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.
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.
Study Type
OBSERVATIONAL
Enrollment
184
Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.
SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
Ancona, AN, Italy
UOC Dermatologia ASST Spedali Civili
Brescia, BS, Italy
Mean age of the patients treated with apremilast
Age at treatment initiation (years)
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
Gender frequency of the patients treated with apremilast
Gender (male/female); frequency in %
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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Dermatologia Azienda Ospedaliera Papardo
Messina, ME, Italy
Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico
Bari, Italy
UOS Clinica Dermatologica Ospedale San Giovanni di Dio
Cagliari, Italy
Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco
Catania, Italy
UOC Dermatologia Arcispedale Sant'Anna
Cona, Italy
Dermatologia Ospedale Piero Palagi
Florence, Italy
UOC Dermatologia A.O.U. Policlinico G. Martino
Messina, Italy
Dermatologia A.O.U. Federico II
Naples, Italy
...and 6 more locations
Mean Body surface area of the patients treated with apremilast
Psoriasis-involved body surface area (BSA) in %
Time frame: 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)
Time frame: 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 %
Time frame: 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 %
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Proportion of participants receiving apremilast at enrollment visit
Persistence on apremilast treatment will be measured up to approximately 7 months after treatment initiation
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 7 months after treatment initiation
Adverse Events (AEs)
Descriptive analysis of AEs will be provided by severity, causality and seriousness
Time frame: 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
Time frame: 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.
Time frame: Up to approximately 7 months after treatment initiation