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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

Paolo Gisondi,1 Francesco Bellinato,1 Martina Maurelli,1 Davide Geat,1 Alen Zabotti,2 Dennis McGonagle,3 Giampiero Girolomoni1 1Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy; 2Rheumatology Clinic, Department of Medical and Biological Sciences, University Hospital ‘Santa Maria della Misericordia’ c/o University of Udine, Udine, Italy; 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UKCorrespondence: Paolo Gisondi, Section of Dermatology and Venereology, Department of Medicine, University of Verona, Piazzale A. Stefani 1, Verona, 37126, Italy, Email paolo.gisondi@univr.itAbstract: Psoriatic arthritis (PsA) is a heterogeneous chronic inflammatory arthritis associated with psoriasis, which may manifest with different domains such as dactylitis, enthesitis, synovitis and spondylitis. The estimated prevalence of PsA in patients with psoriasis ranges widely between 6% and 42%. In most cases, PsA is preceded by skin involvement by an average time of 7– 8 years. In the complex patho-mechanisms involved in the transition from psoriasis to PsA, the gut and skin have been proposed as the sites of immune activation triggering or contributing to the development of PsA. In such a transition, a subclinical phase has been identified, characterized by enthesopathy where soluble biomarkers and imaging findings but no clinical symptoms are detectable. Recent studies have provided some evidence that timely treated psoriasis may reduce the risk of developing PsA.Keywords: psoriatic arthritis, psoriasis, therapy, prevention, early intervention, disease modification

The article discusses a 5-year retrospective study on the long-term effectiveness and tolerability of apremilast in patients with moderate-to-severe plaque psoriasis in Italy. A total of 335 patients were treated with apremilast, with demographic characteristics and treatment outcomes recorded. Results showed significant reductions in Psoriasis Area and Severity Index (PASI) scores over the study period, with a majority of patients achieving PASI 75, PASI 90, and PASI 100. The study concluded that apremilast demonstrated effectiveness and tolerability as a treatment option for patients with contraindications to biological treatments. [Extracted from the article]

Andrea Chiricozzi,1,2 Martina Maurelli,3 Ketty Peris,1,2 Giampiero Girolomoni3 1Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 2Dermatologia, Università Cattolica del Sacro Cuore, Rome, Italy; 3Department of Medicine, Section of Dermatology, University of Verona, Verona, ItalyCorrespondence: Andrea ChiricozziDermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome 00168, ItalyTel +39-339 5668320Fax +39-0761-571321Email chiricozziandrea@gmail.comAbstract: Atopic dermatitis (AD) is an immune-mediated inflammatory skin disease characterized by a predominant type 2 immune response. Type 2 immunity is driven by multiple cytokines, including interleukin (IL)‑4 and IL-13 that are considered central to AD pathogenesis and key therapeutic targets. The dual inhibition of these two cytokines or the selective inhibition of IL-13 proved elevated efficacy in treating AD, whereas the selective inhibition of IL-4 has been poorly investigated as IL-4 inhibiting agents did not show any advance in clinical development programs. This review describes the pathogenic role of IL-4 in AD and briefly resumes the main features of compounds selectively blocking IL-4.Keywords: atopic dermatitis, IL-4, IL-4 inhibitor, dupilumab, pascolizumab, pitrakinra

A retrospective study conducted in Italy analyzed data from 116 patients with severe atopic dermatitis (AD) to determine if the drug upadacitinib could improve symptoms of concomitant allergic rhinitis (AR) or allergic asthma (AA). The study found that after 16 weeks of treatment with upadacitinib, 81.9% of patients achieved a reduction of at least 75% in their AD symptoms, and 56.03% achieved a reduction of at least 90%. Upadacitinib also showed a slight improvement in symptoms of AA and AR. The study suggests that upadacitinib may have a beneficial impact on AA and AR symptoms in patients with severe AD, but further research is needed. [Extracted from the article]

Luca Degli Esposti,1 Valentina Perrone,1 Diego Sangiorgi,1 Stefano Buda,1 Margherita Andretta,2 Maurizio Rossini,3 Giampiero Girolomoni4 1CliCon Srl, Health Economics and Outcomes Research, Ravenna, Italy; 2Pharmaceutical Department Local Health Unit, ULSS 9 Scaligera, Verona, Italy; 3Department of Medicine, Section of Rheumatology, University of Verona, Verona, Italy; 4Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy Objectives: To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic arthritis (PsA) before and after treatment with biological therapies in a real-world setting and to determine the relative consumption of health care resources.Design: Retrospective observational study.Setting: Real-life clinical setting in 5 Italian local health units.Participants: A total of 351 male and female patients with at least 1 prescription for a biological drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid arthritis, ankylosing spondylitis, or Crohn’s disease were excluded.Results: The major health care cost (excluding drug costs) was represented by hospitalizations, mainly related to PSO /PsA-associated disorders and cardiometabolic disorders. Use of conventional drugs among biologics-naïve patients reached 50% in PSO and 80% in PsA; their use decreased following initiation of biological therapy. After the start of biological treatment, the incidence of hospitalization decreased both for PSO (from 12.3% to 3.2% in day hospital regimen and from 2.4% to 0.4% for conventional admission) and for PsA (from 11.1% to 8.1% and from 10.1% to 3.0%, respectively). Mean annual costs for hospitalization before biological treatment were €217 and €537 for PSO and PsA, respectively, while mean annual cost for concomitant drugs slightly increased after biologics initiation: from €249.8 to €269.4 for PSO and from €331.8 to €346.9 for PsA. The major consumption of health care resources occurred in the quarter preceding the beginning of biological treatment.Conclusion: The consumption of health resources is mostly related to hospitalization, seems to peak during the quarter before the beginning of biologics therapies, and subsequently decreases after biologics initiation. Further studies should focus on prescription scheme and economic burden of PSO and PsA in Italy to help optimize health care resources and potentiate services for patients. Keywords: psoriasis, psoriatic arthritis, biological treatment, health care costs, hospitalization

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]

Paolo Gisondi, Giampiero Girolomoni Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy Abstract: Chronic plaque psoriasis presents clinically as an inflammatory disease of the skin, which is often associated with comorbidities and responsible for a poor quality of life. It can widely vary among patients because of different age of onset, type of symptoms, areas of involvement, and disease severity. The choice of the treatment of psoriasis should be person­alized according to the specific needs of the patients. Apremilast is a well-tolerated and effective phosphodiesterase type 4 inhibitor that is indicated for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis. In this article, the pharmacological, clinical, and safety aspects of apremilast are reviewed. Based on these data, apremilast could be indicated for patients with a Psoriasis Area and Severity Index score

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]

Giorgio L Colombo1,2 Sergio Di Matteo,2 Giacomo Bruno,2 Giampiero Girolomoni,3 Gino Antonio Vena41University of Pavia, Department of Drug Sciences, School of Pharmacy, Pavia, Italy; 2S.A.V.E. Studi Analisi Valutazioni Economiche, Milan, Italy; 3Sections of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy; 4Department of Biomedical Sciences and Human Oncology, Unit of Dermatology and Venereology University of Bari, Bari, ItalyBackground: Psoriasis is a chronic inflammatory skin disease with a major impact on the quality of life of affected individuals. Topical therapy has an important role in the treatment of psoriasis. Poor treatment outcomes from topical therapy regimens likely result from poor adherence and ineffective use of medication.Methods: A cost-minimization analysis was performed with the purpose of assessing the use of a gel containing calcipotriol and betamethasone dipropionate (Dovobet® gel) versus the ointment formulation (Dovobet ointment) in the treatment of psoriasis. The analysis was carried out using a Markov model with a one-year time horizon in a hypothetical cohort of patients with a Psoriasis Area and Severity Index score < 10. The model simulates different therapy adherence scenarios for the two different formulations.Results: The Dovobet gel strategy allows a 5% reduction in the number of patients who could potentially be treated with more expensive therapies (biologics and conventional systemic drugs) in comparison with the Dovobet ointment strategy, with a consequent impact on costs for the National Healthcare Service. The total annual cost of Dovobet gel is about €407.00 per patient, ie, 19% less that the total cost of about €500.00 of the Dovobet ointment strategy. The base case results were then examined by sensitivity analysis and budget impact analysis to correlate the various scenarios of Dovobet gel use with cost savings to the National Healthcare Service.Conclusion: The Dovobet gel strategy seems more acceptable to patients, shows better overall adherence, and appears to be favorable from the pharmacoeconomic point of view than the ointment formulation for treatment of patients with mild-to-moderate psoriasis.Keywords: pharmacoeconomics, cost-minimization, cost-consequences, psoriasis, calcipotriol and betamethasone dipropionate, patient adherence