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Abstract Background Brodalumab, a fully human anti‐interleukin (IL)‐17 monoclonal antibody that blocks IL‐17RA, is approved in Europe for the treatment of adult patients with moderate‐to‐severe plaque psoriasis who are candidates for systemic treatment. Objectives This study evaluated the achievement and maintenance of therapeutic response for 1 year in psoriasis patients treated with brodalumab in the Italian clinical practice. Methods Real‐world, multicenter, observational, retrospective and prospective study. The retrospective phase ranged from enrolment visit to initiation of brodalumab (12 ± 4 weeks before). The prospective phase ranged from enrolment to a routine follow‐up visit set after 52 ± 4 weeks. Results One hundred eighty‐four patients were eligible and 164 completed the observation period (median 11.9 months; Q1–Q3: 11.4–12.3). At enrolment, the mean duration of disease was 13.9 years (standard deviation; 13.3), 94% of patients (N = 172) had ≥1 clinical manifestation of psoriasis, mainly erythema and itching, and 95.6% had received ≥1 antipsoriatic treatment before brodalumab. Patients who reached an absolute Psoriasis Area and Severity Index (PASI) score ≤3 at week 12 and maintained it ≤3 through week 52 were 97 (64.7%). At week 12, 72.7% of patients achieved PASI 75, 54.5% PASI 90 and 42.0% PASI 100. At Week 52, 92.9% of patients achieved PASI 75, 84.4% PASI 90 and 61.7% PASI 100. A static Physician's Global Assessment (sPGA) score = 0 was obtained by 55.0% of patients after 12 weeks of brodalumab and by 77.0% after 52 weeks. A Dermatology Life Quality Index ≤1 was reported by 71.9% of patients after 12 weeks and by 89.9% after 52 weeks of treatment. No significant outcome differences were shown among patient subgroups defined by previous antipsoriatic treatments (none, systemic other than biologics or biologic) at either brodalumab initiation or any of the subsequent study visits. Conclusions In this real‐world setting, brodalumab was rapidly effective on skin lesions and quality of life both in biologic‐naïve and biologic‐experienced moderate‐to‐severe psoriasis patients, with a favourable safety profile.

Background Long-term real-life data on secukinumab use in psoriasis are limited. Objectives Determine the long-term effectiveness of secukinumab in moderate-to-severe psoriasis in real-life. Methods Multicenter retrospective study analyzing data from adult patients treated with secukinumab for at least 192 weeks and up to 240 weeks in Southern Italy, between 2016 and 2021. Clinical data, including concurrent comorbidities and prior treatments were collected. Effectiveness was assessed by Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) scores at the initiation of secukinumab and at weeks 4, 12, 24, 48, 96, 144, 192, and 240. Results Two hundred and seventy-five patients (174 males), mean age 50.80 ± 14.78 years, were included; 29.8% had an uncommon localization, 24.4% psoriatic arthritis, 71.6% comorbidities. PASI, BSA, and DLQI improved significantly from week 4 and continued to improve over time. Between weeks 24 and 240, PASI score was mild (≤10) in 97–100% of patients, 83–93% had mild affected BSA (BSA ≤ 3), and 62–90% reported no effect of psoriasis on their quality of life (DLQI 0–1). Only 2.6% of patients reported adverse events and no patient discontinued the treatment during the study period. Conclusions Secukinumab effectiveness in the long-term treatment of psoriasis is confirmed in real-world.

Background: Squamous cell carcinoma (SCC) is one of the most common cancers involving skin and oral mucosa. Although this condition’s gold-standard treatment is the surgical removal of the lesions, the physician must propose alternative treatments in some cases due to the patient’s ineligibility for surgery. Among the available alternative therapies, local chemotherapy may represent an initial treatment in combination with radiotherapy or systemic chemotherapy due to the low frequency of side-effects and the lack of necessity for expensive devices. Methods: In this paper, we review all available literature in various databases (PubMed, Scopus-Embase, Web of Science), proposing local chemotherapy as a treatment for cutaneous and oral SCC. Exclusion criteria included ocular lesions (where topical treatments are common), non-English language, and non-human studies. Results: We included 14 studies in this review. The majority were case reports and case series describing the treatment of non-resectable localized SCC with either imiquimod or 5-fluorouracil. We also analyzed small studies proposing combination treatments. Almost all studies reported an excellent clinical outcome, with a low risk of relapses in time. Conclusions: Resection of the lesion remains the gold-standard treatment for SCC. When this approach is not feasible, local chemotherapy may represent a treatment alternative, and it may also be associated with radiotherapy or systemic chemotherapy.

Background There has recently been growing interest in the roles of inflammation in contributing to the development of anxiety in people with immune-mediated inflammatory diseases (IMID). Patient-reported outcome measures can facilitate the assessment of physical and psychological functioning. The National Institutes of Health (NIH)’s Patient-Reported Outcomes Measurement Information System (PROMIS®) is a set of Patient-Reported Outcomes (PROs) that cover physical appearance, mental health, and social health. The PROMIS has been built through an Item Response Theory approach (IRT), a model-based measurement in which trait level estimates depend on both persons’ responses and on the properties of the items that were administered. The aim of this study is to test the psychometric properties of an Italian custom four-item Short Form of the PROMIS Anxiety item bank in a cohort of outpatients with IMIDs. Methods We selected four items from the Italian standard Short Form Anxiety 8a and administered them to consecutive outpatients affected by Inflammatory Bowel disease (n = 246), rheumatological (n = 100) and dermatological (n = 43) diseases, and healthy volunteers (n = 280). Data was analyzed through an Item Response Theory (IRT) analysis in order to evaluate the psychometric properties of the Italian adaptation of the PROMIS anxiety short form. Results Taken together, Confirmatory Factor Analysis and Exploratory Factor analysis suggest that the unidimensionality assumption of the instrument holds. The instrument has excellent reliability from a Classical Theory of Test (CTT) standpoint (Cronbach’s α = 0.93, McDonald’s ω = 0.92). The 2PL Graded Response Model (GRM) model provided showed a better goodness of fit as compared to the 1PL GRM model, and local independence assumption appears to be met overall. We did not find signs of differential item functioning (DIF) for age and gender, but evidence for uniform (but not non-uniform) DIF was found in three out of four items for the patient vs. control group. Analysis of the test reliability curve suggested that the instrument is most reliable for higher levels of the latent trait of anxiety. The groups of patients exhibited higher levels of anxiety as compared to the control group (ps < 0.001, Bonferroni-corrected). The groups of patients were not different between themselves (p = 1, Bonferroni-corrected). T-scores based on estimated latent trait and raw scores were highly correlated (Pearson’s r = 0.98) and led to similar results. Discussion The Italian custom four-item short form from the PROMIS anxiety form 8a shows acceptable psychometric properties both from a CTT and an IRT standpoint. The Test Reliability Curve shows that this instrument is mostly informative for people with higher levels of anxiety, making it particularly suitable for clinical populations such as IMID patients.

BackgroundImmune checkpoint inhibitors targeting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), programmed death-1 receptor (PD-1), and programmed death-1 receptor and its ligand (PD-L1) increased the survival of patients affected by metastatic malignant melanoma. Due to their mechanism of action, these drugs are associated with a unique toxicity profile. Indeed, immune-related adverse events (irAEs) present a wide clinical spectrum representing the Achilles’ heel of immunotherapy. Overall, cutaneous toxicities are among the most common irAEs. Immunomodulatory drugs are used for the management of irAEs and can theoretically lead to tumor escape.Case PresentationWe report the case of a 75-year-old man with metastatic melanoma receiving the anti-PD1 Pembrolizumab therapy. After 10 treatment cycles, the patient came to our clinic with itchy psoriatic manifestations widespread >30% of the body surface [12.3 Psoriasis Area and Severity Index (PASI) score] that negatively impacted on the patient’s quality of life and compliance with immunotherapy. Additionally, he had no positive personal history of psoriasis. Given the severity of the cutaneous manifestations, in a multidisciplinary approach, Apremilast (an oral small molecule PDE4 inhibitor) was started. Furthermore, Pembrolizumab was interrupted for 4 weeks until the improvement of skin lesions and the disappearance of itching. Immunosuppressive methylprednisolone therapy was initiated with a dose of 16 mg/die; then, this initial dose was progressively reduced until discontinuation. After 10 months, the patient had a good general clinical condition with psoriasis complete remission. Moreover, positron emission tomography (PET) and computed tomography (CT) scans showed complete response by immune Response Evaluation Criteria in Solid Tumors (iRECIST).ConclusionTo the best of our knowledge, this is the first report on the safety and efficacy of Apremilast for the treatment of immunotherapy-induced psoriasis in metastatic melanoma.

(1) Background: Colchicine is a natural alkaloid with anti-inflammatory properties used to treat various disorders, including some skin diseases. This paper aims to incorporate all the available studies proposing colchicine as a treatment alternative in the management of cutaneous conditions. (2) Methods: In this systematic review, the available articles present in various databases (PubMed, Scopus-Embase, and Web of Science), proposing colchicine as a treatment for cutaneous pathological conditions, have been selected. Exclusion criteria included a non-English language and non-human studies. (3) Results: Ninety-six studies were included. Most of them were case reports and case series studies describing colchicine as single therapy, or in combination with other drugs. Hidradenitis suppurativa, pyoderma gangrenosum, erythema nodosum, erythema induratum, storage diseases, perforating dermatosis, bullous diseases, psoriasis, vasculitis, acne, urticaria, stomatitis, actinic keratosis, and pustular dermatosis were the main diseases discussed in literature. Although the therapeutic outcomes were variable, most of the studies reported, on average, good clinical results (4) Conclusions: Colchicine could be, as a single therapy or in combination with other drugs, a possible treatment to manage several skin diseases.

Psoriasis is an inflammatory and chronic skin disorder associated with physical and psychological burden impairing patients' quality of life. In the last decade, biologic drugs have widely changed treatment of moderate-severe psoriasis and their number is increasing overtime. To early identify expected/unexpected adverse events (AEs) with biologic treatments, pharmacovigilance programs are needed. We designed a post-marketing active pharmacovigilance program to monitor and analyse AEs and/or serious adverse events (SAEs) reports. All consecutive patients treated with one biologic drug during a two-years period and satisfying inclusion criteria have been enrolled in five Dermatology tertiary units. Demographic and clinical features of patients, type of treatment used, therapy discontinuation, failures, switch/swap to another biologic, and possible onset of AEs were collected. Overall, 512 patients with a diagnosis of psoriasis (286; 55.9%) or arthropathic psoriasis (226; 44.1%) have been enrolled. Eighty-two (16%) patients with AEs and 5 (1%) with SAEs have been identified. Further, 59 (11.5%) had a primary/secondary failure (mainly on infliximab and etanercept). The adverse events and SAEs were reported with golimumab (4/12), adalimumab (32/167), infliximab (9/48), etanercept (31/175) and ustekinumab (11/73), no adverse events have occurred with secukinumab (0/37). Infliximab and etanercept were significantly associated with primary/secondary failures, whereas no differences have been highlighted for AEs insurgence. On the other hand, ustekinumab seems to be associated with a low rate of AEs (p = 0.01) and no adverse events or failures have been reported with secukinumab (p = 0.04 and 0.03, respectively). Our study, even though limited by a small sample size and a brief follow-up period, provide useful data on widely used biologic drugs and their tolerability, discontinuation rate and the incurrence of severe adverse events. Further studies are necessary to include the recently approved biologic drugs and to increase the sample size for more detailed analysis.

Background: Erythema multiforme (EM) is an acute cutaneous eruption often associated with infections and more rarely with drugs. This review aimed to evaluate the association between erythema multiforme and coronavirus disease 2019 (COVID-19). Methods: A systematic search of PubMed/MEDLINE, Scimago Scopus, and ISI/Web of Science was performed. Original articles, case series, or case reports were evaluated and selected. Results: Fourteen articles were selected, describing a total of 70 patients. EM is a cutaneous eruption rarely occurring in COVID-19 and is, in most cases, associated with a hypersensitivity reaction to the virus. In these cases, EM seems to affect patients younger than 30 years or older than 55 years. Infrequently, some drugs used in the management of COVID-19 may induce EM, especially hydroxychloroquine. The three groups of patients seem to have different clinical characteristics and courses. Conclusions: From these data, it is possible to preliminarily propose that EM or EM-like eruptions linked to COVID-19 might be divided into three types: the virus-related juvenile type (affecting patients 55 years), and the drug-induced type. The occurrence of a skin rash does not seem to be related to the severity and clinical course of COVID-19.

Background: Topical oxygen therapy is a cosmetic procedure that is becoming more and more popular in dermatology; however, only a few articles on this topic are present in the literature. In this work we report our group experience with oxygen therapy as an adjuvant treatment in various dermatological conditions. Methods: Four studies were conducted. In the first study we used vehiculated oxygen therapy for diseases that cause hair loss. In the second study oxygen was used in the treatment of mild acne. In the third study moderate acne was treated with topical oxygen. In the fourth study chronic dermatological conditions such as psoriasis and atopic dermatitis were treated with this procedure. Results: In studies 1 and 2 the outcomes in groups who used topical oxygen therapy as an adjuvant treatment were better than in the groups that did not use it. Studies 3 and 4 also showed very good results, but no control groups were present in the study. Conclusion: Topical oxygen therapy was useful in the treatment of hair loss conditions, mild and moderate acne, and in chronic cutaneous diseases, showing effectiveness as a support therapy in all of these conditions. Further and larger studies should be conducted to better evaluate its effectiveness in dermatological conditions.

Celiac disease (CD) is an autoimmune enteropathy that primarily affects the small intestine and is characterized by atrophy of intestinal villi. The manifestations of the disease improve following a gluten-free diet (GFD). CD is associated with various extra-intestinal diseases. Several skin manifestations are described in CD patients. The present paper reviews all CD-associated skin diseases reported in the literature and tries to analyze the pathogenic mechanisms possibly involved in these associations. Different hypotheses have been proposed to explain the possible mechanisms involved in every association between CD and cutaneous manifestations. An abnormal small intestinal permeability seems to be implicated in various dermatological manifestations. However, most of the associations between CD and cutaneous diseases is based on case reports and case series and a few controlled studies. To better assess the real involvement of the cutaneous district in CD patients, large multicentric controlled clinical trials are required.