Clinical trial NCT04031027: A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice
Official title: DARWIN: Description of Apremilast Real World Italian Psoriasis Network - a Multicenter, Observational, Cross-sectional Study to Describe Patient Characteristics and Treatment Pattern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: apremilast
DARWIN
dermatology
retrospective
observational
psoriasis
cross-sectional
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Adult patients ≥18 years
* Moderate to severe plaque-type psoriasis according to Summary of Product Characteristics

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mean age of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
measure: Gender frequency of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean body weight of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean body mass index of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean blood pressure of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean duration of psoriatic disease of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean Psoriasis area severity index score of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean Body surface area of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Mean Physician global assessment (PGA) score of the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Frequency of previous antipsoriatic treatments in the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
measure: Reasons for discontinuation of previous antipsoriatic treatments in the patients treated with apremilast
timeFrame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Secondary outcomes:
measure: Proportion of participants receiving apremilast at enrollment visit
timeFrame: Up to approximately 7 months after treatment initiation
measure: Apremilast treatment duration
timeFrame: Up to approximately 7 months after treatment initiation
measure: Change from baseline in Body Surface Area (BSA)
timeFrame: Up to approximately 7 months after treatment initiation
measure: Change from baseline in the Physician Global Assessment (PGA) Score
timeFrame: Up to approximately 7 months after treatment initiation
measure: Change from baseline in the Dermatology Life Quality Index (DLQI) score
timeFrame: Up to approximately 7 months after treatment initiation
measure: Proportions of patients achieving PGA score 0 or 1
timeFrame: Up to approximately 7 months after treatment initiation
measure: Proportions of patients achieving DLQI score ≤5
timeFrame: Up to approximately 7 months after treatment initiation
measure: Proportions of patients achieving ≥4 points improvement in DLQI score
timeFrame: Up to approximately 7 months after treatment initiation
measure: Adverse Events (AEs)
timeFrame: Up to approximately 7 months after treatment initiation
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score
timeFrame: Up to approximately 7 months after treatment initiation
measure: Patient Benefit Index for Skin Diseases Score (standard version) (PBI-S) outcome score
timeFrame: Up to approximately 7 months after treatment initiation
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
state: AN
city: Brescia
country: Italy
facility: UOC Dermatologia ASST Spedali Civili
state: BS
city: Messina
country: Italy
facility: Dermatologia Azienda Ospedaliera Papardo
state: ME
city: Bari
country: Italy
facility: Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico
city: Cagliari
country: Italy
facility: UOS Clinica Dermatologica Ospedale San Giovanni di Dio
city: Catania
country: Italy
facility: Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco
city: Cona
country: Italy
facility: UOC Dermatologia Arcispedale Sant'Anna
city: Firenze
country: Italy
facility: Dermatologia Ospedale Piero Palagi
city: Messina
country: Italy
facility: UOC Dermatologia A.O.U. Policlinico G. Martino
city: Napoli
country: Italy
facility: Dermatologia A.O.U. Federico II
city: Napoli
country: Italy
facility: UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli
city: Novara
country: Italy
facility: Dermatologia A.O.U. Maggiore della Carità
city: Palermo
country: Italy
facility: UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone
city: Roma
country: Italy
facility: Clinica Dermatologica Policlinico Tor Vergata
city: Roma
country: Italy
facility: Dermatologia e Venereologia A.O.U. Policlinico Umberto I
city: Terracina
country: Italy
facility: UOC Dermatologia Universitaria Ospedale A. Fiorini
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.