A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice
- Conditions
- Plaque Psoriasis
- Registration Number
- NCT04031027
- Lead Sponsor
- Amgen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean age of the patients treated with apremilast At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment) Age at treatment initiation (years)
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 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)
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 %
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 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 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)
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 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 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 %
- Secondary Outcome Measures
Name Time Method 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.
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
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.
Trial Locations
- Locations (16)
Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico
🇮🇹Bari, Italy
Dermatologia Ospedale Piero Palagi
🇮🇹Firenze, Italy
UOC Dermatologia Arcispedale Sant'Anna
🇮🇹Cona, Italy
Dermatologia A.O.U. Federico II
🇮🇹Napoli, Italy
Dermatologia Azienda Ospedaliera Papardo
🇮🇹Messina, ME, Italy
UOS Clinica Dermatologica Ospedale San Giovanni di Dio
🇮🇹Cagliari, Italy
Clinica Dermatologica Policlinico Tor Vergata
🇮🇹Roma, Italy
UOC Dermatologia A.O.U. Policlinico G. Martino
🇮🇹Messina, Italy
UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli
🇮🇹Napoli, Italy
UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone
🇮🇹Palermo, Italy
UOC Dermatologia ASST Spedali Civili
🇮🇹Brescia, BS, Italy
Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco
🇮🇹Catania, Italy
Dermatologia A.O.U. Maggiore della Carità
🇮🇹Novara, Italy
UOC Dermatologia Universitaria Ospedale A. Fiorini
🇮🇹Terracina, Italy
Dermatologia e Venereologia A.O.U. Policlinico Umberto I
🇮🇹Roma, Italy
SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
🇮🇹Ancona, AN, Italy