The Epidermal Growth Factor Receptor Inhibitor-Related Skin Toxicity Index (EGFRISTI): a new tool for grading and managing skin adverse reactions to epidermal growth factor receptor inhibitors.

BACKGROUND: Skin toxicity is frequent and debilitating in oncologic patients treated with epidermal growth factor receptor inhibitors (EGFRIs). Grading and management of skin adverse events (AEs) are poorly standardized. MATERIALS AND METHODS: We developed a new score (EGFRISTI: Epidermal Growth Factor Receptor Inhibitor-Related Skin Toxicity Index) which is able to quantify and monitor all EGFRI-related dermatologic AEs over time. The utility of this tool was validated in 130 patients treated with 5 different EGFRIs including both monoclonal antibodies and tyrosine kinase inhibitors. RESULTS: The mean baseline EGFRISTI score was 26.9 (range: 6.0-64.5). Mild toxicity was found in 55 patients (42.3%), moderate toxicity in 43 (33.1%), and severe toxicity in 32 patients (24.6%). After the first-line toxicity treatment, an EGFRISTI score reduction of >75% was obtained in 31 patients (34.1%) and one of 50% in 40 patients (43.9%), while an improvement of <50% was observed in the remaining 20 subjects (22.0%). CONCLUSIONS: The EGFRISTI is a simple and reliable tool to quantify and express the severity of all clinical signs and symptoms of EGFRI skin toxicity with a single numerical value, to choose the most suitable therapy, and to measure its efficacy.

Clinical and epidemiological features of textile contact dermatitis: an Italian multicentre study.

BACKGROUND: The prevalence of occupational and non-occupational textile dermatitis seems to be increasing, probably because of changed textile manufacturing techniques. OBJECTIVE: Evaluation of the clinical features and epidemiology of textile contact dermatitis (TCD) in Italy. METHODS: Demographic data, clinical history aspects, atopy and positive patch test reactions to occupational and non-occupational allergens were investigated in 277 textile dermatitis patients. RESULTS: Contact dermatitis was the most frequent clinical presentation (95.3%). TCD was more common in females, in the fourth to fifth decades of life, and in atopic dermatitis patients. The lesions were prevalently eczematous (74.2%), and mostly located on the trunk and lower limbs in non-occupational cases, and on the hands in textile workers. Allergic TCD (58.3%) was more frequent than irritant TCD. The dyes (Disperse Blue 124, Disperse Blue 106, and Disperse Yellow 3) were most frequently responsible (79.8%), especially in non-occupational TCD. Formaldehyde and resins were more important in occupational TCD. Concomitant reactions among textile dyes and/or finishing resins were observed in 50.0% of patients. CONCLUSIONS: Some strategies (sensitization potential of new textile chemicals, more stable dyes, reduced levels of formaldehyde in clothing, and collaboration with textile industry and trade associations) should be adopted to decrease the TCD incidence and update the textile patch testing series.

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 >or=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 >or=50% (PASI50) and a PASI score <10 at the end of treatment. Etanercept treatment was restarted if the PASI score reached >or=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 >or=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 re-treatment 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 50 mg 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.

Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial.

OBJECTIVE: A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex) alone for 12 weeks (group B) for the treatment of psoriasis. MATERIALS AND METHODS: A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures. RESULTS: Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher clinical response compared with group B (p< 0.001). Treatment with calcipotriol was associated with a gradual improvement in group B and maintenance of the results in group A. Similarly, the quality of life assessment showed a marked improvement in terms of Skindex-29 in both groups at weeks 2 and 4 compared to baseline. Both treatments were safe and well tolerated. CONCLUSIONS: Our results demonstrate a higher efficacy and more rapid onset of action with the two-compound ointment compared with calcipotriol cream alone in short-term treatment. However, sequential application of calcipotriol allows maintenance of the results.

Systemic inflammation and imbalance between endothelial injury and repair in patients with psoriasis are associated with preclinical atherosclerosis.

BACKGROUND: Systemic inflammation and imbalance between endothelial injury and repair, the latter referred to as vascular incompetence, are associated with atherosclerosis and cardiovascular risk. Psoriasis, an inflammatory disease of the skin, has been associated with atherosclerosis. We investigated whether, in psoriasis, inflammation and vascular incompetence are associated with carotid intima-media thickness (cIMT) irrespective of metabolic syndrome and other established cardiovascular risk factors. METHODS: High sensitivity C-reactive protein (hsCRP), the ratio between endothelial microparticles (EMPs) and progenitors (EPCs), a marker of vascular incompetence, and cIMT were measured in 84 patients with psoriasis and 90 healthy controls, balanced for age, gender and the prevalence of metabolic syndrome. RESULTS: Patients with psoriasis had higher hsCRP, EMP/EPC ratio and cIMT than controls. Patients with both psoriasis and metabolic syndrome had the highest hsCRP levels, psoriasis and metabolic syndrome being associated with a 3.1- and 2.6-fold increased risk of having high hsCRP levels, respectively. Logarithm transformed hsCRP and EMP/EPC ratio were predictors of high cIMT (odds ratio 3.8; 95% confidence interval 1.3-11.4; p = 0.02 and odds ratio 8.7; 95% confidence interval 2.7-27.5; p < 0.001, respectively) regardless of confounders. Patients with high hsCRP and EMP/EPC ratio had higher cIMT than those with none or at least one of risk variable. CONCLUSIONS: Patients with psoriasis have an increased burden of cardiovascular risk, including inflammation, vascular incompetence and early atherosclerosis. Increased hsCRP levels, possibly sustained by the inflammatory nature of psoriasis and metabolic syndrome, and vascular incompetence are associated with early carotid atherosclerosis, regardless of metabolic syndrome and other established cardiovascular risk factors.

The Italian Euromelanoma Day: evaluation of results and implications for future prevention campaigns.

BACKGROUND: Melanoma incidence/mortality is increasing worldwide. "Euromelanoma Day" is a pan-European campaign for skin cancer prevention. Results of the 2010 Euromelanoma Day in Italy are reported herein. MATERIALS AND METHODS: A questionnaire was used to collect data on participants' characteristics and suspected skin cancers. RESULT: A total of 1085 participants was screened (64.1% females, median age 44 years). Suspicion rate, detection rate, and positive predictive values for melanoma were 1.3, 0.28 and 21.4%, respectively. Poorly educated, ≥35 years old, pale-skinned males were at higher risk for skin cancer than highly educated, <35 years old, darker-skinned females, although the latter groups reported sun-seeking behaviors. Full skin examination and dermoscopy were performed in 85.5 and 79.2% of participants. CONCLUSIONS: The 2010 Italian Euromelanoma Day produced good results in terms of melanoma detection/suspicion rates, likely due to the extensive use of full clinical and dermoscopic examinations. The campaign failed to attract many high-risk individuals. Targeted communication strategies are needed to this regard.

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.

Drug- and virus- or bacteria-induced exanthems: the role of immunohistochemical staining for cytokines in differential diagnosis.

BACKGROUND: The differential clinical diagnosis between drug-induced exanthema (DIE) and virus- or bacteria-induced exanthema (VBIE) is frequently not easy because the serologic analysis for virus and bacteria and skin tests are not always exhaustive. In these cases, only the oral challenge test is nullifying. OBJECTIVES: This study wants to identify 1 or more structural changes and/or cytokine markers that might be helpful in discriminating the etiology and the possible correlation with the clinical features, type of the involved drug, blood and skin eosinophilia, and time of skin biopsy. METHODS: Involved non-sun-exposed skin biopsy specimens were obtained from 36 patients with DIE and 30 patients with VBIE. Blood investigations, skin tests, and oral rechallenge tests were carried out in all subjects. The histopathologic features and the immunohistochemical expression of a cytokine panel [fatty acid synthase-ligand, granzyme B, interleukin (IL) 2, IL-4, IL-5, IL-10, IL-13, interferon γ, perforin, tumor necrosis factor α] were analyzed. CONCLUSIONS: Finally, DIE and VBIE have distinct skin cytokine profile (IL-5 alone or in combination with granzyme B and perforin in DIEs was statistically more frequent than in VBIEs, mainly when skin biopsy was carried out within 2 days from clinical onset), which might be helpful in discriminating the etiology.

Atopic dermatitis in adults.

Atopic dermatitis (AD) is a chronically relapsing eczematous disease, more common in infants and children than in adults and very rare after midlife. The diagnosis of AD is not always easy in adults, especially when the extension of lesions is limited and their distribution atypical. The aim of this study was to investigate epidemiologic and clinical features of adult AD. The medical files of 332 consecutive AD patients were reviewed to ascertain family and personal history of atopy, age at onset, morphology and localization sites of AD lesions, serum total immunoglobulin E levels, skin prick-test and patch-test results. The present study has show that the disease is more frequent in females and during the third decade of life, starts after the 18th year in slightly fewer than half the patients (47.6%), is prevalently localized in the limb flexures, eyelids, and perioral region, but also in the forehead, cheeks, and anterolateral region of the neck, where it is mainly mild to moderate. AD is of the intrinsic type in 30.4% of cases. Positive patch-test reactions to chemical allergens have been observed in 23.8% of patients. These are very important, because they may influence the occupational choices and the development of hand dermatitis.

Quality of life and contact dermatitis: a disease-specific questionnaire.

BACKGROUND: Contact dermatitis (CD) is a chronic disease with a significant impact on quality of life (QoL). There have been relatively few reports in the literature on specific QoL outcomes for patients suffering from CD. OBJECTIVES: To develop a new instrument specifically designed to measure QoL in CD and to investigate which disease features could strongly influence QoL. METHODS: Three hundred seventy-two patients affected by CD were administered a 20-item questionnaire, which comprised some questions taken and modified from the Dermatology Life Quality Index and the Skindex 16. Six more items were added. Univariate analysis and a chi-square test were performed. RESULTS: Females reported lower QoL scores than males. Three aspects (itching, discomfort, and difficulty in daily activities) were strongly associated with a poor QoL; even if patients who experienced difficulty in using their hands at work had a poor QoL, the statistical significance was very low. CONCLUSION: A CD-specific questionnaire can be used to understand a priori the impact on psychological behaviour of the patient and can lead to specific choices, such as the appropriate therapy to be used, the evaluation of treatment efficacy, the choice of preventive devices, and the comparison with QoL of other dermatoses.

Eyelid dermatitis: an evaluation of 447 patients.

BACKGROUND: Eyelids can be affected by various types of dermatitis that are often difficult to diagnose. OBJECTIVE: The aim of the study was to establish some guidelines for a correct diagnosis. METHODS: A total of 447 patients treated at 12 research units for eczema or other inflammatory dermatitis located on the eyelids were invited to complete a questionnaire. When necessary, patch tests with haptens of the standard series from Gruppo Italiano di Ricerca sulle Dermatiti da Contatto e Ambientali della Società Italiana di Dermatologia e Venereologia (SIDEV-GIRDCA) were performed. RESULTS: Of the subjects studied, 50.2 % were diagnosed with allergic contact dermatitis (ACD); 20.9% were affected by irritant contact dermatitis (ICD), 13.5% by atopic dermatitis, 6.3% by seborrheic dermatitis, 6.5% by aspecific xerotic dermatitis, and 2.3% by psoriasis. Approximately 91% of all subjects reported an absence of familial atopy. A significant statistical association between diagnosis type and a personal history of atopy was evident (p <.000001, chi-square test). The results of gradual logistic regression models showed four-eyelid involvement as the main risk factor for ACD (odds ratio [OR] = 3.0; 95% CI, 1.1-8.1); with ICD, the main risk factor was the onset of symptoms at between 2 and 6 months (OR = 2.1; 95% CI, 1.1-4.0), whereas for atopic dermatitis, the main risk factors were the onset of symptoms later than 6 months and a personal history of atopy (OR = 4.9 and 3.6, respectively). CONCLUSION: Results suggest that many characteristics of the patients examined can be used for the differential diagnosis of palpebral eczematous dermatitis.