Publications by authors named "Franco Rongioletti"

133 Publications

Clinicopathologic correlations of COVID-19-related cutaneous manifestations with special emphasis on histopathologic patterns.

Clin Dermatol 2021 Jan-Feb;39(1):149-162. Epub 2020 Dec 14.

Unit of Dermatology, Department Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Skin is one of target organs affected by the novel coronavirus SARS-CoV-2, and in response to the current COVID-19 pandemic, a fast body of literature has emerged on related cutaneous manifestations. Current perspective is that the skin is not only a bystander of the general cytokines storm with thrombophilic multiorgan injury, but it is directly affected by the epithelial tropism of the virus, as confirmed by the detection of SARS-CoV-2 in endothelial cells and epithelial cells of epidermis and eccrine glands. In contrast with the abundance of epidemiologic and clinical reports, histopathologic characterization of skin manifestations is limited. Without an adequate clinicopathologic correlation, nosology of clinically similar conditions is confusing, and effective association with COVID-19 remains presumptive. Several patients with different types of skin lesions, including the most specific acral chilblains-like lesions, showed negative results at SARS-CoV-2 nasopharyngeal and serologic sampling. The aim of this review is to provide an overview of what has currently been reported worldwide, with a particular emphasis on microscopic patterns of the skin manifestations in patients exposed to or affected by COVID-19. Substantial breakthroughs may occur in the near future from more skin biopsies, improvement of immunohistochemistry studies, RNA detection of SARS-CoV-2 strain by real-time polymerase chain reaction-based assay, and electron microscopic studies.
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http://dx.doi.org/10.1016/j.clindermatol.2020.12.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832768PMC
May 2021

Active elderly and health-can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial.

Trials 2021 May 7;22(1):331. Epub 2021 May 7.

Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Background: Aging is marked by a progressive rise in chronic diseases with an impact on social and healthcare costs. Physical activity (PA) may soothe the inconveniences related to chronic diseases, has positive effects on the quality of life and biological rhythms, and can prevent the decline in motor functions and the consequent falls, which are associated with early death and disability in older adults.

Methods: We randomized 120 over-65 males and females into groups of similar size and timing and will give each either moderate physical activity or cultural and recreational activities. Being younger than 65 years, inability to participate in physical activity for any medical reason, and involvement in a massive program of physical exercise are the exclusion criteria. The primary outcome measures are: quality of life, walking speed, and postural sway. Participants are tested at baseline, post-treatment, and 6-month (24 weeks) and 12-month (48 weeks) follow-ups.

Discussion: This study aims at improving the quality of life, wellness, and cognitive functioning in the elderly through a low-cost affordable program of moderate physical activity. Given the growing aging of the world population and the social and economic burden of disability in the elderly, our results might have a major impact on future practices.

Trial Registration: ClinicalTrials.gov NCT03858114 . Registered on 28 February 2019.
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http://dx.doi.org/10.1186/s13063-021-05278-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8103665PMC
May 2021

Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study.

Am J Clin Dermatol 2021 Jul;22(4):581-586

Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Via Francesco De Santis, snc., 86100, Campobasso, Italy.

Objective: The objective of this study was to assess the effectiveness and safety of dupilumab in treating elderly patients with atopic dermatitis from baseline to 52 weeks.

Methods: A retrospective observational real-life study was conducted in a group of elderly patients with severe atopic dermatitis treated with dupilumab for 52 weeks. Inclusion criteria were: age ≥ 65 years; diagnosis of atopic dermatitis made by an expert dermatologist; Eczema Area and Severity Index ≥ 24; and a contraindication, side effects, or failure to respond to cyclosporine. The primary outcome was the mean percentage reduction in the Eczema Area and Severity Index score from baseline to week 52. Secondary measures included the mean percentage reduction in the Pruritus and Sleep Numerical Rating Scales and the Dermatology Life Quality Index, and the types and rates of adverse events from baseline to week 52.

Results: One hundred and five patients were eligible for the study. Flexural dermatitis was the most frequent clinical phenotype (63.8%). The coexistence of more than one clinical phenotype was found in 70/105 (66.6%) patients. We observed a reduction in all disease severity scores from baseline to week 52 (p < 0.001). Adverse events were recorded in 30/105 (28.6%) patients, with conjunctivitis and injection-site reaction the most frequent.

Conclusions: In this study, dupilumab is an effective and safe treatment for the long-term management of atopic dermatitis in patients aged over 65 years.
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http://dx.doi.org/10.1007/s40257-021-00597-5DOI Listing
July 2021

Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis.

Eur J Dermatol 2021 Feb;31(1):3-16

Dermatology Unit "Daniele Innocenzi", Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Corso della Repubblica, 7904100 Latina, Rome, Italy.

Guselkumab, a subcutaneously administered fully human IgG1λ monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.
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http://dx.doi.org/10.1684/ejd.2021.3965DOI Listing
February 2021

Glomeruloid reactive angioendotheliomatosis in a woman with systemic lupus erythematosus and antiphospholipid syndrome mimicking reticular erythematous mucinosis.

JAAD Case Rep 2021 Feb 17;8:56-59. Epub 2020 Dec 17.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1016/j.jdcr.2020.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7814103PMC
February 2021

Don't forget about syphilis: sexually transmitted diseases during COVID-19 pandemic.

J Public Health Res 2020 Oct 23;9(4):2040. Epub 2020 Dec 23.

Unit of Dermatology.

A great heterogeneity of skin manifestations has been increasingly associated with SARS-CoV2 infection, and especially exanthematous eruptions are considered among early presenting signs in symptomatic patients. In this report, a 58-year-old patient presented with fever, generalized rash and systemic symptoms as urgent consultation to the Dermatology Clinic of Cagliari amidst the Italian outbreak in late March 2020. After a negative nasopharyngeal swab for SARS-CoV-2, secondary syphilis was confirmed by serological tests and skin biopsy, underlining that, even during a global pandemic, other common and important diseases should not be overlooked. The case also suggests thought on the ineffectiveness of distancing and social containment measures when dealing with sexually transmitted diseases.
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http://dx.doi.org/10.4081/jphr.2020.2040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789427PMC
October 2020

Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations.

Dermatol Ther (Heidelb) 2021 Feb 11;11(1):235-252. Epub 2021 Jan 11.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Via Università 40, 09124, Cagliari, Italy.

Introduction: Treat-to-target strategies are used in several chronic diseases to improve outcomes. Treatment goals have also been suggested for psoriasis, but there is currently no consensus on targets, and guidance is needed to implement this strategy in clinical practice. The project 'Treat to Target Italia' was launched by a scientific board (SB) of 10 psoriasis experts to generate expert consensus recommendations.

Methods: On the basis of the published literature, their clinical experience, and the results of a survey among Italian dermatologists, the SB identified four relevant topics: (1) clinical remission; (2) quality of life; (3) abrogation of systemic inflammation; (4) safety. They drafted 20 statements addressing these four topics and submitted them to a panel of 28 dermatologists, in a Delphi process, to achieve consensus (greater than 80% agreement).

Results: Consensus was reached on all statements. Treatment goals defining clinical remission should include a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI90 response) or an absolute PASI score of less than or equal to 3. Patient's quality of life and satisfaction are important targets. If PASI targets are achieved, there should be no or very low impact of psoriasis on quality of life [Dermatology Life Quality Index (DLQI) score less than or equal to 3]. If PASI or DLQI goals are not achieved within 3-4 months, treatment should be changed. Abrogation of systemic inflammation may be crucial for preventing or delaying inflammatory comorbidities. Safety is an equally important target as efficacy.

Conclusion: These 20 consensus statements define the parameters of a treat-to-target strategy for psoriasis in Italy. It is hoped that use of these in the management of patients with psoriasis will improve treatment outcomes and patient health-related quality of life.
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http://dx.doi.org/10.1007/s13555-020-00475-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859133PMC
February 2021

Safety of secukinumab treatment in COVID-19 affected psoriatic patients.

Dermatol Ther 2021 Jan 3;34(1):e14710. Epub 2021 Jan 3.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1111/dth.14710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883240PMC
January 2021

Erythema annulare centrifugum with anosmia and ageusia in a SARS-CoV-2 exposed patient successfully treated with doxycycline.

Int J Dermatol 2021 Mar 23;60(3):384-386. Epub 2020 Dec 23.

Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1111/ijd.15356DOI Listing
March 2021

Pseudoepitheliomatous keratotic and micaceous balanitis: low-risk human papilloma virus detection in two further cases.

Int J STD AIDS 2021 Feb 20;32(2):209-212. Epub 2020 Dec 20.

Department of Medical Sciences and Public Health, Dermatology Clinic, University of Cagliari, Cagliari, Italy.

We report two cases of histologically documented pseudoepitheliomatous keratotic and micaceous balanitis in middle-aged male patients, which showed positivity for low-risk serotype human papillomavirus DNA. To our knowledge, only one other case has been documented. Further immunohistochemical proliferative markers were performed and compared to literature findings in penile epithelial proliferations. Evolution to invasive verrucous carcinoma has been associated with absence of HPV DNA. Thus, if confirmed by further studies, HPV testing should be included in pseudoepitheliomatous keratotic and micaceous balanitis assessment to address prognosis, and management.
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http://dx.doi.org/10.1177/0956462420961947DOI Listing
February 2021

Changing gears: Medical gloves in the era of coronavirus disease 2019 pandemic.

Clin Dermatol 2020 Nov - Dec;38(6):734-736. Epub 2020 Aug 4.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1016/j.clindermatol.2020.08.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7402195PMC
January 2021

Cytokine Signature in Schnitzler Syndrome: Proinflammatory Cytokine Production Associated to Th Suppression.

Front Immunol 2020 26;11:588322. Epub 2020 Nov 26.

Laboratoire Inflammation, Tissus Epithéliaux et Cytokines (LITEC), EA4331, Université de Poitiers, Poitiers, France.

Background: Schnitzler syndrome (SchS) is a rare autoinflammatory disease characterized by urticarial exanthema, bone and joint alterations, fever and monoclonal IgM gammopathy. Overactivation of the interleukin(IL)-1 system is reported, even though the exact pathophysiological pathways remain unknown.

Objective: To determine v cytokine profiles of Peripheral Blood Mononuclear Cells (PBMCs) from SchS patients prior to treatment and after initiation of anti-IL-1 therapy (anakinra). The sera cytokine profile was studied in parallel.

Methods: We collected blood samples from thirty-six untreated or treated SchS. PBMCs were cultured with and without LPS or anti-CD3/CD28. Cytokine levels were evaluated in serum and cell culture supernatants using Luminex technology.

Results: Spontaneous TNFα, IL-6, IL-1β, IL-1α, and IL-1RA release by PBMCs of SchS patients were higher than in controls. LPS-stimulation further induced the secretion of these cytokines. In contrast, after T-cell stimulation, TNFα, IL-10, IFNγ, IL-17A, and IL-4 production decreased in SchS patients compared to healthy controls, but less in treated patients. Whereas IL-1β serum level was not detected in most sera, IL-6, IL-10, and TNFα serum levels were higher in patients with SchS and IFNγ and IL-4 levels were lower. Of note, IL-6 decreased after treatment in SchS ( = 0.04).

Conclusion: Our data strengthen the hypothesis of myeloid inflammation in SchS, mediated in particular by IL-1β, TNFα, and IL-6, associated with overproduction of the inhibitors IL-1RA and IL-10. In contrast, we observed a loss of Th1, Th2, and Th17 cell functionalities that tends to be reversed by anakinra.
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http://dx.doi.org/10.3389/fimmu.2020.588322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726442PMC
November 2020

Characteristic of chronic plaque psoriasis patients treated with biologics in Italy during the COVID-19 Pandemic: Risk analysis from the PSO-BIO-COVID observational study.

Expert Opin Biol Ther 2021 02 13;21(2):271-277. Epub 2021 Jan 13.

Division of Dermatology, Santa Chiara Hospital , Trento, Italy.

: The susceptibility of patients with chronic plaque psoriasis and the risks or benefits related to the use of biological therapies for COVID-19 are unknown. Few data about prevalence, clinical course and outcomes of COVID-19 among psoriatic patients were reported. The aims of this study were 1) to assess the prevalence and severity of COVID-19 in psoriatic patients treated with biologic agents during the first phase of the emergency (22 February to 22 April 2020) in Italy, and 2) to report the clinical outcomes of patients who have been exposed to individuals with confirmed SARS-CoV-2 infection. : Patients with moderate-to-severe chronic plaque psoriasis, aged ≥18 years and undergoing treatment with biologic agents as of 22 February 2020, were eligible to be included in PSO-BIO-COVID study. Demographic and clinical characteristics of patients using any biologic for psoriasis treatment between 22 February and 22 April 2020 were registered. : A total of 12,807 psoriatic patients were included in the PSO-BIO-COVID study. In this cohort 26 patients (0.2%) had a swab confirmation of SARS-CoV-2 infection. Eleven patients required hospitalization and two died. : The incidence of COVID-19 observed in our cohort of psoriatic patients (0.2%) is similar to that seen in the general population (0.31%) in Italy. However, the course of the disease was mild in most patients. Biological therapies may likely lessen 'cytokine storm' of COVID-19, which sometimes lead to multiple organ failure, ARDS, and death.
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http://dx.doi.org/10.1080/14712598.2021.1853698DOI Listing
February 2021

Italian guidelines for the diagnosis and treatment of classic and iatrogenic Kaposi's sarcoma.

G Ital Dermatol Venereol 2020 Nov 12. Epub 2020 Nov 12.

U.O. Dermatologia, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano, Italy -

Kaposi's sarcoma (KS) is a lymphangioproliferative disorder associated with human herpesvirus 8 (HHV8) infection. Four clinical subtypes are recognized: classic, endemic, epidemic (HIV-related) and iatrogenic. KS diagnosis is based on clinical features, histopathological assessment, and HHV8 serology. Classic KS is usually skin-limited and has a chronic course, while the iatrogenic variant may show mucosal, nodal or visceral involvement. Clinical staging is fundamental to guide the management. Localized disease may be treated with different local therapies, even if there are no randomized trials comparing these different modalities. Aggressive, disseminated KS and cases with visceral involvement usually require systemic chemotherapy, most commonly vinblastine, bleomycin or paclitaxel. Iatrogenic KS needs immunosuppression tapering/withdrawal and, if possible, switch to m-TOR inhibitors in post-transplant KS. The present work by a panel of Italian experts provides guidelines on KS diagnosis and management based on a critical review of the literature and a long and extensive personal experience.
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http://dx.doi.org/10.23736/S0392-0488.20.06703-6DOI Listing
November 2020

A previously undescribed variant of cutaneous clear-cell squamous cell carcinoma with psammomatous calcification and intratumoral giant cell granulomas.

J Cutan Pathol 2021 Jan 16;48(1):106-109. Epub 2020 Sep 16.

Section of Pathology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Cutaneous clear-cell squamous cell carcinoma (ccSCC) is a rare variant of SCC composed of clear cells that lack cytoplasmic glycogen or evidence of tricholemmal keratinization. We report a previously undescribed variant of ccSCC with psammomatous calcification and intratumoral giant cell granulomas. The differential diagnosis with trichilemmal carcinoma is outlined according to the criteria of the fourth edition of World Health Organization (WHO) classification. Our findings outline that psammomatous calcification may occur inside the keratinous pearls of the neoplastic lobules triggering an intratumoral giant cell granulomatous reaction. The prognostic significance of this histopathological presentation is unknown but the potential for formation of psammoma bodies in cSCC should be considered to avoid diagnostic pitfalls.
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http://dx.doi.org/10.1111/cup.13847DOI Listing
January 2021

Patients' demographic and socioeconomic characteristics influence the therapeutic decision-making process in psoriasis.

PLoS One 2020 12;15(8):e0237267. Epub 2020 Aug 12.

Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, Italy.

Background: Knowledge regarding differences in care for psoriatic patients is limited. The aim of this study was to investigate factors influencing prescription of systemic treatments for patients with psoriasis with a special focus on socioeconomic factors.

Methods And Findings: This was a non-interventional, cross-sectional study, conducted in 18 Italian University and/or hospital centers with psoriasis-specialized units. Questionnaires evaluating demographic and socioeconomic characteristics were administered to participants. Overall, 1880 consecutive patients affected by mild-to-severe psoriasis were recruited. Univariate and multivariable logistic regression analyses of systemic therapy prescription, with a special focus on biologics, accounting for the above mentioned characteristics were performed. Our analysis showed that all analyzed patients' characteristics were significantly associated with biological therapy compared to non-biological systemic one. Particularly, women were less likely to receive biologics than men (OR = 0.66; 95% CI, 0.57-0.77). Elderly patients (≥65 years) and subjects with a BMI ≥30 had lower odds to receive biologics respect to adults (≥35-64 years) (OR = 0.33; 95% CI, 0.25-0.40), and subjects with BMI≥25<30 (OR = 0.64; 95% CI, 0.53-0.77), respectively. Northern and Southern patients were both less likely to receive biologics than Central patients (OR = 0.75; 95% CI, 0.63-0.89, and OR = 0.56; 95% CI,0.47-0.68, respectively). Lower economic profile and never reading books were both associated with decreased odds of receiving biological therapy.

Conclusions: This study shows that sex, age, comorbidities, and socioeconomic characteristics influence the prescription of systemic treatments in psoriasis, highlighting that there are still unmet needs influencing the therapeutic decision-making process that have to be addressed.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237267PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423114PMC
October 2020

Penile Necrosis as a Presenting Sign of Purpura Fulminans Mimicking Fournier's Gangrene.

Am J Dermatopathol 2021 Jan;43(1):e13-e15

Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Abstract: We report the case of a 63-year-old white man who, 3 days after stent removal of endoscopic drainage of pancreatic cysts, developed a penile necrosis due to purpura fulminans (PF) that has been misdiagnosed as Fournier's gangrene. Penile necrosis was rapidly followed by a lethal multiorgan failure due to disseminated intravascular coagulopathy (DIC), triggered by the subsequent development of a severe acute pancreatitis. PF describes a rare syndrome involving intravascular thrombosis and hemorrhagic infarction of the skin. Although reports of penile necrosis secondary to various causes are documented in the literature, penile necrosis secondary to PF in the setting of acute pancreatitis is a rare event. Histopathologic studies of the skin showing an occlusive nonvasculitic vasculopathy are the first step to achieve an accurate diagnosis.
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http://dx.doi.org/10.1097/DAD.0000000000001744DOI Listing
January 2021

A lumpy back: extensive cutaneous collagenomas.

Dermatol Online J 2020 Mar 15;26(3). Epub 2020 Mar 15.

Dermatology Clinic, Department Medical Sciences and Public Health, University of Cagliari.

A widespread form of eruptive collagenomas in a 12-year-old man is presented for the impressive iconography, challenging differential diagnosis, and histopathological considerations associated with such rare connective tissue disorders. Syndromic forms should be carefully investigated for the different course and prognosis. Treatment is a major unsolved issue as aesthetic concerns are significant, especially in young adults.
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March 2020

Clinical efficacy, speed of improvement and safety of apremilast for the treatment of adult Psoriasis during COVID-19 pandemic.

Dermatol Ther 2020 Jul 24;33(4):e13722. Epub 2020 Jun 24.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Time to improvement is a crucial characteristic for effective treatments of chronic inflammatory conditions, such as psoriasis. Apremilast is a recently approved drug, belonging to the small molecule phosphodiesterase 4 inhibitors, whose optimal safety and efficacy profile is somewhat affected by slow activity rate in clinical trials. Real world case series are suggesting a more consistent improvement, and with this additional personal investigation on 48 patients, we signal that 58% of patients achieved Psoriasis Area and Severity Index (PASI) 50, and 19% PASI 75 improvement in the first 8 weeks of treatment. Results at 16-week are remarkable, with overall 55% of patients achieving PASI 75, 21% PASI 90 and 14% PASI 100. Only 8 patients (18, 6%) had slightly improved, although satisfied with the regimen, and determined to continue. Noteworthy, our population was rather problematic in terms of comorbidities (86%), and resistance to other treatments, with only 28% naïve to systemics, including biologics. Moreover, the observation period includes the Italian outbreak of COVID-19 epidemic, and further information on apremilast safety are provided, no one of the patients having stopped treatment. In such a critical period, the apremilast satisfactory speed of therapeutic response in a real-world setting has further strengthens patient's compliance to remain safely at home, which is the best strategy to limit contagion.
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http://dx.doi.org/10.1111/dth.13722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7300475PMC
July 2020

TNF-α inhibitors biosimilars as first line systemic treatment for moderate-to-severe chronic plaque psoriasis.

Expert Rev Clin Immunol 2020 06 4;16(6):591-598. Epub 2020 Jun 4.

Department of Medicine, Section of Dermatology and Venereology, University of Verona , Verona, Italy.

Introduction: Biologics have revolutionized the therapy of moderate-to-severe plaque psoriasis. Despite their greater efficacy over conventional systemic therapies their high cost has represented a burden for health-care systems, which limited their use. The availability of biosimilars at low cost is changing the place in therapy of biologics for psoriasis.

Areas Covered: The role of TNF- α inhibitors in the management of plaque psoriasis, their efficacy and safety profile are presented. Phase 3 clinical trials and real-life data from the use of TNF- α inhibitor biosimilars in the treatment of plaque psoriasis are also reviewed in detail. Furthermore, arguments in favor of the use of TNF- α inhibitor biosimilars as a first-line therapy in moderate-to-severe plaque psoriasis are discussed.

Expert Opinion: An increasing amount of data show that biosimilars represent a safe and effective alternative to the originator biologics. In the face of ever-increasing health-care costs, switching to biosimilars and starting naïve patients on the best-value biologic can reduce expenditure for patients and payers while maintaining a high-quality care. Moreover, as the cost of biosimilars is approaching the cost of conventional systemic treatments, TNF-α inhibitors biosimilars may represent a first-line systemic treatment for psoriasis patients because they are effective and safe.
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http://dx.doi.org/10.1080/1744666X.2020.1771182DOI Listing
June 2020

COVID-19 and impact of personal protective equipment use: From occupational to generalized skin care need.

Dermatol Ther 2020 Jul 29;33(4):e13598. Epub 2020 May 29.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1111/dth.13598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267141PMC
July 2020

Urticaria: recommendations from the Italian Society of Allergology, Asthma and Clinical Immunology and the Italian Society of Allergological, Occupational and Environmental Dermatology.

Clin Mol Allergy 2020 6;18. Epub 2020 May 6.

11Unit of Immunology, Rheumatology Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.

Background: Urticaria is a disorder affecting skin and mucosal tissues characterized by the occurrence of wheals, angioedema or both, the latter defining the urticaria-angioedema syndrome. It is estimated that 12-22% of the general population has suffered at least one subtype of urticaria during life, but only a small percentage (estimated at 7.6-16%) has acute urticaria, because it is usually self-limited and resolves spontaneously without requiring medical attention. This makes likely that its incidence is underestimated. The epidemiological data currently available on chronic urticaria in many cases are deeply discordant and not univocal, but a recent Italian study, based on the consultation of a national registry, reports a prevalence of chronic spontaneous urticaria of 0.02% to 0.4% and an incidence of 0.1-1.5 cases/1000 inhabitants/year.

Methods: We reviewed the recent international guidelines about urticaria and we described a methodologic approach based on classification, pathophysiology, impact on quality of life, diagnosis and prognosis, differential diagnosis and management of all the types of urticaria.

Conclusions: The aim of the present document from the Italian Society of Allergology, Asthma and Clinical Immunology (SIAAIC) and the Italian Society of Allergological, Occupational and Environmental Dermatology (SIDAPA) is to provide updated information to all physicians involved in diagnosis and management of urticaria and angioedema.
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http://dx.doi.org/10.1186/s12948-020-00123-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201804PMC
May 2020

Childhood erythrodermic lichen planus pemphigoides after nonavalent human papillomavirus vaccination.

JAAD Case Rep 2020 May 30;6(5):431-433. Epub 2020 Apr 30.

Section of Dermatology, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1016/j.jdcr.2020.03.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7200189PMC
May 2020

Successful guselkumab treatment in a psoriatic patient affected with Cornelia de Lange syndrome, and prosecution during the COVID-19 pandemic.

Dermatol Ther 2020 Jul 29;33(4):e13433. Epub 2020 Apr 29.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Psychomotor delay and intellectual disability are potential limitations in psoriasis management, due to low compliance, and strict dependence from caregivers intervention. We report our successful experience with a 58-year-old woman, who was genetically affected by Cornelia De Lange syndrome, which causes intellectual disability and psychomotor disorders. The patient had been already treated with topical and traditional therapies, without any clinical benefits. Eventually, she adhered to guselkumab treatment. The compliance was excellent, significant improvements were observed after only 3 months of treatment, without adverse effects. During follow-up, the COVID-19 pandemic address concern on the possible increased risk of infection due to immunosuppression. In agreement with current Italian recommendations, risk and benefits profile was discussed with the patient's legal tutor and the decision to continue the treatment was taken. Psoriasis complete clarification was maintained during the most difficult period of the Italian outbreak, allowing the patient to remain safely at home.
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http://dx.doi.org/10.1111/dth.13433DOI Listing
July 2020

Erythrodermic psoriasis in a dialyzed patient successfully treated with Secukinumab.

Dermatol Ther 2020 05 9;33(3):e13348. Epub 2020 Apr 9.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Erythrodermic psoriasis is a severe, life-threatening condition with additional complications, when occurring in hemodialyzed patients, as the majority of treatments are contraindicated. A 44-years-old man, of Philippine origins, with a 15-years-history of psoriasis treated with cyclosporine developed progressive hypertension and renal insufficiency. Despite drug dismission, renal function worsen to end-stage, and hemodialysis was necessary three times a week. Phototherapy was not able to control the skin condition, progressing to erythroderma, and after nephrology consultation, the patient consent to the off-label secukinumab treatment, at the standard regimen (300 mg subcutaneously once weekly at weeks 0-4 followed by 300 mg every 4 weeks). Seven days after the first injection, a rapid improvement was noted, with the psoriasis area severity index (PASI) score passing from 31.5 to 17.6. At the 52-week-follow-up visit, the patient was completely clarified, without any side effects. The case supports secukinumab effectiveness and safety in difficult patients, including erythrodermic psoriasis with end-stage renal failure, as drug plasma levels seem not to be affected by hemodialysis. Results are rapidly achieved, and long term maintained, with the additional advantage of a very comfortable monthly administration.
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http://dx.doi.org/10.1111/dth.13348DOI Listing
May 2020

Annually recurring acro-erythema.

G Ital Dermatol Venereol 2020 Mar 3. Epub 2020 Mar 3.

Department Medical Sciences and Public Health, Dermatology Clinic, University of Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.23736/S0392-0488.19.06509-XDOI Listing
March 2020

Efficacy of Imiquimod 3.75% for the treatment of extensive Bowen's disease of the face in an elderly patient.

Dermatol Ther 2020 03 19;33(2):e13263. Epub 2020 Feb 19.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Bowen's disease is a cutaneous squamous cell carcinoma (SCC) in situ with a potential risk of progression to invasive SCC. Despite the high number of approved treatments, elderly patients with extensive lesions of critical sites may represent a therapeutical challenge, especially in cases of treatment failure or recalcitrant disease. Here, we report the successfully use of topical Imiquimod 3.75% to treat an extensive Bowen's disease of the cheek in an elderly.
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http://dx.doi.org/10.1111/dth.13263DOI Listing
March 2020

Clear-cell variant of superficial cutaneous leiomyosarcoma associated with RB1 mutation: Clinical, dermoscopic, and histopathological characteristics.

J Cutan Pathol 2020 Jun 9;47(6):571-575. Epub 2020 Feb 9.

Dermatology Clinic, Department Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Leiomyosarcoma is a relatively rare soft tissue tumor whose clear-cell variant has only been reported in leiomyosarcomas of the uterus. We report here for the first time a primary cutaneous clear-cell leiomyosarcoma in the trunk skin of a 49-year-old man, characterized by a very indolent clinical and dermoscopic presentation, mimicking a dermatofibroma. Genetic analysis of the otherwise healthy patient revealed a germline mutation in the retinoblastoma 1 gene (RB1); the same mutation was found in his son, who had previously developed retinoblastoma. Moreover, the mother of the patient had died of uterine leiomyosarcoma with clear-cell changes. Mutations in the RB1 gene occur commonly in human neoplasms. In this patient, we were able to link his clear-cell variant of cutaneous leiomyosarcoma with the loss of retinoblastoma protein expression, as revealed by immunohistochemical staining analysis.
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http://dx.doi.org/10.1111/cup.13655DOI Listing
June 2020