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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 Policlinico, Milano, Italy; 13Section of Dermatology, DiSSal University of Genoa, Ospedale-Policlinico San Martino IRCCS, Genova, Italy; 14Dermatology Division, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy; 15Section of Dermatology, Department of Medicine, University of Udine, Udine, Italy; 16Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy; 17Section of Dermatology, Department of Medicine, University of Verona, Verona, Italy; 18Section of Dermatology, Department of Medical and Surgical Specialties, University of Catania, Catania, Italy; 19Dermatology Clinic of Terni, University of Perugia, Perugia, Italy; 20Section of Dermatology, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; 21Department of Health Sciences, Magna Graecia University, Catanzaro, Italy; 22Department of Medicine and Surgery, University of Parma, Parma, Italy; 23Section of Dermatology, Department of Biotechnological and Applied Clinical Science, University of L’Aquila, L’Aquila, Italy; 24Department of Dermatology, Istituto Dermopatico dell’Immacolata - IRCCS, Roma, Italy; 25Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Dermatology Unit, “Daniele Innocenzi”, Asl Latina, Italy; 26Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy; 27Dermatology Unit, Azienda Ospedaliera San Donato Milanese, Milan, Italy; 28Dermatology Unit, Lucca Azienda USL Toscana Nord Ovest, Pisa, Italy; 29Department of Translational Medicine and Surgery, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy; 30Department of Dermatology, University of Trieste, Trieste, Italy; 31Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 32Department of Dermatology, University of Bari, Bari, Italy; 33Institute of Dermatology, IRCCS Policlinico San Matteo Foundation and University of Pavia, Pavia, Italy; 34Dermatology Unit, Vito Fazzi Hospital, Lecce, Italy; 35Dermatology Clinic, Department of Health Sciences, University of Florence, Florence, Italy; 36Dermatology Unit, IRCCS IO Galeazzi, Milan, Italy; 37Dermatological Clinic, Polytechnic University of the Marche Region, Ancona, Italy; 38Department of Dermatology, Istituto Dermatologico San Gallicano - IRCCS, Roma, Italy; 39Dermatology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy; 40Novartis Farma SpA, Origgio, Italy; 41National Centre for Healthcare Research and Pharmacoepidemiology, Milan, Italy; 42Laboratory of Healthcare Research and Pharmacoepidemiology, Department of Statistics and Quantitative Methods, University of Milano Bicocca, Milan, Italy†Gabriella Fabbrocini passed away on 3 March 2023Correspondence: Filomena Russo, Dermatology Section, Department of Medical, Surgical and Neurological Science, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy, Email file.russo@libero.itPurpose: 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.Keywords: psoriasis, secukinumab, real-world evidence, drug survival, SUPREME

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 to treatment.Results: Twenty-five patients were included in the study. A statistically significant reduction from baseline in PASI, PSSI, ppPASI and DLQI values as early as week 24 was observed, with further improvement up to week 52. Plasma levels of MMP-3, VEGF-A, and hs-PCR decreased during treatment from week 0 to week 52.Conclusion: Our real-life experience suggests brodalumab as a valuable option for the management of psoriasis located in difficult-to-treat areas. Moreover, our study highlights that the use of brodalumab reduces the plasmatic levels of inflammatory biomarkers (MMP-3, VEGF-A and hs-PCR), showing how the drug modulates the skin inflammatory response by reducing systemic inflammation.Keywords: brodalumab, psoriasis, difficult-to-treat areas, biologic drugs, efficacy

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

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

Megna Matteo, Teresa Battista,&ast; Matteo Noto,&ast; Vincenzo Picone, Gabriella Fabbrocini, Angelo Ruggiero,&ast; Lucia Genco&ast; Department of Clinical Medicine and Surgery - Section of Dermatology, 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, 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.Conclusion: Our study highlighted that each different class of biologics for psoriasis was linked to ISRs. These events are more frequently reported with anti-TNF-alpha and anti-IL17.Keywords: psoriasis, injection site reactions, biologic therapy

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

Angelo Ruggiero,1 Fabrizio Martora,1 Gabriella Fabbrocini,1 Alessia Villani,1 Claudio Marasca,1 Matteo Megna,1 Luigi Fornaro,1 Rosita Comune,2 Luca Potestio1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini, 5, Naples, 80131, Italy, Tel +39 - 081 - 7462457, Fax +39 - 081 - 7462442, Email Angeloruggiero1993@libero.itAbstract: Teledermatology represented one of the most important and useful tools during the COVID-19 pandemic era. Indeed, due to the severe restriction, and to reduce the spread of the infection, different measures were applied among different countries and hospitals to ensure a continuity of care for patients. In this scenario, teledermatology played a central role, especially in the management of patients suffering from chronic inflammatory skin diseases. The aim of this narrative review is to describe the role of teledermatology during the COVID-19 pandemic to analyze main strengths and limitations of this tool, as well as to provide future perspectives in clinical applications.Keywords: teledermatology, telemedicine, COVID-19, psoriasis, atopic dermatitis, hidradenitis suppurativa

Fabrizio Martora, Teresa Battista, Claudio Marasca, Lucia Genco, Gabriella Fabbrocini, Luca Potestio Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: 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 outbreak of coronavirus disease 2019 (COVID-19) represented a new worldwide challenge, strongly impacting on the global economy, overall health and lifestyle. Since then, several strategies have been adopted to contain the widespread of infection. Among these, vaccination is currently the most important measure to fight against the pandemic. However, several concerns such as slower-than-hoped-for rollout, the hurried approval with limited data, the mechanism of action (in particular mRNA-based), and the uncertain duration of protection they afforded were initially raised. Moreover, even if cutaneous reactions have been rarely reported in clinical trials, global mass vaccination showed several dermatologic reactions not initially recognized, leaving dermatologists to decide how to diagnose and treat them. In this scenario, dermatologists should be ready to promptly recognize these clinical manifestations. Thus, the aim of this manuscript is to review current literature on cutaneous reactions following COVID-19 vaccination, particularly inflammatory dermatological diseases, in order to help clinicians to better understand these dermatological conditions and to provide an extensive overview of all the vaccine-related skin manifestations.Keywords: cutaneous reactions, COVID-19 vaccinations, side effects

Elisa Camela,1 Luca Potestio,1 Angelo Ruggiero,1 Sonia Sofia Ocampo-Garza,2 Gabriella Fabbrocini,1 Matteo Megna1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Dermatology Department, Universidad Autónoma de Nuevo León, University Hospital &die;Dr. José Eleuterio González&die;, Monterrey, Nuevo León, MéxicoCorrespondence: Elisa Camela, 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 elisacamela@gmail.comAbstract: Although innovative targeted therapies have positively revolutionized psoriasis treatment shifting treatment goals to complete or almost complete skin clearance, primary or secondary lack of efficacy is still possible. Hence, identifying robust biomarkers that reflect the various clinical psoriasis phenotypes would allow stratify patients in subgroups or endotypes, and tailor treatments according to the characteristics of each individual (precision medicine). To sum up the current progress in personalized medicine for psoriasis, we performed a review on the available evidence on biomarkers predictive of response to psoriasis treatments, with focus on phototherapy and systemic agents. Relevant literature published in English was searched for using the following databases from the last five years up to March 20, 2022: PubMed, Embase, Google Scholar, EBSCO, MEDLINE, and the Cochrane library. Currently, more evidence exists towards biologicals, as justified by the huge health care costs as compared to phototherapy or conventional systemic drugs. Among them, most of the studies focused on anti-TNF and IL12/23, with still few on IL17 (mainly secukinumab). The most discussed biomarker gene is the HLA-C&ast;02:06 status that has been shown to be associated with psoriasis, and also differential response to biologicals. Although its positivity is associated with great response to MTX, debatable results were retrieved concerning both anti-TNF and IL12/23 while it seems not to affect secukinumab response. Personalized treatment in psoriasis would provide excellent outcome minimizing the risk of side effects. To date, although several candidates were proposed and assessed, the scarcity and heterogeneity of the results do not allow the identification of the gold-standard biomarker per each treatment. Anyway, the creation of a more comprehensive panel would be more reliable for the treatment decision process.Keywords: precision medicine, stratification medicine, biomarkers, pharmacogenetics, pharmacogenomics, biologicals, small molecules, phototherapy, conventional systemic treatments, apremilast, acitretin, ciclosporin, methotrexate, dimethyl fumarate, MTX, DMF, SM

Angelo Ruggiero, Vincenzo Picone, Fabrizio Martora, Gabriella Fabbrocini, Matteo Megna Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II, Naples, ItalyCorrespondence: 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.itAbstract: Interleukin (IL)-23 inhibitors, guselkumab, risankizumab, and tildrakizumab, represent the latest class of biologics approved for the treatment of moderate-to-severe psoriasis. Since their approval numerous real-life studies were published on anti-IL-23 use in routine clinical practice. Indeed, real-life data are important to improve the dermatological decision-making process, including patients who are typically excluded from clinical trials, such as subjects suffering from several comorbidities, subjects on polypharmacy, as well as multifailure patients. Herein, we performed a comprehensive literature review about real-life data available on guselkumab, risankizumab, and tildrakizumab. Real-life data of anti-IL-23 seem to confirm the promising results of IL-23 shown by clinical trials, highlighting the efficacy and safety profiles of this new class of biologics also in clinical practice.Keywords: guselkumab, tildrakizumab, risankizumab, psoriasis, review, real life, real-world practice, real-world evidence

Matteo Megna, Luigi Fornaro, Luca Potestio, Maria Antonietta Luciano, Mariateresa Nocerino, Mario Delfino, Maria Guarino, Gabriella Fabbrocini, Elisa Camela Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, NA, ItalyCorrespondence: Elisa Camela, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Naples, NA, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email elisacamela@gmail.comPurpose: To determine the efficacy and safety of adalimumab (ADA) and etanercept (ETA) biosimilars in elderly and children with psoriasis.Methods: A real-life retrospective observational study was conducted on pediatric (< 18 years) and geriatric (≥ 65 years) psoriasis patients treated with anti-TNF biosimilar agents referring to the Psoriasis Unit of the University of Naples Federico II, Italy, from January 2018 to January 2022. At baseline, demographic characteristics (age and sex), data on psoriasis duration and severity (measured by Psoriasis Area Severity Index [PASI] and body surface area [BSA]), presence of psoriatic arthritis if applicable, comorbidities, and previous psoriasis treatments were recorded. Patients were monitored by regular follow-ups (week 12, 24, 48 and 72) through clinical and haematological assessments and adverse events (AEs) were registered.Results: A total of 11 children and 23 elderly psoriasis patients were enrolled. Concerning children, 6 (54.5%) were under ADA biosimilar and 5 (45.5%) under ETA biosimilar. ETA and ADA biosimilars were equally effective and safe for up to 72 weeks (mean PASI and BSA < 3). No significant AEs were reported, and none discontinued treatment. In the elderly, 15 (65.2%) were treated with ADA biosimilar and 8 (34.8%) with ETA biosimilar. ETA and ADA biosimilars were equally effective up to 72 weeks (mean PASI < 4 and mean BSA < 5%). AEs (mainly mild) were registered in 9 subjects (39.1%). Also, 4 (17.4%) patients discontinued biologicals for secondary lack of efficacy (3, 75%) or AEs (1, 25%).Conclusion: Our study found that ADA and ETA biosimilars are effective and safe for the treatment of moderate-to-severe psoriasis in children and the elderly. No statistically significant efficacy and safety differences were found between ADA and ETA biosimilars in both children and the elderly. Geriatric patients displayed a higher discontinuation rate and side effects than the pediatric counterpart even if without approaching statistical significance.Keywords: psoriasis, etanercept, adalimumab, biosimilar, treatment

Matteo Megna, Luca Potestio, Gabriella Fabbrocini, Angelo Ruggiero Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, 80131, ItalyCorrespondence: 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.itIntroduction: Guselkumab safety and efficacy profiles in psoriasis have been showed by VOYAGE (1 and 2) trials. Although trial results have been already previously confirmed by real-life studies, long-term real-life data, and drug survival data about guselkumab are still poor.Patients and Methods: We performed a 3-year retrospective study, with the aim of assessing guselkumab efficacy and safety profile in the management of plaque psoriasis in a real-life setting.Results: Thirty-one patients completed the study. Both Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) statistically improved since week 16, and up to week 144 [PASI reduction from 16.4 ± 6.2 to 0.6 ± 0.9 (p < 0.0001) at week 144 while BSA from 33.2 ± 14.6 to 1.9 ± 1.4 (p < 0.0001)]. At week 12 PASI90 and PASI100 were achieved by 19 (61.3%) and 11 (35.4%) patients, respectively, as well as 24 (77.4%) and 18 (58.1%) subjects reached PASI 90 and PASI 100 at week 144. As regards the safety, no cases of injection site reaction, candida, serious AEs, malignancy, or major cardiovascular events were reported. Of note, mild AEs were collected with pharyngitis as the main one (7, 22.6%), followed by headache (5, 16.1%) and flu-like illness (5, 16.1%), all without requiring treatment discontinuation.Conclusion: Our experience confirmed the efficacy and safety of guselkumab in daily clinical practice up to 3 years, suggesting this drug as an effective treatment option in psoriasis long-term management.Keywords: psoriasis, guselkumab, IL-23, anti-IL-23, real life, biologic, IL-23, IL-17A

Angelo Ruggiero, Luca Potestio, Elisa Camela Snr, Gabriella Fabbrocini, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, 80131, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39-0817462457, Fax +39-081-7462442, Email angeloruggiero1993@libero.itAbstract: Bimekizumab, a novel humanized monoclonal IgG1 antibody that neutralizes both IL-17A and IL-17F, was recently approved the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimekizumab represents the latest anti IL-17 treatment available for the management of moderate to severe psoriasis. Bimekizumab safety and efficacy profiles were evaluated in four Phase III clinical trials, which evaluated bimekizumab versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), versus adalimumab (BE SURE), and versus secukinumab (BE RADIANT). Overall, bimekizumab displayed promising results in terms of both efficacy and safety, allowing reach PASI90 and PASI100 in short time (as early as week 4) and maintain it in the long term (52 weeks), with acceptable safety profile. Also, bimekizumab showed a rapid onset of response and a higher efficacy when compared to adalimumab, ustekinumab and secukinumab, with comparable safety profile. Herein, we carried out a comprehensive literature review of the available literature data about bimekizumab in the treatment of moderate to severe psoriasis.Keywords: psoriasis, bimekizumab, IL-17, anti-IL-17, review, biologic, IL-23, IL-17A

Angelo Ruggiero,1 Matteo Megna,1 Alessia Villani,1 Rosita Comune,2 Gabriella Fabbrocini,1 Francesca di Vico1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, 80131, Italy; 2Section of Radiology and Radiotherapy, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, 80138, ItalyCorrespondence: 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.itAbstract: Bullous pemphigoid (BP) is the most frequent autoimmune bullous disease mainly affecting elderlies. Diagnosis usually results from clinical features, histological examination, and the quantification of circulating typical autoantibodies, due to its higher incidence in elderly patients, bullous pemphigoid treatment and management still represents a challenge due to the higher frequency of several comorbidities in this group of patients, which may also be linked to a reduced tolerance to BP treatments. Hence, an early diagnosis and a prompt correct treatment are mandatory to reach better clinical outcomes and improve as much as possible BP outcomes. Herein, we carried out a comprehensive literature review about the known clinical presentations, diagnosis, assessment and monitoring procedures used in daily clinical practice in patients with BP, to better define strategies to improve as much as possible BP clinical outcomes.Keywords: bullous pemphigoid, pemphigoid, review, monitoring, assessment, prognosis

Maddalena Napolitano,1 Gabriella Fabbrocini,2 Angelo Ruggiero,2 Vincenzo Marino,2 Mariateresa Nocerino,2 Cataldo Patruno3 1Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy; 2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 3Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, ItalyCorrespondence: Maddalena NapolitanoDepartment of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, ItalyTel +39 0817462439Email maddy.napolitano@gmail.comAbstract: Atopic dermatitis (AD) is a chronic, pruritic, inflammatory skin disease that predominantly affects children. However, it can persist in adulthood and/or start at older ages. Both dysfunction of the epidermal barrier and immune dysregulation are known to play a role in the pathogenesis of AD. In the last years, numerous studies showed that Janus kinase (JAK) enzymes have a key role in AD pathogenesis. Therefore, oral and topical JAK inhibitors are new emerging treatments for AD. We report the data relating to abrocitinib, an oral JAK1 inhibitor. For this purpose, we examined articles already published concerning, in particular, concluded clinical trials. Furthermore, we also report the design of current ongoing clinical trials. The search was carried out considering the main search engines relating to medical literature and clinical trials. From all the data we collected, abrocitinib proved to be an effective drug in significantly reducing the severity of moderate-to-severe AD when compared to placebo. Furthermore, the efficacy was similar to other well-established treatment for AD, such as dupilumab. Adverse events were generally mild; indeed, the drug was definitively suspended only in few patients.Keywords: atopic dermatitis, abrocitinib, JAK inhibitors, JAK-STAT

Maddalena Napolitano,1 Gabriella Fabbrocini,2 Eleonora Cinelli,2 Luca Stingeni,3 Cataldo Patruno4 1Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy; 2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 3Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy; 4Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, ItalyCorrespondence: Maddalena NapolitanoDepartment of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, ItalyTel +39 0817462439Email maddy.napolitano@gmail.comAbstract: Atopic dermatitis (AD) is the most common chronic cutaneous inflammatory disease of childhood, affecting up to 25% of children; its prevalence in adulthood is currently unknown, since studies reported that AD may affect 0.3– 14.3% of adult population. In the last decade, the advanced understanding of AD molecular pathways along with patient’s and physician’s demand for more effective therapies, led to the introduction of new therapeutic agents. Baricitinib is an oral JAK inhibitor highly selective for JAK1 and JAK2. Treatment with baricitinib improved the signs and symptoms of moderate-to-severe AD compared to placebo, but it will be essential to better understand the safety profile of this drug.Keywords: baricitinib, adult atopic dermatitis, small molecules, JAK/STAT

Federica Dall’Oglio,1 Gabriella Fabbrocini,2 Aurora Tedeschi,1 Marianna Donnarumma,2 Paolo Chiodini,3 Giuseppe Micali1 1Dermatology Clinic, University of Catania, Catania, Italy; 2Section of Dermatology, Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy; 3Medical Statistics Unit, University of Campania “Luigi Vanvitelli”, Naples, ItalyCorrespondence: Giuseppe MicaliDermatology Clinic, University of Catania, A.O.U. Policlinico -Vittorio Emanuele, via Santa Sofia, 78, Catania 95123, ItalyTel +39 095321705Fax +39 0953782425Email cldermct@gmail.comPurpose: Topical cosmetic agents if correctly prescribed and used may improve outcomes in acne therapy. The aim of this study was to assess the efficacy and tolerability of a new daily cosmetic regimen in the treatment of mild facial acne.Patients and methods: A multicenter, prospective, observational, clinical study was conducted on 91 adult patients with mild acne. Subjects were instructed to apply a fluid containing Licochalcone A/Salicylic acid/L-Carnitine in the morning and a cream with Licochalcone A/Hydroxy-Complex 10% at bedtime for 8 weeks. The efficacy was clinically evaluated by Global Acne Grading System (GAGS) score and by comedones/papules lesions count and by instrumental assessment (SebutapeTMand Reveal Photo Imager/VISIA-CR™ imaging) at baseline, at 4 and 8 weeks.Results: At 4 weeks a statistically significant reduction from baseline of GAGSwas observed. In addition, the mean total count of comedones and papules was significantly reduced by 41% and 45%, respectively, from baseline along with a significant reduction of mean sebum of 47%. At 8 weeks, a further statistically significant reduction from baseline of GAGS, total count of comedones and papules (64% and 71%, respectively), along with an additional sebum reduction of about 52% was also recorded.Conclusion: Our results suggest that the daily regimen based on Licochalcone A with Salicylic acid/L-Carnitine as fluid or with Hydroxy-Complex 10% as cream represent an interesting cosmetic approach for treating mild acne.Keywords: mild acne, topical cosmetic, licochalcone A, salicylic acid, hydroxyl-complex

This article examines the effectiveness of risankizumab, a medication used to treat moderate-to-severe plaque psoriasis. The study found that risankizumab was effective in improving psoriasis symptoms, with a high percentage of patients experiencing significant improvement and complete skin clearance. The study also found that patients who had not previously been treated with biologic drugs and those with a shorter disease history had better responses to the treatment. However, the study has some limitations, and further research is needed to fully understand the long-term effects of risankizumab on psoriasis. [Extracted from the article]

Byline: L. Panariello, D. Fattore, E. Cinelli, M. Campanino, G. Mansueto, G. Fabbrocini To the Editor, Foreign body granuloma and migration of the implanted material are possible delayed side effects [...]

Maddalena Napolitano,1 Matteo Megna,2 Elena A Timoshchuk,3 Cataldo Patruno,2 Nicola Balato,2 Gabriella Fabbrocini,2 Giuseppe Monfrecola2 1Dipartimento di Medicina e Scienze della Salute “Vincenzo Tiberio”, Università degli Studi del Molise, Campobasso, 2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 3Department of Dermatovenereology, Saint Petersburg State Pediatric Medical University, Saint Petersburg, Russia Abstract: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease primarily affecting apocrine gland-rich areas of the body and presenting with painful nodules, abscesses, sinus tracts, and scarring. HS is a multifactorial disease in which genetic and environmental factors play a key role. The primary defect in HS pathophysiology involves follicular occlusion of the folliculopilosebaceous unit, followed by follicular rupture, and immune responses (perifollicular lympho-histiocytic inflammation), finally leading to the development of clinical HS lesions. HS has a destructive impact on the patient’s quality of life, being a very challenging disease. Available treatments are limited, mostly off-label and with high variability in the reported efficacy. Fortunately, a monoclonal antibody against tumor necrosis factor alpha has been recently approved for treatment of moderate to severe HS, offering patients a promising new option. This review focuses on the main features of HS, including epidemiology, clinical aspects, pathogenesis, severity classifications, comorbidities, and currently available treatments. Keywords: hidradenitis suppurativa, pathogenesis, diagnosis, treatment

Giuseppe Monfrecola, Sara Cacciapuoti, Claudia Capasso, Mario Delfino, Gabriella Fabbrocini Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II, Naples, Italy Background: A novel face compact cream (FCC) containing a new patented formulation was recently developed to provide acne patients with cosmetic camouflage for their lesions and to have beneficial effects on the multifactorial components of the disease. This pilot investigation aimed to evaluate the real-life tolerability, potential for comedogenicity and covering effect provided by this FCC.Methods: This single-center study evaluated the FCC applied once daily for 28 days in 20 females with facial acne. Tolerability was assessed by rating skin reactions on a scale from 1 =absent to 4 =evident. Comedogenicity potential was evaluated by determining the number of facial acne lesions before and after use of the FCC. The covering effect was rated in ten patients 30 minutes after application on a scale from 1 =none to 5 =excellent. Patients rated their opinions on the FCC on day 28 using a questionnaire.Results: Assessment of tolerability on days 0, 14, and 28 showed that skin reactions, including erythema, edema, dryness, desquamation, tight feeling, itching, and burning, were absent in all patients. The FCC was noncomedogenic and provided a significant 15.8% reduction in facial acne lesions after 28 days (P