Assessing the Impact of Atopic Dermatitis on the Patients' Parents with the Visual Instrument 'Caregiver-PRISM'.

BACKGROUND: There is a need to improve the quality of communication between clinicians and parents of young patients with atopic eczema (AE). OBJECTIVE: To create a tool to measure the suffering that caregivers experience in association with their child's AE (Caregiver Pictorial Representation of Illness and Self-Measure, Caregiver-PRISM), assess the validity and reliability, and identify factors associated with caregiver suffering. METHODS: Caregiver-PRISM was administered to 45 parents of patients from an AE outpatient service (Padua, Italy). RESULTS: Caregiver-PRISM had a good test-retest reliability (r = 0.85; t7 = 4.13; p < 0.05), content validity and construct validity when used in parents of AE children. Parents with a less positive family affective climate, higher education, or with children following a diet experienced higher suffering associated with their child's AE, demonstrated by lower Caregiver-PRISM scores (p < 0.05). CONCLUSION: Our results support the use of Caregiver-PRISM in parents of AE patients to assess suffering associated with patients' illness.

Psoriasis - The Life Course Approach.

Over the last decades, Life Course Research (LCR), predominantly the domain of sociology, has been increasingly applied in health research, as Life Course Epidemiology (LCE). The latter is concerned with disease patterns over time, accumulation of exposures over time, critical time periods and patterns of risk. We argue that concepts from LCR and LCE could be widely applied in dermatology, in general, and, more precisely, in the study of chronic inflammatory skin diseases, e.g. atopic eczema and psoriasis. The life course approach can generally be applied in two different ways. It may be used in the more traditional manner, in which the disease and its patterns over time are examined as the outcome vari-able. Conversely, it can examine life course as the outcome variable, which is dependent on the disease course, the treatments administered, and other physical or psychosocial environmental exposures. In dermatology, this second application of the LCR concepts is both promising and relevant because of the notable impact of chronic skin diseases on the patients' quality of life. In particular, we argue how LCR may be conducive to a better understanding of the concept of 'Cumulative Life Course Impairment', which is increasingly gaining acceptance. This approach helps identifying not only individuals at risk and particularly vulnerable patients but also critical periods for optimising interventions in order to avoid life course impairment. It also may facilitate more appropriate treatment decisions in clinical practice.

Efficacy of Biofeedback and Cognitive-behavioural Therapy in Psoriatic PatientsA Single-blind, Randomized and Controlled Study with Added Narrow-band Ultraviolet B Therapy.

Increasing data suggests that there is a connection between stress and the appearance of psoriasis symptoms. We therefore performed a clinical trial enrolling 40 participants who were randomly allocated to either an 8-week cognitive-behavioural therapy (CBT) (treatment group) plus narrow-band UVB phototherapy or to an 8-week course of only narrow-band UVB phototherapy (control group). We evaluated the clinical severity of psoriasis (PASI), General Health Questionnaire (GHQ)-12, Skindex-29 and State-Trait Anxiety Inventory (STAI) at baseline and by the end of the study. Sixty-five percent of patients in the treatment group achieved PASI75 compared with 15% of standard UVB patients (p = 0.007). GHQ-12 cases were reduced from 45% to 10% in the treatment group and from 30% to 20% in the control group (p = 0.05). The Skindex-29 emotional domain showed a significant improvement in the CBT/biofeedback group compared with control patients (-2.8 points, p = 0.04). This study shows that an adjunctive 8-week intervention with CBT combined with biofeedback increases the beneficial effect of UVB therapy in the overall management of psoriasis, reduces the clinical severity of psoriasis, improving quality of life and decreases the number of minor psychiatric disorders.

Contact Sensitization in Children: A Retrospective Study of 2,614 Children from a Single Center.

BACKGROUND: Contact sensitization in children is more common than previously thought, but few studies have been performed on a large population assessed by the same team. The objective was to evaluate contact sensitization in children with suspected contact dermatitis, the relationship with atopic dermatitis (AD), and the most common allergens. METHODS: The same team patch tested 2,614 children younger than 11 years old with a standard series of 30 allergens. RESULTS: A total of 1220 children (46.7%) developed at least one positive reaction, 606 of which were clinically relevant (49.7%). The most frequent reactions were to nickel sulfate (22.7%), cobalt chloride (11.1%), potassium dichromate (9.9%), neomycin sulfate (5.2%), thimerosal (4.2%), cocamidopropyl betaine (3.4%), and methylchloroisothiazolinone/methylisothiazolinone (3.2%). The prevalence of contact sensitization was similar in children with (47.3%) and without (46.1%) AD. Children with AD had a higher prevalence of positive reactions to potassium dichromate (p < 0.001), Compositae mix (p = 0.01), and disperse blue (p = 0.03). CONCLUSIONS: Contact sensitization is quite common in young children. This study adds some information on the most common contact allergens. A similar prevalence of positive patch test reactions was found in children with and without AD, but children with AD had a greater prevalence of positive patch test reactions to potassium dichromate, Compositae mix, and disperse blue.

Treatment with tumor necrosis factor inhibitors restores coronary microvascular function in young patients with severe psoriasis.

BACKGROUND AND AIMS: In patients with psoriasis, the chronic exposure to systemic inflammation can result in coronary microvascular dysfunction (CMD). In this self-controlled, prospective pilot study, we investigated whether a long-term treatment with TNF-α inhibitors effective against skin symptoms also improves coronary flow reserve in psoriasis patients (CFR). METHODS: We prospectively studied 37 consecutive psoriasis patients (31 male; age, 37.7 ± 8.5 years) without cardiovascular disease, before and after anti-TNF-α treatment. CFR in the left anterior descending coronary artery was detected by transthoracic Doppler echocardiography, at rest and during adenosine infusion. CFR was the ratio of hyperemic to resting diastolic flow velocity. A CFR≤2.5 was considered a marker of CMD. Psoriasis was assessed by Psoriasis Area and Severity Index (PASI). High sensitive C-reactive protein (hs-CRP) and serum TNF-α were assessed. RESULTS: Overall, CFR increased from 2.2 ± 0.7 to 3.02 ± 0.8 (p < 0.0001) after TNF-α inhibitors therapy. In patients with CMD, CFR increased from 1.88 ± 0.3 to 2.74 ± 0.5 (p < 0.0001). In patients with normal CFR, CFR increased from 3.0 ± 0.5 to 3.7 ± 0.9 (p = 0.08). CFR improvement after TNF-α inhibitors treatment was correlated with hs-CRP and TNF-α reduction (p = 0.004 and p = 0.02, respectively), but not with change in PASI (p = 0.5). CONCLUSIONS: The present study demonstrates that TNF-α inhibitors treatment ameliorates CMD in patients with established psoriasis not responding to long-term conventional therapy. These findings suggest that a therapy specifically targeted against inflammation is able to positively affect coronary microvascular function.

Differential management of mild-to-severe psoriasis with biologic drugs: An Italian Delphi consensus expert panel.

BACKGROUND: In the management of moderate-to-severe psoriasis, increasingly complex clinical scenarios necessitate practical tools for appropriate biologic therapy selection in individual patients. An Italian Delphi consensus panel provided guidance on biologic use in selected clinical scenarios. METHODS: Ten experts defined statements under consideration, which were distributed as an online survey to a dermatologist panel. Plenary discussions of contentious statements were held to achieve consensus. RESULTS: The survey was sent to 30 clinicians. After plenary discussions, consensus was reached on all 20 statements on the following topics: special populations; infections; comorbidities; immunogenicity; extra-cutaneous involvement; pregnancy; and adherence. Three statements required further discussion in order to gain consensus: use of subcutaneous biologics in mild liver impairment (final 94% agreement), use of any biologic in discoid lupus erythematosus (final 100% disagreement), and use of etanercept in patients with history of hypersensitivity reactions to drugs and/or food (final 75% disagreement). CONCLUSIONS: This Delphi expert consensus on the use of biologics in psoriasis provides practical recommendations for dermatologists to use when choosing an appropriate biologic in challenging but common clinical scenarios. More data are required to clarify clinical differences of biologic drugs used to treat psoriasis.

The use of biochip immunofluorescence microscopy for the diagnosis of Pemphigus vulgaris.

Pemphigus vulgaris is an autoimmune intraepithelial blistering skin disease characterized by the presence of circulating autoantibodies directed against surfaces of keratinocytes. Diagnosis is generally based on clinical features, histology, direct and indirect immunofluorescence and ELISA. This study describes a new BIOCHIP mosaic-based indirect immunofluorescence technique based on recombinant antigenic substrates and transfected cells. We investigated the diagnostic use of BIOCHIP for the serological diagnosis of Pemphigus vulgaris. Autoantibodies against desmoglein 3 were detected in 97.62% of patients (41/42) with P. vulgaris. There were no positive results in the negative control group. Our study revealed that BIOCHIP has high sensitivity and specificity comparable to that of the ELISA assays. Therefore the BIOCHIP technique seems to be an appropriate method for the diagnosis of P. vulgaris as it has been shown to be a simple, standardized and readily available novel tool, which could facilitate the diagnosis of this autoimmune bullous disease. We suggest that it could be used as an initial screening test to identify patients with P. vulgaris before using the ELISA approach.

The cost effectiveness of biologic therapy for the treatment of chronic plaque psoriasis in real practice settings in Italy.

BACKGROUND AND OBJECTIVES: Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service's pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate. METHODS: To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window. RESULTS: The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to 15,073.7 per year (prior to their enrolment, the same patients cost 2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to 28,656.3. CONCLUSION: At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies.

Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry.

BACKGROUND: Some studies have shown that switching patients from one tumor necrosis factor (TNF)-alfa inhibitor to another may be beneficial when they have an inadequate response or an adverse event. OBJECTIVE: We sought to assess the variables predicting the efficacy of the second TNF-alfa inhibitor in patients discontinuing the first TNF-alfa inhibitor. METHODS: Data from all 5423 consecutive patients starting TNF-alfa inhibitor therapy for psoriasis between September 2005 and September 2010 who were included in the Italian Psocare registry were analyzed. RESULTS: In 105 patients who switched to a second TNF-alfa inhibitor who had complete follow-up data, 75% improvement in the Psoriasis Area Severity Index score (PASI 75) was reached by 29% after 16 weeks and by 45.6% after 24 weeks. Patients who switched because of secondary loss of efficacy (loss of initial PASI 75 response) or adverse events/intolerance were more likely to reach PASI 75 than those who switched as a result of primary inefficacy (PASI 75 never achieved) (hazard ratio 2.7, 95% confidence interval 1.3-5.5 vs hazard ratio 2.0, 95% confidence interval 1.0-3.9 and 1, respectively). LIMITATIONS: There was a small number of patients with complete follow-up data. CONCLUSION: PASI 75 response in patients who switched from one anti-TNF-alfa agent to another was significantly reduced in patients who showed primary inefficacy of the first anti-TNF-alfa.

Quality of life assessment of patients with scalp dermatitis using the Italian version of the Scalpdex.

The aim of this study was to assess quality of life in patients with scalp dermatitis using the Italian version of the Scalpdex, and to validate the instrument in Italian. The survey was conducted in outpatients with psoriasis, seborrhoeic dermatitis, alopecia, or follicular lichen. Data were completed on 194 patients, 78% of whom had psoriasis. Scalpdex scores were always higher in women than in men, and in younger people compared to elderly people. The most frequent items were: being ashamed, embarrassed, bleeding scalp, feeling self-conscious, bothered that the condition is incurable, having the choice of colour of clothes affected, having a negative effect on daily life. The Italian Scalpdex showed good internal consistency, test-retest reliability, convergent validity, and responsiveness. In conclusion, the Italian version of the Scalpdex is a useful instrument to measure quality of life in patients with a scalp condition.

In vitro evaluation of sunscreens: an update for the clinicians.

Topical sunscreens contain molecules or molecular complexes that can absorb, reflect, or scatter UV photons. Evaluation of the efficacy of sunscreen products has been made through the Sun Protection Factor (SPF), a mean of quantitatively assessing in vivo the degree of protection offered by sunscreen products against solar radiation. In vivo evaluation of SPF has several drawbacks. First of all, this evaluation method is expensive in terms of money and time. Moreover, it raises several ethical issues concerning the potential damage to skin volunteers. Several in vitro techniques have been developed, but at present there is no broadly accepted method. In this paper, we will discuss some of the recent advances concerning the in vitro evaluation of sunscreens which would be acceptable for replacing in vivo assays.

Current patch test results with the European baseline series and extensions to it from the 'European Surveillance System on Contact Allergy' network, 2007-2008.

BACKGROUND: The pattern of contact sensitization to the supposedly most important allergens assembled in the baseline series differs between countries, presumably at least partly because of exposure differences. Objectives. To describe the prevalence of contact sensitization to allergens tested in consecutive patients in the years 2007 and 2008, and to discuss possible differences. METHODS: Data from the 39 departments in 11 European countries comprising the European Surveillance System on Contact Allergy network (www.essca-dc.org) in this period have been pooled and analysed according to common standards. RESULTS: Patch test results with the European baseline series, and country-specific or department-specific additions to it, obtained in 25 181 patients, showed marked international variation. Metals and fragrances are still the most frequent allergens across Europe. Some allergens tested nationally may be useful future additions to the European baseline series, for example methylisothiazolinone, whereas a few long-term components of the European baseline series, namely primin and clioquinol, no longer warrant routine testing. CONCLUSIONS: The present analysis points to 'excess' prevalences of specific contact sensitization in some countries, although interpretation must be cautious if only few, and possibly specialized, centres are representing one country. A comparison as presented may help to target in-depth research into possible causes of 'excess' exposure, and/or consideration of methodological issues, including modifications to the baseline series.

Skin cancer and other cutaneous disorders in liver transplant recipients.

Patients who have received liver transplant are at increased risk of skin complications due to long-term immunosuppression regimen. The aim of this study was to analyze the incidence and risk factors of skin complications in liver transplant patients. We analyzed 161 liver transplant recipients. The mean age at transplantation was 47.4 years. Mean follow-up was 6 years. Seventy-one percent of patients presented with skin complications, including aestethic alterations, infections, precancerous lesions and malignancies, which represented 57%, 43%, 18% and 9%, respectively. Risk factors were: age at transplantation ≥ 45 years, immunosuppressive therapy with cyclosporine, and phototype II and III. Our study indicates that although liver transplant recipients are at greater risk of developing skin complications compared to the general population, the risk is lower than for other solid organ transplants, particularly for premalignant and malignant lesions.