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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT04031027

Collaborator

(none)

184

Enrollment

Locations

18.2

Actual Duration (Months)

11.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: Apremilast

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.

Study Design

Study Type:

Observational

Actual Enrollment :

184 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 22, 2019

Actual Primary Completion Date :

Jan 27, 2021

Actual Study Completion Date :

Jan 27, 2021

Outcome Measures

Primary Outcome Measures

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 %
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 %

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi	Ancona	AN	Italy	60126
2	UOC Dermatologia ASST Spedali Civili	Brescia	BS	Italy	25123
3	Dermatologia Azienda Ospedaliera Papardo	Messina	ME	Italy	98158
4	Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico	Bari		Italy	70124
5	UOS Clinica Dermatologica Ospedale San Giovanni di Dio	Cagliari		Italy	09123
6	Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco	Catania		Italy	95100
7	UOC Dermatologia Arcispedale Sant'Anna	Cona		Italy	44124
8	Dermatologia Ospedale Piero Palagi	Firenze		Italy	50025
9	UOC Dermatologia A.O.U. Policlinico G. Martino	Messina		Italy	98125
10	Dermatologia A.O.U. Federico II	Napoli		Italy	80131
11	UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli	Napoli		Italy	80138
12	Dermatologia A.O.U. Maggiore della Carità	Novara		Italy	28100
13	UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone	Palermo		Italy	90127
14	Clinica Dermatologica Policlinico Tor Vergata	Roma		Italy	00133
15	Dermatologia e Venereologia A.O.U. Policlinico Umberto I	Roma		Italy	00161
16	UOC Dermatologia Universitaria Ospedale A. Fiorini	Terracina		Italy	04019