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 6 months 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 1 year 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.

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

BACKGROUND: Psoriasis 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. METHODS: The 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%). RESULTS: The 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. CONCLUSION: Biologic 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.

Ixekizumab improves disease severity, clinical symptoms and quality of life in patients with genital psoriasis: A 24-week real-life experience.

Genital psoriasis (GenPs) has been traditionally considered a difficult to treat psoriasis area. Ixekizumab was the first biologic agent demonstrating efficacy and safety in a formal clinical trial on GenPs; however, real-life experiences are limited. To assess real-life effectiveness and safety of ixekizumab in the treatment of GenPs in a case series of patients with moderate-to-severe plaque psoriasis. Adult patients with moderate-to-severe plaque psoriasis involving the genital area received subcutaneous ixekizumab. Evaluation of disease severity, clinical symptoms, and quality of life was performed at baseline, after 4, 16, and 24 weeks of treatment. Assessment tools were: Static Physician's Global Assessment of Genitalia (sPGA-G), Psoriasis Area and Severity Index (PASI) score, Itch Numerical-Rating-Score (Itch-NRS), and Dermatology-Life-Quality-Index (DLQI). Adverse events were recorded. A total of 14 patients were treated with ixekizumab achieving consistent and significant reduction of disease and quality of life parameters, with a mean percentage reduction from baseline to week 24 of 91.4% for sPGA-G, 95.2% for PASI, 95.6% for Itch-NRS, and 93.7% for DLQI. Ixekizumab treatment was well tolerated. Ixekizumab significantly improved disease severity, itch, and quality of life with an acceptable safety profile in a real-life setting in adult patients affected by GenPs.

Patients' demographic and socioeconomic characteristics influence the therapeutic decision-making process in psoriasis.

BACKGROUND: Knowledge regarding differences in care for psoriatic patients is limited. The aim of this study was to investigate factors influencing prescription of systemic treatments for patients with psoriasis with a special focus on socioeconomic factors. METHODS AND FINDINGS: This was a non-interventional, cross-sectional study, conducted in 18 Italian University and/or hospital centers with psoriasis-specialized units. Questionnaires evaluating demographic and socioeconomic characteristics were administered to participants. Overall, 1880 consecutive patients affected by mild-to-severe psoriasis were recruited. Univariate and multivariable logistic regression analyses of systemic therapy prescription, with a special focus on biologics, accounting for the above mentioned characteristics were performed. Our analysis showed that all analyzed patients' characteristics were significantly associated with biological therapy compared to non-biological systemic one. Particularly, women were less likely to receive biologics than men (OR = 0.66; 95% CI, 0.57-0.77). Elderly patients (≥65 years) and subjects with a BMI ≥30 had lower odds to receive biologics respect to adults (≥35-64 years) (OR = 0.33; 95% CI, 0.25-0.40), and subjects with BMI≥25<30 (OR = 0.64; 95% CI, 0.53-0.77), respectively. Northern and Southern patients were both less likely to receive biologics than Central patients (OR = 0.75; 95% CI, 0.63-0.89, and OR = 0.56; 95% CI,0.47-0.68, respectively). Lower economic profile and never reading books were both associated with decreased odds of receiving biological therapy. CONCLUSIONS: This study shows that sex, age, comorbidities, and socioeconomic characteristics influence the prescription of systemic treatments in psoriasis, highlighting that there are still unmet needs influencing the therapeutic decision-making process that have to be addressed.

Safety and efficacy of certolizumab pegol in a real-life cohort of patients with psoriasis and psoriatic arthritis.

Background: The aim of this observational study was to assess safety and efficacy of certolizumab pegol (CZP) in a real-life cohort of patients affected by psoriasis (PsO) and psoriatic arthritis (PsA), who had an inadequate response to previous systemic immunosuppressive treatments, with a follow-up of 24 weeks.Materials and methods: Twelve patients with PsO and PsA, referring to our Dermatology/Rheumatology combined outpatient clinic, were enrolled. Primary endpoints were safety and efficacy of CZP, defined as statistically significant improvement of DAPSA, clinical DAPSA and PASI. Secondary endpoints validated clinical and laboratory measures and patient-reported outcomes.Results: CZP injections were well-tolerated. We observed a rapid and significant improvement in all primary endpoints, in the 24-week treatment period of the study. We described positive effects of CZP in several domains, including joint and skin involvement, pain, patient and physician global assessment, physical function, and health-related quality of life. CZP was effective and safe in patients who were either naïve or previously unresponsive to other anti-TNFα. No difference was found in terms of efficacy and safety between patients treated with CZP monotherapy and patients in combination therapy with methotrexate.Conclusions: CZP was safe and effective in a real-life cohort of patients affected by PsO and PsA, who have had an inadequate response to previous systemic treatments.

Frequency of melanocytic nevi in psoriatic patients is related to treatment and not to disease severity.

BACKGROUND: Few data exist on the relationship between psoriasis and melanocytic lesions. OBJECTIVES: We sought to investigate number of melanocytic nevi in psoriatic patients compared with control subjects and its relationship with disease severity and treatment. METHODS: We performed a prospective study in 189 psoriatic patients and 189 control subjects. Sociodemographic and clinical data were recorded for all participants. RESULTS: As compared with control subjects, patients had fewer nevi overall [χ(2)(5) = 52.24, P < .001], fewer nevi less than 5 mm [χ(2)(4) = 60.28, P < .001], and fewer congenital nevi [χ(2)(1) = 10.41, P = .002]; no differences in atypical nevi and family history of cancer, including melanoma, were observed. Among psoriatic patients, number of biologics used was a risk factor for a higher nevus count [odds ratio 1.35 (95% CI 1.04-1.76), P = .02] whereas disease severity did not correlate with number of nevi. LIMITATIONS: Low number of psoriatic patients naïve to systemic therapies was a limitation. CONCLUSIONS: Psoriatic patients have fewer nevi than control subjects. Frequency of nevi in psoriatic patients is related to treatment, not to disease severity.