Francesco Loconsole

We have conducted an open label, non-comparative study in order to assess the efficacy and tolerability of Dexyane Med in combination with corticosteroids in patients with chronic hand eczema (CHE) and contact eczema (CE) in a real-life setting.Twenty patients, 10 with CHE and 10 with CE, have been enrolled in the study. After the enrollment and the baseline evaluation, patients were treated with topical mometasone once daily and Dexyane Med once daily for one week, followed by Dexyane Med twice daily for three weeks. After the enrollment visit, patients were seen at the end of treatment, after four weeks. A telephone contact was foreseen at the second week. During the visits, mTLSS Score (CHE patients only), IGA Score and VAS for pruritus and pain were calculated. Patients' satisfaction was recorded during the phone contact after two weeks of treatment and at the final visit. Tolerability was evaluated at the end of the study.All patients experienced a remarkable improvement in mTLSS Score, IGA Score (from a mean of 2.8 to 0.5) and VAS (from 4.5 to 0.6 for pruritus and from 2.9 to 0.3 for pain). The treatment was well tolerated and all patients were satisfied or very satisfied either at the second week or at the end of the study.Our study has shown that the treatment of chronic hand eczema and contact eczema with a medical device administered twice a day for three weeks, following a one week treatment in combination with a topical corticosteroid, is effective in decreasing the burden of symptoms and well tolerated. To confirm our data, further controlled trials are warranted in order to explore the efficacy and tolerability of Dexyane Med in different types of eczema.

Psoriasis is a chronic inflammatory skin disease with systemic involvement that might predispose to many psoriasis-related comorbidities, such as metabolic syndrome and cardiovascular disorders. Clusterin (Clu), also known as apolipoprotein J (ApoJ), is a highly conserved disulfide-linked heterodimeric glycoprotein implicated in a great variety of physiological and pathophysiological processes including lipid transportation, tissue remodeling, senescence, cell interaction, stress response, inflammation, apoptosis, diabetes mellitus and metabolic syndrome. Serum levels of Clu were assessed in 15 patients with moderate-to-severe psoriasis defined by the presence of a Psoriasis Area and a Severity Index (PASI) value of 10 or more. It was found that the Clu value was significantly higher in patients than in healthy subjects (p <0.001). Our data confirm that the association of psoriatic disease with some comorbidities, especially metabolic and cardiovascular disease, might support the correlation with increased circulating Clu. In particular, it should be pointed out that, according to the recent literature, the Clu could also have a protective role in the comorbidity of psoriasis patients. In addition, it has been published that Clu protects cardiomyocytes against ischemic cell death and is a potential therapeutic agent in the treatment of myocardial infarction; therefore it can be assumed that an artificial enhancement of Clu in the blood could limit the severity of damage also in respect to skin lesions. Although the increase in serum level of Clu was found in all patients with psoriasis, more studies on a larger cohort of patient samples is necessary to confirm the significance of high serum levels of clusterin/ApoJ and to suggest the use of this glycoprotein as an additional new marker in psoriasis pathogenesis. It could be a possibility to improve the prognosis in patients with psoriasis.

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Background: Current guidelines recommend the use of systemic therapy and phototherapy for the treatment of moderate-to-severe plaque psoriasis. Objectives: To evaluate the effectiveness, impact on health status perception, and costs of traditional systemic therapies and phototherapy in real-life patients with moderate-to-severe psoriasis. Methods: Retrospective analysis of data from 100 psoriatic patients referring to a dermatology clinic in Italy and treated with traditional therapies. Results: Patients were predominantly treated with cyclosporine (72%). Cyclosporine was associated with fewer treatment discontinuations due to lack of efficacy (37%) compared with methotrexate (65%), acitretin (67%) and phototherapy (50%). Rates of treatment discontinuation due to adverse events were: cyclosporine (24%), methotrexate (9%), acitretin (25%) and phototherapy (0%). Improvements in PASI scores were comparable between treatments. The need for topical therapy was reduced with cyclosporine versus other therapies (35% vs 71%, p = 0.0009); respectively, 33% of patients treated with cyclosporine versus 14% of patients receiving other therapies perceived an improvement in their health status (p = 0.0018). Mean total per-patient direct costs of the first treatment cycle were higher with cyclosporine than with other therapies (€1812.85 vs €648.90, p < 0.0001). Conclusions: Cyclosporine was effective even if more expensive than other traditional therapies. Nevertheless patients’ perception of improvement was quite low.

CT-P13, a biosimilar of infliximab, was the first biosimilar monoclonal antibody to be approved in both the European Union and Korea. As a monoclonal antibody, CT-P13 is a large molecule with a high molecular weight, and as such it differs from other biosimilars currently in the market. The comparability exercise for CT-P13, therefore, requires special consideration, as it was the first demonstration of biosimilarity between a biosimilar monoclonal antibody and its originator. This paper summarizes current regulations on the approval of biosimilars, describes the evidence leading to the approval of CT-P13, and discusses the potential role of this molecule in the Italian scenario on the basis of the view of a group of experts.

In July 2013 a 43-year-old Caucasian man presented to our outpatient Dermatology clinic with multiple extensive ulcerative lesions on the posterior aspects of both legs, which reportedly appeared some weeks before and had since rapidly extended. The lesions, which were very painful, had first developed as multiple erythemato-violaceous plaques which later became deeply ulcerated, showing irregular margins and a seropurulent bed

This was a prospective, multicentre study conducted in 14 Italian psoriasis referral centres (January-June 2014) with the objective of identifying factors associated with different levels of patient awareness on psoriasis. Overall, 298 patients (119 females, mean age 49.4 years, range 20-88) with a diagnosis of psoriasis (median of 14.1 years) were enrolled. Patients were more knowledgeable about the pathogenic nature of their condition compared with the other parameters (diagnosis, clinical course, prognosis, effect on QoL). Variables associated with significantly higher awareness, included years of education (the higher the educational levels the greater awareness), internet usage, other family member with the disease, diet rich in fruit/vegetables, cigarette smoking and bone and joint involvement. Older age, diabetes, and alcohol abuse were inversely associated. Having established factors that affect awareness in our patients we can now go on to devise educational interventions to address these needs.

Psoriasis can have a profound impact on quality of life (QoL) and an awareness of the processes of the disease and its treatment is important in coping with symptoms. Patients do not always understand the potential consequences of their disease and the wide range of effective treatment strategies now available. We designed and validated a questionnaire to investigate patient awareness and understanding of psoriasis including pathogenesis, diagnosis, prognosis and treatment. This was a multicentre, cross-sectional investigation involving 14 psoriasis referral centres in Italy. The focus group technique was used by a panel of experts in psoriasis, to draw-up a list of questions exploring pathogenesis, diagnosis, prognosis, factors influencing clinical course of psoriasis as well as QoL issues and sources of information on their condition. Psychometric properties of the questionnaire were tested on a sample of 240 adult patients with psoriasis (including treatment-naïve and -experienced patients). The mean age of patients was 50.3±14.9 years and 34.2% were female. The median time from diagnosis was 13.7 years (IQR 7.3-23.2). The Cronbach alpha was 0.77 and all items showed higher correlations within their own dimensions than to other dimensions. Each domain of awareness was well represented by a single dimension. Mean overall awareness was 59.7±13.1 on a 100-point scale. Our questionnaire was valid in assessing patient awareness in five relevant areas of psoriasis, and can be useful in both the clinical setting and research studies to evaluate patients' knowledge of psoriasis better, with the final aim of reducing the burden of this chronic condition.

Immunogenicity of antitumor necrosis factor-alpha (TNFα) agents has been proven to play a significant role in the variability of clinical responses among patients with chronic inflammatory diseases. However, its clinical impact on the outcome of patients with psoriasis and psoriatic arthritis receiving anti-TNFα treatment is not yet fully clear. Despite the high rates of efficacy of anti-TNFα agents in psoriasis, a substantial proportion of patients remain who experience a primary or secondary failure or significant side effects, which are potentially ascribable to immunogenicity. Topics include immunologic response elicited by anti-TNFα agents, the impact of immunogenicity on treatment response to anti-TNFα and the role played by immunogenicity in the lack of efficacy of anti-TNFα agents (infliximab, adalimumab and etanercept) in psoriasis. Based on data available in the literature and the clinical experience of the authors, this article suggests the optimal approach to drug monitoring and antidrug antibody assay and the most effective use of biologic immunotherapies in this setting. Immunogenicity should be taken into account in the adoption of therapeutic choices in psoriatic patients, such as anti-TNFα agent intensification, or switching to another anti-TNFα agent or a drug with a different mechanism of action.