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

IntroductionWhile 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.methodsThe 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).ResultsOf 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-naive (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 clinical trials.gov identifier, NCT04031027.