Plaque Psoriasis
Conditions
Keywords
apremilast, DARWIN, dermatology, retrospective, observational, psoriasis, cross-sectional
Brief summary
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
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.
Interventions
DRUGApremilast
Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must have understood and voluntarily signed the informed consent and privacy form. 2. Age ≥ 18 years at the time of signing the informed consent and privacy form. 3. Patients with available hospital medical chart since the start of apremilast treatment ('index date'). 4. Diagnosis of plaque psoriasis. 5. 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. 6. Ability to understand (read & write) the Italian language and to follow the study instructions.
Exclusion criteria
1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial. 2. Started apremilast as part of a clinical trial, or previous apremilast use (prior to the index date).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for discontinuation of previous antipsoriatic treatments in the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Frequency distribution of reasons in % |
| Mean age of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment) | Age at treatment initiation (years) |
| Gender frequency of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Gender (male/female); frequency in % |
| Mean body weight of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Body weight in kg |
| Mean body mass index of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | BMI (combined outcome of weight and height in the form of kg/m\^2) |
| Mean blood pressure of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Blood pressure in mmHg |
| Mean duration of psoriatic disease of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Duration in years |
| Mean Psoriasis area severity index score of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Psoriasis area severity index score (PASI) |
| Mean Body surface area of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Psoriasis-involved body surface area (BSA) in % |
| Mean Physician global assessment (PGA) score of the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Physician global assessment (PGA) |
| Frequency of previous antipsoriatic treatments in the patients treated with apremilast | At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment) | Previous treatments classes in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants receiving apremilast at enrollment visit | Up to approximately 7 months after treatment initiation | Persistence on apremilast treatment will be measured up to approximately 7 months after treatment initiation |
| Apremilast treatment duration | Up to approximately 7 months after treatment initiation | Apremilast treatment duration is defined as the difference between the start date and the end date of apremilast treatment. |
| Change from baseline in Body Surface Area (BSA) | Up to approximately 7 months after treatment initiation | BSA is measurement of the body area involved in relation to the whole body surface. |
| Change from baseline in the Physician Global Assessment (PGA) Score | Up to approximately 7 months after treatment initiation | A 4 to 6-point scoring system used to assess plaque psoriasis disease severity |
| Change from baseline in the Dermatology Life Quality Index (DLQI) score | Up to approximately 7 months after treatment initiation | 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. |
| Proportions of patients achieving PGA score 0 or 1 | Up to approximately 7 months after treatment initiation | 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. |
| Proportions of patients achieving DLQI score ≤5 | Up to approximately 7 months after treatment initiation | 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. |
| Proportions of patients achieving ≥4 points improvement in DLQI score | Up to approximately 7 months after treatment initiation | 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. |
| Adverse Events (AEs) | Up to approximately 7 months after treatment initiation | Descriptive analysis of AEs will be provided by severity, causality and seriousness |
| Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score | Up to approximately 7 months after treatment initiation | The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy |
| Patient Benefit Index for Skin Diseases Score (standard version) (PBI-S) outcome score | Up to approximately 7 months after treatment initiation | The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. |
Countries
Italy
Outcome results
None listed