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Luca Potestio,* Angelo Ruggiero,* Gabriella Fabbrocini, Fabrizio Martora, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy*These authors contributed equally to this workCorrespondence: Luca Potestio, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 - 81 -7462457, Fax +39 - 081 - 7462442, Email potestioluca@gmail.comAbstract: Psoriasis management may be challenging, particularly for moderate-to-severe forms of the disease. Indeed, conventional systemic treatments are often avoided for contraindications or the risk of adverse events as well as phototherapy is often limited by logistic concerns. Despite the development of biological drugs and small molecules revolutionized the treatment options showing promising results in terms of safety and effectiveness, some limitations remain. Thus, there is still a need for new therapies that are always welcome in order to tailor the treatment to the patient and to have a higher level of performance, especially in order to maintain long-term effectiveness. In this scenario, deucravacitinib, an oral small molecule which selectively inhibits Tyrosine Kinase 2, may represent a promising weapon in psoriasis management. The aim of our manuscript is to review the current knowledge on the efficacy and safety of deucravacitinib for the management of psoriasis.Keywords: deucravacitinib, psoriasis, JAK inhibitors, TYK2 inhibitors

Sara Cacciapuoti,* Luca Potestio,* Gianluca Guerrasio, Gabriella Fabbrocini ,†Massimiliano Scalvenzi, Angelo Ruggiero,* Giuseppina Caiazzo,* Matteo Megna* Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy*These authors contributed equally to this work†Professor Gabriella Fabbrocini passed away on 3rd March 2023Correspondence: Angelo Ruggiero, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email angeloruggiero1993@libero.itBackground: Recent knowledge of psoriasis pathogenesis has led to the development of selective drugs. Among these, brodalumab is a monoclonal antibody targeting the interleukin (IL)-17A receptor approved for the treatment of moderate-to-severe plaque psoriasis. Biologics may be considered in patients with milder diseases in case of active psoriatic arthritis, severe impact on patient’s quality of life, and involvement of sensitive and difficult-to-treat areas. These skin locations commonly require systemic drugs. Recently, psoriasis severity monitoring has also changed. Indeed, the clinical evaluation by means of specific efficacy scores was combined with serological evaluation by means of the assay of specific inflammatory biomarkers.Methods: An observational study enrolled patients affected by moderate-to-severe plaque psoriasis involving difficult-to-treat areas, undergoing treatment with brodalumab to evaluate the effectiveness and safety of brodalumab in patients with psoriasis affecting difficult-to-treat areas (scalp and palmoplantar regions). Secondary outcomes were the assessment of the development of serum markers of inflammation during the treatment period as well as the evaluation of the dermoscopic features of the affected sites to quantify disease activity and response

Filomena Russo,1 Marco Galluzzo,2,3 Luca Stingeni,4 Severino Persechino,5 Leonardo Zichichi,6 Andrea Conti,7 Claudia Giofrè,8 Valentina Dini,9 Martina Vispi,10 Laura Atzori,11 Angelo Cattaneo,12 Aurora Parodi,13 Federico Bardazzi,14 Giuseppe Stinco,15 Paolo Dapavo,16 Giampiero Girolomoni,17 Maria Letizia Musumeci,18 Manuela Papini,19 Marina Venturini,20 Stefano Dastoli,21 Sergio Di Nuzzo,22 Maria Concetta Fargnoli,23 Gianluca Pagnanelli,24 Nicoletta Bernardini,25 Daniele Mario Gambini,26 Piergiorgio Malagoli,27 Carlo Mazzatenta,28 Ketty Peris,29 Iris Zalaudek,30 Gabriella Fabbrocini31 ,†Francesco Loconsole,32 Camilla Vassallo,33 Lucia Pietroleonardo,34 Francesca Prignano,35 Chiara Franchi,36 Anna Maria Offidani,37 Claudio Bonifati,38 Vito Di Lernia,39 Giovanni Gigante,40 Marta Silvia Bartezaghi,40 Matteo Franchi,41,42 Paola Ursoleo,40 Elisabetta Aloisi40 1Dermatology Section, Department of Medical, Surgical and Neurological Science, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy; 2Department of Systems Medicine, University of Rome “Tor Vergata”, Rome, Italy; 3Dermatology Unit, Fondazione Policlinico “Tor Vergata”, Rome, Italy; 4Section of Dermatology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 5Dermatology Unit, NESMOS Department, Faculty of Medicine & Psychology, Sapienza University of Rome, Sant’Andrea University Hospital, Rome, Italy; 6Unit of Dermatology, San Antonio Abate Hospital, Trapani, Italy; 7Section of Dermatology, Department of Specialized Medicine, University of Modena and Reggio Emilia, Modena, Italy; 8U.O.C. Dermatologia, A.O. Papardo, Messina, Italy; 9Section of Dermatology, Department of Medicine and Oncology, University of Pisa, Pisa, Italy; 10Dermatology Unit, Misericordia Hospital, Grosseto, Italy; 11Dermatology Unit, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; 12Dermatology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policl

Luca Potestio,* Fabrizio Martora,* Gabriella Fabbrocini, Teresa Battista, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy*These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 081 7462457, Fax +39 081 7462442, Email fabriziomartora92@libero.itAbstract: The introduction of biologic drugs revolutionized the treatment of psoriasis, shifting treatment goals to higher treatment outcomes and less frequent safety issues. The outbreak of Coronavirus disease 2019 (COVID-19) represented a worldwide challenge, strongly affecting lifestyle, global economy, and overall health. Among the strategies adopted to contain the spreading of the infection, vaccination is the main one. In this context, the introduction of COVID-19 vaccines raised several doubts about their effectiveness and safety in patients undergoing therapy with biological for psoriasis. Even if molecular and cellular mechanisms by which COVID-19 vaccines lead to psoriasis development have not yet been fully elucidated, vaccination itself can trigger the release of interleukin (IL)-6, interferon (IFN) and tumor necrosis factor (TNF) α by T-helper (Th)1/Th17 cells. All these cytokines are involved in psoriasis pathogenesis. Thus, the aim of this manuscript is to review current literature on the safety and effectiveness of COVID-19 vaccination in psoriasis patients undergoing treatment with biologics, in order to clarify any concerns.Keywords: psoriasis, COVID-19 vaccinations, biologic therapies, efficacy, safety

Background: Advanced basal cell carcinoma (aBCC) represents a complex and clinically heterogeneous group of lesions for which curative surgery and/or radiotherapy is unlikely. Systemic therapy with hedgehog pathway inhibitors (HHI) changed the treatment landscape for this complex patient population.Objectives: to describe the clinical characteristics of a real-life Italian cohort diagnosed with aBCC, and to investigate effectiveness and safety of HHI.Methods: a multicenter observational study was performed by twelve Italian centers in the period January 1, 2016 - October 15, 2022. Patients aged >= 18 years and diagnosed with aBCC (locally advanced and metastatic BCC) were eligible for the study. Methods for investigating tumor response to HHI included clinical and dermatoscopic evaluation, radiological imaging, and histopathology. For HHI safety assessment, therapy-related adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Results: we enrolled 178 patients under treatment with HHI: 126 (70.8%) and 52 patients (29.2%) received sonidegib and vismodegib, respectively. Comprehensive data on HHI effectiveness and disease outcome was available for 132 (74.1%) of 178 patients: 129 patients had a diagnosis of locally advanced BCC (laBCC) (n=84, sonidegib; n=45, vismodegib), and 3 patients of metastatic BCC (mBCC) (n=2, vismodegib; n=1, sonidegib, off-label). Objective response rate (ORR) was 76.7% (95% CI: 82.3-68.7) and 33.3% (95% CI: 88.2-1.7) for laBCC (CR: 43/129; PR: 56/129) and mBCC (CR: 0/3; PR: 1/3), respectively. High-risk aBCC histopathological subtypes and occurrence of >2 therapy-related AEs were significantly associated with non-response to HHI therapy [(OR: 2.61; 95% CI: 1.09-6.05; p:0.03) and (OR: 2.74; 95% CI: 1.03-7.9; p:0.04)], respectively. Majority of our cohort (54.5%) developed at least 1 therapy-related AE, most of which were mild-moderate in severity.Conclusions: our

Matteo Megna, Teresa Battista,* Matteo Noto,* Vincenzo Picone, Gabriella Fabbrocini, Angelo Ruggiero,* Lucia Genco* Department of Clinical Medicine and Surgery - Section of Dermatology, University of Naples Federico II, Naples, Italy*These authors contributed equally to this workCorrespondence: Angelo Ruggiero, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email angeloruggiero1993@libero.itBackground: Biologic selection for psoriasis treatment should take into account numerous factors including injection site reactions (ISRs) such as swelling at the injection site, pain, burning, erythema, all possibly reducing patient adherence.Methods: A 6-months observational real life study was performed involving psoriasis patients. Inclusion criteria were age ≥ 18 years, moderate-to-severe psoriasis diagnosis since at least 1 year, patients being on biologic treatment for psoriasis ≥ 6 months. A 14-item questionnaire was administered to all patients enrolled to assess whether the patient ever experienced ISRs after the injection of the biologic drug.Results: 234 patients were included: 32.5% received an anti-TNF-alpha drug, 9.4% received anti-IL12/23, 32.5% received an anti-IL17, 25.6% received an anti-IL23. 51.2% of study population reported at least one symptom related to ISR. 35.9% of patients experienced pain, 31.6% swelling, 28.2% burning sensation and 17.9% erythema. 3.4% of the surveyed population experienced anxiety or fear of the biologic injection due to ISRs symptoms. The greater incidence of pain was registered in anti-TNF-alpha and anti-IL17 groups (47.4% and 42.1%, p< 0.01). Ixekizumab proved to be the drug with the highest rate of patients experiencing pain (72.2%), burning (77.7%) and swelling (83.3%). No patients reported biologics discontinuation or delay for ISRs symptoms.Con

Introduction: Despite advances in treatment options and the management of patients with psoriasis, considerable unmet needs remain. Our objective was to identify ways to elevate the standard of care for patients with psoriasis by combining the perspectives of three important stakeholders: patients, clinicians and payors, and define ‘Calls to Action’ designed to achieve the identified changes. Methods: Eight themes relevant to elevating the standard of care were identified from an insights-gathering questionnaire completed by all three stakeholder groups. A modified Delphi exercise gained consensus on statements informed by the insights. Statements were then used to inspire ‘Calls to Action’ – practical steps that could be taken to realise the desired changes and elevate the standard of care. Results: In total, 18 European experts (10 dermatologists, 3 payors and 5 patient representatives) took part in the Delphi process. Consensus was reached on statements relating to all eight themes: improve healthcare systems to better support multidisciplinary team working and digital services, real-world data generation and optimal use, improve patient access, elevate quality-of-life measures as the most important outcomes, involve patients in patient-centred and personalised approaches to care, improve the relevance and reach of guidelines, education, and multistakeholder engagement. ‘Calls to Action’ common to all three stakeholder groups recognised the need to capitalise on the shift to digital healthcare, the need for consistent input into registries to generate real-world evidence to support guideline development, and the necessity of educating patients on the benefits of reporting outcomes to generate real-world data. The enormous quality-of-life burden and psychological impact of psoriasis, as well as the clinical needs of patients must be better understood, including by healthcare commissioners, so that funding priorities are assessed appropriately. Conclusion: This

Luca Potestio, Ilaria Piscitelli, Gabriella Fabbrocini, Fabrizio Martora, Angelo Ruggiero,&ast; Matteo Megna&ast; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini, 5, Naples, 80131, Italy, Tel +39 - 81 -7462457, Fax +39 - 81 – 7462442, Email Angeloruggiero1993@libero.itAbstract: The introduction of biologic drugs revolutionized the management of moderate-to-severe forms of psoriasis. However, safety concerns still remain, particularly on patient affected by opportunistic infections. In this scenario, the safety of biologic drugs in patient with HBV infection is debated. Globally, screening for hepatitis before starting biological treatment is mandatory as well as a referral to an infectivologist and eventual prophylactic management should be evaluated case by case, also considering risk factors. On the one hand, the use of anti-Tumor Necrosis Factor seems to increase the risk of HBV reactivation, conversely, the use of recently approved classes of biologics [anti-interleukin (IL) 17 and anti-IL23] seems to have a lower risk of HBV reactivation. However, the evidence on the safety of anti-IL23 drugs in patients affected by HBV is scant, particularly for patients undergoing treatment with tildrakizumab. Herein, we report the first case of a female patient affected by moderate-to-severe psoriasis and with chronic HBV infection undergoing prophylaxis, successfully treated with tildrakizumab without reporting hepatitis reactivation. Even if limited, our case seems to confirm available evidence about the safety of anti-IL23, particularly tildrakizumab, on patients with chronic HBV infection undergoing prophylaxis.Keywords: psoriasis, HBV infection, biologic therapy, anti-IL23, tildrakizumab

Fabrizio Martora, Matteo Megna,&ast; Teresa Battista,&ast; Luca Potestio,&ast; Maria Carmela Annunziata, Claudio Marasca, Alessia Villani, Gabriella Fabbrocini Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email fabriziomartora92@libero.itAbstract: To date, adalimumab (ADA) is the only biotechnology drug approved for the management of hidradenitis suppurativa (HS), an inflammatory skin condition. However, it quickly became apparent that the efficacy of adalimumab in daily practice was highly variable. In our review, we highlighted the current evidence from literature on the use of biologics in HS in a real-life setting, particularly adalimumab, secukinumab and ustekinumab. Data on the effectiveness and safety of biologic drugs in HS management have been analyzed. Even if the results are promising, more studies are needed. In our opinion, the armamentarium of drugs for HS management is increasing, and treatment will be based on a tailored-tail approach, minimizing the risk of adverse events. In this context, we want to point out the reported effectiveness and safety data concerning adalimumab, ustekinumab and secukinumab as well as ixekizumab.Keywords: hidradenitis suppurativa, adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, real life evidence

Purpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts. Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6–positive and HLA-Cw6–negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6–positive and HLA–Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings. Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile.