Effectiveness and safety of secukinumab in Italian patients with psoriasis: an 84 week, multicenter, retrospective real-world study

Background: Long term data on the real-life use of secukinumab are scant. The aim of this study was to investigate the real-life effectiveness, safety and treatment persistence of secukinumab in patients with moderate-to-severe psoriasis. Research design and methods: This 84-week, multicenter (n = 7) retrospective study analyzed data from patients who initiated and received at least 6 months of secukinumab treatment between June 2016 and June 2018 in the Campania region of Italy. Patient demographic and treatment characteristics, duration of treatment and reasons for discontinuation as well as Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI) scores were assessed. Results: 324 patients (63% male, mean age 50.2 years) were enrolled and received a mean 11.7 months of secukinumab treatment. Overall, 9.5% discontinued secukinumab, including 5.2% who discontinued due to secondary inefficacy and 1.8% due to adverse events. PASI, BSA and DLQI scores were significantly improved from baseline at every follow-up visit (p < 0.001) and mean PASI decreased from 15.3 ± 6.3 at baseline to 0.5 ± 1.0 at week 84. Secukinumab had comparable effectiveness in biologic naïve and non-naïve patients. Conclusions: This study confirmed the effectiveness and safety of secukinumab in real-world patients with psoriasis

Metabolic syndrome prevalence in psoriasis: A cross-sectional study in the Italian population

Background: The pathogenesis of psoriasis is complex, with a significant role suggested for pro-inflammatory mediators. There is strong evidence of an association between psoriasis and the metabolic syndrome (MetS), a cluster of cardiovascular risk factors, which impose a substantial disease burden. Objective: This study aimed to evaluate the prevalence of MetS and to examine the implications of disease severity, type 2 diabetes mellitus, and cardiovascular disease in a large cohort of Italian psoriatic patients representative of the whole population. Methods: This was a cross-sectional study involving 13 dermatological clinics in Italy. The primary study endpoint was a comparison of the prevalence of MetS between psoriatic patients and a non-psoriatic control group; secondary endpoints included the influence of psoriasis severity on the prevalence of MetS, and the relative prevalence and risk of type 2 diabetes mellitus and cardiovascular disorders. Results: A total of 720 patients were enrolled (n = 360 per group). The prevalence of MetS was 26.84 % in the psoriatic population and 15.16 % in the control population (p = 0.0001; adjusted odds ratio 1.96). MetS was associated with a greater degree of psoriasis severity, and the prevalence and risk of diabetes tended to be higher in psoriatic patients than in the control group. Conclusion: In the Italian population, the prevalence of MetS and associated comorbidities is elevated in patients with psoriasis compared with non-psoriatic subjects, as has been demonstrated in other countries. Our findings reinforce the importance of considering the implications of metabolic comorbidities in treating patients with psoriasis. © 2014 Springer International Publishing

Metabolic syndrome prevalence in psoriasis: A cross-sectional study in the Italian population

Background: The pathogenesis of psoriasis is complex, with a significant role suggested for pro-inflammatory mediators. There is strong evidence of an association between psoriasis and the metabolic syndrome (MetS), a cluster of cardiovascular risk factors, which impose a substantial disease burden. Objective: This study aimed to evaluate the prevalence of MetS and to examine the implications of disease severity, type 2 diabetes mellitus, and cardiovascular disease in a large cohort of Italian psoriatic patients representative of the whole population. Methods: This was a cross-sectional study involving 13 dermatological clinics in Italy. The primary study endpoint was a comparison of the prevalence of MetS between psoriatic patients and a non-psoriatic control group; secondary endpoints included the influence of psoriasis severity on the prevalence of MetS, and the relative prevalence and risk of type 2 diabetes mellitus and cardiovascular disorders. Results: A total of 720 patients were enrolled (n = 360 per group). The prevalence of MetS was 26.84 % in the psoriatic population and 15.16 % in the control population (p = 0.0001; adjusted odds ratio 1.96). MetS was associated with a greater degree of psoriasis severity, and the prevalence and risk of diabetes tended to be higher in psoriatic patients than in the control group. Conclusion: In the Italian population, the prevalence of MetS and associated comorbidities is elevated in patients with psoriasis compared with non-psoriatic subjects, as has been demonstrated in other countries. Our findings reinforce the importance of considering the implications of metabolic comorbidities in treating patients with psoriasis. \ua9 2014 Springer International Publishing

Treating psoriasis with etanercept in Italian clinical practice: Prescribing practices and duration of remission following discontinuation

Background: Conventional antipsoriatic therapies are often administered until remission, with treatment resumed in the case of relapse, in order to reduce the likelihood of cumulative, dose-dependent toxicities. Biological agents have been safely used in continuous therapy. Objective: To assess the use of etanercept for psoriasis in clinical practice in Italy. Methods: This was an observational study carried out in 13 dermatological centres across Italy in patients with plaque psoriasis (with a Psoriasis Area and Severity Index [PASI] score ≥10) treated with etanercept. The study comprised a treatment and subsequent discontinuation period. Patients were eligible if they had plaque psoriasis and had begun treatment with etanercept between 1 September 2007 and 1 April 2008. Patients were evaluable for the duration of discontinuation analysis if they achieved a PASI reduction ≥50% (PASI50) and a PASI score <10 at the end of treatment. Etanercept treatment was restarted if the PASI score reached ≥10 or the patient had a clinical relapse. Data were collected retrospectively up to June 2008 and prospectively between July 2008 and January 2009. Patients received etanercept during the treatment period, followed by no etanercept treatment (other psoriasis treatment permitted) during the discontinuation period, and etanercept again during re-treatment. The main outcome measures were: PASI scores (type A responders: PASI reduction ≥75% [PASI75]; type B responders: PASI50 and PASI final score <10), Dermatology Life Quality Index (DLQI) scores and body surface area (BSA) involvement. Time from discontinuation to retreatment was evaluated. Use of other antipsoriatic medications was recorded throughout. Results: Eighty-five patients were evaluable for the treatment period. Overall, 55 (64.7%) of these patients were prescribed etanercept 50mg twice weekly. The mean treatment duration was approximately 25 weeks. In total, 79 patients (92.9%) were considered type B responders and 77 of these patients were evaluable for the duration of discontinuation analysis. Overall, 68/85 (80%) were type A responders. During the treatment period, 7/85 (8.2%) patients received other antipsoriatic therapies. Improvements in mean DLQI score (-71.5%) and mean BSA involvement (-79.2%) were also observed. Etanercept was well tolerated. During the discontinuation period, 40/77 (51.9%) patients used other antipsoriatic medications (group 1) and 37/77 (48.1%) did not (group 2). The mean duration of discontinuation was significantly longer in group 1 (174 days) than in group 2 (117 days, log-rank test: p = 0.0013). Conclusion: In clinical practice, the duration of discontinuation from etanercept was in accordance with previously reported data, and was longer in patients who received other antipsoriatic drugs during discontinuation of etanercept than in those who did not. High rates of PASI50 and PASI75 response were obtained with etanercept, and these rates were higher than those observed in controlled clinical studies. Etanercept treatment was flexible, effective and well tolerated, and was associated with improved quality of life. © 2010 Adis Data Information BV. All rights reserved

Treating psoriasis with etanercept in Italian clinical practice: Prescribing practices and duration of remission following discontinuation

Background: Conventional antipsoriatic therapies are often administered until remission, with treatment resumed in the case of relapse, in order to reduce the likelihood of cumulative, dose-dependent toxicities. Biological agents have been safely used in continuous therapy. Objective: To assess the use of etanercept for psoriasis in clinical practice in Italy. Methods: This was an observational study carried out in 13 dermatological centres across Italy in patients with plaque psoriasis (with a Psoriasis Area and Severity Index [PASI] score 6510) treated with etanercept. The study comprised a treatment and subsequent discontinuation period. Patients were eligible if they had plaque psoriasis and had begun treatment with etanercept between 1 September 2007 and 1 April 2008. Patients were evaluable for the duration of discontinuation analysis if they achieved a PASI reduction 6550% (PASI50) and a PASI score <10 at the end of treatment. Etanercept treatment was restarted if the PASI score reached 6510 or the patient had a clinical relapse. Data were collected retrospectively up to June 2008 and prospectively between July 2008 and January 2009. Patients received etanercept during the treatment period, followed by no etanercept treatment (other psoriasis treatment permitted) during the discontinuation period, and etanercept again during re-treatment. The main outcome measures were: PASI scores (type A responders: PASI reduction 6575% [PASI75]; type B responders: PASI50 and PASI final score <10), Dermatology Life Quality Index (DLQI) scores and body surface area (BSA) involvement. Time from discontinuation to retreatment was evaluated. Use of other antipsoriatic medications was recorded throughout. Results: Eighty-five patients were evaluable for the treatment period. Overall, 55 (64.7%) of these patients were prescribed etanercept 50mg twice weekly. The mean treatment duration was approximately 25 weeks. In total, 79 patients (92.9%) were considered type B responders and 77 of these patients were evaluable for the duration of discontinuation analysis. Overall, 68/85 (80%) were type A responders. During the treatment period, 7/85 (8.2%) patients received other antipsoriatic therapies. Improvements in mean DLQI score (-71.5%) and mean BSA involvement (-79.2%) were also observed. Etanercept was well tolerated. During the discontinuation period, 40/77 (51.9%) patients used other antipsoriatic medications (group 1) and 37/77 (48.1%) did not (group 2). The mean duration of discontinuation was significantly longer in group 1 (174 days) than in group 2 (117 days, log-rank test: p = 0.0013). Conclusion: In clinical practice, the duration of discontinuation from etanercept was in accordance with previously reported data, and was longer in patients who received other antipsoriatic drugs during discontinuation of etanercept than in those who did not. High rates of PASI50 and PASI75 response were obtained with etanercept, and these rates were higher than those observed in controlled clinical studies. Etanercept treatment was flexible, effective and well tolerated, and was associated with improved quality of life. \ua9 2010 Adis Data Information BV. All rights reserved

Efficacy of cyclosporine a as monotherapy in patients with psoriatic arthritis: A subgroup analysis of the SYNERGY Study

BACKGRO UND: The SYNER GY Study is an observational, multicenter Italian study, conducted in patients with diagnosis of psoriatic arthritis (PsA) treated from at least 3 months with cyclosporine and aimed at assessing patients' seropositivity for viral infections and efficacy and safety of cyclosporine, administered as monotherapy or in combination with other systemic drugs in the routine clinical practice. The aim of this subanalysis of the SYNER GY study was to evaluate the effects of CsA as monotherapy only in PsA over 12 months of observation. MET HOD S: Psoriasis was evaluated by Body Surface Area and the Psoriasis Area Severity Index (PASI). PsA was evaluated by number of swollen and tender joints, painful entheses and fingers with dactylitis, the Bath Ankylosing Spondylitis Activity Index (BASDAI) and by patients' and physicians' global assessment on a 10-point Visual Analogue Scale. RE SULTLTS: Cyclosporine in monotherapy was effective in reducing all the measured disease parameters. The major indexes of cutaneous and spinal involvement, PASI and BASDAI were significantly reduced over the study period, as were the number of swollen and tender peripheral joints, and enthesitis and dactylitis. CONCLUSIONS: Cyclosporine in monotherapy confirmed its efficacy in cutaneous psoriasis and suggested to be effective also on PsA, reducing spinal and peripheral joints' signs and symptoms