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Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.

Background: Treatment of moderate-to-severe atopic dermatitis (AD) in the elderly may be challenging, due to side-effects of traditional anti-inflammatory drugs and to comorbidities often found in this age group. Furthermore, efficacy and safety of innovative drugs such as dupilumab are not yet well known. Objectives: A multicentre retrospective, observational, real-life study on the efficacy and safety of dupilumab was conducted in a group of patients aged ≥65years and affected by severe AD. Their main clinical features were also examined. Methods: Data of elderly patients with severe (EASI ≥24) AD treated with dupilumab at label dosage for 16weeks were retrospectively collected. Treatment outcome was assessed by comparing objective (EASI) and subjective (P-NRS, S-NRS and DLQI) scores at baseline and after 16weeks of treatment. Results: Two hundred and seventy-six patients were enrolled in the study. They represented 11.37% of all patients with severe AD. Flexural eczema was the most frequent clinical phenotype, followed by prurigo nodularis. The coexistence of more than one phenotype was found in 63/276 (22.82%) subjects. Data on the 16-week treatment with dupilumab were available for 253 (91.67%) patients. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores. No statistically significant difference regarding efficacy was found in elderly patients when compared to the group of our AD patients aged 18–64years, treated with dupilumab over the same period. Furthermore, only 18 (6.52%) patients discontinued the drug due to inefficacy. Sixty-one (22.51%) patients reported adverse events, conjunctivitis and flushing being the most frequent. One (0.36%) patient only discontinued dupilumab due to an adverse event. Conclusions: Therapy with dupilumab led to a significant improvement of AD over a 16-week treatment period, with a good safety profile. Therefore, dupilumab could be considered as an efficacious and safe treatment for AD also in the elderly.

Recent studies have shown that biological drugs approved for treating psoriasis and psoriatic arthritis are not effective in all patients, and that variations in the genome have been associated with different clinical responses or side effects. HLA-Cw6 gene is associated with more severe and early-onset psoriasis. Recent reports have shown that HLA-Cw6 status predicts efficacy of some biologic treatments in psoriasis patients. The Phase 3b SUPREME study (NCT02394561) demonstrated the efficacy of secukinumab in patients with moderate-to-severe plaque-type psoriasis, irrespective of HLA-Cw6 status at week 24. This article is protected by copyright. All rights reserved.

Background Understanding genetic variations is important in predicting treatment response and forms the basis for identifying new pharmacogenetic and pharmacogenomic targets for psoriasis treatment. There are limited data on the efficacy of secukinumab in relation to genetic markers. Objectives To evaluate the efficacy and safety of secukinumab 300 mg in HLA-Cw6-positive (Cw6-POS) and HLA-Cw6-negative (Cw6-NEG) patients with moderate-to-severe chronic plaque-type psoriasis. Methods SUPREME was a 24-week, phase IIIb study with an extension period up to 72 weeks. Primary end point was Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks. Results In total, 434 patients were recruited: 185 (42·6%) were Cw6-POS and 246 (56·7%) were Cw6-NEG (three not assessed). Mean ± SD age was 45·2 ± 13·2 years (Cw6-POS 42·7 ± 13·1; Cw6-NEG 47·2 ± 12·9). The baseline PASI score was comparable between the cohorts [Cw6-POS 20·7 ± 8·99; Cw6-NEG 21·5 ± 9·99 (P = 0·777)]. At week 16, PASI 90 was achieved in 80·4% of Cw6-POS and 79·7% of Cw6-NEG patients (difference 0·76; 95% confidence interval -7·04 to 8·23). No differences in absolute PASI at week 16 (Cw6-POS 1·36 ± 3·58; Cw6-NEG 1·18 ± 2·29) were observed. The overall safety profile of secukinumab was consistent with that previously reported. No statistically significant difference was detected in the rate of treatment-emergent adverse events [Cw6-POS 42·7%; Cw6-NEG 49·6% (P = 0·295)]. A high PASI 90 response was achieved with secukinumab with a fast reduction in absolute PASI. Conclusions Determination of HLA-Cw6 status for secukinumab therapy is unnecessary, as it is highly effective regardless of HLA-Cw6 status.

Pressure ulcers (PrUs) remain a concern for clinicians, patients, caregivers, and researchers. Although data on prevalence and incidence are available, as well as evidence-based prevention and management intervention, PrU healing time is underreported. OBJECTIVE: The objective of this study was to evaluate the healing time of Stage II PrUs. METHODS: Secondary analysis of data collected from a multicenter randomized clinical trial was undertaken. Patients (a) with a Stage II PrU, (b) older than 18 years, and (c) who had given informed consent were included. The endpoints of the study were complete re-epithelialization of the PrU measured with the Pressure Ulcer Scale for Healing Tool 3.0 and the healing time. A network of 46 healthcare centers located in northern Italy participated in the study. RESULTS: Two hundred seventy patients with an average age of 83.9 years (95% confidence interval [CI], 82.71Y85.10) were recruited. Among 270 Stage II PrUs included, 153 lesions healed (56.7%), whereas 74 (27.4%) were still present after 10 weeks of follow-up. For 43 lesions (15.9%), the follow-up evaluation was interrupted because of patient death or transfer to units not included in the study. The PrUs healed on an average of 22.9 days (95% CI, 20.47Y25.37 days), with a median of 18 days. The average healing time for PrUs of less than 3.1 cm2 was significantly shorter (19.2 days; 95% CI, 16.6Y21.8) compared with those 3.1 cm2 or greater (31.0 days; 95% CI, 26.4Y35.6 days) (P = .000). CONCLUSIONS: To achieve complete re-epithelialization in Stage II PrUs, it takes approximately 23 days. This is quite a long time if we consider that pressures of only 60 to 70mmHg for between 30 and 240minutes are needed to cause tissue damage. On average, a small ulcer heals 12 days faster compared with those with a surface of 3.1 cm2 or greater. KEYWORDS: Stage II pressure ulcer, healing time, re-epithelialization

The long-term efficacy and safety of dupilumab has been demonstrated in clinical trials and only in few real-world studies. We conducted an extension analysis from a previous 16-week study on 109 adult patients affected by moderate-to-severe atopic dermatitis treated with dupilumab. Eczema-Area-and-Severity-Index (EASI), itch numerical-rating-score (itch-NRS), Dermatology-Life-Quality-Index (DLQI) scores, drug survival rate and occurrence of adverse events after 24 and 48 weeks of dupilumab treatment were retrospectively collected. Dupilumab demonstrated sustained improvement of disease severity, pruritus, and quality of life in our series with an increasing percentage of patients gaining EASI75 and EASI90 response during the study period. Few patients interrupted treatment resulting in a very high drug survival rate. We also confirmed the favorable safety profile of the drug with absence of serious adverse events and serious infections throughout the 48-week period. The prevalence of conjunctivitis was low and mainly occurred in the mid-term with resolution of the majority of cases at 48 weeks.

Background Mammary Paget's disease (MPD) is a rare intraepidermal adenocarcinoma of the nipple-areola complex, associated with an underlying breast cancer in approximately 90% of cases. Delayed diagnosis of MPD is common. Its dermoscopic features have been ill defined in the literature. Objectives To determine the clinical and dermoscopic features of MPD versus other dermatologic entities that involve nipple and areola. Methods Members of the IDS were invited to submit any case of histologically confirmed MPD, as well as other benign and malignant dermatoses that involve the nipple and areola complex. A standardized evaluation of the dermoscopic images was performed and the results were statistically analyzed. Results Sixty-five lesions were included in the study, 22 (33.8%) of them MPD and 43 (66.2%) controls. The most frequent dermoscopic criteria of MPD were white scales (86.4%) and pink structureless areas (81.8%), followed by dotted vessels (72.7%), erosion/ulceration (68.2%) and white shiny lines (63.6%). The multivariate analysis showed that white scales and pink structureless areas were significant predictors of MPD, posing a 68-fold and a 31-fold probability of MPD, respectively. Split of the population into pigmented and non-pigmented lesions showed that in pigmented MPD, pink structureless areas, white lines and grey granules and dots are positive predictors of the disease. Among non-pigmented lesions, pink structureless areas, white lines, erosion/ulceration and white scales served as predictors of MPD. Conclusions The most frequent profile of an individual with MPD is an elderly female with unilateral, asymptomatic, erythematous plaque of the nipple, dermoscopically displaying pink structureless areas, fine white scales, dotted and a few short linear vessels. In case of pigmentation we may also observe brown structureless areas and pigmented granules. Limitations Small sample size, retrospective design.

We report the first registered cases of cutaneous adverse reactions in North-East Italy after the m-RNA COVID-19 vaccine Comirnaty®-BioNTech/Pfizer, During January 2021, in the public health jurisdiction of Trieste, a total of 19,485 individuals have been vaccinated: 13,266 (68.08%) first doses and 6,219 (31.92%) completed cycles of two doses. In this population, 266 (1.36%) adverse reactions have been reported to the Pharmacovigilance Service. Notably, one or more cutaneous adverse effects were present in 44 people, accounting for 0.22% of all vaccinated individuals and 16.54% of communicated adverse effects. The reactions included both those at the injection site and more extensive manifestations (Table 1).

Background Limited data on dermatoscopy of nodular/plaque-type T-/B-cell primary cutaneous lymphomas (PCLs) is available. Objective To describe dermatoscopic features of nodular/plaque-type PCLs, comparing them with those of clinical mimickers (pseudolymphomas, tumors, and inflammatory lesions) and investigating possible differences according to histologic subtypes. Methods Participants were invited to join this retrospective, multicenter case-control study by submitting histologically/immunohistochemically confirmed instances of nodular/plaque-type PCLs and controls. Standardized assessments of the dermatoscopic images and comparative analyses were performed. Results A total of 261 lesions were included (121 PCLs and 140 controls). Orange structureless areas were the strongest PCL dermatoscopic predictor on multivariate analysis compared with tumors and noninfiltrative inflammatory dermatoses. On the other hand, a positive association was found between PCLs and either unfocused linear vessels with branches or focal white structureless areas compared with infiltrative inflammatory dermatoses, whereas white lines were predictive of PCLs over pseudolymphomas. Differences in the vascular pattern were also seen between B- and T-cell PCLs and among B-cell PCL subtypes. Limitations Retrospective design and the lack of a dermatoscopic-pathologic correlation analysis. Conclusion Nodular/plaque-type PCLs display dermatoscopic clues, which may partially vary according to histologic subtype and whose diagnostic relevance depends on the considered clinical differential diagnoses.

Background: Cyclosporine A (CsA) is one of the systemic therapeutic options for moderate-to-severe psoriasis, based on its efficacy and rapidity of action. The current study investigated the response to CsA in patients with moderate-to-severe plaque psoriasis. Materials and Methods: TRANSITION was an observational, cross-sectional, multicentre study which evaluated the proportion of partial- and suboptimal-responders among patients with moderate-to-severe plaque psoriasis treated with continuous CsA for >= 12 weeks. Patients demonstrating a Psoriasis Area and Severity Index (PASI) response of >= 90, >= 75 and = 50 and

Over the last few years, several articles on dermoscopy of non-neoplastic dermatoses have been published, yet there is poor consistency in the terminology among different studies.We aimed to standardize the dermoscopic terminology and identify basic parameters to evaluate in non-neoplastic dermatoses through an expert consensus.The modified Delphi method was followed, with two phases: (i) identification of a list of possible items based on a systematic literature review and (ii) selection of parameters by a panel of experts through a three-step iterative procedure (blinded e-mail interaction in rounds 1 and 3 and a face-to-face meeting in round 2). Initial panellists were recruited via e-mail from all over the world based on their expertise on dermoscopy of non-neoplastic dermatoses.Twenty-four international experts took part in all rounds of the consensus and 13 further international participants were also involved in round 2. Five standardized basic parameters were identified: (i) vessels (including morphology and distribution); (ii) scales (including colour and distribution); (iii) follicular findings; (iv) 'other structures' (including colour and morphology); and (v) 'specific clues'. For each of them, possible variables were selected, with a total of 31 different subitems reaching agreement at the end of the consensus (all of the 29 proposed initially plus two more added in the course of the consensus procedure).This expert consensus provides a set of standardized basic dermoscopic parameters to follow when evaluating inflammatory, infiltrative and infectious dermatoses. This tool, if adopted by clinicians and researchers in this field, is likely to enhance the reproducibility and comparability of existing and future research findings and uniformly expand the universal knowledge on dermoscopy in general dermatology. What's already known about this topic? Over the last few years, several papers have been published attempting to describe the dermoscopic features of non-neoplastic dermatoses, yet there is poor consistency in the terminology among different studies. What does this study add? The present expert consensus provides a set of standardized basic dermoscopic parameters to follow when evaluating inflammatory, infiltrative and infectious dermatoses. This consensus should enhance the reproducibility and comparability of existing and future research findings and uniformly expand the universal knowledge on dermoscopy in general dermatology.

Primary localized cutaneous amyloidosis is an uncommon lesion (1,2). Recently, Merika EE and coworkers (3) described two patients with localized amyloid lesion of the glans penis and in the literature review they found only 10 previously reported cases. A 50-year-old uncircumcised man presented with an asymptomatic penile lesion, unresponsive to topical steroid. The patient reported that he first noticed two small non-painful raised areas on his glans penis approximately 3 years previously. Since that time, these two areas had been slowly increasing in size. This article is protected by copyright. All rights reserved.

Background: Brain metastases commonly occur in patients with metastatic melanoma and are associated with a poor prognosis. Only a few chemotherapeutic agents have been shown to be potentially active. Resistance to chemotherapy is one of the main limitations to treatment. A key mechanism of resistance is O6-methylguanine-DNA methyltransferase (MGMT). The methylation of its promotor could inhibit the activity of this enzyme; consequently, it is very important to evaluate the methylation status of all available specimens. Case Report: We report the case of a long-surviving patient in whom combination treatment with an alkylating agent inhibiting MGMT, such as temozolomide, was useful in clinical control of the disease.

Malignant melanoma presenting as a giant cutaneous mass is rarely observed in clinical practice. A few patients with giant melanoma have been reported, Herein, we document our experience with a patient with giant cutaneous melanoma of the abdomen and review the features of previously reported individuals.

Introduction : Nailfold videocapillaroscopy (NVC) is a non-invasive imaging technique widely used to investigate microvascular abnormalities in different connective tissue diseases (CTDs). Methods : We conducted a retrospective study where we analysed 415 patients submitted to NVC. Patients with scleroderma-like pattern were selected to investigate if there are specific NCV changes, which discriminate among the different CTDs. Ninety-one patients met this requirement and had a diagnosis of CTD. For each patient the following abnormalities were observed: enlarged and giant capillaries, oedema, loss and rarefaction of capillaries, long loops and minor dystrophies. Results : Multivariate analyses did not reveal any specific modification among the analysed co-variables for scleroderma (SS) and dermatomyositis (DM). For the others CTDs analysed in this study, logistic regression revealed that some of the capilloroscopic features could be indicative of specific diseases. Of note, the presence of megacapillaries with long loops in a scleroderma-like pattern seems to be highly indicative for a diagnosis of systemic lupus erythaematosus (SLE). Conclusions : Our data showed that in CTDs with a scleroderma-like pattern, the NVC variables alone are not able to discriminate for a specific diagnosis of CTD. Nevertheless, there are some NVC features, which could strongly address the differential diagnosis toward a specific CTD.

Interstitial granulomatous dermatitis (IGD) is a rare dermatosis of unknown cause with characteristic histopathological features and variable clinical expression. [1] It has been associated with systemic diseases which include rheumatoid arthritis, lupus erythematosus, autoimmune thyroiditis, carcinoma, infections and drug intake. It has recently been proposed that interstitial granulomatous dermatitis could be a cutaneous manifestation of Lyme borreliosis in Borrelia burgdorferi endemic areas. [2],[3],[4] We report a similar case below.