Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

Giofrè;Claudia; Fabbrocini;Gabriella; Potenza;Concetta; Tiberio;Rossana; Gisondi;Paolo; Marasca;Claudio; Nuzzo;Carmen M A; Benincasa;Emiliana; Bianchi;Luca;DARWIN study group: Paolo Dapavo;Paolo Gisondi;Aurora Parodi;Luca Bianchi;Laura Atzori

Member of the Collaboration Group

;Gabriella Fabbrocini; Concetta Potenza; Rocco De Pasquale; Ketty Peris; Paolo Amerio; Rossana Tiberio; Marina Venturini; Ada Lo Schiavo; Marco Romanelli; Antonio Richetta; Francesco Cusano; Maria Concetta Fargnoli; Annamaria Offidani; Claudio Guarneri; Francesca Prignano; Monica Corazza; Maria Rita Bongiorno; Claudia Giofre; Francesco Loconsole.

2023-01-01

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Abstract

Introduction: While several European studies have reported real-world apremilast use, patient-perceived benefits, and treatment satisfaction, local reimbursement criteria for apremilast vary and data from Italy are limited. Methods: The cross-sectional DARWIN study enrolled consecutive patients who had initiated apremilast for plaque psoriasis 6 (± 1) months prior to enrolment at a single visit across 24 Italian dermatological sites. Disease severity was assessed using body surface area (BSA) and Physician Global Assessment (PGA). Patient-reported outcomes assessed 6 (± 1) months after apremilast initiation were Dermatology Life Quality Index (DLQI), Patient Benefit Index (PBI), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Results: Of 184 patients enrolled between July 2019 and January 2021, 180 were included in the analysis. At apremilast initiation, median (25th-75th percentile) time since psoriasis diagnosis was 8.6 (3.2-22.2) years; median BSA, 10.0% (5.0-16.0); mean (standard seviation, SD) DLQI total score, 13.5 (8.0). Over half (54.9%) of patients with available data reported psoriasis had a very or extremely large effect on their quality of life (QoL); half reported itching (50.6%) and/or special areas involvement (50.0%). Most (73.9%) had comorbidities and were biologic-naïve (81.5%). The most common reasons for initiating apremilast were lack of efficacy of previous treatment (56.7%) and contraindications to other treatments (44.4%). At 6 (± 1) months, most patients were continuing apremilast and/or reported a Global PBI score ≥ 1 (minimum clinical benefit) (86.1% and 90.0%, respectively); approximately half achieved BSA ≤ 3% and/or DLQI total score ≤ 5 (47.1% and 48.5%); 18.8% achieved PGA = 0; mean (SD) TSQM-9 global treatment satisfaction score was 59.0 (24.8). Apremilast was well tolerated; no new safety signals were identified. Conclusions: Patients treated with apremilast for 6 months in Italian clinical practice reported improved QoL, clinically relevant improvements in symptoms, high treatment satisfaction, and high treatment persistence. Our data indicate apremilast is a valuable treatment option for moderate plaque psoriasis. Study registration: ClinicalTrials.gov identifier, NCT04031027.