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Federica Rega, Federica Trovato, Giulio Bortone, Giovanni Pellacani, Antonio Giovanni Richetta, Annunziata Dattola Dermatology Unit, Department of Clinical Internal, Anesthesiological and Cardiovascular Science, University of La Sapienza, Rome, ItalyCorrespondence: Giulio Bortone, Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy, Email giuliobortone93@gmail.comAbstract: Generalized pustular psoriasis (GPP) is a rare, chronic, and severe skin disorder characterized by the eruption of non-infectious pustules on an erythematous background often associated with systemic symptoms. It may appear in association with plaque psoriasis or occur in previously healthy individuals. It differs from psoriasis vulgaris in clinical presentation, immunopathogenesis, histology, and therapeutic strategies. Overexpression of interleukin 36 (IL-36) or a loss-of-function mutation of IL-36 receptor antagonist (IL-36RA) are thought to play a pivotal role in the pathogenesis of this disease. There are currently no globally approved guidelines for the treatment of GPP, and the therapies used so far, with variable results, have given unsatisfactory results. Spesolimab, a selective humanized antibody against the IL-36 receptor that blocks its activation, is the first biologic drug approved in Europe in December 2022 for the treatment of GPP flares. It represents a promising therapy, demonstrating efficacy in reducing disease severity and improving patient outcomes. In our review, we have analyzed the latest advancements and findings regarding the efficacy and safety of spesolimab in the context of GPP management.Keywords: spesolimab, anti-IL36R, GPP, pustular psoriasis

Daniel Cassuto,1 Giovanni Pellacani,2 Antonello Tateo,1 Ofir Artzi,3 Fabio Massimo Ingallina,4 Giovanni Salti,5 Elena Rossi,2 Arturo Lanzarotti,6 Malika Laouedj,7 Nicolas Dapis,7 Gilberto Bellia8 1Private Practice, Milan, Italy; 2Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy; 3Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; 4Private Practice, Catania, Italy; 5Private Practice, Florence, Italy; 6IBSA Institut Biochimique SA, Lugano, Switzerland; 7Quantificare SA, Valbonne, France; 8IBSA Farmaceutici Italia, Lodi, ItalyCorrespondence: Gilberto BelliaIBSA Farmaceutici Italia, Lodi, ItalyEmail gilberto.bellia@ibsa.itObjective: To describe the development and validation of the 5-grade photographic IBSA inner upper arm scale.Methods: From 2 real-life pictures, a scale made up of 5 morphed images showing increasing severity of inner upper arm laxity was created. For validation, a set of 50 images (half of which real and the other morphed) was developed and sent to 5 trained physicians in two rounds 30 days apart. Raters’ task was to make a selection of each image according to the given scale. Inter-rater and intra-rater reliability were evaluated in both rounds.Results: As to intra-rater reliability, single-rater kappa scores between 0.74 and 1.00 and a global kappa score of 0.846 were observed, while inter-rater agreement was calculated with intra-class correlation coefficient reporting scores higher than 0.91, which indicate excellent reliability.Conclusion: IBSA inner upper arm laxity scale proved to be a validated and reliable tool.Keywords: photographic scale, upper inner arm, laxity, aesthetic medicine, scale validation, scale development

Background: Basal cell carcinoma (BCC) is the most common cancer in the Caucasian population. It has a multifactorial pathogenesis, in which constitutive activation of the Sonic Hedgehog signalling (SHH) pathway (via mutations in PTCH1 or SMO genes) represents by far the most common genetic aberration. The introduction of vismodegib and sonidegib, two SHH pathway inhibitors, changed the therapeutic approach of locally advanced and metastatic BCCs. EADO's (European Association of Dermato-Oncology) new staging system refers to these as 'difficult-to- treat' BCCs. Objective: The aim was to evaluate sonidegib's effectiveness in patients affected by difficult-to-treat BCCs by using non-invasive diagnostic techniques. Methods: We retrospectively evaluated 14 patients (4 females, 10 males; mean age 77 ± 11 years) affected by difficult-to-treat BCCs treated with oral sonidegib 200 mg/ day that were followed with total body videodermoscopy (V-Track, Vidix 4.0) and dynamic optical coherence tomography (D-OCT, VivoSight Dx) since May 2022. Considering the risk of rhabdomyolysis routine blood tests, especially for creatine kinase concentrations, were performed. All treated patients were inserted in the BasoCare database, which aims to offer support to patients taking sonidegib. Complete and partial responses were evaluated by the overall reduction of the number of lesions and their individual sizes. Safety was evaluated by assessing the occurrence and severity of adverse reactions. Results: Eighty per cent achieved complete clearance and 75% reduction of diameter. D-OCT scans performed at every follow-up showed concordance with clinical appearance and demonstrated reduction of hyporeflective structures, that is, islets of tumour cells and overall improvement of morphology. Conclusion: Sonidegib can be considered an effective treatment option in cases where surgery or radiotherapy would be unfeasible or has previously failed, although pigmented lesions did not show complete clearance, suggesting that there are factors other than the SHH pathway involved in tumour growth. Videodermoscopy and DOCT were useful in the quick and seamless follow-up of lesions and added valuable information in assessing efficacy. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Several clinical studies have shown that hyaluronic acid collagenase is well-tolerated and very effective in managing chronic venous ulcers. The aim of the present study is to confirm the safety and tolerability of daily application in patients suffering from cutaneous ulcers of different etiologies. The efficacy of the treatment and its impact on patients' quality of life are also assessed. PATIENTS AND METHODS: Patients with a clinical diagnosis of skin ulcer with devitalized/fibrinous/slough tissue that could delay the healing process were enrolled in the study. The hyaluronic acid/collagenase ointment was applied topically until wound closure or total debridement of non-viable tissue was achieved, however, with a limit of 30 days. Monitoring was performed weekly, either through outpatient visits or telephone surveys. Assessments included adverse events, local irritation reactions, pain at dressing changes, and wound bed status. Patients were also requested to complete a quality-of-life questionnaire. RESULTS: The study involved 96 patients with a mean age of 71 years. The patients suffered mainly from traumatic (21.9%), venous (15.6%), or pressure ulcers (12.5%); in 26% of cases, ulcers had mixed etiology. In approximately 32% of patients, the ulcer had been present for more than 6 months, and 18.1% of subjects had previously undergone surgical wound debridement. CONCLUSIONS: Daily application of hyaluronic acid-collagenase achieved the following results: i) absence of adverse events related to the use of the product; ii) significant reduction in the degree of localized irritation and pain at dressing changes; iii) significant support to wound bed preparation; iv) trend towards improvement in the quality of life and health status of the patients. [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) is a common inflammatory skin disease that affects both children and adults. However, limited research has been conducted on gender differences in AD. Objectives: This study aimed to assess gender differences in adult AD patients, focusing on demographic and clinical features, comorbidities and treatment approaches. Methods: In this multicentre, observational, cross‐sectional study, we enrolled 686 adult patients with AD (357 males and 329 females). For each patient, we collected demographic data (age and sex), anthropometric measurements (weight, height, hip circumference, waist circumference and waist‐to‐hip ratio), clinical information (onset age, disease duration, severity, itching intensity, impact on quality of life) and noted comorbidities (metabolic, atopic and other). We recorded past and current topical and systemic treatments. We analysed all collected data using statistical techniques appropriate for both quantitative and qualitative variables. Multiple correspondence analysis (MCA) was employed to evaluate the relationships among all clinical characteristics of the patients. Results: We found no differences in age at onset, disease duration, severity and quality of life impact between males and females. Males exhibited higher rates of hypertriglyceridaemia and hypertension. No significant gender differences were observed in atopic or other comorbidities. Treatment approaches were overlapping, except for greater methotrexate use in males. MCA revealed distinct patterns based on gender, disease severity, age of onset, treatment and quality of life. Adult males with AD had severe disease, extensive treatments and poorer quality of life, while adult females had milder disease, fewer treatments and moderate quality of life impact. Conclusions: Our study reveals that gender differences in adult AD patients are largely due to inherent population variations rather than disease‐related disparities. However, it highlights potential undertreatment of females with moderate AD and quality of life impact, emphasizing the need for equitable AD treatment. JAK inhibitors may offer a solution for gender‐based therapeutic parity. [ABSTRACT FROM AUTHOR]

Background: The 31st European Academy of Dermatology and Venereology (EADV) Congress took place between 7th and 10th of September 2022 in Milan, Italy. Objectives: We report presented clinical data on the efficacy/effectiveness, safety and tolerability of tirbanibulin 1% ointment that has recently been licensed for actinic keratosis (AK) of the face or scalp in adults. Methods: Summary of presentations given at the EADV Congress. Results: Prof. Pellacani presented two post hoc analyses from two phase‐III trials with AK patients (NCT03285477 [N = 351] and NCT03285490 [N = 351]): A descriptive analysis of medical history, concomitant medications, and safety results confirming a favourable profile for tirbanibulin showing that number of baseline AK lesions was not correlated to severity of local skin reactions. The latter analysis showed that cases of tirbanibulin application site pain or pruritus were few, and most were found to be mild. Prof. Kunstfeld reported six real‐life clinical cases in Austria showing good tirbanibulin effectiveness, safety and tolerability for the treatment of new or recurring AK lesions. Results demonstrated that after 2‐ to 4‐month follow‐up, tirbanibulin was well tolerated and effective in AK patients. Presentations by Dr. Patel confirmed good outcomes and tolerability of tirbanibulin in Olsen grade 1–2 AK (N = 12) and porokeratosis patients (N = 4) treated once daily for 5 consecutive days in the United Kingdom. Furthermore, real‐world experience in solid organ transplant recipients (N = 2) demonstrated effectiveness of tirbanibulin in skin field cancerization treatment. A symposium sponsored by Almirall was conducted during the congress in which Dr. Hadshiew and Dr. Lear brought together their clinical experience in Germany and the United Kingdom respectively. Interesting clinical cases of 5 consecutive days of tirbanibulin treatment compared to other treatments were discussed with attendees, as well as current treatment needs of AK patients. Conclusions: This article provides an overview of presentations and symposium discussions, summarizing key phase‐III results and real‐life clinical experience with tirbanibulin shared by dermatologists across Europe. [ABSTRACT FROM AUTHOR]

This article discusses the use of a new antibody called spesolimab in treating patients with flare-ups of generalized pustular psoriasis (GPP), a rare and potentially life-threatening inflammatory disease. The study focuses on a group of 11 patients with GPP flare-ups who were treated with intravenous spesolimab. The results showed that spesolimab was effective in reducing the severity of GPP symptoms and improving the patients' quality of life. The study suggests that spesolimab could be a viable treatment option for GPP flare-ups that do not respond to other conventional and biological systemic treatments. The article also provides information about the authors and their affiliations, references to related studies and publications, and discloses potential conflicts of interest. The data from the study are available upon request, and the patients involved have given consent for the publication of their case details. [Extracted from the article]

Background: Checkpoint inhibitors provide an effective approach for the melanoma treatment. They prolong lymphocyte effects, which explains the cytotoxicity underlying immune‐related adverse events (IrAEs). Cutaneous IrAEs affect nearly 40% of PD‐1i and 50% of CTLA4i‐treated patients. Severe cutaneous irAE do not often occur but could be life‐threatening and may persist despite treatment discontinuation. Methods: We aimed to investigate cutaneous IrAEs in a cohort of patients treated with ICI across Europe in an effort to characterize the reactions in a real‐world, phase IV, post‐marketing study using a follow‐up questionnaire. Data since November 2016 until March 2021 were obtained from the Melskintox database, a European multicentric biobank dedicated to the follow‐up of melanoma and cutaneous adverse events, supported by EADO. The dermatoses reported were pooled into four categories: inflammatory dermatosis, bullous diseases, drug‐related eruptions and pigmentary diseases. Results: Inflammatory benign dermatoses (n = 63) represented the most common group of reactions (52.5%), followed by drug‐related eruptions (n = 24, 20%), pigmentary diseases (n = 23, 19.2%) and bullous diseases (n = 10, 8.3%). Grade II (n = 41, 34.2%) are represented by bullous pemphigoid, eczema, hypodermitis, lichenoid eruption, maculopapular rash, pruritus, psoriasis‐like rash, urticarial eruption and vitiligo. Grade III (n = 18, 15.0%) are represented by bullous pemphigoid, lichenoid eruption and rashes. Grade IV (n = 2, 1.7%) is only represented by bullous disease. Most cutaneous IrAEs led to immunotherapy continuation (n = 95, 88.0%). CR is associated with more severe the cutaneous irAEs. We report an average time‐to‐onset of 208 days and some late‐onset events. Conclusion: Our study has characterized the clinical spectrum of cutaneous irAEs, their timing and severity and their relationship with tumour response. Grade I–II cutaneous IrAE are easily managed allowing ongoing anticancer treatment. Severe late‐onset cutaneous irAE are not uncommon. A dermatological follow‐up helps mitigate the risk of life‐threatening adverse events. These findings highlight the importance of oncodermatological involvement in management of patients with melanoma receiving immunotherapy. [ABSTRACT FROM AUTHOR]