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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. Spotlight on brodalumab in the treatment of plaque psoriasis: the evidence to date

Author

Galluzzo M, D'Adamio S, Massaro A, Piccolo A, Bianchi L, and Talamonti M

Subjects
psoriasis, biologics, anti-IL17RA, brodalumab, PASI100, atopic dermatitis, Dermatology, RL1-803
Abstract

M Galluzzo,* S D’Adamio,* A Massaro, A Piccolo, L Bianchi, M TalamontiDermatology, Department of “Medicina dei Sistemi”, University of Rome Tor Vergata, Rome, Italy *These authors contributed equally to this work Abstract: The IL-17/IL-23 axis is now understood to influence psoriasis, and the development of novel IL-17 inhibitor medications marks a sea change in the treatment of psoriasis. Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against IL-17RA. This article discusses the mechanism of action and the efficacy and safety profile of brodalumab presented in the literature. Brodalumab, the latest approved anti-IL-17-class medication, is the only one that exerts its effects on IL-17C as well as on IL-17A and IL-17F, blocking the shared IL-17 receptor A. In this sense, considering the recent evidence, brodalumab could have beneficial effects not only on psoriasis, but also on atopic dermatitis. It could also serve as a therapeutic alternative in patients who develop paradoxical eczematous reactions or atopic-like dermatitis during treatment with other anti-IL-17A (secukinumab, ixekizumab).Keywords: psoriasis, biologics, anti-IL17RA, brodalumab, PASI100, atopic dermatitis

Published
2019

3. New insight into the pathogenesis of nail psoriasis and overview of treatment strategies

Author

Ventura A, Mazzeo M, Gaziano R, Galluzzo M, Bianchi L, and Campione E

Subjects
Nail, Psoriasis, Onychomycosis., Therapeutics. Pharmacology, RM1-950
Abstract

Alessandra Ventura,1 Mauro Mazzeo,1 Roberta Gaziano,2 Marco Galluzzo,1 Luca Bianchi,1 Elena Campione1 1Department of Dermatology, University of Rome “Tor Vergata”, Rome, Italy; 2Department of Experimental Medicine and Surgery, Rome, Italy Abstract: Psoriasis is a chronic inflammatory disease affecting up to 3% of the general population. The prevalence of nail involvement in psoriasis patients varies between 15% and 79%. While the nails represent a small portion of the body surface area, psoriasis in these areas can have a disproportionate influence on a patient’s physical and psychosocial activities. Differential diagnosis between an onychomycosis and a psoriatic nail could be challenging; nevertheless, coexistence of onychomycosis and nail psoriasis also occurs and both are common disorders in the general population. Nail psoriasis can be difficult to treat. Treatment of nail psoriasis should consider the body surface area of skin disease, psoriatic arthritis, severity of nail disease, and the impairment in the quality of life. All patients should be tested for onychomycosis before starting a therapy. This recommendation is underlined by the fact that nail psoriasis is mostly treated by immunosuppressive drugs, like steroids, methotrexate, or biologics, which may aggravate mycotic nail infections. Conventional systemic therapy, such as use of steroids, cyclosporine, methotrexate, and retinoid in the long term, can cause organ toxicities. Currently, use of apremilast and tofacitinib favors an early healing of nail psoriasis because they act directly on the pathogenic targets, distressing the inflammatory signals associated with the initiation and maintenance of the disease activity, and as with several conventional synthetic disease modifying antirheumatic drugs, they are characterized by the convenience of oral administration. The number of treatment options has increased considerably in recent years; however, given the heterogeneity of the disease, the therapy should be personalized to individual cases. Keywords: nail, psoriasis, onychomycosis

Published
2017

5. The cannabinoid receptor agonist WIN 55,212-2 attenuates the effects induced by quinolinic acid in the rat striatum

Author

Pintor, A, Tebano, MT, Martire, A, Grieco, R, Galluzzo, M, Scattoni, ML, Pèzzola, A, Coccurello, R, Felici, F, Cuomo, V, Piomelli, D, Calamandrei, G, and Popoli, P

Subjects
Prevention, Neurosciences, Cannabinoid Research, Animals, Behavior, Animal, Benzoxazines, Cerebral Cortex, Cerebral Ventricles, Corpus Striatum, Dose-Response Relationship, Drug, Drug Interactions, Exploratory Behavior, In Vitro Techniques, Male, Maze Learning, Membrane Potentials, Morpholines, Motor Activity, Naphthalenes, Neurons, Neuroprotective Agents, Neurotoxins, Patch-Clamp Techniques, Quinolinic Acid, Rats, Rats, Wistar, Receptor, Cannabinoid, CB1, cannabinoids, WIN 55, 212-2, quinolinic acid, excitotoxicity, striatum, Pharmacology and Pharmaceutical Sciences, Psychology, Neurology & Neurosurgery
Abstract

The ability of CB(1) receptors to regulate the release of glutamate in the striatum, together with the finding that, in experimental models of Huntington disease (HD), both endocannabinoid levels and CB(1) receptor densities are reduced, has prompted the investigation on the neuroprotective role of the cannabinoids in HD. Quinolinic acid (QA) is an excitotoxin that, when injected in the rat striatum reproduces many features of HD and that acts by stimulating glutamate outflow. The aim of the present study was to test the ability of the cannabinoid receptor agonist WIN 55,212-2 to prevent the effects induced by QA in the rat striatum. In microdialysis experiments, probe perfusion with WIN 55,212-2 significantly and dose-dependently prevented the increase in extracellular glutamate induced by QA. In electrophysiological recordings in corticostriatal slices, the application of WIN 55,212-2 prevented QA-induced reduction of the field potential amplitude. Both effects of WIN 55,212-2 were prevented by the CB(1) receptor antagonist AM 251. In in vivo experiments, intrastriatal WIN 55,212-2 significantly attenuated the striatal damage induced by QA, although no significant effects were observed on a behavioural ground. These data demonstrate that the stimulation of CB(1) receptors might lead to neuroprotective effects against excitotoxic striatal toxicity.

Published
2006

6. Patients Withdrawing Dupilumab Monotherapy for COVID-19-Related Reasons Showed Similar Disease Course Compared With Patients Continuing Dupilumab Therapy

Author

Chiricozzi, A, Di Nardo, L, Talamonti, M, Galluzzo, M, De Simone, C, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Antonelli, F, Ferrucci, S, Guarneri, F, Peris, K, Chiricozzi, A., Di Nardo, L., Talamonti, M., Galluzzo, M., De Simone, C., Fabbrocini, G., Marzano, A. V., Girolomoni, G., Offidani, A., Rossi, M. T., Bianchi, L., Cristaudo, A., Fierro, M. T., Stingeni, L., Pellacani, G., Argenziano, G., Patrizi, A., Pigatto, P., Romanelli, M., Savoia, P., Rubegni, P., Foti, C., Milanesi, N., Belloni Fortina, A., Bongiorno, M. R., Grieco, T., Di Nuzzo, S., Fargnoli, M. C., Carugno, A., Motolese, A., Rongioletti, F., Amerio, P., Balestri, R., Potenza, C., Micali, G., Patruno, C., Zalaudek, I., Lombardo, M., Feliciani, C., Antonelli, F., Ferrucci, S. M., Guarneri, F., Peris, K., Chiricozzi, A, Di Nardo, L, Talamonti, M, Galluzzo, M, De Simone, C, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Antonelli, F, Ferrucci, S, Guarneri, F, Peris, K, Chiricozzi, A., Di Nardo, L., Talamonti, M., Galluzzo, M., De Simone, C., Fabbrocini, G., Marzano, A. V., Girolomoni, G., Offidani, A., Rossi, M. T., Bianchi, L., Cristaudo, A., Fierro, M. T., Stingeni, L., Pellacani, G., Argenziano, G., Patrizi, A., Pigatto, P., Romanelli, M., Savoia, P., Rubegni, P., Foti, C., Milanesi, N., Belloni Fortina, A., Bongiorno, M. R., Grieco, T., Di Nuzzo, S., Fargnoli, M. C., Carugno, A., Motolese, A., Rongioletti, F., Amerio, P., Balestri, R., Potenza, C., Micali, G., Patruno, C., Zalaudek, I., Lombardo, M., Feliciani, C., Antonelli, F., Ferrucci, S. M., Guarneri, F., and Peris, K.

Published
2022

8. 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

9. Analysis of predictive factors influencing dupilumab continuation rate in adult patients with atopic dermatitis: results from an Italian multicenter study

Author

Gori, Niccolo', Sernicola, A., Tolino, E., Mariano, M., Galluzzo, M., Moretta, G., Coppola, R., D'Alessio, A., Sansone, Martina, Maffei, V., Paolino, C., Ferrao, C., Cascia, L., Addio, P., Di Nardo, Lucia, Chiricozzi, Andrea, Del Duca, E., Cristaudo, A., Bianchi, L., Pallotta, S., Panasiti, V., Pellacani, G., Potenza, C., Peris, Ketty, Gori N., Sansone M., Di Nardo L., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Gori, Niccolo', Sernicola, A., Tolino, E., Mariano, M., Galluzzo, M., Moretta, G., Coppola, R., D'Alessio, A., Sansone, Martina, Maffei, V., Paolino, C., Ferrao, C., Cascia, L., Addio, P., Di Nardo, Lucia, Chiricozzi, Andrea, Del Duca, E., Cristaudo, A., Bianchi, L., Pallotta, S., Panasiti, V., Pellacani, G., Potenza, C., Peris, Ketty, Gori N., Sansone M., Di Nardo L., Chiricozzi A. (ORCID:0000-0002-6739-0387), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Objectives: The purpose of this study was to analyze the drug survival rate of dupilumab up to 2 years in a large real-world cohort of adult patients affected by moderate/severe atopic dermatitis (AD), and to investigate the clinical, demographic and predictive factors influencing the patients’ treatment persistence. Material and methods: This study included adult patients affected by moderate-to-severe AD treated with dupilumab for at least 16 weeks who visited 7 dermatologic outpatient clinics in Lazio, Italy, from January 2019 until August 2021. Results: A total of 659 adult patients (345 male [52.3%], mean age: 42.8 years) with an average treatment duration of 23.3 months were enrolled in the study. Overall, 88.6% and 76.1% of patients were still on treatment after 12 and 24 months, respectively. The drug survival rate for discontinuation due to AEs and dupilumab ineffectiveness was 95.0% at 12 months and 90.0% at 24 months. The main reasons for drug discontinuation included inefficacy (29.6%), failed compliance (17.4%), persistent efficacy (20.4%) and adverse events (7.8%). Adult AD onset (≥18 years) and EASI score severity measured at the last follow-up visit were the only factors significantly associated with lower drug survival. Conclusion: This study revealed an increased cumulative probability of dupilumab survival at 2 years, reflected by a sustained effectiveness and a favorable safety profile of the drug.

Published
2023

11. 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

12. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

Author

Chiricozzi, Andrea, Ferrucci, S. M., Di Nardo, Lucia, Gori, Niccolo', Balato, A., Ortoncelli, M., Maurelli, M., Galluzzo, M., Munera Campos, M., Seremet, T., Caldarola, Giacomo, De Simone, Clara, Ippoliti, Elena, Torres, T., Gkalpakiotis, S., Conrad, C., Carrascosa, J. M., Bianchi, L., Argenziano, G., Ribero, S., Girolomoni, G., Marzano, A. V., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Di Nardo L., Gori N., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Ippoliti E., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi, Andrea, Ferrucci, S. M., Di Nardo, Lucia, Gori, Niccolo', Balato, A., Ortoncelli, M., Maurelli, M., Galluzzo, M., Munera Campos, M., Seremet, T., Caldarola, Giacomo, De Simone, Clara, Ippoliti, Elena, Torres, T., Gkalpakiotis, S., Conrad, C., Carrascosa, J. M., Bianchi, L., Argenziano, G., Ribero, S., Girolomoni, G., Marzano, A. V., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Di Nardo L., Gori N., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Ippoliti E., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. Research design and methods: A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts. Results: A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16. Conclusions: This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

Published
2023

13. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

Author

Chiricozzi, A, Ferrucci, SM, Di Nardo, L, Gori, N, Balato, A, Ortoncelli, M, Maurelli, M, Galluzzo, M, Munera Campos, M, Seremet, T, Caldarola, G, De Simone, C, Ippoliti, E, Torres, T, Gkalpakiotis, S, Conrad, C, Carrascosa, JM, Bianchi, L, Argenziano, G, Ribero, S, Girolomoni, G, Marzano, AV, and Peris, K

Abstract

ABSTRACTBackgroundTralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce.Research design and methodsA European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts.ResultsA total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16.ConclusionsThis retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

Published
2023
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15. Assessing the Economic Benefit due to BESS Management in a Renewable Energy Community of a Small Island

Author

Barberi A., Di Dio V., Di Pietra B., Favuzza S., Galluzzo M., Massaro F., Musca R., Zizzo G., Barberi A., Di Dio V., Di Pietra B., Favuzza S., Galluzzo M., Massaro F., Musca R., and Zizzo G.

Subjects
Settore ING-IND/33 - Sistemi Elettrici Per L'Energia, Batteries, photovoltaics, RECs, microgrids, BESS, small islands
Abstract

The paper presents a study carried out on the island of Pantelleria regarding the interaction among distributed energy resource and energy storage systems in renewable energy communities. EU, in the Clean Energy Package, defines the 'Jointly acting renewables self-consumers' (JARSCs) and the 'Renewable Energy Communities' (RECs) as innovative models to share energy from renewables facilities. Nevertheless, the behaviour of JARSCs and RECs is designed to maximize the final users' self-consumption without considering the impacts on the power grid operation. A comparison of various operational strategies of BESS and an investigation of their effect on the distribution network are key elements for the evolution and development of JACSRs and RECs in small islands. In the following, a model is proposed to size a PV plant and a battery storage system in an energy community and to analyse the economic impact of the management of the battery, considering the Italyn regulatory framework for RECs and the peculiar conditions of the power system of Pantelleria. The Energy Community model consists of a set of electrical loads, some controllable and some not, a photovoltaic generator representing the set of generators installed at the Energy Community users and a storage system representing the set of Battery Energy Storage System of the Energy Community members.

Published
2022

17. 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

18. Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry

Author

Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, Piras, V, Chiricozzi A., Talamonti M., De Simone C., Galluzzo M., Gori N., Fabbrocini G., Marzano A. V., Girolomoni G., Offidani A., Rossi M. T., Bianchi L., Cristaudo A., Fierro M. T., Stingeni L., Pellacani G., Argenziano G., Patrizi A., Pigatto P., Romanelli M., Savoia P., Rubegni P., Foti C., Milanesi N., Belloni Fortina A., Bongiorno M. R., Grieco T., Di Nuzzo S., Fargnoli M. C., Carugno A., Motolese A., Rongioletti F., Amerio P., Balestri R., Potenza C., Micali G., Patruno C., Zalaudek I., Lombardo M., Feliciani C., Di Nardo L., Guarneri F., Peris K., Caldarola G., Silvaggio D., Dattola A., Napolitano M., Ferrucci S. M., Dal Bello G., Bianchelli T., Rovati C., Pigliacelli F., Ortoncelli M., Hansel K., Calabrese G., Loi C., Iannone M., Veronese F., Romita P., Tronconi G., Caroppo F., Tilotta G., Sernicola A., Esposito M., Raponi F., Gualdi G., Rech G., Musumeci M. L., Nistico S. P., Campitiello A., Bonzano L., Piras V., Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, Piras, V, Chiricozzi A., Talamonti M., De Simone C., Galluzzo M., Gori N., Fabbrocini G., Marzano A. V., Girolomoni G., Offidani A., Rossi M. T., Bianchi L., Cristaudo A., Fierro M. T., Stingeni L., Pellacani G., Argenziano G., Patrizi A., Pigatto P., Romanelli M., Savoia P., Rubegni P., Foti C., Milanesi N., Belloni Fortina A., Bongiorno M. R., Grieco T., Di Nuzzo S., Fargnoli M. C., Carugno A., Motolese A., Rongioletti F., Amerio P., Balestri R., Potenza C., Micali G., Patruno C., Zalaudek I., Lombardo M., Feliciani C., Di Nardo L., Guarneri F., Peris K., Caldarola G., Silvaggio D., Dattola A., Napolitano M., Ferrucci S. M., Dal Bello G., Bianchelli T., Rovati C., Pigliacelli F., Ortoncelli M., Hansel K., Calabrese G., Loi C., Iannone M., Veronese F., Romita P., Tronconi G., Caroppo F., Tilotta G., Sernicola A., Esposito M., Raponi F., Gualdi G., Rech G., Musumeci M. L., Nistico S. P., Campitiello A., Bonzano L., and Piras V.

Abstract

Background: Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID-19) pandemic. Methods: A national registry, named DA-COVID-19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID-19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID-19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician- and patient-reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity. Results: A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS-CoV-2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS-CoV-2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID-related death occurred. Conclusions: Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab-treated patients.

Published
2021

19. 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

21. 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

23. 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

25. Tildrakizumab in moderate-to-severe plaque psoriasis: A multicenter, retrospective, real-life study

Author

Caldarola, G., Galluzzo, M., Bernardini, N., Calabrese, L., Grimaldi, M., Moretta, G., Pagnanelli, G., Shumak, R. G., Talamonti, M., Tofani, L., Pallotta, S., Peris, K., Potenza, C., De Simone, C., Campione, E., Caldarola G. (ORCID:0000-0002-8837-9232), Peris K. (ORCID:0000-0002-5237-0463), De Simone C. (ORCID:0000-0002-0898-0045), Caldarola, G., Galluzzo, M., Bernardini, N., Calabrese, L., Grimaldi, M., Moretta, G., Pagnanelli, G., Shumak, R. G., Talamonti, M., Tofani, L., Pallotta, S., Peris, K., Potenza, C., De Simone, C., Campione, E., Caldarola G. (ORCID:0000-0002-8837-9232), Peris K. (ORCID:0000-0002-5237-0463), and De Simone C. (ORCID:0000-0002-0898-0045)

Abstract

New biologic agents targeting interleukin (IL)23/T-helper17 axis, such as tildrakizumab, have been developed for the treatment of plaque psoriasis. To analyze the efficacy and safety of tildrakizumab in a real life setting of patients affected by moderate-to-severe psoriasis over a 28-week treatment period. A multicentric retrospective study was conducted in patients who initiated tildrakizumab between February 2020 and March 2021. Psoriasis Area and Severity Index—PASI was measured at baseline and after 4, 16 and 28 weeks. The percentage change in PASI value from baseline to the considered time-points, proportion of patients with absolute PASI <3 at week 28 and the percentages of achieving a PASI75 or PASI90 response were assessed. Data about potential safety issues and adverse events (AEs) were collected. Statistical analysis were performed for establish clinical efficacy and for variables predicting clinical response. Fifty nine patients with psoriasis were included. Overall mean PASI percentage reduction was of 88% from baseline to week 28 and 47 out of 59 patients (79.7%) at week 28 had an absolute PASI <3. PASI75 and PASI90 responses at week 28 were achieved by 48 (81.40%) patients and 38 (64.4.0%) patients, respectively. No substantial associations between gender, body mass index - BMI, PASI at baseline and prior exposition to biological therapies and the efficacy endpoints were retrieved. No serious safety issues or discontinuations related to adverse events were reported. In our real-life study, tildrakizumab showed high efficacy and a favorable safety profile, regardless of patient- and disease-related factors.

Published
2022

26. Tildrakizumab for treatment of moderate to severe psoriasis: an expert opinion of efficacy, safety, and use in special populations

Author

Galluzzo, M., Chiricozzi, Andrea, Cinotti, E., Brunasso, G., Congedo, M., Esposito, M., Franchi, C., Malara, G., Narcisi, A., Piaserico, S., Tiberio, R., Argenziano, G., Fabbrocini, G., Parodi, A., Chiricozzi A. (ORCID:0000-0002-6739-0387), Galluzzo, M., Chiricozzi, Andrea, Cinotti, E., Brunasso, G., Congedo, M., Esposito, M., Franchi, C., Malara, G., Narcisi, A., Piaserico, S., Tiberio, R., Argenziano, G., Fabbrocini, G., Parodi, A., and Chiricozzi A. (ORCID:0000-0002-6739-0387)

Abstract

Introduction: Tildrakizumab is a monoclonal antibody that targets the p19 subunit of IL-23, a crucial cytokine for Th17 cells. Tildrakizumab has been assessed in several Phase I, II, and III clinical trials and is approved for treatment of adults with moderate to severe plaque psoriasis who are indicated for systemic therapy. Areas covered: The available evidence on the efficacy, safety, and use of tildrakizumab in special populations was evaluated by 14 experts who critically reviewed the current literature. Expert opinion: Tildrakizumab has good efficacy that lasts for at least 5 years in patients with moderate to severe psoriasis, and appears to be safe and well tolerated in the long-term with no apparent dose-related differences in adverse events, a low incidence of discontinuation due to adverse events, and no evidence of increased risk of malignancies. The safety and the efficacy of tildrakizumab has also been confirmed in special populations such as those with inflammatory bowel disease, cardiovascular disease, metabolic syndrome, and advanced age. Early intervention with IL-23-inhibitors, such as tildrakizumab, may help to control symptoms and change the long-term course of the disease in patients affected by plaque psoriasis, while improving the quality of life and potentially minimizing the risk of developing comorbidities.

Published
2022

27. AB0915 GUSELKUMAB REAL WORD DATA: EFFICACY AND SAFETY IN A COHORT OF 69 PATIENTS WITH PSORIATIC ARTHRITIS

Author

Chimenti, M. S., primary, Galluzzo, M., additional, Talamonti, M., additional, Campanati, A., additional, Bonifati, C., additional, Bruni, P., additional, Caldarola, G., additional, Carpentieri, A., additional, Chiricozzi, A., additional, De Simone, C., additional, Diotallevi, F., additional, Esposito, M., additional, Fiorella, C., additional, Graceffa, D., additional, Loconsole, F., additional, Hansel, K., additional, Mugheddu, C., additional, Papini, M., additional, Richetta, A., additional, Bergamini, A., additional, Luchetti, M. M., additional, Atzori, L., additional, Peris, K., additional, Offidani, A., additional, Stingeni, L., additional, and Bianchi, L., additional

Published
2022
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29. Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study

Author

Patruno, C., Fabbrocini, G., Longo, G., Argenziano, G., Ferrucci, S. M., Stingeni, L., Peris, K., Ortoncelli, M., Offidani, A., Amoruso, G. F., Talamonti, M., Girolomoni, G., Grieco, T., Iannone, M., Nettis, E., Foti, C., Rongioletti, F., Corazza, M., Veneri, M. D., Napolitano, M., Angileri, L., Bianchelli, T., Borghi, A., Calabrese, G., Chello, C., Dal Bello, G., Dastoli, S., Ferrillo, M., Galluzzo, M., Gori, N., Hansel, K., Macchia, L., Piras, V., Provenzano, E., Ribero, S., Romanelli, M., Romita, P., Patruno, C., Fabbrocini, G., Longo, G., Argenziano, G., Ferrucci, S. M., Stingeni, L., Peris, K., Ortoncelli, M., Offidani, A., Amoruso, G. F., Talamonti, M., Girolomoni, G., Grieco, T., Iannone, M., Nettis, E., Foti, C., Rongioletti, F., Corazza, M., Veneri, M. D., Napolitano, M., Angileri, L., Bianchelli, T., Borghi, A., Calabrese, G., Chello, C., Dal Bello, G., Dastoli, S., Ferrillo, M., Galluzzo, M., Gori, N., Hansel, K., Macchia, L., Piras, V., Provenzano, E., Ribero, S., Romanelli, M., and Romita, P.

Subjects
Male, medicine.medical_specialty, Time Factors, Injections, Subcutaneous, Socio-culturale, Dermatology, Antibodies, Monoclonal, Humanized, Eczema Area and Severity Index, elderly, Severity of Illness Index, Drug Administration Schedule, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Settore MED/35, Internal medicine, atopic dermatitis, dupilumab, medicine, Humans, Adverse effect, Contraindication, Aged, Retrospective Studies, Aged, 80 and over, business.industry, Pruritus, Age Factors, General Medicine, Atopic dermatitis, Dermatology Life Quality Index, medicine.disease, Conjunctivitis, Dupilumab, Injection Site Reaction, Treatment Outcome, Quality of Life, Observational study, Female, Settore MED/35 - MALATTIE CUTANEE E VENEREE, business
Abstract

Objective: The objective of this study was to assess the effectiveness and safety of dupilumab in treating elderly patients with atopic dermatitis from baseline to 52 weeks. Methods: A retrospective observational real-life study was conducted in a group of elderly patients with severe atopic dermatitis treated with dupilumab for 52 weeks. Inclusion criteria were: age ≥ 65 years; diagnosis of atopic dermatitis made by an expert dermatologist; Eczema Area and Severity Index ≥ 24; and a contraindication, side effects, or failure to respond to cyclosporine. The primary outcome was the mean percentage reduction in the Eczema Area and Severity Index score from baseline to week 52. Secondary measures includedthe mean percentage reduction in the Pruritus and Sleep Numerical Rating Scales and the Dermatology Life Quality Index, and the types and rates of adverse events from baseline to week 52. Results: One hundred and five patients were eligible for the study. Flexural dermatitis was the most frequent clinical phenotype (63.8%). The coexistence of more than one clinical phenotype was found in 70/105 (66.6%) patients. We observed a reduction in all disease severity scores from baseline to week 52 (p < 0.001). Adverse events were recorded in 30/105 (28.6%) patients, with conjunctivitis and injection-site reaction the most frequent. Conclusions: In this study, dupilumab is an effective and safe treatment for the long-term management of atopic dermatitis in patients aged over 65 years.

Published
2021

30. 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

31. Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study

Author

Patruno C., Napolitano M., Argenziano G., Peris K., Ortoncelli M., Girolomoni G., Offidani A., Ferrucci S. M., Amoruso G. F., Rossi M., Stingeni L., Malara G., Grieco T., Foti C., Gattoni M., Loi C., Iannone M., Talamonti M., Stinco G., Rongioletti F., Pigatto P. D., Cristaudo A., Nettis E., Corazza M., Guarneri F., Amerio P., Esposito M., Belloni Fortina A., Potenza C., Fabbrocini G., Angileri L., Bianchelli T., Borghi A., Buligan C., Calabrese G., Calzavara Pinton P., Caroppo F., Chello C., Dal Bello G., Damiani G., Fargnoli M. C., Ferrillo M., Galluzzo M., Gori N., Gualdi G., Hansel K., Macchia L., Mariano M., Nistico S. P., Pertusi G., Piras V., Provenzano E., Ravaioli G. M., Ribero S., Romanelli M., Romita P., Tolino E., Trifiro C., Patruno, C., Napolitano, M., Argenziano, G., Peris, K., Ortoncelli, M., Girolomoni, G., Offidani, A., Ferrucci, S. M., Amoruso, G. F., Rossi, M., Stingeni, L., Malara, G., Grieco, T., Foti, C., Gattoni, M., Loi, C., Iannone, M., Talamonti, M., Stinco, G., Rongioletti, F., Pigatto, P. D., Cristaudo, A., Nettis, E., Corazza, M., Guarneri, F., Amerio, P., Esposito, M., Belloni Fortina, A., Potenza, C., Fabbrocini, G., Angileri, L., Bianchelli, T., Borghi, A., Buligan, C., Calabrese, G., Calzavara Pinton, P., Caroppo, F., Chello, C., Dal Bello, G., Damiani, G., Fargnoli, M. C., Ferrillo, M., Galluzzo, M., Gori, N., Gualdi, G., Hansel, K., Macchia, L., Mariano, M., Nistico, S. P., Pertusi, G., Piras, V., Provenzano, E., Ravaioli, G. M., Ribero, S., Romanelli, M., Romita, P., Tolino, E., and Trifiro, C.

Subjects
Adult, medicine.medical_specialty, Adolescent, multicentre, Treatment outcome, Eczema, Socio-culturale, Dermatitis, Dupilumab, atopic dermatitis, multicentre, real-life study, Dermatology, Antibodies, Monoclonal, Humanized, elderly, Severity of Illness Index, Antibodies, Atopic, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, Young Adult, Settore MED/35, 0302 clinical medicine, Internal medicine, Aged, Humans, Middle Aged, Retrospective Studies, Monoclonal, Medicine, 030212 general & internal medicine, Adverse effect, Humanized, atopic dermatitis, business.industry, dupilumab, Atopic dermatitis, medicine.disease, humanities, Safety profile, Infectious Diseases, Observational study, real-life study, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Life study, business, Prurigo nodularis
Abstract

Background: Treatment of moderate-to-severe atopic dermatitis (AD) in the elderly may be challenging, due to side-effects of traditional anti-inflammatory drugs and to comorbidities often found in this age group. Furthermore, efficacy and safety of innovative drugs such as dupilumab are not yet well known. Objectives: A multicentre retrospective, observational, real-life study on the efficacy and safety of dupilumab was conducted in a group of patients aged ≥65years and affected by severe AD. Their main clinical features were also examined. Methods: Data of elderly patients with severe (EASI ≥24) AD treated with dupilumab at label dosage for 16weeks were retrospectively collected. Treatment outcome was assessed by comparing objective (EASI) and subjective (P-NRS, S-NRS and DLQI) scores at baseline and after 16weeks of treatment. Results: Two hundred and seventy-six patients were enrolled in the study. They represented 11.37% of all patients with severe AD. Flexural eczema was the most frequent clinical phenotype, followed by prurigo nodularis. The coexistence of more than one phenotype was found in 63/276 (22.82%) subjects. Data on the 16-week treatment with dupilumab were available for 253 (91.67%) patients. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores. No statistically significant difference regarding efficacy was found in elderly patients when compared to the group of our AD patients aged 18–64years, treated with dupilumab over the same period. Furthermore, only 18 (6.52%) patients discontinued the drug due to inefficacy. Sixty-one (22.51%) patients reported adverse events, conjunctivitis and flushing being the most frequent. One (0.36%) patient only discontinued dupilumab due to an adverse event. Conclusions: Therapy with dupilumab led to a significant improvement of AD over a 16-week treatment period, with a good safety profile. Therefore, dupilumab could be considered as an efficacious and safe treatment for AD also in the elderly.

Published
2020

33. Use of brodalumab for the treatment of chronic plaque psoriasis: a one-year real-life study in the Lazio region, Italy

Author

Galluzzo, M., Caldarola, Giacomo, De Simone, Clara, Bernardini, N., Moretta, G., Pallotta, S., Botti, E., Campione, E., Pirro, Federico, Potenza, C., Bianchi, L., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Pirro F., Peris K. (ORCID:0000-0002-5237-0463), Galluzzo, M., Caldarola, Giacomo, De Simone, Clara, Bernardini, N., Moretta, G., Pallotta, S., Botti, E., Campione, E., Pirro, Federico, Potenza, C., Bianchi, L., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Pirro F., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Information is limited from real-life studies evaluating the efficacy and safety of brodalumab.Research design and methods: In this real-life study, we retrospectively examined a database of 90 patients with moderate-to-severe psoriasis treated with brodalumab (210 mg, s.c.) and followed for 1 year. Disease severity and treatment response were assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 4, 12, 24, 36, and 48 weeks. Predictors of a PASI response were evaluated by logistic regression.Results: After 48 weeks, 92.2% of patients (mean age 50.2 ± 15 years) treated with brodalumab achieved a PASI score of <3. PASI score decreased from 17.4 ± 10.3 at baseline to 1.7 ± 3.9 and 1.4 ± 3.7 at 12 and 24 weeks, and PASI 75, 90, and 100 response was achieved in 87.3%, 81.8%, and 72.7% of patients, respectively, at 48 weeks. Univariate regression revealed that previous exposure to anti-IL17A treatment was associated with poorer PASI response between 36 and 48 weeks. In difficult-to-treat cases previously having failed with other biologics, brodalumab significantly improved outcome, leading to complete remission.Conclusion: Brodalumab was observed to be effective and safe in patients with moderate-to-severe chronic psoriasis in a real-world setting.

Published
2021

34. Secukinumab Exhibits Sustained and Stable Response in Patients with Moderate-to-Severe Psoriasis: Results from the SUPREME Study

Author

Costanzo, A., Russo, F., Galluzzo, M., Stingeni, L., Scuderi, R., Zichichi, L., Papini, M., Di Costanzo, L., Conti, A., Burlando, M., Chiricozzi, Andrea, Gaiani, F. M., Mugheddu, C., Musumeci, M. L., Gisondi, P., Piaserico, S., Dapavo, P., Venturini, M., Pagnanelli, G., Amerio, P., Potenza, C., Peris, Ketty, Cantoresi, F., Trevisini, S., Loconsole, F., Offidani, A., Mercuri, S. R., Lora, V., Prignano, F., Bartezaghi, M., Oliva, G., Aloisi, E., Orsenigo, R., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Costanzo, A., Russo, F., Galluzzo, M., Stingeni, L., Scuderi, R., Zichichi, L., Papini, M., Di Costanzo, L., Conti, A., Burlando, M., Chiricozzi, Andrea, Gaiani, F. M., Mugheddu, C., Musumeci, M. L., Gisondi, P., Piaserico, S., Dapavo, P., Venturini, M., Pagnanelli, G., Amerio, P., Potenza, C., Peris, Ketty, Cantoresi, F., Trevisini, S., Loconsole, F., Offidani, A., Mercuri, S. R., Lora, V., Prignano, F., Bartezaghi, M., Oliva, G., Aloisi, E., Orsenigo, R., Chiricozzi A. (ORCID:0000-0002-6739-0387), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Secukinumab, a fully human monoclonal antibody, neutralizes interleukin-17A, a cornerstone cytokine driving the multiple manifestations of psoriasis. This post-hoc analysis of the SUPREME study was performed to determine the sustainability of response to secukinumab in terms of Psoriasis Area and Severity Index (PASI) 90 in patients with moderate-to-severe plaque psoriasis. Based on PASI 90 response at week 16, patients were stratified as PASI 90 responders (PASI90R, n = 337) or non-responders (PASI90NR, n = 72). At week 20, 94.2% (n = 295/313) achieved PASI 90/100 response in PASI90R, with response maintained through week 48 (89.6%, n = 189/211). An increased proportion of patients achieved PASI 90/100 response in PASI90NR (week 20: 29.9%, n = 20/67; week 48: 57.1%, n = 20/35). Overall, 64.4% patients achieved absolute PASI score = 0 at week 24 with response sustained to week 48 (66.9%). Secukinumab showed sustained and stable efficacy in maintaining PASI 90 response in patients with moderate-to-severe plaque psoriasis up to week 48.

Published
2021

36. Secukinumab shows high efficacy irrespective of HLA-Cw6 status in patients with moderate-to-severe plaque-type psoriasis. results from extension phase of the SUPREME study

Author

Papini, M, Cusano, F, Romanelli, M, Burlando, M, Stinco, G, Girolomoni, G, Peris, K, Potenza, C, Offidani, A, Bartezaghi, M, Aloisi, E, Costanzo A, Bianchi L, Bottoni U, Buligan C, Brazzelli V, Campanati A, Cantoresi F, Capo A, Cattaneo A, Dapavo P, Del Giglio M, Di Lernia V, Di Nuzzo S, De Simone C, Dusi D, Fargnoli MC, Flori ML, Franchi C, Galluzzo M, Ghilardi A, Hansel K, Loconsole F, Lora V, Malagoli P, Malara G, Mastrandrea V, Megna M, Mercuri SR, Musumeci ML, Naldi L, Narcisi A, Orsini D, Pagnanelli G, Patrizi A, Pau M, Pellacani G, Persechino S, Piaserico S, Pietroleonardo L, Prignano F, Reseghetti A, Russo F, Sirna R, Skroza N, Stingeni L, Trevisini S, Zane C, Zichichi L, Zini A., Papini, M, Cusano, F, Romanelli, M, Burlando, M, Stinco, G, Girolomoni, G, Peris, K, Potenza, C, Offidani, A, Bartezaghi, M, Aloisi, E, Costanzo, A, Bianchi, L, Bottoni, U, Buligan, C, Brazzelli, V, Campanati, A, Cantoresi, F, Capo, A, Cattaneo, A, Dapavo, P, Del Giglio, M, Di Lernia, V, Di Nuzzo, S, De Simone, C, Dusi, D, Fargnoli, Mc, Flori, Ml, Franchi, C, Galluzzo, M, Ghilardi, A, Hansel, K, Loconsole, F, Lora, V, Malagoli, P, Malara, G, Mastrandrea, V, Megna, M, Mercuri, Sr, Musumeci, Ml, Naldi, L, Narcisi, A, Orsini, D, Pagnanelli, G, Patrizi, A, Pau, M, Pellacani, G, Persechino, S, Piaserico, S, Pietroleonardo, L, Prignano, F, Reseghetti, A, Russo, F, Sirna, R, Skroza, N, Stingeni, L, Trevisini, S, Zane, C, Zichichi, L, and Zini, A.

Subjects
Moderate to severe, medicine.medical_specialty, business.industry, secukinumab, HLA-Cw6, Dermatology, Plaque type psoriasis, moderate-to-severe plaque-type psoriasis, Clinical trial, Severity of illness, Monoclonal, Medicine, In patient, Secukinumab, Settore MED/35 - MALATTIE CUTANEE E VENEREE, business, Prospective cohort study
Abstract

Recent studies have shown that biological drugs approved for treating psoriasis and psoriatic arthritis are not effective in all patients, and that variations in the genome have been associated with different clinical responses or side effects. HLA-Cw6 gene is associated with more severe and early-onset psoriasis. Recent reports have shown that HLA-Cw6 status predicts efficacy of some biologic treatments in psoriasis patients. The Phase 3b SUPREME study (NCT02394561) demonstrated the efficacy of secukinumab in patients with moderate-to-severe plaque-type psoriasis, irrespective of HLA-Cw6 status at week 24. This article is protected by copyright. All rights reserved.

Published
2019

38. Response to IL-17A inhibitors secukinumab and ixekizumab cannot be explained by genetic variation in the protein-coding and untranslated regions of the IL-17A gene: results from a multicentre study of four European psoriasis cohorts

Author

Vugt, L.J. van, Reek, J.M.P.A. van den, Meulewaeter, E., Hakobjan, M.H., Heddes, N., Traks, T., Kingo, K., Galluzzo, M., Talamonti, M., Lambert, J., Coenen, M.J.H., Jong, E.M.G.J. de, Vugt, L.J. van, Reek, J.M.P.A. van den, Meulewaeter, E., Hakobjan, M.H., Heddes, N., Traks, T., Kingo, K., Galluzzo, M., Talamonti, M., Lambert, J., Coenen, M.J.H., and Jong, E.M.G.J. de

Abstract

Contains fulltext : 218238.pdf (Publisher’s version ) (Open Access), BACKGROUND: Genetic predictors for treatment response could optimize allocation of biological treatment in patients with psoriasis. There is minimal knowledge about pharmacogenetics of anti-IL-17 agents. OBJECTIVES: To assess whether genetic variants in the protein-coding region or untranslated regions of the IL-17A gene are associated with response to IL-17A inhibitors in patients with psoriasis. METHODS: This was a multicenter European cohort study investigating pharmacogenetics of IL-17A inhibitors in patients with psoriasis. Patients with plaque psoriasis treated with secukinumab or ixekizumab in daily practice were included. For all participants, the protein-coding region and untranslated regions of the IL-17A gene were analysed using Sanger sequencing. Identified genetic variants were tested for association with response to secukinumab/ixekizumab, measured as PASI, after 12 weeks (primary outcome) and after 24 weeks (secondary outcome). Association was tested using a linear regression model with correction for baseline PASI as a fixed covariate and for biological naivety and body mass index as additional covariates. RESULTS: In total, 134 patients treated with secukinumab or ixekizumab were included. Genotyping of the cohort identified genetic variants present in untranslated regions and intronic DNA, but not in the protein-coding region of the IL-17A gene. Five genetic variants in non-coding DNA with a known or suspected functional effect on IL-17A expression were selected for association analyses: rs2275913, rs8193037, rs3819025, rs7747909 and rs3748067. After 12 weeks, 62% of patients achieved PASI75 and 39% achieved PASI90. At week 24, PASI75 and PASI90 response rates were 72% and 62%, respectively. No associations were found between the five genetic variants and PASI, PASI75 or PASI90 after 12 and 24 weeks of anti-IL-17A treatment. CONCLUSIONS: Response to IL-17A inhibitors secukinumab and ixekizumab cannot be explained by genetic variation in the protein

Published
2020

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

Author

Talamonti, M., Galluzzo, M., Chiricozzi, Andrea, 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, Ketty, Balestri, R., Bernardini, N., Botti, E., Burlando, M., Caldarola, Giacomo, Cattaneo, A., Dapavo, P., Dastoli, S., De Simone, Clara, Di Nuzzo, S., Diotallevi, F., Fierro, M. T., Fidanza, R., Foti, C., Gambini, D. M., Gambardella, A., Girolomoni, G., Guarneri, C., Gualdi, G., Hansel, C., 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., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Talamonti, M., Galluzzo, M., Chiricozzi, Andrea, 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, Ketty, Balestri, R., Bernardini, N., Botti, E., Burlando, M., Caldarola, Giacomo, Cattaneo, A., Dapavo, P., Dastoli, S., De Simone, Clara, Di Nuzzo, S., Diotallevi, F., Fierro, M. T., Fidanza, R., Foti, C., Gambini, D. M., Gambardella, A., Girolomoni, G., Guarneri, C., Gualdi, G., Hansel, C., 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., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Caldarola G. (ORCID:0000-0002-8837-9232), and De Simone C. (ORCID:0000-0002-0898-0045)

Abstract

N/A

Published
2020

40. Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study

Author

Patruno, C., Napolitano, M., Argenziano, G., Peris, Ketty, Ortoncelli, M., Girolomoni, G., Offidani, A., Ferrucci, S. M., Amoruso, G. F., Rossi, M., Stingeni, L., Malara, G., Grieco, T., Foti, C., Gattoni, M., Loi, C., Iannone, Maria Teresa, Talamonti, M., Stinco, G., Rongioletti, F., Pigatto, P. D., Cristaudo, A., Nettis, E., Corazza, M., Guarneri, F., Amerio, P., Esposito, M., Belloni Fortina, A., Potenza, C., Fabbrocini, G., Angileri, L., Bianchelli, T., Borghi, A., Buligan, C., Calabrese, G., Calzavara Pinton, P., Caroppo, F., Chello, C., Dal Bello, G., Damiani, G., Fargnoli, Maria Concetta, Ferrillo, M., Galluzzo, M., Gori, Niccolo', Gualdi, G., Hansel, K., Macchia, L., Mariano, M., Nistico, S. P., Pertusi, G., Piras, V., Provenzano, Katia Elisabetta, Ravaioli, G. M., Ribero, S., Romanelli, Margherita, Romita, P., Tolino, E., Trifiro, C., Peris K. (ORCID:0000-0002-5237-0463), Iannone M., Fargnoli M. C., Gori N., Provenzano E., Romanelli M., Patruno, C., Napolitano, M., Argenziano, G., Peris, Ketty, Ortoncelli, M., Girolomoni, G., Offidani, A., Ferrucci, S. M., Amoruso, G. F., Rossi, M., Stingeni, L., Malara, G., Grieco, T., Foti, C., Gattoni, M., Loi, C., Iannone, Maria Teresa, Talamonti, M., Stinco, G., Rongioletti, F., Pigatto, P. D., Cristaudo, A., Nettis, E., Corazza, M., Guarneri, F., Amerio, P., Esposito, M., Belloni Fortina, A., Potenza, C., Fabbrocini, G., Angileri, L., Bianchelli, T., Borghi, A., Buligan, C., Calabrese, G., Calzavara Pinton, P., Caroppo, F., Chello, C., Dal Bello, G., Damiani, G., Fargnoli, Maria Concetta, Ferrillo, M., Galluzzo, M., Gori, Niccolo', Gualdi, G., Hansel, K., Macchia, L., Mariano, M., Nistico, S. P., Pertusi, G., Piras, V., Provenzano, Katia Elisabetta, Ravaioli, G. M., Ribero, S., Romanelli, Margherita, Romita, P., Tolino, E., Trifiro, C., Peris K. (ORCID:0000-0002-5237-0463), Iannone M., Fargnoli M. C., Gori N., Provenzano E., and Romanelli M.

Abstract

Background: Treatment of moderate-to-severe atopic dermatitis (AD) in the elderly may be challenging, due to side-effects of traditional anti-inflammatory drugs and to comorbidities often found in this age group. Furthermore, efficacy and safety of innovative drugs such as dupilumab are not yet well known. Objectives: A multicentre retrospective, observational, real-life study on the efficacy and safety of dupilumab was conducted in a group of patients aged ≥65 years and affected by severe AD. Their main clinical features were also examined. Methods: Data of elderly patients with severe (EASI ≥24) AD treated with dupilumab at label dosage for 16 weeks were retrospectively collected. Treatment outcome was assessed by comparing objective (EASI) and subjective (P-NRS, S-NRS and DLQI) scores at baseline and after 16 weeks of treatment. Results: Two hundred and seventy-six patients were enrolled in the study. They represented 11.37% of all patients with severe AD. Flexural eczema was the most frequent clinical phenotype, followed by prurigo nodularis. The coexistence of more than one phenotype was found in 63/276 (22.82%) subjects. Data on the 16-week treatment with dupilumab were available for 253 (91.67%) patients. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores. No statistically significant difference regarding efficacy was found in elderly patients when compared to the group of our AD patients aged 18–64 years, treated with dupilumab over the same period. Furthermore, only 18 (6.52%) patients discontinued the drug due to inefficacy. Sixty-one (22.51%) patients reported adverse events, conjunctivitis and flushing being the most frequent. One (0.36%) patient only discontinued dupilumab due to an adverse event. Conclusions: Therapy with dupilumab led to a significant improvement of AD over a 16-week treatment period, with a good safety profile. Therefore, dupilumab could be considered as an efficacious and safe tre

Published
2020

41. Clinical and histopathological characterization of eczematous eruptions occurring in course of anti IL-17 treatment: a case series and review of the literature

Author

Caldarola, Giacomo, Pirro, Federico, Di Stefani, Alessandro, Talamonti, M., Galluzzo, M., D'Adamio, S., Magnano, M., Bernardini, N., Malagoli, P., Bardazzi, F., Potenza, C., Bianchi, L., Peris, Ketty, De Simone, Clara, Caldarola G. (ORCID:0000-0002-8837-9232), Pirro F., Di Stefani A., Peris K. (ORCID:0000-0002-5237-0463), De Simone C. (ORCID:0000-0002-0898-0045), Caldarola, Giacomo, Pirro, Federico, Di Stefani, Alessandro, Talamonti, M., Galluzzo, M., D'Adamio, S., Magnano, M., Bernardini, N., Malagoli, P., Bardazzi, F., Potenza, C., Bianchi, L., Peris, Ketty, De Simone, Clara, Caldarola G. (ORCID:0000-0002-8837-9232), Pirro F., Di Stefani A., Peris K. (ORCID:0000-0002-5237-0463), and De Simone C. (ORCID:0000-0002-0898-0045)

Abstract

Background: Real-life data often highlight the side effects of certain drugs not previously reported in randomized controlled trials (RCTs). Objective: To describe cutaneous inflammatory eruptions in psoriatic patients treated with an anti IL-17A agent (secukinumab or ixekizumab). Methods: Retrospective analysis of a cohort of patients with chronic plaque psoriasis who started an anti IL-17A agent between September 2016-February 2019 and who developed cutaneous inflammatory eruptions during treatment. A systematic review of similar events reported in the literature was performed. Results: Data of 468 patients were reviewed and 27 cutaneous inflammatory eruptions of 27 (5.8%) patients were collected. The eruptions appeared after a mean of 16.9 ± 17.0 weeks of therapy showing a classical acute eczema in 11 patients (40.7%), an atopic dermatitis-like rash in 11 patients (40.7%) and a psoriasiform eruption in 5 patients (18.5%). Histopathology of 12/27 cases showed epidermal spongiosis in all these variants. Conclusion: We described the clinic-pathologic features of some eczematous eruptions occurring in psoriatic patients, 3–4 months after treatment initiation with an anti IL-17A agent. Further investigations are needed to explain this phenomenon, that might be defined a paradoxical adverse event, based upon the role of IL17 in eczema pathogenesis.

Published
2020

47. Clinical and histopathological characterization of eczematous eruptions occurring in course of anti IL-17 treatment: a case series and review of the literature

Author

Caldarola, G., primary, Pirro, F., additional, Di Stefani, A., additional, Talamonti, M., additional, Galluzzo, M., additional, D’Adamio, S., additional, Magnano, M., additional, Bernardini, N., additional, Malagoli, P., additional, Bardazzi, F., additional, Potenza, C., additional, Bianchi, L., additional, Peris, K., additional, and De Simone, C., additional

Published
2020
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