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

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico
  • Cagliari, Italy, 09123
    • UOS Clinica Dermatologica Ospedale San Giovanni di Dio
  • Catania, Italy, 95100
    • Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco
  • Cona, Italy, 44124
    • UOC Dermatologia Arcispedale Sant'Anna
  • Firenze, Italy, 50025
    • Dermatologia Ospedale Piero Palagi
  • Messina, Italy, 98125
    • UOC Dermatologia A.O.U. Policlinico G. Martino
  • Napoli, Italy, 80131
    • Dermatologia A.O.U. Federico II
  • Napoli, Italy, 80138
    • UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli
  • Novara, Italy, 28100
    • Dermatologia A.O.U. Maggiore della Carità
  • Palermo, Italy, 90127
    • UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone
  • Roma, Italy, 00133
    • Clinica Dermatologica Policlinico Tor Vergata
  • Roma, Italy, 00161
    • Dermatologia e Venereologia A.O.U. Policlinico Umberto I
  • Terracina, Italy, 04019
    • UOC Dermatologia Universitaria Ospedale A. Fiorini
  • AN
    • Ancona, AN, Italy, 60126
      • SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
  • BS
    • Brescia, BS, Italy, 25123
      • UOC Dermatologia ASST Spedali Civili
  • ME
    • Messina, ME, Italy, 98158
      • Dermatologia Azienda Ospedaliera Papardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• Adult patients ≥18 years
• Moderate to severe plaque-type psoriasis according to Summary of Product Characteristics

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean age of the patients treated with apremilast	Age at treatment initiation (years)	At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Adverse Events (AEs)	Descriptive analysis of AEs will be provided by severity, causality and seriousness	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	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.	Up to approximately 7 months after treatment initiation

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): January 27, 2021
• Study Completion (Actual): January 27, 2021

Study Registration Dates

• First Submitted: July 6, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dermatology; psoriasis; cross-sectional; observational; apremilast; DARWIN; retrospective
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: CC-10004-PSOR-026; U1111-1236-1175 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No