4 points improvement in DLQI score | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. | Up to approximately 7 months after treatment initiation | 
| Adverse Events (AEs) | Descriptive analysis of AEs will be provided by severity, causality and seriousness | Up to approximately 7 months after treatment initiation | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score | The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy | Up to approximately 7 months after treatment initiation | 
| Patient Benefit Index for Skin Diseases Score (standard version) (PBI-S) outcome score | The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. | Up to approximately 7 months after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apremilast, DARWIN, dermatology, retrospective, observational, psoriasis, cross-sectional