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

Plaque Psoriasis Clinical Trial

— DARWIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031027
• Other study ID #: CC-10004-PSOR-026
• Secondary ID: U1111-1236-1175
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: January 27, 2021

Study information

• Verified date: March 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Apremilast
Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.

Locations

Country	Name	City	State
Italy	SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi	Ancona	AN
Italy	Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico	Bari
Italy	UOC Dermatologia ASST Spedali Civili	Brescia	BS
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	Firenze
Italy	Dermatologia Azienda Ospedaliera Papardo	Messina	ME
Italy	UOC Dermatologia A.O.U. Policlinico G. Martino	Messina
Italy	Dermatologia A.O.U. Federico II	Napoli
Italy	UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli	Napoli
Italy	Dermatologia A.O.U. Maggiore della Carità	Novara
Italy	UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone	Palermo
Italy	Clinica Dermatologica Policlinico Tor Vergata	Roma
Italy	Dermatologia e Venereologia A.O.U. Policlinico Umberto I	Roma
Italy	UOC Dermatologia Universitaria Ospedale A. Fiorini	Terracina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Giofre C, Fabbrocini G, Potenza C, Tiberio R, Gisondi P, Marasca C, Nuzzo CMA, Benincasa E, Bianchi L; DARWIN study group. Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study. Adv Ther. 2023 Jul;40(7):3021-3037. doi: 10.1007/s12325-023-02516-y. Epub 2023 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean age of the patients treated with apremilast	Age at treatment initiation (years)	At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs)	Descriptive analysis of AEs will be provided by severity, causality and seriousness	Up to approximately 7 months after treatment initiation
Secondary	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
Secondary	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

External Links

•   AmgenTrials clinical trials website