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1. Long-Term Drug Survival and Effectiveness of Secukinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: 42-Month Results from the SUPREME 2.0 Study

Author

Russo F, Galluzzo M, Stingeni L, Persechino S, Zichichi L, Conti A, Giofrè C, Dini V, Vispi M, Atzori L, Cattaneo A, Parodi A, Bardazzi F, Stinco G, Dapavo P, Girolomoni G, Musumeci ML, Papini M, Venturini M, Dastoli S, Di Nuzzo S, Fargnoli MC, Pagnanelli G, Bernardini N, Gambini DM, Malagoli P, Mazzatenta C, Peris K, Zalaudek I, Fabbrocini G, Loconsole F, Vassallo C, Pietroleonardo L, Prignano F, Franchi C, Offidani AM, Bonifati C, Di Lernia V, Gigante G, Bartezaghi MS, Franchi M, Ursoleo P, and Aloisi E

Subjects
psoriasis, secukinumab, real-world evidence, drug survival, supreme, Dermatology, RL1-803
Abstract

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

Published
2023

2. Efficacy and Safety of Secukinumab in Elderly Patients with Moderate to Severe Plaque-Type Psoriasis: Post-Hoc Analysis of the SUPREME Study

Author

Talamonti M, Russo F, Malara G, Hansel K, Papini M, Cattaneo A, Parodi A, Chiricozzi A, Malagoli P, Bardazzi F, Brazzelli V, Dapavo P, Gisondi P, Zane C, Potenza C, Cantoresi F, Fargnoli MC, Trevisini S, Brianti P, Pescitelli L, Gigante G, Bartezaghi M, Caputo L, Aloisi E, and Costanzo A

Subjects
psoriasis, biologics, interleukin-17a, secukinumab, elderly, Dermatology, RL1-803
Abstract

Marina Talamonti,1 Filomena Russo,2 Giovanna Malara,3,4 Katharina Hansel,5 Manuela Papini,6 Angelo Cattaneo,7 Aurora Parodi,8 Andrea Chiricozzi,9,10 Piergiorgio Malagoli,11 Federico Bardazzi,12 Valeria Brazzelli,13 Paolo Dapavo,14 Paolo Gisondi,15 Cristina Zane,16 Concetta Potenza,17 Franca Cantoresi,18 Maria Concetta Fargnoli,19 Sara Trevisini,20 Pina Brianti,21 Leonardo Pescitelli,22 Giovanni Gigante,23 Marta Bartezaghi,23 Luisa Caputo,23 Elisabetta Aloisi,23 Antonio Costanzo24,25 On behalf of the SUPREME Study Group1Dermatology, University of Rome Tor Vergata, Rome, Italy; 2Department of Medical, Surgical and Neurological Science, Dermatology Section, University of Siena, S. Maria alle Scotte Hospital, Siena, Italy; 3Dermatology Unit, Hospital “Bianchi Melacrino Morelli”, Reggio, Calabria, Italy; 4Department of Dermatology, Papardo Hospital, Messina, Italy; 5Section of Dermatology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 6Dermatologic Clinic of Terni, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 7U.O. Dermatologia, Fondazione IRCCS Ca’ Granda - Ospedale Maggiore Policlinico, Milano, Italy; 8Di.S.Sal. Section of Dermatology, Ospedale Policlinico San Martino, University of Genova, Genova GE, 16132, Italy; 9UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy; 10Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy; 11Psocare Unit, I.R.C.C.S Policlinico San Donato, Milano, Italy; 12Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 13Dermatology, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy; 14Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Torino, Torino, Italy; 15Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy; 16Dermatology Department, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy; 17Dermatology Unit “Daniele Innocenzi”, Department of Medico-Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome – Polo Pontino, Latina, Italy; 18Dermatology Unit, Department of Medicine, University of Roma, Roma, Italy; 19Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy; 20Department of Dermatology, University of Trieste, Trieste, Italy; 21Dermatology and Cosmetology Unit - San Raffaele Hospital, Milan, Italy; 22Department of Health Sciences, Dermatology Clinic, University of Firenze, Firenze, Italy; 23Novartis Farma SpA, Origgio, Italy; 24Unit of Dermatology, IRCCS Humanitas Research Hospital, Milano, Italy; 25Department of Biomedical Sciences, Humanitas University, Milano, ItalyCorrespondence: Marina Talamonti, Dermatology-Department of Systems Medicine, University of Rome Tor Vergata, PTV – Policlinico Tor Vergata, V.le Oxford 81, Rome, 00133, Italy, Tel +39 0620902743, Fax +39 0620902742, Email talamonti.marina@gmail.comPurpose: Secukinumab is a fully human monoclonal antibody that inhibits interleukin (IL)-17A approved for the treatment of moderate to severe plaque psoriasis in adults and children. We compared the efficacy and safety of secukinumab in patients aged < 65 years (adult patients) versus patients aged ≥ 65 years (elderly patients) in a post-hoc analysis of the SUPREME study.Patients and Methods: Patients with moderate to severe plaque psoriasis received subcutaneous secukinumab 300 mg per week for the first 5 weeks, then 300 mg per month. We compared the following outcomes in patients aged ≥ 65 years vs < 65 years: baseline characteristics; PASI50/75/90/100 response rates (improvements ≥ 50%/75%/90%/100% in Psoriasis Area and Severity Index (PASI) from baseline); changes in Dermatology Life Quality Index (DLQI); Hospital Anxiety and Depression Scale (HAD-A, HAD-D) score changes; treatment-emergent adverse events (TEAEs).Results: Secukinumab was slightly less effective in elderly patients than in adult patients (response rates at week 16: PASI90, 69.4% vs 80.9%, p = 0.4528; PASI100, 44.4% vs 56.7%, p = 0.8973). Elderly and adult patients showed a similar time course of changes in absolute PASI scores. Patients aged ≥ 65 years had a statistically significantly lower improvement in quality of life (mean DLQI reduction) than patients aged < 65 years at week 16 [− 5.4 (± 4.3) vs − 8.8 (± 6.9), p = 0.0065] and at week 24 [− 5.3 (± 4.4) vs − 9.2 (± 7.1), p = 0.0038]. Secukinumab treatment resulted in comparable mean reductions in anxiety and depression scores in both cohorts at 24 weeks [HAD-A, − 1.3 (± 3.3) vs − 2.1 (± 3.8), p = 0.9004; HAD-D, − 1.0 (± 3.3) vs − 1.5 (± 3.1), p = 0.4598]. The frequency of TEAEs in the two cohorts was similar (16.7% vs 14.6%, p = 0.7391).Conclusion: Secukinumab is a valid option for the management of moderate to severe psoriasis in elderly patients.Keywords: psoriasis, biologics, interleukin-17A, secukinumab, elderly

Published
2023

3. Efficacy of Secukinumab in Psoriasis: Post Hoc Gender-Wise Analysis of the SUPREME Study

Author

Stingeni L, Malara G, Conti A, Di Costanzo L, Carrera CG, Burlando M, Malagoli P, Musumeci ML, Bardazzi F, Brazzelli V, Amerio P, De Simone C, Trevisini S, Balato A, Megna M, Loconsole F, De Felice C, Bartezaghi M, Rausa A, Aloisi E, Orsenigo R, and Costanzo A

Subjects
plaque psoriasis, pasi, patient-reported outcomes, dermatology quality of life index, hospital anxiety and depression scale, Dermatology, RL1-803
Abstract

Luca Stingeni,1 Giovanna Malara,2,3 Andrea Conti,4 Luisa Di Costanzo,5 Carlo Giovanni Carrera,6 Martina Burlando,7 Piergiorgio Malagoli,8 Maria Letizia Musumeci,9 Federico Bardazzi,10 Valeria Brazzelli,11 Paolo Amerio,12 Clara De Simone,13,14 Sara Trevisini,15 Anna Balato,16 Matteo Megna,17 Francesco Loconsole,18 Catia De Felice,19 Marta Bartezaghi,20 Alice Rausa,20 Elisabetta Aloisi,20 Roberto Orsenigo,20 Antonio Costanzo21,22 On behalf of the SUPREME Study Group1Dermatology Section, Medical and Surgical Department, University of Perugia, Perugia, Italy; 2Dermatology Unit, Hospital “Bianchi Melacrino Morelli”, Reggio Calabria, Italy; 3Department of Dermatology, Papardo Hospital, Messina, Italy; 4Dermatologic Unit, Department of Surgery, Infermi Hospital, AUSL Romagna, Rimini, Italy; 5Department of Dermatology, “Gaetano Rummo” Hospital, Benevento UOC Dermatologia, AO G. Rummo, Benevento, Italy; 6U.O. Dermatologia, Fondazione IRCCS Ca’ Granda - Ospedale Maggiore Policlinico, Milano, Italy; 7IRCCS San Martino Polyclinic Hospital, Di.S.Sal. Section of Dermatology, Genoa, Italy; 8Dermatology Unit IRCCS Policlinico San Donato, Milan, Italy; 9Dermatology Clinic, University of Catania, Catania, Italy; 10Division of Dermatology, University Hospital Policlinico “S. Orsola-Malpighi”, Bologna, Italy; 11Institute of Dermatology, Foundation IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy; 12Dermatologic Clinic, G. D’Annunzio University, Chieti, Italy; 13Istituto di Dermatologia, Università Cattolica del Sacro Cuore, Rome, Italy; 14Fondazione Policlinico Universitario A. Gemelli – IRCCS, Rome, Italy; 15Dermatology Department, University of Trieste, Trieste, Italy; 16Dermatology Unit, University of Campania “Luigi Vanvitelli”, Naples, Italy; 17Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 18Department of Biomedical Sciences and Human Oncology, University of Bari, Bari, Italy; 19Department of Clinical Dermatology, Centre for the Study and Treatment of Psoriasis, San Gallicano Dermatological Institute, IRCCS, Rome, Italy; 20Novartis Farma SpA, Origgio, Italy; 21Unit of Dermatology, IRCCS Humanitas Research Hospital, Milan, Italy; 22Department of Biomedical Sciences, Humanitas University, Milan, ItalyCorrespondence: Luca Stingeni, Dermatology Section, Medical and Surgical Department, University of Perugia, Perugia, Italy, Tel +39075-5783881, Email luca.stingeni@unipg.itPurpose: Psoriasis, a common systemic inflammatory disorder, presents with gender-related differences in the quality of life (QoL) and treatment outcomes. This post hoc analysis from the Phase 3b SUPREME study explored gender-related differences in patient characteristics and efficacy of secukinumab 300 mg on Psoriasis Area and Severity Index (PASI) 75/90/100 and impact on QoL using the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis through week 24.Patients and Methods: The proportion of patients achieving PASI 75/90/100 was computed using a nonresponder imputation approach. Differences between cohorts were analyzed using a logistic regression model. The mean change from baseline in DLQI was computed using the Wilcoxon test.Results: Among the 433 patients (males: 71.6%), females had a higher DLQI than males at baseline (13.1 vs 9.5; P< 0.0001). Males had a slightly higher response for PASI 90 than females at week 16 (80.7% vs 78.1%; P=0.0779) and 24 (83.2% vs 79.7%; P=0.0319). No differences were observed between genders in PASI 100/75 responses at week 24. Both genders showed an improvement in DLQI with secukinumab at week 24 (− 10.9 vs − 8.1, respectively, in females vs males; P=0.0004).Conclusion: In summary, secukinumab was effective in the treatment of psoriasis, irrespective of gender.Keywords: plaque psoriasis, PASI, patient-reported outcomes, Dermatology Quality of Life Index, Hospital Anxiety and Depression Scale

Published
2023

4. Long‐term effectiveness and tolerability of apremilast in patients with moderate‐to‐severe plaque psoriasis: A 5‐year multicentre retrospective study—IL PSO (Italian landscape psoriasis).

Author

Gargiulo, L., Ibba, L., Malagoli, P., Amoruso, F., Balato, A., Bardazzi, F., Burlando, M., Carrera, C. G., Dapavo, P., Dini, V., Gaiani, F. M., Girolomoni, G., Guarneri, C., Lasagni, C., Loconsole, F., Marzano, A. V., Maurelli, M., Megna, M., Travaglini, M., and Costanzo, A.

Subjects
ORAL drug administration, COMORBIDITY, ANTIRHEUMATIC agents, APREMILAST, ELECTRONIC health records
Abstract

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]

Published
2024
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5. Comparative effectiveness of tildrakizumab 200 mg versus tildrakizumab 100 mg in psoriatic patients with high disease burden or above 90 kg of body weight: a 16-week multicenter retrospective study - IL PSO (Italian landscape psoriasis)

Author

Gargiulo, L, Ibba, L, Cascio Ingurgio, R, Malagoli, P, Amoruso, F, Balato, A, Bardazzi, F, Brianti, P, Brunasso, G, Burlando, M, Cagni, A, Caproni, M, Carrera, C, Carugno, A, Caudullo, F, Cuccia, A, Dapavo, P, Di Brizzi, E, Dini, V, Gaiani, F, Gisondi, P, Guarneri, C, Lasagni, C, Licata, G, Loconsole, F, Marzano, A, Megna, M, Mercuri, S, Musumeci, M, Orsini, D, Ribero, S, Ruffo Di Calabria, V, Satolli, F, Strippoli, D, Travaglini, M, Trovato, E, Venturini, M, Zichichi, L, Valenti, M, Costanzo, A, Narcisi, A, Gargiulo, Luigi, Ibba, Luciano, Cascio Ingurgio, Ruggero, Malagoli, Piergiorgio, Amoruso, Fabrizio, Balato, Anna, Bardazzi, Federico, Brianti, Pina, Brunasso, Giovanna, Burlando, Martina, Cagni, Anna E, Caproni, Marzia, Carrera, Carlo G, Carugno, Andrea, Caudullo, Francesco, Cuccia, Aldo, Dapavo, Paolo, Di Brizzi, Eugenia V, Dini, Valentina, Gaiani, Francesca M, Gisondi, Paolo, Guarneri, Claudio, Lasagni, Claudia, Licata, Gaetano, Loconsole, Francesco, Marzano, Angelo V, Megna, Matteo, Mercuri, Santo R, Musumeci, Maria L, Orsini, Diego, Ribero, Simone, Ruffo Di Calabria, Valentina, Satolli, Francesca, Strippoli, Davide, Travaglini, Massimo, Trovato, Emanuele, Venturini, Marina, Zichichi, Leonardo, Valenti, Mario, Costanzo, Antonio, Narcisi, Alessandra, Gargiulo, L, Ibba, L, Cascio Ingurgio, R, Malagoli, P, Amoruso, F, Balato, A, Bardazzi, F, Brianti, P, Brunasso, G, Burlando, M, Cagni, A, Caproni, M, Carrera, C, Carugno, A, Caudullo, F, Cuccia, A, Dapavo, P, Di Brizzi, E, Dini, V, Gaiani, F, Gisondi, P, Guarneri, C, Lasagni, C, Licata, G, Loconsole, F, Marzano, A, Megna, M, Mercuri, S, Musumeci, M, Orsini, D, Ribero, S, Ruffo Di Calabria, V, Satolli, F, Strippoli, D, Travaglini, M, Trovato, E, Venturini, M, Zichichi, L, Valenti, M, Costanzo, A, Narcisi, A, Gargiulo, Luigi, Ibba, Luciano, Cascio Ingurgio, Ruggero, Malagoli, Piergiorgio, Amoruso, Fabrizio, Balato, Anna, Bardazzi, Federico, Brianti, Pina, Brunasso, Giovanna, Burlando, Martina, Cagni, Anna E, Caproni, Marzia, Carrera, Carlo G, Carugno, Andrea, Caudullo, Francesco, Cuccia, Aldo, Dapavo, Paolo, Di Brizzi, Eugenia V, Dini, Valentina, Gaiani, Francesca M, Gisondi, Paolo, Guarneri, Claudio, Lasagni, Claudia, Licata, Gaetano, Loconsole, Francesco, Marzano, Angelo V, Megna, Matteo, Mercuri, Santo R, Musumeci, Maria L, Orsini, Diego, Ribero, Simone, Ruffo Di Calabria, Valentina, Satolli, Francesca, Strippoli, Davide, Travaglini, Massimo, Trovato, Emanuele, Venturini, Marina, Zichichi, Leonardo, Valenti, Mario, Costanzo, Antonio, and Narcisi, Alessandra

Abstract

Purpose: Tildrakizumab is a selective inhibitor of IL-23 approved for the treatment of moderate-to-severe plaque psoriasis in two dosages. We conducted a 16-week multicenter retrospective study to compare the effectiveness and safety of tildrakizumab 200 mg versus tildrakizumab 100 mg in patients with a high disease burden or high body weight. Materials and methods: Our retrospective study included 134 patients treated with tildrakizumab 200 mg and 364 patients treated with tildrakizumab 100 mg from 28 Italian Dermatology Units affected by moderate-to-severe plaque psoriasis. The patients had a body weight above 90 kg or a high disease burden (Psoriasis Area and Severity Index [PASI] ≥ 16 or the involvement of difficult-to-treat areas). We evaluated the effectiveness of tildrakizumab at the week-16 visit in terms of PASI90, PASI100 and absolute PASI ≤ 2. Results: After 16 weeks of treatment with tildrakizumab 200 mg, PASI90 was reached by 57.5% of patients and PASI100 by 39.6% of patients. At the same time point, 34.3% and 24.2% of patients treated with tildrakizumab 100 mg achieved PASI90 and PASI100, respectively. Conclusions: Our data suggest that tildrakizumab 200 mg has better effectiveness than tildrakizumab 100 mg in patients with a body weight ≥ 90 kg and a high disease burden.

Published
2024

7. Autoimmune Bullous Disorders induced by Cyclin-Dependent Kinase 4/6 inhibitors – first case series from the EADV Task Force “Dermatology for Cancer Patients”

Author

Ortiz Brugués, A., primary, Sollena, P., additional, Starace, M., additional, Bardazzi, F., additional, Koumaki, D., additional, Apalla, Z., additional, Iorizzo, M., additional, Bost, C., additional, Milesi, S., additional, Lacaze, J.L., additional, Peris, K., additional, and Sibaud, V., additional

Published
2024
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9. PsoBioVax: A multicentric Italian case–control study of the immunological response to anti‐SARS‐CoV‐2 vaccine among psoriatic patients under biological therapy

Author

Sacchelli, L., primary, Filippi, F., additional, Balato, A., additional, Balestri, R., additional, Bellinato, F., additional, Bernardini, N., additional, Bianchi, L., additional, Burlando, M., additional, Campanati, A., additional, Chessa, M. A., additional, Corazza, M., additional, Di Cesare, A., additional, Di Lernia, V., additional, Diotallevi, F., additional, Esposito, M., additional, Fargnoli, M. C., additional, Gisondi, P., additional, Giunta, A., additional, Hansel, K., additional, Magnano, M., additional, Megna, M., additional, Odorici, G., additional, Prignano, F., additional, Potenza, C., additional, Rech, G., additional, Rovesti, M., additional, Ruggiero, A., additional, Satolli, F., additional, Stingeni, L., additional, Gibertoni, D., additional, and Bardazzi, F., additional

Published
2023
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10. Biologics in psoriatic patients with malignancies: Where are we now? An Italian multicentric study.

Author

Magnano, M., Balestri, R., Gisondi, P., Bardazzi, F., Di Lernia, V., Ioris, T., Girardelli, C. R., and Rech, G.

Abstract

This article explores the use of biologics in psoriatic patients who have had a malignancy. While there are concerns about the safety of biologics in psoriasis, their use in oncologic patients is still uncertain. Guidelines recommend avoiding biologics in individuals with a current or recent malignancy, unless it has been treated more than 5 years ago. However, biologics may be considered in patients with severe psoriasis and a recent malignancy diagnosis. The article presents the findings of a study conducted in Italy, which evaluated the impact of a cancer diagnosis in psoriatic patients treated with biologics. The study analyzed three groups of patients and found that restarting biologic therapy after a cancer diagnosis did not significantly increase the risk of cancer recurrence. The study suggests that biologics can be considered as a treatment option for patients with a history of malignancy, but more research is needed. [Extracted from the article]

Published
2024
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12. Clinical course and therapeutic management of juvenile pemphigus vulgaris: A retrospective analysis from an Italian referral centre.

Author

Filippi, F., Loi, C., Chessa, M. A., Sacchelli, L., Gabusi, A., Gissi, D. B., and Bardazzi, F.

Subjects
PEMPHIGUS vulgaris, PEMPHIGUS, RETROSPECTIVE studies, CHILD patients
Abstract

This article provides a retrospective analysis of the clinical course and therapeutic management of juvenile pemphigus vulgaris (PV) at an Italian referral center. The study included five Caucasian female patients with a mean age of 15.4 years at diagnosis. The patients were treated with rituximab, a monoclonal antibody, and all achieved a complete clinical response without any side effects. The study suggests that rituximab is an effective and safe treatment option for juvenile PV, although further research is needed to validate its use as a first-line option. [Extracted from the article]

Published
2024
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13. A risankizumab super responder profile identified by long‐term real‐life observation‐IL PSO (ITALIAN LANDSCAPE PSORIASIS)

Author

Gargiulo, L., primary, Ibba, L., additional, Malagoli, P., additional, Amoruso, F., additional, Argenziano, G., additional, Balato, A., additional, Bardazzi, F., additional, Burlando, M., additional, Carrera, C. G., additional, Damiani, G., additional, Dapavo, P., additional, Dini, V., additional, Fabbrocini, G., additional, Franchi, C., additional, Gaiani, F. M., additional, Girolomoni, G., additional, Guarneri, C., additional, Lasagni, C., additional, Loconsole, F., additional, Marzano, A. V., additional, Maurelli, M., additional, Megna, M., additional, Orsini, D., additional, Sampogna, F., additional, Travaglini, M., additional, Valenti, M., additional, Costanzo, A., additional, and Narcisi, A., additional

Published
2023
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14. A risankizumab super responder profile identified by long‐term real‐life observation‐IL PSO (ITALIAN LANDSCAPE PSORIASIS).

Author

Gargiulo, L., Ibba, L., Malagoli, P., Amoruso, F., Argenziano, G., Balato, A., Bardazzi, F., Burlando, M., Carrera, C. G., Damiani, G., Dapavo, P., Dini, V., Fabbrocini, G., Franchi, C., Gaiani, F. M., Girolomoni, G., Guarneri, C., Lasagni, C., Loconsole, F., and Marzano, A. V.

Subjects
PSORIASIS, PATIENT experience, PATIENTS' attitudes
Abstract

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]

Published
2024
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16. 032 Immunogenicity of biologic therapies in psoriasis

Author

Di Caprio, R., primary, Sacchelli, L., additional, Di Spigna, G., additional, Ricciardone, M., additional, Bardazzi, F., additional, Ladogana, P., additional, Scala, E., additional, Covelli, B., additional, Balato, A., additional, and Postiglione, L., additional

Published
2023
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17. Brodalumab for the Treatment of Moderate-to-Severe Psoriasis: An Expert Delphi Consensus Statement

Author

Fargnoli, Maria Concetta, Bardazzi, F., Bianchi, L., Dapavo, P., Fabbrocini, G., Gisondi, P., Micali, G., Offidani, A. M., Pellacani, G., Skroza, N., Angileri, R. G., Burlando, M., Campanati, A., Carrera, C. G., Chiricozzi, Andrea, Conti, A., Simone, C. D., Di Lernia, V., Errichetti, E., Galluzzo, M., Guarneri, C., Lasagni, C., Lembo, S., Loconsole, F., Megna, M., Musumeci, M. L., Prignano, F., Richetta, A. G., Trovato, E., Venturini, M., Peris, Ketty, Pinton, P. C., Fargnoli M. C., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Fargnoli, Maria Concetta, Bardazzi, F., Bianchi, L., Dapavo, P., Fabbrocini, G., Gisondi, P., Micali, G., Offidani, A. M., Pellacani, G., Skroza, N., Angileri, R. G., Burlando, M., Campanati, A., Carrera, C. G., Chiricozzi, Andrea, Conti, A., Simone, C. D., Di Lernia, V., Errichetti, E., Galluzzo, M., Guarneri, C., Lasagni, C., Lembo, S., Loconsole, F., Megna, M., Musumeci, M. L., Prignano, F., Richetta, A. G., Trovato, E., Venturini, M., Peris, Ketty, Pinton, P. C., Fargnoli M. C., Chiricozzi A. (ORCID:0000-0002-6739-0387), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against interleukin-17RA that has been approved for the treatment of moderate-to-severe psoriasis in Europe. We developed a Delphi consensus document focused on brodalumab for the treatment of moderate-to-severe psoriasis. Based on published literature and their clinical experience a steering committee drafted 17 statements covering 7 domains specific to the treatment of moderate-to-severe psoriasis with brodalumab. A panel of 32 Italian dermatologists indicated their level of agreement using a 5-point Likert scale (from 1 = “strongly disagree” to 5 = “strongly agree”) using an online modified Delphi method. After the first round of voting (32 participants), positive consensus was reached for 15/17 (88.2%) of the proposed statements. Following a face-to-face virtual meeting, the steering committee decided that 5 statements would form “main principles” and 10 statements formed the final list. After a second round of voting, consensus was reached in 4/5 (80%) of the main principles and 8/10 (80%) for consensus statements. The final list of 5 main principles and 10 consensus statements identify key indications specific to the use of brodalumab in the treatment of moderate-to-severe psoriasis in Italy. These statements aid dermatologists in the management of patients with moderate-to-severe psoriasis.

Published
2023

18. Long-Term Drug Survival and Effectiveness of Secukinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: 42-Month Results from the SUPREME 2.0 Study

Author

Russo, F, Galluzzo, M, Stingeni, L, Persechino, S, Zichichi, L, Conti, A, Giofrè, C, Dini, V, Vispi, M, Atzori, L, Cattaneo, A, Parodi, A, Bardazzi, F, Stinco, G, Dapavo, P, Girolomoni, G, Musumeci, M, Papini, M, Venturini, M, Dastoli, S, Di Nuzzo, S, Fargnoli, M, Pagnanelli, G, Bernardini, N, Gambini, D, Malagoli, P, Mazzatenta, C, Peris, K, Zalaudek, I, Fabbrocini, G, Loconsole, F, Vassallo, C, Pietroleonardo, L, Prignano, F, Franchi, C, Offidani, A, Bonifati, C, Di Lernia, V, Gigante, G, Bartezaghi, M, Franchi, M, Ursoleo, P, Aloisi, E, Russo, Filomena, Galluzzo, Marco, Stingeni, Luca, Persechino, Severino, Zichichi, Leonardo, Conti, Andrea, Giofrè, Claudia, Dini, Valentina, Vispi, Martina, Atzori, Laura, Cattaneo, Angelo, Parodi, Aurora, Bardazzi, Federico, Stinco, Giuseppe, Dapavo, Paolo, Girolomoni, Giampiero, Musumeci, Maria Letizia, Papini, Manuela, Venturini, Marina, Dastoli, Stefano, Di Nuzzo, Sergio, Fargnoli, Maria Concetta, Pagnanelli, Gianluca, Bernardini, Nicoletta, Gambini, Daniele, Malagoli, Piergiorgio, Mazzatenta, Carlo, Peris, Ketty, Zalaudek, Iris, Fabbrocini, Gabriella, Loconsole, Francesco, Vassallo, Camilla, Pietroleonardo, Lucia, Prignano, Francesca, Franchi, Chiara, Offidani, Anna Maria, Bonifati, Claudio, Di Lernia, Vito, Gigante, Giovanni, Bartezaghi, Marta, Franchi, Matteo, Ursoleo, Paola, Aloisi, Elisabetta, Russo, F, Galluzzo, M, Stingeni, L, Persechino, S, Zichichi, L, Conti, A, Giofrè, C, Dini, V, Vispi, M, Atzori, L, Cattaneo, A, Parodi, A, Bardazzi, F, Stinco, G, Dapavo, P, Girolomoni, G, Musumeci, M, Papini, M, Venturini, M, Dastoli, S, Di Nuzzo, S, Fargnoli, M, Pagnanelli, G, Bernardini, N, Gambini, D, Malagoli, P, Mazzatenta, C, Peris, K, Zalaudek, I, Fabbrocini, G, Loconsole, F, Vassallo, C, Pietroleonardo, L, Prignano, F, Franchi, C, Offidani, A, Bonifati, C, Di Lernia, V, Gigante, G, Bartezaghi, M, Franchi, M, Ursoleo, P, Aloisi, E, Russo, Filomena, Galluzzo, Marco, Stingeni, Luca, Persechino, Severino, Zichichi, Leonardo, Conti, Andrea, Giofrè, Claudia, Dini, Valentina, Vispi, Martina, Atzori, Laura, Cattaneo, Angelo, Parodi, Aurora, Bardazzi, Federico, Stinco, Giuseppe, Dapavo, Paolo, Girolomoni, Giampiero, Musumeci, Maria Letizia, Papini, Manuela, Venturini, Marina, Dastoli, Stefano, Di Nuzzo, Sergio, Fargnoli, Maria Concetta, Pagnanelli, Gianluca, Bernardini, Nicoletta, Gambini, Daniele, Malagoli, Piergiorgio, Mazzatenta, Carlo, Peris, Ketty, Zalaudek, Iris, Fabbrocini, Gabriella, Loconsole, Francesco, Vassallo, Camilla, Pietroleonardo, Lucia, Prignano, Francesca, Franchi, Chiara, Offidani, Anna Maria, Bonifati, Claudio, Di Lernia, Vito, Gigante, Giovanni, Bartezaghi, Marta, Franchi, Matteo, Ursoleo, Paola, and Aloisi, Elisabetta

Abstract

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.

Published
2023

19. Profile of tofacitinib citrate and its potential in the treatment of moderate-to-severe chronic plaque psoriasis

Author

Di Lernia V and Bardazzi F

Subjects
psoriasis, treatment, therapy, systemic, tofacitinib., Therapeutics. Pharmacology, RM1-950
Abstract

V Di Lernia,1 F Bardazzi2 1Dermatology Unit, Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia, 2Division of Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy Abstract: The outlook for patients with psoriasis has improved significantly over the last 10 years with the introduction of targeted therapies. Cytokines exert their effects by activating intracellular signaling and transcription pathways, among which there are Janus kinases (JAKs) and signal transducers and activators of transcription (STAT) pathways. JAKs are intracellular second messengers that are crucial for transmitting extracellular cytokine signals to the cell. JAK inhibition interrupts intracellular signaling and can suppress immune cell activation and inflammation in T-cell-mediated disorders, such as psoriasis. Consequently, JAKs are the subject of intensive research activity, since they represent possible therapeutic targets. Tofacitinib is an orally available compound belonging to a novel category of nonbiologic drugs, the “JAK inhibitors”, which target JAKs. Recently, oral and topical formulations of tofacitinib have been demonstrated to be safe and effective for the treatment of plaque psoriasis in randomized clinical trials. In particular, a 10 mg bid dose of tofacitinib was shown to be noninferior to etanercept 50 mg subcutaneously twice weekly. Questions remain unresolved regarding the safety risk beyond the 5 mg bid dose. This review, assessing the available scientific literature, focuses on the profile of tofacitinib, as investigational compound in the treatment of plaque psoriasis. An overview of the efficacy and safety data from randomized clinical trials is provided. In addition, the authors highlight future potential applications of tofacitinib in other skin diseases, in particular alopecia areata and vitiligo. Keywords: treatment, therapy, systemic, JAKs, vitiligo, alopecia

Published
2016

21. Prevalence of acute and chronic viral seropositivity and characteristics of disease in patients with psoriatic arthritis treated with cyclosporine: a post hoc analysis from a sex point of view on the observational study of infectious events in psoriasis complicated by active psoriatic arthritis

Author

Colombo D, Chimenti S, Grossi PA, Marchesoni A, Bardazzi F, Ayala F, Simoni L, Vassellatti D, and Bellia G

Subjects
Gender medicine, psoriatic arthritis, cyclosporine, viral infections, Dermatology, RL1-803
Abstract

Delia Colombo,1 Sergio Chimenti,2 Paolo Antonio Grossi,3 Antonio Marchesoni,4 Federico Bardazzi,5 Fabio Ayala,6 Lucia Simoni,7 Donatella Vassellatti,1 Gilberto Bellia1 On behalf of SYNERGY Study Group 1Novartis Farma Italia, Origgio (VA), 2Tor Vergata Polyclinic Rome, 3Macchi Hospital and Foundation, Varese, 4Orthopaedic Institute Pini, Milan, 5S Orsola-Malpighi Polyclinic, Bologna, 6University Federico II Naples, 7MediData srl, Modena, Italy Background: Sex medicine studies have shown that there are sex differences with regard to disease characteristics in immune-mediated inflammatory diseases, including psoriasis, in immune response and susceptibility to viral infections. We performed a post hoc analysis of the Observational Study of infectious events in psoriasis complicated by active psoriatic arthritis (SYNERGY) study in patients with psoriatic arthritis (PsA) treated with immunosuppressive regimens including cyclosporine, in order to evaluate potential between-sex differences in severity of disease and prevalence of viral infections.Methods: SYNERGY was an observational study conducted in 24 Italian dermatology clinics, which included 238 consecutively enrolled patients with PsA, under treatment with immunosuppressant regimens including cyclosporin A. In this post hoc analysis, patients' demographical data and clinical characteristics of psoriasis, severity and activity of PsA, prevalence of seropositivity for at least one viral infection, and treatments administered for PsA and infections were compared between sexes.Results: A total of 225 patients were evaluated in this post hoc analysis, and 121 (54%) were males. Demographic characteristics and concomitant diseases were comparable between sexes. Statistically significant sex differences were observed at baseline in Psoriasis Area and Severity Index score (higher in males), mean number of painful joints, Bath Ankylosing Spondylitis Disease Activity Index, and the global activity of disease assessed by patients (all higher in females). The percentage of patients with at least one seropositivity detected at baseline, indicative of concomitant or former viral infection, was significantly higher among women than among men. No between-sex differences were detected in other measures, at other time points, and in treatments. Patients developed no hepatitis B virus or hepatitis C virus reactivation during cyclosporine treatment.Conclusion: Our post hoc sex analysis suggests that women with PsA have a greater articular involvement and a higher activity of disease compared to males. Immunosuppressive treatment with cyclosporine seems not to increase susceptibility to new infections or infectious reactivations, with no sex differences. Keywords: psoriatic arthritis, sex, viral infections, SYNERGY, cyclosporine

Published
2015

22. Mortality and prognostic factors in patients with bullous pemphigoid: a retrospective multicenter Italian study

Author

Bardazzi, F., primary, Filippi, F., additional, Chessa, M.A., additional, Iommi, M., additional, Loi, C., additional, Campanati, A., additional, Rizzetto, G., additional, Tagliati, C., additional, Atzori, L., additional, Muratori, S., additional, Genovese, G., additional, Gisondi, P., additional, Schena, D., additional, Balestri, R., additional, Rech, G., additional, Feliciani, C., additional, Lasagni, C., additional, Bigi, L., additional, De Simone, C., additional, Di Zenzo, G., additional, Moro, F., additional, Borghi, A., additional, Di Lernia, V., additional, D'Arrigo, G., additional, Tripepi, G., additional, Gori, M., additional, and Pitino, A., additional

Published
2022
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23. Diagnosis and management of cutaneous and anogenital lichen sclerosus: Recommendations from the Italian Society of Dermatology (SIDemaSt)

Author

Papini, M, Russo, A, Simonetti, O, Borghi, A, Corazza, M, Piaserico, S, Feliciani, C, Calzavara-Pinton, P, Amendolagine, G, Arisi, M, Babino, G, Bardazzi, F, Belloni Fortina, A, Cac-Cavale, S, Campanati, A, Campione, E, Caposiena, C, Carugno, A, Coati, I, Cinotti, E, D'Antuono, A, Dattola, A, Dika, E, Fai, D, Fusano, M, Galluzzo, M, Ganzetti, G, Gisondi, P, Hansel, K, Lora, V, Maione, V, Mandel, V, Menni, S, Negosanti, M, Neri, I, Offidani, A, Parodi, A, Patrizi, A, Peserico, A, Rossi, M, Rivetti, N, Saccani, E, Stan, T, Stingeni, L, Talamonti, M, Vascellaro, A, Vezzoli, P, Virgili, A, Zanca, A, Papini M., Russo A., Simonetti O., Borghi A., Corazza M., Piaserico S., Feliciani C., Calzavara-Pinton P., Amendolagine G., Arisi M., Babino G., Bardazzi F., Belloni Fortina A., Cac-Cavale S., Campanati A., Campione E., Caposiena C. D., Carugno A., Coati I., Cinotti E., D'Antuono A., Dattola A., Dika E., Fai D., Fusano M., Galluzzo M., Ganzetti G., Gisondi P., Hansel K., Lora V., Maione V., Mandel V. D., Menni S., Negosanti M., Neri I., Offidani A., Parodi A., Patrizi A., Peserico A., Rossi M., Rivetti N., Saccani E., Stan T. R., Stingeni L., Talamonti M., Vascellaro A., Vezzoli P., Virgili A., Zanca A., Papini, M, Russo, A, Simonetti, O, Borghi, A, Corazza, M, Piaserico, S, Feliciani, C, Calzavara-Pinton, P, Amendolagine, G, Arisi, M, Babino, G, Bardazzi, F, Belloni Fortina, A, Cac-Cavale, S, Campanati, A, Campione, E, Caposiena, C, Carugno, A, Coati, I, Cinotti, E, D'Antuono, A, Dattola, A, Dika, E, Fai, D, Fusano, M, Galluzzo, M, Ganzetti, G, Gisondi, P, Hansel, K, Lora, V, Maione, V, Mandel, V, Menni, S, Negosanti, M, Neri, I, Offidani, A, Parodi, A, Patrizi, A, Peserico, A, Rossi, M, Rivetti, N, Saccani, E, Stan, T, Stingeni, L, Talamonti, M, Vascellaro, A, Vezzoli, P, Virgili, A, Zanca, A, Papini M., Russo A., Simonetti O., Borghi A., Corazza M., Piaserico S., Feliciani C., Calzavara-Pinton P., Amendolagine G., Arisi M., Babino G., Bardazzi F., Belloni Fortina A., Cac-Cavale S., Campanati A., Campione E., Caposiena C. D., Carugno A., Coati I., Cinotti E., D'Antuono A., Dattola A., Dika E., Fai D., Fusano M., Galluzzo M., Ganzetti G., Gisondi P., Hansel K., Lora V., Maione V., Mandel V. D., Menni S., Negosanti M., Neri I., Offidani A., Parodi A., Patrizi A., Peserico A., Rossi M., Rivetti N., Saccani E., Stan T. R., Stingeni L., Talamonti M., Vascellaro A., Vezzoli P., Virgili A., and Zanca A.

Abstract

Lichen sclerosus (LS) is a disabling chronic inflammatory disease of skin and genital mucous membrane causing itch, pain, dysuria and restriction of micturition, and significant sexual dysfunction and dyspareunia both in women and men. If left untreated, LS is associated with a high degree of sclerosis and scarring, as well as with an elevated risk of cancer in the genital area. Although a central role of autoimmunity is suggested, the pathogenesis of LS is still not clearly understood and the disease remains difficult to treat. The goals of treatment of LS are to alleviate symptoms and discomfort, prevent anatomical changes and prevent malignant transformation. this guideline has been developed by an Italian group of experts. It summarizes evidence-based and expert- based recommendations. The highest level of evidence favors the use of topical high potency corticosteroids; second- and third-line treatments include topical calcineurin inhibitors and topical retinoids, respectively. Surgical treatment has become the treatment of choice in male genital LS with persistent phimosis not responsive to medical treatment. The aim of this paper is to offer evidence-based and easily applicable recommendations for the management of lS.

Published
2021

24. Characteristic of chronic plaque psoriasis patients treated with biologics in Italy during the COVID-19 Pandemic: Risk analysis from the PSO-BIO-COVID observational study

Author

Talamonti, M, Galluzzo, M, Chiricozzi, A, Quaglino, P, Fabbrocini, G, Gisondi, P, Marzano, A, Potenza, C, Conti, A, Parodi, A, Piaserico, S, Bardazzi, F, Argenziano, G, Rongioletti, F, Stingeni, L, Micali, G, Loconsole, F, Rossi, M, Bongiorno, M, Feliciani, C, Rubegni, P, Amerio, P, Fargnoli, M, Pigatto, P, Savoia, P, Nisticò, S, Giustini, S, Carugno, A, Cannavo’, S, Rech, G, Prignano, F, Offidani, A, Lombardo, M, Zalaudek, I, Bianchi, L, Peris, K, Talamonti, M., Galluzzo, M., Chiricozzi, A., Quaglino, P., Fabbrocini, G., Gisondi, P., Marzano, A. V., Potenza, C., Conti, A., Parodi, A., Piaserico, S., Bardazzi, F., Argenziano, G., Rongioletti, F., Stingeni, L., Micali, G., Loconsole, F., Rossi, M. T., Bongiorno, M. R., Feliciani, C., Rubegni, P., Amerio, P., Fargnoli, M. C., Pigatto, P., Savoia, P., Nisticò, S. P., Giustini, S., Carugno, A., Cannavo’, S. P., Rech, G., Prignano, F., Offidani, A., Lombardo, M., Zalaudek, I., Bianchi, L., Peris, K., Talamonti, M, Galluzzo, M, Chiricozzi, A, Quaglino, P, Fabbrocini, G, Gisondi, P, Marzano, A, Potenza, C, Conti, A, Parodi, A, Piaserico, S, Bardazzi, F, Argenziano, G, Rongioletti, F, Stingeni, L, Micali, G, Loconsole, F, Rossi, M, Bongiorno, M, Feliciani, C, Rubegni, P, Amerio, P, Fargnoli, M, Pigatto, P, Savoia, P, Nisticò, S, Giustini, S, Carugno, A, Cannavo’, S, Rech, G, Prignano, F, Offidani, A, Lombardo, M, Zalaudek, I, Bianchi, L, Peris, K, Talamonti, M., Galluzzo, M., Chiricozzi, A., Quaglino, P., Fabbrocini, G., Gisondi, P., Marzano, A. V., Potenza, C., Conti, A., Parodi, A., Piaserico, S., Bardazzi, F., Argenziano, G., Rongioletti, F., Stingeni, L., Micali, G., Loconsole, F., Rossi, M. T., Bongiorno, M. R., Feliciani, C., Rubegni, P., Amerio, P., Fargnoli, M. C., Pigatto, P., Savoia, P., Nisticò, S. P., Giustini, S., Carugno, A., Cannavo’, S. P., Rech, G., Prignano, F., Offidani, A., Lombardo, M., Zalaudek, I., Bianchi, L., and Peris, K.

Abstract

Background: The susceptibility of patients with chronic plaque psoriasis and the risks or benefits related to the use of biological therapies for COVID-19 are unknown. Few data about prevalence, clinical course and outcomes of COVID-19 among psoriatic patients were reported. The aims of this study were 1) to assess the prevalence and severity of COVID-19 in psoriatic patients treated with biologic agents during the first phase of the emergency (22 February to 22 April 2020) in Italy, and 2) to report the clinical outcomes of patients who have been exposed to individuals with confirmed SARS-CoV-2 infection. Methods: Patients with moderate-to-severe chronic plaque psoriasis, aged ≥18 years and undergoing treatment with biologic agents as of 22 February 2020, were eligible to be included in PSO-BIO-COVID study. Demographic and clinical characteristics of patients using any biologic for psoriasis treatment between 22 February and 22 April 2020 were registered. Results: A total of 12,807 psoriatic patients were included in the PSO-BIO-COVID study. In this cohort 26 patients (0.2%) had a swab confirmation of SARS-CoV-2 infection. Eleven patients required hospitalization and two died. Conclusion: The incidence of COVID-19 observed in our cohort of psoriatic patients (0.2%) is similar to that seen in the general population (0.31%) in Italy. However, the course of the disease was mild in most patients. Biological therapies may likely lessen ‘cytokine storm’ of COVID-19, which sometimes lead to multiple organ failure, ARDS, and death.

Published
2021

25. Diagnosis and management of cutaneous and anogenital lichen sclerosus: Recommendations from the Italian Society of Dermatology (SIDemaSt)

Author

Papini, M., Russo, A., Simonetti, O., Borghi, A., Corazza, M., Piaserico, S., Feliciani, C., Calzavara-Pinton, P., Amendolagine, G., Arisi, M., Babino, G., Bardazzi, F., Belloni Fortina, A., Cac-Cavale, S., Campanati, A., Campione, E., Caposiena, C. D., Carugno, A., Coati, I., Cinotti, E., D'Antuono, A., Dattola, A., Dika, E., Fai, D., Fusano, M., Galluzzo, M., Ganzetti, G., Gisondi, P., Hansel, K., Lora, V., Maione, V., Mandel, V. D., Menni, S., Negosanti, M., Neri, I., Offidani, A., Parodi, A., Patrizi, A., Peserico, A., Rossi, M., Rivetti, N., Saccani, E., Stan, T. R., Stingeni, L., Talamonti, M., Vascellaro, A., Vezzoli, P., Virgili, A., Zanca, A., Papini, M., Russo, A., Simonetti, O., Borghi, A., Corazza, M., Piaserico, S., Feliciani, C., Calzavara-Pinton, P., Amendolagine, G., Arisi, M., Babino, G., Bardazzi, F., Belloni Fortina, A., Caccavale, S., Campanati, A., Campione, E., Caposiena, C. D., Carugno, A., Coati, I., Cinotti, E., D'Antuono, A., Dattola, A., Dika, E., Fai, D., Fusano, M., Galluzzo, M., Ganzetti, G., Gisondi, P., Hansel, K., Lora, V., Maione, V., Mandel, V. D., Menni, S., Negosanti, M., Neri, I., Offidani, A., Parodi, A., Patrizi, A., Peserico, A., Rossi, M., Rivetti, N., Saccani, E., Stan, T. R., Stingeni, L., Talamonti, M., Vascellaro, A., Vezzoli, P., Virgili, A., Zanca, A., Papini, M, Russo, A, Simonetti, O, Borghi, A, Corazza, M, Piaserico, S, Feliciani, C, Calzavara-Pinton, P, Amendolagine, G, Arisi, M, Babino, G, Bardazzi, F, Belloni Fortina, A, Cac-Cavale, S, Campanati, A, Campione, E, Caposiena, C, Carugno, A, Coati, I, Cinotti, E, D'Antuono, A, Dattola, A, Dika, E, Fai, D, Fusano, M, Galluzzo, M, Ganzetti, G, Gisondi, P, Hansel, K, Lora, V, Maione, V, Mandel, V, Menni, S, Negosanti, M, Neri, I, Offidani, A, Parodi, A, Patrizi, A, Peserico, A, Rossi, M, Rivetti, N, Saccani, E, Stan, T, Stingeni, L, Talamonti, M, Vascellaro, A, Vezzoli, P, Virgili, A, Zanca, A, Papini M., Russo A., Simonetti O., Borghi A., Corazza M., Piaserico S., Feliciani C., Calzavara-Pinton P., Amendolagine G., Arisi M., Babino G., Bardazzi F., Belloni Fortina A., Cac-Cavale S., Campanati A., Campione E., Caposiena C.D., Carugno A., Coati I., Cinotti E., D'Antuono A., Dattola A., Dika E., Fai D., Fusano M., Galluzzo M., Ganzetti G., Gisondi P., Hansel K., Lora V., Maione V., Mandel V.D., Menni S., Negosanti M., Neri I., Offidani A., Parodi A., Patrizi A., Peserico A., Rossi M., Rivetti N., Saccani E., Stan T.R., Stingeni L., Talamonti M., Vascellaro A., Vezzoli P., Virgili A., and Zanca A.

Subjects
Male, medicine.medical_specialty, Calcineurin Inhibitors, Socio-culturale, Disease, Dermatology, Lichen sclerosus, Guideline, Settore MED/35, Lichen sclerosus et atrophicu, medicine, Dysuria, Humans, Sex organ, Drug therapy, Lichen sclerosus et atrophicus, Operative surgical procedures, Rare diseases, Vulvar lichen sclerosus, Female, Italy, Mometasone Furoate, Lichen Sclerosus et Atrophicus, Calcineurin Inhibitor, business.industry, Mucous membrane, Evidence-based medicine, medicine.disease, Infectious Diseases, medicine.anatomical_structure, Sexual dysfunction, Operative surgical procedure, Vulvar lichen sclerosu, medicine.symptom, business, Rare disease, Human
Abstract

Lichen sclerosus (LS) is a disabling chronic inflammatory disease of skin and genital mucous membrane causing itch, pain, dysuria and restriction of micturition, and significant sexual dysfunction and dyspareunia both in women and men. If left untreated, LS is associated with a high degree of sclerosis and scarring, as well as with an elevated risk of cancer in the genital area. Although a central role of autoimmunity is suggested, the pathogenesis of LS is still not clearly understood and the disease remains difficult to treat. The goals of treatment of LS are to alleviate symptoms and discomfort, prevent anatomical changes and prevent malignant transformation. This guideline has been developed by an Italian group of experts. It summarizes evidence-based and expert- based recommendations. The highest level of evidence favors the use of topical high potency corticosteroids; second- and third-line treatments include topical calcineurin inhibitors and topical retinoids, respectively. Surgical treatment has become the treatment of choice in male genital LS with persistent phimosis not responsive to medical treatment. The aim of this paper is to offer evidence-based and easily applicable recommendations for the management of LS.

Published
2021

26. Management of biological therapies for chronic plaque psoriasis during COVID-19 emergency in Italy

Author

Talamonti, M, Galluzzo, M, Chiricozzi, A, Quaglino, P, Fabbrocini, G, Gisondi, P, Marzano, A, Potenza, C, Conti, A, Parodi, A, Belloni Fortina, A, Bardazzi, F, Argenziano, G, Rongioletti, F, Stingeni, L, Micali, G, Loconsole, F, Venturini, M, Bongiorno, M, Feliciani, C, Rubegni, P, Amerio, P, Fargnoli, M, Pigatto, P, Savoia, P, Nistico, S, Giustini, S, Carugno, A, Cannavo, S, Rech, G, Prignano, F, Offidani, A, Lombardo, M, Zalaudek, I, Bianchi, L, Peris, K, Balestri, R, Bernardini, N, Botti, E, Burlando, M, Caldarola, G, Cattaneo, A, Dapavo, P, Dastoli, S, De Simone, C, Di Nuzzo, S, Diotallevi, F, Fierro, M, Fidanza, R, Foti, C, Gambini, D, Gambardella, A, Girolomoni, G, Guarneri, C, Gualdi, G, Hansel, K, Megna, M, Mugheddu, C, Musumeci, M, Patrizi, A, Pellacani, G, Piaserico, S, Richetta, A, Rosi, E, Rossi, M, Sacchelli, L, Tiberio, R, Tilotta, G, Trovato, E, Vezzoni, R, Zangrilli, A, Talamonti M., Galluzzo M., Chiricozzi A., Quaglino P., Fabbrocini G., Gisondi P., Marzano A. V., Potenza C., Conti A., Parodi A., Belloni Fortina A., Bardazzi F., Argenziano G., Rongioletti F., Stingeni L., Micali G., Loconsole F., Venturini M., Bongiorno M. R., Feliciani C., Rubegni P., Amerio P., Fargnoli M. C., Pigatto P., Savoia P., Nistico S. P., Giustini S., Carugno A., Cannavo S. P., Rech G., Prignano F., Offidani A., Lombardo M., Zalaudek I., Bianchi L., Peris K., Balestri R., Bernardini N., Botti E., Burlando M., Caldarola G., Cattaneo A., Dapavo P., Dastoli S., De Simone C., Di Nuzzo S., Diotallevi F., Fierro M. T., Fidanza R., Foti C., Gambini D. M., Gambardella A., Girolomoni G., Guarneri C., Gualdi G., Hansel K., Megna M., Mugheddu C., Musumeci M. L., Patrizi A., Pellacani G., Piaserico S., Richetta A. G., Rosi E., Rossi M. T., Sacchelli L., Tiberio R., Tilotta G., Trovato E., Vezzoni R., Zangrilli A., Talamonti, M, Galluzzo, M, Chiricozzi, A, Quaglino, P, Fabbrocini, G, Gisondi, P, Marzano, A, Potenza, C, Conti, A, Parodi, A, Belloni Fortina, A, Bardazzi, F, Argenziano, G, Rongioletti, F, Stingeni, L, Micali, G, Loconsole, F, Venturini, M, Bongiorno, M, Feliciani, C, Rubegni, P, Amerio, P, Fargnoli, M, Pigatto, P, Savoia, P, Nistico, S, Giustini, S, Carugno, A, Cannavo, S, Rech, G, Prignano, F, Offidani, A, Lombardo, M, Zalaudek, I, Bianchi, L, Peris, K, Balestri, R, Bernardini, N, Botti, E, Burlando, M, Caldarola, G, Cattaneo, A, Dapavo, P, Dastoli, S, De Simone, C, Di Nuzzo, S, Diotallevi, F, Fierro, M, Fidanza, R, Foti, C, Gambini, D, Gambardella, A, Girolomoni, G, Guarneri, C, Gualdi, G, Hansel, K, Megna, M, Mugheddu, C, Musumeci, M, Patrizi, A, Pellacani, G, Piaserico, S, Richetta, A, Rosi, E, Rossi, M, Sacchelli, L, Tiberio, R, Tilotta, G, Trovato, E, Vezzoni, R, Zangrilli, A, Talamonti M., Galluzzo M., Chiricozzi A., Quaglino P., Fabbrocini G., Gisondi P., Marzano A. V., Potenza C., Conti A., Parodi A., Belloni Fortina A., Bardazzi F., Argenziano G., Rongioletti F., Stingeni L., Micali G., Loconsole F., Venturini M., Bongiorno M. R., Feliciani C., Rubegni P., Amerio P., Fargnoli M. C., Pigatto P., Savoia P., Nistico S. P., Giustini S., Carugno A., Cannavo S. P., Rech G., Prignano F., Offidani A., Lombardo M., Zalaudek I., Bianchi L., Peris K., Balestri R., Bernardini N., Botti E., Burlando M., Caldarola G., Cattaneo A., Dapavo P., Dastoli S., De Simone C., Di Nuzzo S., Diotallevi F., Fierro M. T., Fidanza R., Foti C., Gambini D. M., Gambardella A., Girolomoni G., Guarneri C., Gualdi G., Hansel K., Megna M., Mugheddu C., Musumeci M. L., Patrizi A., Pellacani G., Piaserico S., Richetta A. G., Rosi E., Rossi M. T., Sacchelli L., Tiberio R., Tilotta G., Trovato E., Vezzoni R., and Zangrilli A.

Published
2020

27. Update on the Management of Pediatric Psoriasis: An Italian Consensus

Author

Peris, Ketty, Fortina, A. B., Bianchi, L., Fabbrocini, G., Gisondi, P., Balato, A., Bardazzi, F., Bernardini, N., Bonamonte, D., Bongiorno, M. R., Buligan, C., Cusano, F., Del Giudice, M. B. D. F., Hachem, M. E., Fargnoli, Maria Concetta, Gualdi, G., Guarneri, C., Hansel, K., Malara, G., Mazzatenta, C., Micali, G., Narcisi, A., Neri, I., Oranges, T., Panzone, M., Parodi, A., Restano, L., Simonetti, O., Venturini, M., Di Lernia, V., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Peris, Ketty, Fortina, A. B., Bianchi, L., Fabbrocini, G., Gisondi, P., Balato, A., Bardazzi, F., Bernardini, N., Bonamonte, D., Bongiorno, M. R., Buligan, C., Cusano, F., Del Giudice, M. B. D. F., Hachem, M. E., Fargnoli, Maria Concetta, Gualdi, G., Guarneri, C., Hansel, K., Malara, G., Mazzatenta, C., Micali, G., Narcisi, A., Neri, I., Oranges, T., Panzone, M., Parodi, A., Restano, L., Simonetti, O., Venturini, M., Di Lernia, V., Peris K. (ORCID:0000-0002-5237-0463), and Fargnoli M. C.

Abstract

Introduction: Psoriasis affects children with a considerable burden in early life. Treating pediatric psoriasis is challenging also because of the lack of updated specific guidelines. With the recent approval of several biologics for pediatric psoriasis and the ongoing COVID-19 pandemic, the management of young psoriatic patients is facing major changes. A revision of treatment recommendations is therefore needed. Methods: In September 2021, a board of six Italian dermatologists convened to update treatment recommendations. The board issued evidence- and consensus-based statements covering relevant areas of pediatric psoriasis, namely: assessment of psoriasis severity, management of children with psoriasis, and treatment of pediatric psoriasis. To reach consensus, the statements were submitted to a panel of 24 experts in a Delphi process performed entirely via videoconference. A treatment algorithm was produced. Results: There was full consensus that psoriasis severity is determined by the extension/severity of skin lesions, site of lesions, and impact on patient quality of life. Agreement was reached on the need for a multidisciplinary approach to pediatric psoriasis and the importance of patient/parents education. The relevance of vaccinations, including COVID-19 vaccination, for psoriatic children was acknowledged by all participants. Management issues that initially failed to reach consensus included the screening for psoriasis comorbidities and early treatment with biologics to prevent them and the use of telemedicine to facilitate patient follow-up. There was full consensus that topical corticosteroids are the first choice for the treatment of mild pediatric psoriasis, while phototherapy and systemic therapy are used in children with moderate-severe psoriasis. According to the proposed treatment algorithm, biologics are the first line of systemic therapy. Conclusions: Targeted systemic therapies are changing the treatment of moderate-severe pediatric psoriasis

Published
2022

28. Real-world evidence of biologic treatments in moderate–severe psoriasis in Italy: Results of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional longitudinal study of real-life clinical practice) study

Author

Colombo, Dario Angelo, Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Ori, A., Fiocchi, M., Zagni, E., Colombo D., Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), Provenzano E., Colombo, Dario Angelo, Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Ori, A., Fiocchi, M., Zagni, E., Colombo D., Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), and Provenzano E.

Abstract

EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional (CANOVA) study was aimed at providing real-world evidence of the effectiveness of biologics in Italian patients with moderate–severe psoriasis. It was an observational, retro-prospective cohort study conducted in 17 Italian dermatology clinics. Adult patients with moderate–severe plaque psoriasis, who started a biologic treatment between 24 weeks and 24 months before enrolment, were included. With a follow-up visit at 6 months after enrolment, each patient had at least 12 months of observation. The primary objective was to describe the clinical response rates (PASI 75) after 16/24/52 weeks from biologic treatment start. Secondary outcomes were sustained response, quality of life, and treatment satisfaction. Of the 669 eligible patients (64% males), 52% were naïve to biologics, though a mean duration of psoriasis since first diagnosis of 18.6 years (SD 13.2). The most frequently prescribed biologics were secukinumab (41%), ustekinumab (25%), TNF-inhibitors (22%) and ixekizumab (12%). PASI 75 was achieved by 86% of patients (95% CI: 82%–89%) at 16 weeks, 90% (87%–93%) at 24 weeks, and 91% (89%–94%) at 52 weeks. Patients achieving PASI 90 and PASI 100 at 52 weeks were 75% (71%–79%) and 53% (49%–57%), respectively. Sustained PASI 75 response after 1 year from treatment start was achieved by 78% (74%–82%) of patients. Mean DLQI total score was 2.3 (SD 3.9) at enrollment and decreased at the final visit to 1.8 (3.6). A high level of treatment satisfaction was expressed by patients over the study period. This large real-world study confirms in the clinical practice the good effectiveness and acceptability of biologics in psoriasis patients.

Published
2022

29. Italian adaptation of EuroGuiDerm guideline on the systemic treatment of chronic plaque psoriasis

Author

Gisondi, P., Fargnoli, M. C., Amerio, P., Argenziano, G., Bardazzi, F., Bianchi, L., Chiricozzi, Andrea, Conti, A., Corazza, M., Costanzo, A., Dapavo, P., De Simone, Clara, Fabbrocini, G., Feliciani, C., Foti, C., Girolomoni, G., Guarneri, C., Marzano, A. V., Micali, G., Offidani, A., Parodi, A., Pellacani, G., Piaserico, S., Prignano, F., Romanelli, M., Rongioletti, F., Rubegni, P., Stinco, G., Stingeni, L., Tomasini, C. F., Venturini, M., Peris, Ketty, Calzavara-Pinton, P., Chiricozzi A. (ORCID:0000-0002-6739-0387), DE Simone C. (ORCID:0000-0002-0898-0045), Peris K. (ORCID:0000-0002-5237-0463), Gisondi, P., Fargnoli, M. C., Amerio, P., Argenziano, G., Bardazzi, F., Bianchi, L., Chiricozzi, Andrea, Conti, A., Corazza, M., Costanzo, A., Dapavo, P., De Simone, Clara, Fabbrocini, G., Feliciani, C., Foti, C., Girolomoni, G., Guarneri, C., Marzano, A. V., Micali, G., Offidani, A., Parodi, A., Pellacani, G., Piaserico, S., Prignano, F., Romanelli, M., Rongioletti, F., Rubegni, P., Stinco, G., Stingeni, L., Tomasini, C. F., Venturini, M., Peris, Ketty, Calzavara-Pinton, P., Chiricozzi A. (ORCID:0000-0002-6739-0387), DE Simone C. (ORCID:0000-0002-0898-0045), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

SIDeMaST (Società Italiana di Dermatologia Medica, Chirurgica, Estetica e delle Malattie Sessualmente Trasmesse) contributed to the development of the present guideline on the systemic treatment of chronic plaque psoriasis. With the permission of EuroGuiDerm, SIDeMaST adapted the guideline to the Italian healthcare context to supply a reliable and affordable tool to Italian physicians who take care of patients affected by moderate to severe plaque psoriasis. The content of the guideline includes general information on the scope and purpose, health questions covered, target users and strength/limitations of the guideline, suggestions for disease severity grading and treatment goals. It presents the general treatment recommendations as well as detailed management and monitoring recommendations for the individual drugs including acitretin, cyclosporine, fumarates, methotrexate, adalimumab, apremilast, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab. Moreover, the guideline provides guidance for specific clinical situations such as patient with concomitant psoriatic arthritis, inflammatory bowel disease, a history of malignancies, a history of depression, diabetes, viral hepatitis, disease affecting the heart or the kidneys as well as concomitant neurological disease. Advice on how to screen for tuberculosis and recommendations on how to manage patients with a positive tuberculosis test result are given. It further covers treatment for pregnant women or those with childbearing potential. Information on vaccination, immunogenicity and systemic treatment during the COVID-19 pandemic is also provided.

Published
2022

30. Brodalumab for the treatment of moderate-to-severe plaque-type psoriasis: a real-life, retrospective 24-week experience

Author

Fargnoli M. C., Esposito M., Dapavo P., Parodi A., Rossi M., Tiberio R., Dastoli S., Offidani A. M., Argenziano G., Gisondi P., Lo Schiavo A., Loconsole F., Pella P., Bardazzi F., Cusano F., Gattoni M., Nacca M., Cannavo S. P., Pellegrini C., Costanzo A., Pertusi G., Stroppiana E., Gambardella A., Romano F., Sassetti C., Carpentieri A., Bellinato F., Burlando M., Graziola F., Sacchelli L., Campanati A., Ronza G., Fargnoli, M. C., Esposito, M., Dapavo, P., Parodi, A., Rossi, M., Tiberio, R., Dastoli, S., Offidani, A. M., Argenziano, G., Gisondi, P., Lo Schiavo, A., Loconsole, F., Pella, P., Bardazzi, F., Cusano, F., Gattoni, M., Nacca, M., Cannavo, S. P., Pellegrini, C., Costanzo, A., Pertusi, G., Stroppiana, E., Gambardella, A., Romano, F., Sassetti, C., Carpentieri, A., Bellinato, F., Burlando, M., Graziola, F., Sacchelli, L., Campanati, A., and Ronza, G.

Subjects
Adult, Male, medicine.medical_specialty, Brodalumab, Dermatology, Antibodies, Monoclonal, Humanized, Severity of Illness Index, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Patient satisfaction, Quality of life, Psoriasis Area and Severity Index, Psoriasis, Internal medicine, medicine, Humans, Adverse effect, Retrospective Studies, business.industry, Antibodies, Monoclonal, Retrospective cohort study, Dermatology Life Quality Index, Middle Aged, medicine.disease, Treatment Outcome, Infectious Diseases, 030220 oncology & carcinogenesis, Quality of Life, Female, business
Abstract

Background: Brodalumab was efficacious and safe in moderate-to-severe plaque-type psoriasis in the AMAGINE trials; published reports under real-life conditions are limited. Objectives: To evaluate the effectiveness and safety of brodalumab in patients with moderate-to-severe plaque-type psoriasis in a real-world setting. Methods: This observational, retrospective study enrolled adult patients (≥18years) with moderate-to-severe plaque-type psoriasis who underwent 24weeks of treatment with brodalumab at 17 Italian dermatological centres. Baseline data included demographics, comorbidities, age of onset and duration of psoriasis and previous treatments. Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), static PGA of Genitalia, Dermatology Life Quality Index and patient satisfaction were assessed at weeks 0, 4, 12 and 24; adverse events were recorded. Results: Seventy-eight patients (mean age 47.9years, 71.8% male, average disease duration 16.8years) were enrolled. A rapid and significant reduction in mean PASI score was observed after 4weeks of treatment, decreasing further at weeks 12 and 24 (all P&nbsp

Published
2021

34. Italian guidelines in diagnosis and treatment of alopecia areata

Author

Rossi, A, Muscianese, M, Piraccini, B, Starace, M, Carlesimo, M, Mandel, V, Alessandrini, A, Calvieri, S, Caro, G, D'Arino, A, Federico, A, Magri, F, Pigliacelli, F, Amendolagine, G, Annunziata, M, Arisi, M, Astorino, S, Babino, G, Bardazzi, F, Barruscotti, S, Belloni Fortina, A, Borghi, A, Bruni, F, Caccavale, S, Calzavara-Pinton, P, Cameli, N, Cardone, M, Carugno, A, Coppola, R, Dattola, A, De Felici Del Giudice, M, Di Cesare, A, Dika, E, Dinunno, D, D'Ovidio, R, Fabbrocini, G, Feliciani, C, Fulgione, E, Galluzzo, M, Garcovich, S, Garelli, V, Guerriero, C, Hansel, K, La Placa, M, Lacarrubba, F, Lora, V, Marinello, E, Megna, M, Micali, G, Misciali, C, Monari, P, Monfrecola, G, Neri, I, Offidani, A, Orlando, G, Papini, M, Patrizi, A, Piaserico, S, Rivetti, N, Simonetti, O, Stan, T, Stingeni, L, Talamonti, M, Tassone, F, Villa, L, Vincenzi, C, Fortuna, M, Rossi A., Muscianese M., Piraccini B. M., Starace M., Carlesimo M., Mandel V. D., Alessandrini A., Calvieri S., Caro G., D'Arino A., Federico A., Magri F., Pigliacelli F., Amendolagine G., Annunziata M. C., Arisi M. C., Astorino S., Babino G., Bardazzi F., Barruscotti S., Belloni Fortina A., Borghi A., Bruni F., Caccavale S., Calzavara-Pinton P., Cameli N., Cardone M., Carugno A., Coppola R., Dattola A., De Felici Del Giudice M. B., Di Cesare A., Dika E., Dinunno D., D'Ovidio R., Fabbrocini G., Feliciani C., Fulgione E., Galluzzo M., Garcovich S., Garelli V., Guerriero C., Hansel K., La Placa M., Lacarrubba F., Lora V., Marinello E., Megna M., Micali G., Misciali C., Monari P., Monfrecola G., Neri I., Offidani A., Orlando G., Papini M., Patrizi A., Piaserico S., Rivetti N., Simonetti O., Stan T. R., Stingeni L., Talamonti M., Tassone F., Villa L., Vincenzi C., Fortuna M. C., Rossi, A, Muscianese, M, Piraccini, B, Starace, M, Carlesimo, M, Mandel, V, Alessandrini, A, Calvieri, S, Caro, G, D'Arino, A, Federico, A, Magri, F, Pigliacelli, F, Amendolagine, G, Annunziata, M, Arisi, M, Astorino, S, Babino, G, Bardazzi, F, Barruscotti, S, Belloni Fortina, A, Borghi, A, Bruni, F, Caccavale, S, Calzavara-Pinton, P, Cameli, N, Cardone, M, Carugno, A, Coppola, R, Dattola, A, De Felici Del Giudice, M, Di Cesare, A, Dika, E, Dinunno, D, D'Ovidio, R, Fabbrocini, G, Feliciani, C, Fulgione, E, Galluzzo, M, Garcovich, S, Garelli, V, Guerriero, C, Hansel, K, La Placa, M, Lacarrubba, F, Lora, V, Marinello, E, Megna, M, Micali, G, Misciali, C, Monari, P, Monfrecola, G, Neri, I, Offidani, A, Orlando, G, Papini, M, Patrizi, A, Piaserico, S, Rivetti, N, Simonetti, O, Stan, T, Stingeni, L, Talamonti, M, Tassone, F, Villa, L, Vincenzi, C, Fortuna, M, Rossi A., Muscianese M., Piraccini B. M., Starace M., Carlesimo M., Mandel V. D., Alessandrini A., Calvieri S., Caro G., D'Arino A., Federico A., Magri F., Pigliacelli F., Amendolagine G., Annunziata M. C., Arisi M. C., Astorino S., Babino G., Bardazzi F., Barruscotti S., Belloni Fortina A., Borghi A., Bruni F., Caccavale S., Calzavara-Pinton P., Cameli N., Cardone M., Carugno A., Coppola R., Dattola A., De Felici Del Giudice M. B., Di Cesare A., Dika E., Dinunno D., D'Ovidio R., Fabbrocini G., Feliciani C., Fulgione E., Galluzzo M., Garcovich S., Garelli V., Guerriero C., Hansel K., La Placa M., Lacarrubba F., Lora V., Marinello E., Megna M., Micali G., Misciali C., Monari P., Monfrecola G., Neri I., Offidani A., Orlando G., Papini M., Patrizi A., Piaserico S., Rivetti N., Simonetti O., Stan T. R., Stingeni L., Talamonti M., Tassone F., Villa L., Vincenzi C., and Fortuna M. C.

Abstract

Alopecia areata (AA) is an organ-specific autoimmune disorder that targets anagen phase hair follicles. The course is unpredictable and current available treatments have variable efficacy. Nowadays, there is relatively little evidence on treatment of AA from well-designed clinical trials. Moreover, none of the treatments or devices commonly used to treat AA are specifically approved by the Food and Drug Administration. The Italian Study Group for Cutaneous Annexial Disease of the Italian Society of dermatology proposes these Italian guidelines for diagnosis and treatment of Alopecia Areata deeming useful for the daily management of the disease. This article summarizes evidence-based treatment associated with expert-based recommendations.

Published
2019

36. The unforeseen during biotechnological therapy for moderate-to-severe psoriasis: How to manage pregnancy and breastfeeding, infections from Mycobacterium tuberculosis, hepatitis B virus, hepatitis C virus, and HIV, surgery, vaccinations, diagnosis of malignancy, and dose tapering

Author

Sacchelli L., Magnano M., Loi C., Patrizi A., Bardazzi F., Sacchelli L., Magnano M., Loi C., Patrizi A., and Bardazzi F.

Subjects
Hepatitis B virus, tapering, Drug Tapering, Vaccination, HIV Infections, vaccinations, Hepacivirus, Mycobacterium tuberculosis, infection, surgery, Breast Feeding, malignancie, real life, unforeseen, Pregnancy, Neoplasms, Humans, Psoriasis, Female, biotechnological therapy, psoriasi
Abstract

The use of biotechnological therapies for moderate-to-severe psoriasis is ever-expanding and it is becoming increasingly more frequent to encounter different unforeseen events during their use, such as fertile patients becoming pregnant and breastfeeding, development of infections due to personal habits like tuberculosis, hepatitis B virus, hepatitis C virus, or HIV, scheduling of surgical procedures, need of vaccinations, development of malignancy, and evaluation of dose tapering. As any clinician may experience at least one of these unexpected events, it should be good practice to know how to manage them. Thus, a practical analysis has been proposed in this study.

Published
2020

39. Latent tuberculosis infection in patients with chronic plaque psoriasis: evidence from the Italian Psocare Registry*

Author

Gisondi, P., Cazzaniga, S., Chimenti, S., Maccarone, M., Picardo, M., Girolomoni, G., Naldi, L., Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnù, B., Spaziani, G., Cusano, F., Iannazzone, Saletta S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Balestri, R., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Grilli, Cilioni E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., di Luzio, Scotto G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., dʼAmico, D., Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Domaneschi, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., DʼOria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., González Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavò, S., Manfrè, C., Borgia, F., Guerra, Puglisi A., Sedona, P., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Mozzillo, R., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Aricò, M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M.G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvarà, M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., Amerio, P., De Simone, C., DʼAgostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigò, M., De Felice, C., Gubinelli, E., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappalà, L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Fornasa, Veller C., and Trevisan, G. P.

Published
2015
Full Text
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43. Effect of secukinumab on perception of anxiety and depression in patients with moderate to severe psoriasis: a post hoc analysis of the SUPREME study

Author

Talamonti, M, Malara, G, Natalini, Y, Bardazzi, F, Conti, A, Chiricozzi, A, Mugheddu, C, Gisondi, P, Piaserico, S, Pagnanelli, G, Amerio, P, Potenza, C, Cantoresi, F, M Concetta Fargnoli, Balato, A, Loconsole, F, Offidani, A, Bonifati, C, Prignano, F, Bartezaghi, M, Rausa, A, Aloisi, E, Orsenigo, R, and Costanzo, A

Subjects
depression, psoriasis, quality of life, secukinumab, anxiety, Settore MED/35
Published
2021

44. A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study

Author

Zagni, E., Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Zullo, A., Fiocchi, M., Colombo, Dario Angelo, Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), Provenzano E., Colombo D., Zagni, E., Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Zullo, A., Fiocchi, M., Colombo, Dario Angelo, Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), Provenzano E., and Colombo D.

Abstract

Background: Psoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy. Methods: The annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%). Results: The most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 – €39,280) and ixekizumab (range: €11,092 – €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60–80%), which was achieved early in time. Conclusion: Biologic therapy is a v

Published
2021

45. Secukinumab Improves Patient Perception of Anxiety and Depression in Patients with Moderate to Severe Psoriasis: A Post hoc Analysis of the SUPREME Study

Author

Talamonti, M., Malara, G., Natalini, Y., Bardazzi, F., Conti, A., Chiricozzi, Andrea, Mugheddu, C., Gisondi, P., Piaserico, S., Pagnanelli, G., Amerio, P., Potenza, C., Cantoresi, F., Fargnoli, M. C., Balato, A., Loconsole, F., Offidani, A., Bonifati, C., Prignano, F., Bartezaghi, M., Rausa, A., Aloisi, E., Orsenigo, R., Costanzo, A., Chiricozzi A. (ORCID:0000-0002-6739-0387), Talamonti, M., Malara, G., Natalini, Y., Bardazzi, F., Conti, A., Chiricozzi, Andrea, Mugheddu, C., Gisondi, P., Piaserico, S., Pagnanelli, G., Amerio, P., Potenza, C., Cantoresi, F., Fargnoli, M. C., Balato, A., Loconsole, F., Offidani, A., Bonifati, C., Prignano, F., Bartezaghi, M., Rausa, A., Aloisi, E., Orsenigo, R., Costanzo, A., and Chiricozzi A. (ORCID:0000-0002-6739-0387)

Abstract

This study evaluated whether secukinumab treatment for patients with moderate to severe plaque psoriasis correlates with improvements in symptoms of anxiety and depression. SUPREME was a 24-week, phase IIIb, multicentre, prospective study conducted across 50 centres in Italy with an extension period of up to 72 weeks. Assessments used were: Psoriasis Area Sever-ity Index (PASI), Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A), and HADS - Depression (HADS-D) scores and Dermatology Quality Life Index (DLQI). Compared with baseline, a significantly greater proportion of patients who reported moderate to severe clinical symptoms of anxiety or depression (HADS-A or HADS-D ≥ 11) were free of moderate to severe symptoms at weeks 16 and 48. The PASI and DLQI scores reduced over time with secukinumab treatment. Psoriasis treatment with secukinumab for 48 weeks resulted in significantly improved skin clearance and a parallel improvement in symptoms of anxiety and depression, assessed by HADS.

Published
2021

46. Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis

Author

Chiricozzi, Andrea, Costanzo, A., Fargnoli, M. C., Malagoli, P., Piaserico, S., Amerio, P., Argenziano, G., Balato, N., Bardazzi, F., Bianchi, L., Carrera, C. G., Conti, A., Dapavo, P., De Simone, Clara, Loconsole, F., Lo Schiavo, A., Malara, G., Musumeci, M. L., Parodi, A., Peris, Ketty, Prignano, F., Rongioletti, F., Talamonti, M., Potenza, C., Chiricozzi A. (ORCID:0000-0002-6739-0387), De Simone C. (ORCID:0000-0002-0898-0045), Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi, Andrea, Costanzo, A., Fargnoli, M. C., Malagoli, P., Piaserico, S., Amerio, P., Argenziano, G., Balato, N., Bardazzi, F., Bianchi, L., Carrera, C. G., Conti, A., Dapavo, P., De Simone, Clara, Loconsole, F., Lo Schiavo, A., Malara, G., Musumeci, M. L., Parodi, A., Peris, Ketty, Prignano, F., Rongioletti, F., Talamonti, M., Potenza, C., Chiricozzi A. (ORCID:0000-0002-6739-0387), De Simone C. (ORCID:0000-0002-0898-0045), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Guselkumab, a subcutaneously administered fully human IgG1lambda monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.

Published
2021

49. Pruritus characteristics in a large Italian cohort of psoriatic patients

Author

Damiani, G., Cazzaniga, S., Conic, R. R. Z., Naldi, L., Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnu, B., Spaziani, G., Cusano, F., Saletta Iannazzone, S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Cilioni Grilli, E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., Scotto di Luzio, G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., Amico, Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Amerio, P., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., D'Oria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., Gonzalez Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavo, S., Manfre, C., Borgia, F., Puglisi Guerra, A., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Arico, M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M. G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvara, M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., De Simone, C., D'Agostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigo, M., De Felice, C., Gubinelli, E., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Zumiani, G., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappala, L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Girolomoni, G., Gisondi, P., Veller Fornasa, C., Trevisan, G. P., Damiani G., Cazzaniga S., Conic R.R.Z., Naldi L., Griseta V., Miracapillo A., Azzini M., Mocci L., Michelini M., Offidani A., Bernardini L., Campanati A., Ricotti G., Giacchetti A., Norat M., Gualco F., Castelli A., Cuccia A., Diana A., Roncarolo G., Belli M.A., Baldassarre M.A., Santoro G., Vena G.A., Lo Console F., Filotico R., Mastrandrea V., Brunetti B., Musumeci F., Carrabba E., Dal Mas P., Annicchiarico F., Benvegnu B., Spaziani G., Cusano F., Saletta Iannazzone S., Galluccio A., Pezza M., Marchesi L., Imberti G., Reseghetti A., Barbera C., Reggiani M., Lanzoni A., Patrizi A., Bardazzi F., Antonucci A., De Tommaso S., Wallnofer W., Ingannamorte F., Calzavara-Pinton P., Iannazzi S., Zane C., Capezzera R., Bassisi S., Rossi M.T., Altamura V., Vigl W., Nobile C., Aste N., Murgia S., Mugheddu C., Scuderi G., Baglieri F., Di Dio C., Cilioni Grilli E., Mastronardi C., Agnusdei C.P., Antrilli A., Aulisa L., Raimondo U., Scotto di Luzio G., Battarra V.C., Farro P., Plaitano R., Micali G., Musumeci M.L., Massimino D., Li Calzi M., La Greca S., Pettinato M., Sapienza G., Valenti G., De Giacomo P.F., Amico, Arcangeli F., Brunelli D., Ghetti E., Tulli A., Assi G., Amerio P., Laria G., Prestinari F., Spadafora S., Coppola M., Caresana G., Pezzarossa E., Felisi C., Donato L., Bertero M., Musso L., Pa lazzini S., Bruscino P., Agozzino U.C., Ottaviani M., Simoncini C., Virgili A., Osti F., Fabbri P., Volpi W., Caproni M., Lotti T., Prignano F., Buggiani G., Troiano M., Fenizi G., Altobella A., Amoruso A., Condello M., Goffredo A., Righini M.G., Alessandrini F., Satolli F., Zampetti M., Bertani E., Fossati S., Parodi A., Burlando M., Fiorucci C., Nigro A., Ghigliotti G., Massone L., Moise G.M., Serrai M., Cannata G., Campagnoli A.M., Daly M., Leporati C., Peila R., Filosa G., Bugatti L., Nicolini M., Nazzari G., Cestari R., Anastasio F., Larussa F.M., Pollice N., De Francesco F., Mazzocchetti G., Peris K., Fargnoli M.C., Di Cesare A., De Angelis L., Flati G., Biamonte A.S., Quarta G., Congedo M., Carcaterra A., Strippoli D., Fideli D., Marsili F., Celli M., Ceccarini M., Bachini L., D'Oria M., Schirripa V., De Filippi C., Martini P., Lapucci E., Mazzatenta C., Ghilardi A., Simonacci M., Bettacchi A., Gasco R., Zanca A., Battistini S., Dattola S., Vernaci R., Postorino F., Zampieri P.F., Padovan C., Gonzalez Intchaurraga M.A., Ladurner J., Guarneri B., Cannavo S., Manfre C., Borgia F., Puglisi Guerra A., Cattaneo A., Carrera C., Fracchiolla C., Mozzanica N., Prezzemolo L., Menni S., Lodi A., Martino P., Monti M., Mancini L., Sacrini F., Altomare G.F., Taglioni M., Lovati C., Mercuri S.R., Schiesari G., Giannetti A., Conti A., Lasagni C., Greco M., Ronsini G., Schianchi S., Fiorentini C., Niglietta S., Maglietta R., Padalino C., Crippa D., Pini M., Rossi E., Tosi D., Armas M., Ruocco V., Ayala F., Balato N., Gaudiello F., Cimmino G.F., Monfrecola G., Gallo L., Argenziano G., Fulgione E., Berruti G., Ceparano S., De Michele I., Giorgiano D., Leigheb G., Deledda S., Peserico A., Alaibac M., Piaserico S., Schiesari L., Dan G., Mattei I., Oro E., Arico M., Bongiorno M.R., Angileri R., Amato S., Todaro F., Milioto M., Bellastro R., Di Nuzzo S., De Panfilis G., Zanni M., Borroni G., Cananzi R., Brazzelli V., Lisi P., Stingeni L., Hansel K., Pierfelice V., Donelli S., Rastelli D., Gasperini M., Barachini P., Cecchi R., Bartoli L., Pavesi M., De Paola S., Corradin M.T., Ricciuti F., Piccirillo A., Viola L., Tataranni M., Mautone M.G., Lo Scocco G., Niccoli M.C., Brunasso Vernetti A.M.G., Gaddoni G., Resta F., Casadio M.C., Arcidiaco M.C., Luvara M.C., Albertini G., Di Lernia V., Guareschi E., Catrani S., Morri M., De Simone C., D'Agostino M., Agostino I., Calvieri S., Cantoresi F., Richetta A., Sorgi P., Carnevale C., Nicolucci F., Berardesca E., Ardigo M., De Felice C., Gubinelli E., Talamonti M., Camplone G., Cruciani G., Riccardi F., Barbati R., Zumiani G., Pagani W., Malagoli P.G., Pellicano R., Donadio D., Di Vito C., Cottoni F., Montesu M.A., Pirodda C., Addis G., Marongiu P., Farris A., Cacciapuoti M., Verrini A., Desirello G., Gnone M., Fimiani M., Pellegrino M., Castelli G., Zappala L., Sesana G., Ingordo V., Vozza E., Di Giuseppe D., Fasciocco D., Nespoli P., Papini M., Cicoletti M., Bernengo M.G., Ortoncelli M., Bonvicino A., Capella G., Doveil G.C., Forte M., Peroni A., Salomone B., Savoia P., Pippione M., Zichichi L., Frazzitta M., De Luca G., Tasin L., Simonetto D., Ros S., Trevisan G., Patamia M., Miertusova S., Patrone P., Frattasio A., Piccirillo F., La Spina S., Di Gaetano L., Marzocchi V., Motolese A., Venturi C., Gai F., Pasquinucci S., Bellazzi R.M., Silvestri T., Girolomoni G., Gisondi P., Veller Fornasa C., and Trevisan G.P.

Subjects
Male, Cross-sectional study, Severity of Illness Index, Cohort Studies, 030207 dermatology & venereal diseases, 0302 clinical medicine, Risk Factors, education, itch, pruritus, psoriasis, pustular psoriasis, treatment, Adolescent, Adult, Cross-Sectional Studies, Educational Status, Facial Dermatoses, Female, Foot Dermatoses, Genitalia, Hand Dermatoses, Humans, Italy, Middle Aged, Pruritus, Psoriasis, Registries, Sex Factors, Young Adult, Epidemiology, Young adult, skin and connective tissue diseases, Settore MED/33 - MALATTIE APPARATO LOCOMOTORE, Infectious Diseases, 030220 oncology & carcinogenesis, Cohort, PRURITIS EPIDEMIOLOGY, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Cohort study, medicine.medical_specialty, PSORIAS, Dermatology, Article, 03 medical and health sciences, Pharmacotherapy, Settore MED/35, Severity of illness, medicine, business.industry, medicine.disease, Pruritus,Itch sensation, business
Abstract

Background: Psoriasis (Ps) is a chronic systemic autoimmune disease associated with pruritus in 64–98% of patients. However, few modestly sized studies assess factors associated with psoriatic pruritus. Objective: To investigate factors associated with Ps pruritus intensity. Methods: Psoriasis patients 18years or older seen in one of 155 centres in Italy between September 2005 and 2009 were identified from the Italian PsoCare registry. Patients without cutaneous psoriasis and those with missed information on pruritus were excluded. Results: We identified 10802 patients, with a mean age 48.8±14.3years. Mild itch was present in 33.2% of patients, moderate in 34.4%, severe in 18.7% and very severe in 13.7%. Higher itch intensity was associated with female gender, lower educational attainment compared to university degree, pustular psoriasis, psoriasis on the head, face, palmoplantar areas, folds and genitalia, more severe disease, disease duration

Published
2019

50. Patients' demographic and socioeconomic characteristics influence the therapeutic decision-making process in psoriasis

Author

Scala, E., Megna, M., Amerio, P., Argenziano, G., Babino, G., Bardazzi, F., Bianchi, L., Caldarola, Giacomo, Campanati, A., Cannavo, S. P., Chiricozzi, Andrea, Conti, A., Damiani, G., Dapavo, P., De Simone, C., Esposito, M., Fabbrocini, G., Fargnoli, M. C., Ferrara, F., Fidanza, R., Gualdi, G., Guarneri, C., Hansel, K., Malagoli, P., Malara, G., Micali, G., Mugheddu, C., Musumeci, M. L., Odorici, G., Offidani, A., Pescitelli, L., Prignano, F., Raimondo, A., Ribero, S., Rongioletti, F., Stingeni, L., Trifiro, C., Zanframundo, S., Balato, A., Chiricozzi A. (ORCID:0000-0002-6739-0387), Scala, E., Megna, M., Amerio, P., Argenziano, G., Babino, G., Bardazzi, F., Bianchi, L., Caldarola, Giacomo, Campanati, A., Cannavo, S. P., Chiricozzi, Andrea, Conti, A., Damiani, G., Dapavo, P., De Simone, C., Esposito, M., Fabbrocini, G., Fargnoli, M. C., Ferrara, F., Fidanza, R., Gualdi, G., Guarneri, C., Hansel, K., Malagoli, P., Malara, G., Micali, G., Mugheddu, C., Musumeci, M. L., Odorici, G., Offidani, A., Pescitelli, L., Prignano, F., Raimondo, A., Ribero, S., Rongioletti, F., Stingeni, L., Trifiro, C., Zanframundo, S., Balato, A., and Chiricozzi A. (ORCID:0000-0002-6739-0387)

Abstract

Background Knowledge regarding differences in care for psoriatic patients is limited. The aim of this study was to investigate factors influencing prescription of systemic treatments for patients with psoriasis with a special focus on socioeconomic factors. Methods and findings This was a non-interventional, cross-sectional study, conducted in 18 Italian University and/ or hospital centers with psoriasis-specialized units. Questionnaires evaluating demographic and socioeconomic characteristics were administered to participants. Overall, 1880 consecutive patients affected by mild-to-severe psoriasis were recruited. Univariate and multivariable logistic regression analyses of systemic therapy prescription, with a special focus on biologics, accounting for the above mentioned characteristics were performed. Our analysis showed that all analyzed patients' characteristics were significantly associated with biological therapy compared to non-biological systemic one. Particularly, women were less likely to receive biologics than men (OR = 0.66; 95% CI, 0.57-0.77). Elderly patients (≥65 years) and subjects with a BMI ≥30 had lower odds to receive biologics respect to adults (≥35-64 years) (OR = 0.33; 95% CI, 0.25-0.40), and subjects with BMI≥25<30 (OR = 0.64; 95% CI, 0.53-0.77), respectively. Northern and Southern patients were both less likely to receive biologics than Central patients (OR = 0.75; 95% CI, 0.63-0.89, and OR = 0.56; 95% CI,0.47-0.68, respectively). Lower economic profile and never reading books were both associated with decreased odds of receiving biological therapy. Conclusions This study shows that sex, age, comorbidities, and socioeconomic characteristics influence the prescription of systemic treatments in psoriasis, highlighting that there are still unmet needs influencing the therapeutic decision-making process that have to be addressed.

Published
2020

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