Dataset Information

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

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.

SUBMITTER: Giofre C

PROVIDER: S-EPMC10175925 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Giofrè Claudia C Fabbrocini Gabriella G Potenza Concetta C Tiberio Rossana R Gisondi Paolo P Marasca Claudio C Nuzzo Carmen M A CMA Benincasa Emiliana E Bianchi Luca L

Advances in therapy 20230512 7

<h4>Introduction</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 37171752

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Project description:IntroductionThe broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria. This is the first study to report data on the real-world use of apremilast in the region.MethodsAPPRECIATE (NCT02740218) was an observational, retrospective, cross-sectional study assessing psoriasis patients 6 (± 1) months after apremilast treatment initiation. The study aimed to describe the characteristics of patients with psoriasis receiving apremilast, estimate treatment outcomes, including Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI), and assess dermatologists' and patients' perspectives on treatment using questionnaires including the Patient Benefit Index (PBI). Adverse event reports were taken from the medical records.ResultsFifty patients (Croatia: 25; Czech Republic: 20; Slovenia: 5) were enrolled. In patients continuing apremilast at 6 (± 1) months, mean (± SD) PASI score was reduced from 16.2 ± 8.7 points at treatment initiation to 3.1 ± 5.2 at 6 (± 1) months; BSA from 11.9% ± 10.3% to 0.8% ± 0.9%; DLQI from 13.7 ± 7.4 points to 1.6 ± 3.2. PASI 75 was reached by 81% of patients. Physicians reported that the overall treatment success fulfilled their expectations in more than two thirds of patients (68%). At least three-quarters of patients reported apremilast had a quite or very high benefit on the needs they identified as being most important. Apremilast was well tolerated; no serious or fatal adverse events were identified.ConclusionApremilast was effective in reducing skin involvement and improving quality of life in CEE patients having severe disease. Treatment satisfaction among physicians and patients was very high. These data add to the growing body of evidence showing consistent effectiveness of apremilast across the continuum of psoriasis disease severity and manifestations.Trial registrationClinicalTrials.gov identifier, NCT02740218.

Project description:BackgroundPsoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy.MethodsThe annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%).ResultsThe most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 - €39,280) and ixekizumab (range: €11,092 - €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60-80%), which was achieved early in time.ConclusionBiologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.

Dataset Information

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

Introduction

Methods

Results

Conclusions

Study registration

Publications

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

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