Psoriasis In Italy Research Articles

EE713 Cost-of-Illness of Generalized Pustular Psoriasis in Italy

EE713 Cost-of-Illness of Generalized Pustular Psoriasis in Italy

Drug Utilization and Measurement of Medication Adherence: A Real World Study of Psoriasis in Italy.

Exceptional advances have been made with systemic treatment for psoriasis (PSO). However, that disease still represents a heavy burden in terms of impact on healthcare systems worldwide. This study comprehensively assesses medication adherence in a real world setting in Italy across all phases-initiation, implementation, and persistence-of PSO therapies. By distinguishing between switches and swaps, it provides unique insights into the patient's own approach to prescribed therapy as well as clinical decision-making processes, enhancing our understanding of medication adherence and discontinuation in a real world daily setting. The study's refined methodology for assessing persistence, considering variations in refill gaps and complex dosing regimens, shows that anti-interleukin (IL) therapies are associated with longer periods of adherence compared with other available therapeutic strategies. Among the selected drugs, ixekizumab and secukinumab were the ones with higher rate of treatment adherence at the expense of anti-TNF-α and anti-PDE4 agents. Notably, patients who opt for swaps are approximately 2.8 times more likely to discontinue their PSO therapy within one year. These findings carry practical implications for optimizing medication adherence, including tailored patient counseling, monitoring, and therapeutic adjustments, highlighting the need for a comprehensive and patient-centered approach to managing these conditions.

Brodalumab for the Treatment of Moderate-to-Severe Psoriasis: An Expert Delphi Consensus Statement.

Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against interleukin-17RA that has been approved for the treatment of moderate-to-severe psoriasis in Europe. We developed a Delphi consensus document focused on brodalumab for the treatment of moderate-to-severe psoriasis. Based on published literature and their clinical experience a steering committee drafted 17 statements covering 7 domains specific to the treatment of moderate-to-severe psoriasis with brodalumab. A panel of 32 Italian dermatologists indicated their level of agreement using a 5-point Likert scale (from 1 = "strongly disagree" to 5 = "strongly agree") using an online modified Delphi method. After the first round of voting (32 participants), positive consensus was reached for 15/17 (88.2%) of the proposed statements. Following a face-to-face virtual meeting, the steering committee decided that 5 statements would form "main principles" and 10 statements formed the final list. After a second round of voting, consensus was reached in 4/5 (80%) of the main principles and 8/10 (80%) for consensus statements. The final list of 5 main principles and 10 consensus statements identify key indications specific to the use of brodalumab in the treatment of moderate-to-severe psoriasis in Italy. These statements aid dermatologists in the management of patients with moderate-to-severe psoriasis.

Epidemiology of psoriasis in Italy: burden, cost, comorbidities and patients' satisfaction. A systematic review.

The Italian data on psoriasis are partial and, in most cases, come from monocentric studies, not representative of the population. Our aim was to conduct a systematic review of the available evidence in order to get the overall picture of the Italian epidemiology (prevalence and incidence); burden of disease (direct and indirect costs, the impact on quality of life); comorbidities; and finally, the patients' satisfaction and acknowledgement of both the disease and the care services available. This systematic review followed the guidelines of the Cochrane Collaboration and the Prepared Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020. The literature search was conducted on PubMed/Medline and Scopus. Out of 387 retrieved articles, 41 were included in the analysis. Psoriasis is a frequent condition in Italy: the prevalence is between 1,8% and 4,8% and the incidence is between 107,742 and 230,62 per 100.000 person-years. The most frequent comorbidities associated to psoriasis are: diabetes, hypertension, obesity, depression, cardiovascular diseases, hypertriglyceridemia, and hypercholesterolemia. The quality of life and severity of the disease are mostly affected by other concurrent diseases, early onset of the disease, low income, and low level of education. The costs of psoriasis were estimated between 500 euro and 15.000 euro depending on the disease's severity, the treatments used and hospitalization. In conclusion, psoriasis is a high-impact chronic disease. It is therefore fundamental to advocate a multidisciplinary approach to obtain a better health outcome, the patients' management and the cost savings could benefit from it.

EE515 Cost Per Responder Analysis of Methotrexate Versus Other Therapies in the Treatment of Moderate to Severe Plaque Psoriasis in Italy

Conventional synthetic disease modifying antirheumatic drugs (csDMARDs) was recommended in 2019 as first line therapy from Italian Drug Agency (AIFA) for the treatment of moderate to severe psoriasis. Updated local guidelines recommended methotrexate (MTX) as the drug of first choice. Nevertheless, MTX is reported by AIFA to be underused. Since no study evaluated jointly the first-line efficacy and costs of the most widely used biologic/biosimilar drugs (adalimumab, etanercept, secukinumab and ustekinumab) and methotrexate in Italy, a cost per responder analysis was performed.

Cost per responder for methotrexate versus other therapies in patients with moderate-to-severe plaque psoriasis in Italy

Objective: Conventional synthetic disease modifying antirheumatic drugs (csDMARDs) were recommended in 2019 as first line therapy from Italian Medicines Agency (AIFA) for the treatment of moderate to severe psoriasis. Updated local guidelines recommended methotrexate (MTX) as the drug of first choice. Nevertheless, MTX is reported by AIFA to be underused. Since no study evaluated jointly the first-line efficacy and costs of the most widely used biologic drugs (adalimumab, etanercept, secukinumab and ustekinumab) and methotrexate in Italy, a cost per responder (CPR) analysis was performed. Methods: A CPR model was developed based on efficacy data from a published Cochrane network meta-analysis.Drug costs included in the model were estimated based on average regional tender prices. The primary analysisassessed the CPR of both Psoriasis Area and Severity Index (PASI) 90 at weeks 12 and 52. A secondary analysis was conducted considering PASI 75. For methotrexate, both an average dosage of 13.4 mg, estimated by an expertpanel, and a dosage of 15 mg reported in European guidelines were considered. Results: At weeks 12 and 52, the costs per responder PASI 90 were lower for methotrexate 13.4 mg compared to the most widely used biologics in Italy, € 566.71 and € 2,455.72 respectively. Methotrexate also showed a lowest CPR both at 12 and 52 weeks, € 529.95 and € 2,296.47 respectively, in the secondary analysis. Conclusions: The analysis showed a lower cost per responder for methotrexate than for adalimumab, etanercept,secukinumab and ustekinumab. For healthcare budget holders, this means using the saved resources to treat more patients.

Hepatitis Virus Reactivation in Patients with Psoriasis Treated with Secukinumab in a Real-World Setting of Hepatitis B or Hepatitis C Infection.

Background and ObjectiveBiologics for psoriasis, especially anti-tumor necrosis factor-α therapies, may reactivate hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, as well in inactive carriers or patients with occult infection. However, some biologics, including anti-interleukin-17 therapies such as secukinumab, seem to be less likely to cause hepatitis reactivation. This study assessed the safety of secukinumab treatment in patients with psoriasis with HBV or HBC infection.MethodsThis was a retrospective cohort study of patients with moderate-to-severe psoriasis treated with secukinumab at seven Italian centers. Patients serologically positive for one or more of the following viral hepatitis markers were included: HCV antibody (± HCV-RNA positivity) and/or hepatitis B surface antigen, and/or HBV core antibody and/or HBV surface antibody (± HBV-DNA positivity). Patients received secukinumab 300 mg subcutaneously at week 0/1/2/3/4 then every 4 weeks; prophylactic therapy before starting secukinumab was prescribed where indicated. The primary study endpoint was the reactivation of hepatitis viral infection, defined as conversion to HBV-DNA or HCV-RNA positivity, with or without elevation of transaminases.ResultsSixty patients (17 with concomitant psoriatic arthritis) were included. Thirteen subjects were hepatitis B surface antigen positive, 19 were HBV core antibody positive, and 30 were positive for the HCV antibody; however, all were HCV-RNA negative. After 53.5 ± 37.5 weeks of secukinumab therapy, hepatitis reactivation occurred in only one patient, who had a reactivation of both hepatitis B and hepatitis C. This patient had not undergone hepatitis B prophylaxis or hepatitis C treatment before secukinumab.ConclusionsThese real-world data support the safety of secukinumab in patients with positive markers of HBV or HCV infection, when administered together with dedicated prophylaxis.

Real-world evidence of biologic treatments in moderate-severe psoriasis in Italy: Results of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional longitudinal study of real-life clinical practice) study.

EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional (CANOVA) study was aimed at providing real-world evidence of the effectiveness of biologics in Italian patients with moderate-severe psoriasis. It was an observational, retro-prospective cohort study conducted in 17 Italian dermatology clinics. Adult patients with moderate-severe plaque psoriasis, who started a biologic treatment between 24 weeks and 24 months before enrolment, were included. With a follow-up visit at 6months after enrolment, each patient had at least 12 months of observation. The primary objective was to describe the clinical response rates (PASI 75) after 16/24/52 weeks from biologic treatment start. Secondary outcomes were sustained response, quality of life, and treatment satisfaction. Of the 669 eligible patients (64% males), 52% were naïve to biologics, though a mean duration of psoriasis since first diagnosis of 18.6 years (SD 13.2). The most frequently prescribed biologics were secukinumab (41%), ustekinumab (25%), TNF-inhibitors (22%) and ixekizumab (12%). PASI 75 was achieved by 86% of patients (95% CI: 82%-89%) at 16 weeks, 90% (87%-93%) at 24 weeks, and 91% (89%-94%) at 52 weeks. Patients achieving PASI 90 and PASI 100 at 52 weeks were 75% (71%-79%) and 53% (49%-57%), respectively. Sustained PASI 75 response after 1year from treatment start was achieved by 78% (74%-82%) of patients. Mean DLQI total score was 2.3 (SD 3.9) at enrollment and decreased at the final visit to 1.8 (3.6). A high level of treatment satisfaction was expressed by patients over the study period. This large real-world study confirms in the clinical practice the good effectiveness and acceptability of biologics in psoriasis patients.

Assessing the Beneficial Impact of a Patient Support Program in Secukinumab-Treated Patients with Psoriasis in Italy.

PurposeFor patients with psoriasis, treatment adherence and persistence are fundamental if therapeutic goals are to be met. Patient Support Programs (PSPs) may be used as a support tool to assist patients and health care professionals optimize treatment and improve disease management.Patients and MethodsIn Italy, the PSP PSOLife CARE, which began on the 9th of February 2017 and is ongoing, aimed to support patients with psoriasis under therapy with secukinumab (Cosentyx®). A team of medical professionals including Dermatologists, Psychologists, Nutritionists, and field Nurses provided outpatient treatment as well as remote support via phone calls. Patients had a standard duration in the Program of 6 months. This report analyzes the data of patients who benefited from the Program from February 2017 to August 2020, for a total observation of 42 months.ResultsWe provide here a descriptive report on the benefits of participation in the PSOLife CARE Program for patients with psoriasis and medical professionals involved in their care. Throughout their time in the PSOLife CARE Program, patient satisfaction remained consistently high with sustained improvements observed in all aspects of quality of life (ie emotional, social, physical, and economic). Despite exiting from the Program, most patients continued to adhere to secukinumab. Medical professionals also reported positive outcomes on their interactions with patients, with more than half of those surveyed rating the overall quality of the Program as “Outstanding”.ConclusionBy supporting treatment adherence, the PSOLife CARE Program may have empowered patients to better manage their psoriasis, increasing their satisfaction with treatment and quality of life.

Cost per responder for risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis in Italy

Purpose: The objective of this analysis was to compare the cost per responder between risankizumab and secukinumab among patients with moderate-to-severe plaque psoriasis in Italy. Methods: The clinical efficacy was assessed based on IMMerge study of published efficacy data as measured by Psoriasis Area and Severity Index response (PASI 90 and PASI 100) for risankizumab and secukinumab. The treatment cost was based on the number of administrations dispensed in the first (induction plus maintenance period) and the second (maintenance period only) year of treatment and the ex-factory price of each treatment. The cost per responder was adopted as a cost-effectiveness indicator. Results: Independently of the PASI response (PASI 90 and PASI 100) used and the year of treatment considered, the cost per responder was consistently lower for risankizumab compared to secukinumab in all clinical measures. For example, considering the first-year costs and PASI 100, the cost per responder for risankizumab was € 24,506.83 compared to € 38,000.00 for secukinumab. The differences in the cost per responder between risankizumab and secukinumab increased when higher PASI response levels were considered. Conclusion: This economic evaluation suggested that the cost per responder is consistently lower for risankizumab compared to secukinumab from the perspective of the Italian National Health Service in the treatment of moderate-to-severe plaque psoriasis.

A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study

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.

Number needed to treat for interleukin inhibitors approved for the treatment of moderate-to-severe plaque psoriasis in Italy.

Interleukin (IL) inhibitors achieve greater levels of efficacy than older systemic therapies. We calculated the number needed to treat (NNT) of ixekizumab compared with other IL inhibitors approved in Italy for the treatment of moderate-to-severe plaque psoriasis. The clinical efficacy was evaluated in terms of NNT, based on the results of a recent network meta--analysis (NMA) by the Cochrane Database of Systematic Reviews. The NMA investigated many systemic and biological treatments, but this analysis compared only the efficacy of the following IL inhibitors - brodalumab, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab - for patients with moderate-to-severe plaque psoriasis. Drugs were compared and ranked according to effectiveness considering the PASI (Psoriasis Area and Severity Index) 90 score. One-hundred and forty trials (51,749 patients) were included in the NMA. Considering the proportion of patients who achieve PASI90, ixekizumab showed the lowest NNT among all comparators (ixekizumab 2.01 [2.46-3.00]; risankizumab 2.05 [2.50-3-05]; guselkumab 2.16 [2.68-3.36]; secukinumab 2.40 [2.90-3.51]; brodalumab 2.61 [3.18-3.88]; ustekinumab 3.44 [4.12-4.95]; tildrakizumab 3.10 [4.15-5.59]. The findings show that ixekizumab is the most effective option (NNT) for the treatment of moderate-to-severe plaque psoriasis.

Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations.

IntroductionTreat-to-target strategies are used in several chronic diseases to improve outcomes. Treatment goals have also been suggested for psoriasis, but there is currently no consensus on targets, and guidance is needed to implement this strategy in clinical practice. The project ‘Treat to Target Italia’ was launched by a scientific board (SB) of 10 psoriasis experts to generate expert consensus recommendations.MethodsOn the basis of the published literature, their clinical experience, and the results of a survey among Italian dermatologists, the SB identified four relevant topics: (1) clinical remission; (2) quality of life; (3) abrogation of systemic inflammation; (4) safety. They drafted 20 statements addressing these four topics and submitted them to a panel of 28 dermatologists, in a Delphi process, to achieve consensus (greater than 80% agreement).ResultsConsensus was reached on all statements. Treatment goals defining clinical remission should include a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI90 response) or an absolute PASI score of less than or equal to 3. Patient’s quality of life and satisfaction are important targets. If PASI targets are achieved, there should be no or very low impact of psoriasis on quality of life [Dermatology Life Quality Index (DLQI) score less than or equal to 3]. If PASI or DLQI goals are not achieved within 3–4 months, treatment should be changed. Abrogation of systemic inflammation may be crucial for preventing or delaying inflammatory comorbidities. Safety is an equally important target as efficacy.ConclusionThese 20 consensus statements define the parameters of a treat-to-target strategy for psoriasis in Italy. It is hoped that use of these in the management of patients with psoriasis will improve treatment outcomes and patient health-related quality of life.

PSS3 Cost-Effectiveness Analysis of Biologic Treatments for Plaque Psoriasis in Italy: Results of the Canova Study

To estimate the cost per responder of biologics for plaque psoriasis in Italy based on the CANOVA study. CANOVA was an observational (retrospective and prospective) cohort study conducted in 17 Italian dermatology clinics, including adult patients with moderate-severe plaque psoriasis, who had started a biologic treatment in a retrospective period between 24 and 6 months before enrollment. Patients were observed from the start of the most recent retrospective biologic (baseline) until a 6-month visit after enrollment. Data on resource consumption (biologic and non-biologic drugs, inpatient and outpatient care) and response ( achievement of 75%/90%/100% improvement in baseline PASI-Psoriasis Area and Severity Index) were collected at 16/24/52 weeks from baseline. Cost per responder was calculated as direct costs (retrieved from national databases) divided by number of responders. Descriptive analyses were performed on the overall sample and stratified by the currently most-frequently prescribed biologics (i.e. adalimumab originator; ixekizumab; secukinumab; ustekinumab). Among 669 eligible patients, median annualized cost was €14,699 (interquartile range: €13,785 - €15,779), with biologics being the driver of expenditure. Costs per PASI-75, PASI-90 and PASI-100 responder at 52 weeks were €20,281 (N=551; response rate: 91%), €24,662 (N=540; 75%) and €35,045 (N=564; 53%), respectively. Cost per responder (considering PASI-90) at 52 weeks varied by treatment group, with lowest values in adalimumab (€22,755; N=62) and secukinumab (€23,978; N=238) and highest values in ixekizumab (€24,743; N=63) and ustekinumab (€27,522; N=140). The lowest cost per sustained response, i.e. achievement of at least PASI-75 response both at 16 and at 52 weeks, was observed for secukinumab (€21,375; N=169; response rate: 86%). Cost-effectiveness profile of biologics was positive (because of high response) with some trends in favour of adalimumab and secukinumab. Besides patient preferences and comorbidities, cost per response is useful to guide treatment decisions.

PDG25 Dimethyl Fumarate for the Treatment of First-LINE Moderate-to-Severe Plaque Psoriasis in Italy: A Budget-IMPACT Analysis

PDG25 Dimethyl Fumarate for the Treatment of First-LINE Moderate-to-Severe Plaque Psoriasis in Italy: A Budget-IMPACT Analysis

A cost-effectiveness and budget impact analysis of apremilast in patients with psoriasis in the Italian setting

Aims: The aim of this study was to conduct a cost-effectiveness analysis, as well as a budget impact analysis, on the use of apremilast for the treatment of adult patients with moderate-to-severe plaque psoriasis (defined as a psoriasis area severity index [PASI] ≥ 10), who failed to respond to, had a contraindication to, or were intolerant to other systemic therapies, within the Italian National Health Service (NHS).Materials and methods: A Markov state-transition cohort model adapted to the Italian context was used to compare the costs of the currently available treatments and of the patients’ quality of life with two alternative treatment sequences, with or without apremilast as pre-biologic therapy. Moreover, a budget impact model was developed based on the population of patients treated for psoriasis in Italy, who would be eligible for treatment with apremilast.Results: Over 5 years, the cost-effectiveness analysis showed that the strategy of using apremilast before biologic therapy was dominant compared with the sequence of biologic treatments without apremilast. In addition, it is important to underline that the use of apremilast slightly increases the quality-adjusted life years gained over 5 years. Furthermore, within the budget impact analysis, the strategy including apremilast would lead to a saving of €16 million within 3 years. Savings would mainly be related to a reduction in pharmaceutical spending, hospital admissions and other drug administration-related costs.Conclusion: These models proved to be robust to variation in parameters and it suggested that the use of apremilast would lead to savings to the Italian healthcare system with potential benefits in terms of patients’ quality of life.

Cost per responder for ixekizumab and other biologic drugs approved for the treatment of moderate-to-severe plaque psoriasis in Italy

Cost per responder for ixekizumab and other biologic drugs approved for the treatment of moderate-to-severe plaque psoriasis in Italy

Cost per responder for ixekizumab and other biologic drugs approved for the treatment of moderate-to-severe plaque psoriasis in Italy

This analysis was aimed at estimating the cost per responder as measured by number needed to treat of ixekizumab as compared with other biologic drugs approved in Italy for the treatment of moderat...

PSS19 - Cost Effectiveness Analysis of The Use of Enstilar® Compared To Dovobet® Gel In The Treatment of Psoriasis In Italy

PSS19 - Cost Effectiveness Analysis of The Use of Enstilar® Compared To Dovobet® Gel In The Treatment of Psoriasis In Italy

PSS9 - Budget Impact Analysis of Enstilar® for The Treatment of Psoriasis In Italy

PSS9 - Budget Impact Analysis of Enstilar® for The Treatment of Psoriasis In Italy