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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. Synthesis of the Data on COVID-19 Skin Manifestations: Underlying Mechanisms and Potential Outcomes

Author

Farinazzo E, Dianzani C, Zalaudek I, Conforti C, Grabbe S, and Goldust M

Subjects
covid-19, skin rashes, sars-cov-2, cutaneous manifestations, Dermatology, RL1-803
Abstract

Eleonora Farinazzo,1 Caterina Dianzani,2 Iris Zalaudek,1 Claudio Conforti,1 Stephan Grabbe,3 Mohamad Goldust3 1Dermatology Clinic, Maggiore Hospital, University of Trieste, Trieste, Italy; 2Dermatology Section, Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Biomedico University Hospital, Rome, Italy; 3Department of Dermatology, University Medical Center Mainz, Mainz, GermanyCorrespondence: Mohamad GoldustDepartment of Dermatology, University Medical Center of the Johannes Gutenberg University, Mainz, GermanyTel +49 1786-97-425Fax +49 6131-17-6629Email mgoldust@uni-mainz.deAbstract: The incidence of coronavirus disease 2019 (COVID-19)-related skin manifestations has progressively grown, in parallel with the global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreading. The available evidence indicates that cutaneous signs are heterogeneous and can be divided as follows: a) erythematous rashes, b) lesions of vascular origin, c) vesicular rashes, d) urticarial rashes, and e) acute generalized exanthematous pustulosis (AGEP), erythema multiforme (EM) and other polymorphic/atypical reactions. Most cutaneous manifestations appear simultaneously or after respiratory and/or systemic symptoms such as fever, even if rarely urticaria has been reported as the first sign of the disease. It has been proposed that erythematous and vesicular rashes, as well as urticaria, are the result of immunological activation against Sars-CoV-2, similarly to other viral exanthems; alternatively, reactivation or co-infection of herpesviruses and drug hypersensitivity represent possible etiologic diagnosis that has to be considered. Regarding lesions of vascular origin, ischemic ones are the result of systemic hypercoagulability established in severe infections, whereas chilblains seem to be linked to the type I-interferon massively produced to halt virus replication. AGEP is triggered by drugs, whereas EM could represent a delayed immune response to the virus or a hypersensitivity reaction to drugs elicited by the inflammatory process built to fight the infection. A further pathogenic hypothesis is that the virus, or its particles detected in the skin (particularly in endothelium and eccrine glands), could be responsible for certain skin reactions, including chilblains and EM. From the available data, it appears that chilblains are correlated with younger age and less severe disease, while ischemic manifestations occur in the elderly with severe infection. In conclusion, larger studies are needed to confirm the suggested pathogenetic mechanisms of COVID-19-related skin reactions and to determine the potential prognostic significance of each one.Keywords: COVID-19, skin rashes, SARS-CoV-2, cutaneous manifestations

Published
2021

5. Prediction of melanoma metastasis using dermatoscopy deep features. An international multicenter cohort study

Author

Lallas, K., primary, Spyridonos, P., additional, Kittler, H., additional, Tschandl, P., additional, Liopyris, K., additional, Argenziano, G., additional, Bakos, R., additional, Braun, R., additional, Cabos, H., additional, Dika, E., additional, Malvehy, J., additional, Marghoob, A., additional, Puig, S., additional, Scope, A., additional, Stolz, W., additional, Tanaka, M., additional, Thomas, L., additional, Apalla, Z., additional, Vakirlis, E., additional, Zalaudek, I., additional, and Lallas, A., additional

Published
2024
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10. More than 5000 patients with metastatic melanoma in Europe per year do not have access to recommended first-line innovative treatments

Author

Kandolf Sekulovic, L., Peris, K., Hauschild, A., Stratigos, A., Grob, J.-J., Nathan, P., Dummer, R., Forsea, A.-M., Hoeller, C., Gogas, H., Demidov, L., Lebbe, C., Blank, C., Olah, J., Bastholt, L., Herceg, D., Neyns, B., Vieira, R., Hansson, J., Rutkowski, P., Krajsova, I., Bylaite-Bucinskiene, M., Zalaudek, I., Maric-Brozic, J., Babovic, N., Banjin, M., Putnik, K., Weinlich, G., Todorovic, V., Kirov, K., Ocvirk, J., Zhukavets, A., Kukushkina, M., De La Cruz Merino, L., Ymeri, A., Risteski, M., and Garbe, C.

Published
2017
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11. 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

12. Topical ruxolitinib: A new treatment for vitiligo

Author

Tavoletti, G., primary, Avallone, G., additional, Conforti, C., additional, Roccuzzo, G., additional, Maronese, C. A., additional, Mattioli, M. A., additional, Quaglino, P., additional, Zalaudek, I., additional, Marzano, A. V., additional, Ribero, S., additional, and Alberti‐Violetti, S., additional

Published
2023
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13. European consensus-based interdisciplinary guideline for diagnosis and treatment of basal cell carcinoma—update 2023

Author

Peris, Ketty, Fargnoli, Maria Concetta, Kaufmann, R., Arenberger, P., Bastholt, L., Seguin, N. B., Bataille, V., Brochez, L., del Marmol, V., Dummer, R., Forsea, A. -M., Gaudy-Marqueste, C., Harwood, C. A., Hauschild, A., Holler, C., Kandolf, L., Kellerners-Smeets, N. W. J., Lallas, A., Leiter, U., Malvehy, J., Marinovic, B., Mijuskovic, Z., Moreno-Ramirez, D., Nagore, E., Nathan, P., Stratigos, A. J., Stockfleth, E., Tagliaferri, Luca, Trakatelli, M., Vieira, R., Zalaudek, Iri, Garbe, C., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Tagliaferri L. (ORCID:0000-0003-2308-0982), Zalaudek I., Peris, Ketty, Fargnoli, Maria Concetta, Kaufmann, R., Arenberger, P., Bastholt, L., Seguin, N. B., Bataille, V., Brochez, L., del Marmol, V., Dummer, R., Forsea, A. -M., Gaudy-Marqueste, C., Harwood, C. A., Hauschild, A., Holler, C., Kandolf, L., Kellerners-Smeets, N. W. J., Lallas, A., Leiter, U., Malvehy, J., Marinovic, B., Mijuskovic, Z., Moreno-Ramirez, D., Nagore, E., Nathan, P., Stratigos, A. J., Stockfleth, E., Tagliaferri, Luca, Trakatelli, M., Vieira, R., Zalaudek, Iri, Garbe, C., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Tagliaferri L. (ORCID:0000-0003-2308-0982), and Zalaudek I.

Abstract

Basal cell carcinoma (BCC) is the most common malignant tumour in white populations. Multidisciplinary experts from European Association of Dermato-Oncology (EADO), European Dermatology Forum, European Society for Radiotherapy and Oncology (ESTRO), Union Européenne des Médecins Spécialistes, and the European Academy of Dermatology and Venereology developed updated recommendations on diagnosis and treatment of BCC. BCCs were categorised into ‘easy-to-treat’ (common) and ‘difficult-to-treat’ according to the new EADO clinical classification. Diagnosis is based on clinico-dermatoscopic features, although histopathological confirmation is mandatory in equivocal lesions. The first-line treatment of BCC is complete surgery. Micrographically controlled surgery shall be offered in high-risk and recurrent BCC, and BCC located on critical anatomical sites. Topical therapies and destructive approaches can be considered in patients with low-risk superficial BCC. Photodynamic therapy is an effective treatment for superficial and low-risk nodular BCCs. Management of ‘difficult-to-treat’ BCCs should be discussed by a multidisciplinary tumour board. Hedgehog inhibitors (HHIs), vismodegib or sonidegib, should be offered to patients with locally advanced and metastatic BCC. Immunotherapy with anti-PD1 antibodies (cemiplimab) is a second-line treatment in patients with a progression of disease, contraindication, or intolerance to HHI therapy. Radiotherapy represents a valid alternative in patients who are not candidates for or decline surgery, especially elderly patients. Electrochemotherapy may be offered when surgery or radiotherapy is contraindicated. In Gorlin patients, regular skin examinations are required to diagnose and treat BCCs at an early stage. Long-term follow-up is recommended in patients with high-risk BCC, multiple BCCs, and Gorlin syndrome.

Published
2023

14. 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

18. Benefits and Pitfalls of Using in Vivo Reflectance Confocal Microscopy in Lentigo Maligna Diagnostics: Case Reports

Author

Povilaite I., Argenziano G., Babino G., Conforti C., Moscarella E., Pagliuca F., Ronchi A., Zalaudek I., Agozzino M., Povilaite, I., Argenziano, G., Babino, G., Conforti, C., Moscarella, E., Pagliuca, F., Ronchi, A., Zalaudek, I., and Agozzino, M.

Subjects
Oncology, Genetics, diagnostic accuracy, in vivo reflectance confocal microscopy, Dermatology, lentigo maligna, Molecular Biology, pigmented facial lesion
Published
2022

19. Nationwide multidisciplinary consensus on the clinical management of Merkel cell carcinoma: a Delphi panel

Author

Spada F., Bossi P., Caraco C., Sileni V. C., Dei Tos A. P., Fazio N., Grignani G., Maio M., Quaglino P., Queirolo P., Ascierto P. A., Antonini Cappellini G. C., Antonuzzo L., Badalamenti G., Barberis M., Bassetto F., Berardi R., Berruti A., Bongiovanni A., Bonomo P., Borgognoni L., Borzillo V., Bruder F., Campana D., Consoli F., Cordova A., Depenni R., Di Giacomo A. M., Fabbrocini G., Fargnoli M. C., Ferraresi V., Ferrau F., Fierro M. T., Gatti M., Gelsomino F., Giuffrida D., Graziano P., Gregorelli C., Guida M., Massi D., Mazzarotto R., Milesi L., Minisini A. M., Morgese F., Muto P., Palmieri G., Patuzzo R., Pellacani G., Picciotto F., Pigozzo J., Pimpinelli N., Poletti P., Repetto L., Rinaldi G., Rubegni P., Rubino G., Spagnolo F., Tagliaferri L., Tanda E., Tronconi M. C., Tucci M., Valente M., Vincenzi B., Zalaudek I., Spada F., Bossi P., Caraco C., Sileni V.C., Dei Tos A.P., Fazio N., Grignani G., Maio M., Quaglino P., Queirolo P., Ascierto P.A., Antonini Cappellini G.C., Antonuzzo L., Badalamenti G., Barberis M., Bassetto F., Berardi R., Berruti A., Bongiovanni A., Bonomo P., Borgognoni L., Borzillo V., Bruder F., Campana D., Consoli F., Cordova A., Depenni R., Di Giacomo A.M., Fabbrocini G., Fargnoli M.C., Ferraresi V., Ferrau F., Fierro M.T., Gatti M., Gelsomino F., Giuffrida D., Graziano P., Gregorelli C., Guida M., Massi D., Mazzarotto R., Milesi L., Minisini A.M., Morgese F., Muto P., Palmieri G., Patuzzo R., Pellacani G., Picciotto F., Pigozzo J., Pimpinelli N., Poletti P., Repetto L., Rinaldi G., Rubegni P., Rubino G., Spagnolo F., Tagliaferri L., Tanda E., Tronconi M.C., Tucci M., Valente M., Vincenzi B., and Zalaudek I.

Subjects
Pharmacology, Cancer Research, Skin Neoplasms, Immunology, Carcinoma, Carcinoma, Merkel Cell, Oncology, Italy, Merkel cell polyomavirus, Merkel Cell, Molecular Medicine, Immunology and Allergy, immunotherapy, radiotherapy, skin neoplasms, Humans, Immunotherapy
Abstract

Merkel cell carcinoma (MCC) is a rare and highly aggressive cutaneous neuroendocrine carcinoma. The MCC incidence rate has rapidly grown over the last years, with Italy showing the highest increase among European countries. This malignancy has been the focus of active scientific research over the last years, focusing mainly on pathogenesis, new therapeutic trials and diagnosis. A national expert board developed 28 consensus statements that delineated the evolution of disease management and highlighted the paradigm shift towards the use of immunological strategies, which were then presented to a national MCC specialists panel for review. Sixty-five panelists answered both rounds of the questionnaire. The statements were divided into five areas: a high level of agreement was reached in the area of guidelines and multidisciplinary management, even if in real life the multidisciplinary team was not always represented by all the specialists. In the diagnostic pathway area, imaging played a crucial role in diagnosis and initial staging, planning for surgery or radiation therapy, assessment of treatment response and surveillance of recurrence and metastases. Concerning diagnosis, the usefulness of Merkel cell polyomavirus is recognized, but the agreement and consensus regarding the need for cytokeratin evaluation appears greater. Regarding the areas of clinical management and follow-up, patients with MCC require customized treatment. There was a wide dispersion of results and the suggestion to increase awareness about the adjuvant radiation therapy. The panelists unanimously agreed that the information concerning avelumab provided by the JAVELIN Merkel 200 study is adequate and reliable and that the expanded access program data could have concrete clinical implications. An immunocompromised patient with advanced MCC can be treated with immunotherapy after multidisciplinary risk/benefit assessment, as evidenced by real-world analysis and highlighted in the guidelines. A very high consensus regarding the addition of radiotherapy to treat the ongoing focal progression of immunotherapy was observed. This paper emphasizes the importance of collaboration and communication among the interprofessional team members and encourages managing patients with MCC within dedicated multidisciplinary teams. New insights in the treatment of this challenging cancer needs the contribution of many and different experts.

Published
2022

20. 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

21. 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

22. Position statement on classification of basal cell carcinomas. Part 2: EADO proposal for new operational staging system adapted to basal cell carcinomas

Author

Grob, J. J., Gaudy-Marqueste, C., Guminski, A., Malvehy, J., Basset-seguin, N., Bertrand, B., Fernandez-Penas, P., Kaufmann, R., Zalaudek, I., Fargnoli, M. C., Tagliaferri, L., Fertil, B., Del Marmol, V., Stratigos, A., Garbe, C., Peris, K., Zalaudek I., Fargnoli M. C., Tagliaferri L. (ORCID:0000-0003-2308-0982), Peris K. (ORCID:0000-0002-5237-0463), Grob, J. J., Gaudy-Marqueste, C., Guminski, A., Malvehy, J., Basset-seguin, N., Bertrand, B., Fernandez-Penas, P., Kaufmann, R., Zalaudek, I., Fargnoli, M. C., Tagliaferri, L., Fertil, B., Del Marmol, V., Stratigos, A., Garbe, C., Peris, K., Zalaudek I., Fargnoli M. C., Tagliaferri L. (ORCID:0000-0003-2308-0982), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: No simple staging system has emerged for basal cell carcinomas (BCCs), since they do not follow the TNM process, and practitioners failed to agree on simple clinical or pathological criteria as a basis for a classification. Operational classification of BCCs is required for decision-making, trials and guidelines. Unsupervised clustering of real cases of difficult-to-treat BCCs (DTT-BCCs; part 1) has demonstrated that experts could blindly agree on a five groups classification of DTT-BCCs based on five patterns of clinical situations. Objective: Using this five patterns to generate an operational and comprehensive classification of BCCs. Method: Testing practitioner's agreement, when using the five patterns classification to ensure that it is robust enough to be used in the practice. Generating the first version of a staging system of BCCs based on pattern recognition. Results: Sixty-two physicians, including 48 practitioners and the 14 experts who participated in the generation of the five different patterns of DTT-BCCs, agreed on 90% of cases when classifying 199 DTT-BCCs cases using the five patterns classification (part 1) attesting that this classification is understandable and usable in practice. In order to cover the whole field of BCCs, these five groups of DTT-BCCs were added a group representing the huge number of easy-to-treat BCCs, for which sub-classification has little interest, and a group of very rare metastatic cases, resulting in a four-stage and seven-substage staging system of BCCs. Conclusion: A practical classification adapted to the specificities of BCCs is proposed. It is the first tumour classification based on pattern recognition of clinical situations, which proves to be consistent and usable. This EADO staging system version 1 will be improved step by step and tested as a decision tool and a prognostic instrument.

Published
2021

25. Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis

Author

Fargnoli, M. C., Esposito, M., Ferrucci, S., Girolomoni, G., Offidani, A., Patrizi, A., Peris, K., Costanzo, A., Malara, G., Pellacani, G., Romanelli, M., Amerio, P., Cristaudo, A., Flori, M. L., Motolese, A., Betto, P., Patruno, C., Pigatto, P., Sirna, R., Stinco, G., Zalaudek, I., Bianchi, L., Boccaletti, V., Cannavo, S. P., Cusano, F., Lembo, S., Mozzillo, R., Gallo, R., Potenza, C., Rongioletti, F., Tiberio, R., Grieco, T., Micali, G., Persechino, S., Pettinato, M., Pucci, S., Savi, E., Stingeni, L., Romano, A., Argenziano, G., Hansel, K., Fargnoli, M. C., Esposito, M., Ferrucci, S., Girolomoni, G., Offidani, A., Patrizi, A., Peris, K., Costanzo, A., Malara, G., Pellacani, G., Romanelli, M., Amerio, P., Cristaudo, A., Flori, M. L., Motolese, A., Betto, P., Patruno, C., Pigatto, P., Sirna, R., Stinco, G., Zalaudek, I., Bianchi, L., Boccaletti, V., Cannavo, S. P., Cusano, F., Lembo, S., Mozzillo, R., Gallo, R., Potenza, C., Rongioletti, F., Tiberio, R., Grieco, T., Micali, G., Persechino, S., Pettinato, M., Pucci, S., Savi, E., Stingeni, L., Romano, A., Argenziano, G., Fargnoli, Mc, Esposito, M, Ferrucci, S, Girolomoni, G, Offidani, A, Patrizi, A, Peris, K, Costanzo, A, Malara, G, Pellacani, G, Romanelli, M, Amerio, P, Cristaudo, A, Flori, Ml, Motolese, A, Betto, P, Patruno, C, Pigatto, P, Sirna, R, Stinco, G, Zalaudek, I, Bianchi, L, Boccaletti, V, Cannavò, Sp, Cusano, F, Lembo, S, Mozzillo, R, Gallo, R, Potenza, C, Rongioletti, F, Tiberio, R, Grieco, T, Micali, G, Persechino, S, Pettinato, M, Pucci, S, Savi, E, Stingeni, L, Romano, A, Argenziano, G, and Dupilumab Italian National Access Program (Dup-INAP, group).

Subjects
Male, Dermatitis, Severity of Illness Index, Cohort Studies, 030207 dermatology & venereal diseases, 0302 clinical medicine, Quality of life, Monoclonal, 80 and over, Humanized, Aged, 80 and over, Real-life, Atopic dermatitis, Middle Aged, Atopic dermatiti, Dupilumab, humanities, Treatment Outcome, atopic dermatitis, dupilumab, real-life, Female, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Cohort study, atopic dermatiti, Adult, medicine.medical_specialty, Context (language use), Dermatology, Antibodies, Monoclonal, Humanized, Antibodies, Atopic, Dermatitis, Atopic, 03 medical and health sciences, Young Adult, Internal medicine, Severity of illness, medicine, Humans, Adverse effect, Aged, Retrospective Studies, 030203 arthritis & rheumatology, business.industry, Pruritus, Retrospective cohort study, medicine.disease, Quality of Life, business, Sleep
Abstract

Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.

Published
2021

26. Cutaneous adverse reactions following SARS‐CoV ‐2 vaccine booster dose: a real‐life multicentre experience

Author

Avallone, G., primary, Cavallo, F., additional, Astrua, C., additional, Caldarola, G., additional, Conforti, C., additional, De Simone, C., additional, di Meo, N., additional, di Stefani, A., additional, Genovese, G., additional, Maronese, C.A., additional, Marzano, A.V., additional, Parente, R., additional, Quaglino, P., additional, Roccuzzo, G., additional, Tassone, F., additional, Zalaudek, I., additional, Senetta, R., additional, and Ribero, S., additional

Published
2022
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27. 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

28. Likelihood of finding melanoma when removing a melanocytic lesion with peripheral clods

Author

Ribero, S., Argenziano, G., Di Stefani, A., Guidante, M., Moscarella, E., Peris, K., Manganoni, A., Ingordo, V., Zalaudek, I., Senetta, R., Gambardella, A., Venturini, M., Di Meo, N., Quaglino, P., Broganelli, P., Di Stefani A., Peris K. (ORCID:0000-0002-5237-0463), Zalaudek I., Ribero, S., Argenziano, G., Di Stefani, A., Guidante, M., Moscarella, E., Peris, K., Manganoni, A., Ingordo, V., Zalaudek, I., Senetta, R., Gambardella, A., Venturini, M., Di Meo, N., Quaglino, P., Broganelli, P., Di Stefani A., Peris K. (ORCID:0000-0002-5237-0463), and Zalaudek I.

Abstract

na

Published
2020

29. Diagnosis and treatment of Merkel cell carcinoma: European consensus-based interdisciplinary guideline – Update 2022

Author

Gauci, M. -L., Aristei, Cynthia, Becker, J. C., Blom, A., Bataille, V., Dreno, B., Del Marmol, V., Forsea, A. M., Fargnoli, Maria Concetta, Grob, J. -J., Gomes, F., Hauschild, A., Hoeller, C., Harwood, C., Kelleners-Smeets, N., Kaufmann, R., Lallas, A., Malvehy, J., Moreno-Ramirez, D., Peris, Ketty, Pellacani, G., Saiag, P., Stratigos, A. J., Vieira, R., Zalaudek, Iri, van Akkooi, A. C. J., Lorigan, P., Garbe, C., Lebbe, C., Aristei C., Fargnoli M. C., Peris K. (ORCID:0000-0002-5237-0463), Zalaudek I., Gauci, M. -L., Aristei, Cynthia, Becker, J. C., Blom, A., Bataille, V., Dreno, B., Del Marmol, V., Forsea, A. M., Fargnoli, Maria Concetta, Grob, J. -J., Gomes, F., Hauschild, A., Hoeller, C., Harwood, C., Kelleners-Smeets, N., Kaufmann, R., Lallas, A., Malvehy, J., Moreno-Ramirez, D., Peris, Ketty, Pellacani, G., Saiag, P., Stratigos, A. J., Vieira, R., Zalaudek, Iri, van Akkooi, A. C. J., Lorigan, P., Garbe, C., Lebbe, C., Aristei C., Fargnoli M. C., Peris K. (ORCID:0000-0002-5237-0463), and Zalaudek I.

Abstract

Merkel cell carcinoma (MCC) is a rare skin cancer, accounting for less than 1% of all cutaneous malignancies. It is found predominantly in white populations and risk factors include advanced age, ultraviolet exposure, male sex, immunosuppression, such as AIDS/HIV infection, haematological malignancies or solid organ transplantation, and Merkel cell polyomavirus infection. MCC is an aggressive tumour with 26% of cases presenting lymph node involvement at diagnosis and 8% with distant metastases. Five-year overall survival rates range between 48% and 63%. Two subsets of MCC have been characterised with distinct molecular pathogenetic pathways: ultraviolet-induced MCC versus virus-positive MCC, which carries a better prognosis. In both subtypes, there are alterations in the retinoblastoma protein and p53 gene structure and function. MCC typically manifests as a red nodule or plaque with fast growth, most commonly on sun exposed areas. Histopathology (small-cell neuroendocrine appearance) and immunohistochemistry (CK20 positivity and TTF-1 negativity) confirm the diagnosis. The current staging systems are the American Joint Committee on Cancer/Union for international Cancer control 8th edition. Baseline whole body imaging is encouraged to rule out regional and distant metastasis. For localised MCC, first-line treatment is surgical excision with postoperative margin assessment followed by adjuvant radiation therapy (RT). Sentinel lymph node biopsy is recommended in all patients with MCC without clinically detectable lymph nodes or distant metastasis. Adjuvant RT alone, eventually combined with complete lymph nodes dissection is proposed in case of micrometastatic nodal involvement. In case of macroscopic nodal involvement, the standard of care is complete lymph nodes dissection potentially followed by post-operative RT. Immunotherapy with anti-PD-(L)1 antibodies should be offered as first-line systemic treatment in advanced MCC. Chemotherapy can be used when patients fai

Published
2022

30. European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics: Update 2022

Author

Garbe, C., Amaral, T., Peris, Ketty, Hauschild, A., Arenberger, P., Basset-Seguin, N., Bastholt, L., Bataille, V., del Marmol, V., Dreno, B., Fargnoli, Maria Concetta, Forsea, A. -M., Grob, J. -J., Holler, C., Kaufmann, R., Kelleners-Smeets, N., Lallas, A., Lebbe, C., Lytvynenko, B., Malvehy, J., Moreno-Ramirez, D., Nathan, P., Pellacani, G., Saiag, P., Stratigos, A. J., Van Akkooi, A. C. J., Vieira, R., Zalaudek, Iri, Lorigan, P., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Zalaudek I., Garbe, C., Amaral, T., Peris, Ketty, Hauschild, A., Arenberger, P., Basset-Seguin, N., Bastholt, L., Bataille, V., del Marmol, V., Dreno, B., Fargnoli, Maria Concetta, Forsea, A. -M., Grob, J. -J., Holler, C., Kaufmann, R., Kelleners-Smeets, N., Lallas, A., Lebbe, C., Lytvynenko, B., Malvehy, J., Moreno-Ramirez, D., Nathan, P., Pellacani, G., Saiag, P., Stratigos, A. J., Van Akkooi, A. C. J., Vieira, R., Zalaudek, Iri, Lorigan, P., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., and Zalaudek I.

Abstract

Cutaneous melanoma (CM) is potentially the most dangerous form of skin tumor and causes 90% of skin cancer mortality. A unique collaboration of multi-disciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC) was formed to make recommendations on CM diagnosis and treatment, based on systematic literature reviews and the experts' experience. The diagnosis of melanoma can be made clinically and shall always be confirmed with dermatoscopy. If a melanoma is suspected, a histopathological examination is always required. Sequential digital dermatoscopy and full body photography can be used in high-risk patients to improve the detection of early melanoma. Where available, confocal reflectance microscopy can also improve clinical diagnosis in special cases. Melanoma shall be classified according to the 8th version of the American Joint Committee on Cancer classification. Thin melanomas up to 0.8 mm tumor thickness do not require further imaging diagnostics. From stage IB onwards, examinations with lymph node sonography are recommended, but no further imaging examinations. From stage IIC onwards whole-body examinations with computed tomography (CT) or positron emission tomography CT (PET-CT) in combination with brain magnetic resonance imaging are recommended. From stage III and higher, mutation testing is recommended, particularly for BRAF V600 mutation. It is important to provide a structured follow-up to detect relapses and secondary primary melanomas as early as possible. There is no evidence to define the frequency and extent of examinations. A stage-based follow-up scheme is proposed which, according to the experience of the guideline group, covers the optimal requirements, but further studies may be considered. This guideline is valid until the end of 2024.

Published
2022

31. Cutaneous adverse reactions following SARS-CoV-2 vaccine booster dose: a real-life multicentre experience

Author

Avallone, Giulia, Cavallo, F., Astrua, C., Caldarola, Giacomo, Conforti, C., De Simone, Clara, di Meo, N., Di Stefani, Alessandro, Genovese, G., Maronese, C. A., Marzano, A. V., Parente, R., Quaglino, P., Roccuzzo, G., Tassone, F., Zalaudek, Iri, Senetta, R., Ribero, S., Avallone G., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), di Stefani A., Zalaudek I., Avallone, Giulia, Cavallo, F., Astrua, C., Caldarola, Giacomo, Conforti, C., De Simone, Clara, di Meo, N., Di Stefani, Alessandro, Genovese, G., Maronese, C. A., Marzano, A. V., Parente, R., Quaglino, P., Roccuzzo, G., Tassone, F., Zalaudek, Iri, Senetta, R., Ribero, S., Avallone G., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), di Stefani A., and Zalaudek I.

Abstract

nd

Published
2022

33. Update on dermoscopy of Spitz/Reed naevi and management guidelines by the International Dermoscopy Society

Author

Lallas, A., Apalla, Z., Ioannides, D., Lazaridou, E., Kyrgidis, A., Broganelli, P., Alfano, R., Zalaudek, I., Argenziano, G., Bakos, Renato, Blum, Andreas, Braun, Ralph, Cabo, Horacio, Halpern, Allan, Hofmann‐Wellenhof, Rainer, Kittler, Harald, Malvehy, Josep, Marghoob, Ashfaq, Menzies, Scott, Moscarella, Elvira, Paoli, John, Pellacani, Giovanni, Puig, Susana, Rabinovitz, Harold, Scope, Alon, Soyer, Peter, Stolz, Wilhelm, Tanaka, Masaru, Thomas, Luc, and Tschandl, Philipp

Published
2017
Full Text
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37. European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics: Update 2022

Author

Garbe, C. Amaral, T. Peris, K. Hauschild, A. Arenberger, P. Basset-Seguin, N. Bastholt, L. Bataille, V. del Marmol, V. Dréno, B. Fargnoli, M.C. Forsea, A.-M. Grob, J.-J. Höller, C. Kaufmann, R. Kelleners-Smeets, N. Lallas, A. Lebbé, C. Lytvynenko, B. Malvehy, J. Moreno-Ramirez, D. Nathan, P. Pellacani, G. Saiag, P. Stratigos, A.J. Van Akkooi, A.C.J. Vieira, R. Zalaudek, I. Lorigan, P. European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), the European Organization for Research Treatment of Cancer (EORTC)

Abstract

Cutaneous melanoma (CM) is potentially the most dangerous form of skin tumor and causes 90% of skin cancer mortality. A unique collaboration of multi-disciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC) was formed to make recommendations on CM diagnosis and treatment, based on systematic literature reviews and the experts' experience. The diagnosis of melanoma can be made clinically and shall always be confirmed with dermatoscopy. If a melanoma is suspected, a histopathological examination is always required. Sequential digital dermatoscopy and full body photography can be used in high-risk patients to improve the detection of early melanoma. Where available, confocal reflectance microscopy can also improve clinical diagnosis in special cases. Melanoma shall be classified according to the 8th version of the American Joint Committee on Cancer classification. Thin melanomas up to 0.8 mm tumor thickness do not require further imaging diagnostics. From stage IB onwards, examinations with lymph node sonography are recommended, but no further imaging examinations. From stage IIC onwards whole-body examinations with computed tomography (CT) or positron emission tomography CT (PET-CT) in combination with brain magnetic resonance imaging are recommended. From stage III and higher, mutation testing is recommended, particularly for BRAF V600 mutation. It is important to provide a structured follow-up to detect relapses and secondary primary melanomas as early as possible. There is no evidence to define the frequency and extent of examinations. A stage-based follow-up scheme is proposed which, according to the experience of the guideline group, covers the optimal requirements, but further studies may be considered. This guideline is valid until the end of 2024. © 2022 Elsevier Ltd

Published
2022

45. Diagnosis and treatment of basal cell carcinoma: European consensus-based interdisciplinary guidelines.

Author

Peris, K, Fargnoli, Mc, Garbe, C, Kaufmann, R, Bastholt, L, Seguin, Nb, Bataille, V, Marmol, Vd, Dummer, R, Harwood, Ca, Hauschild, A, Höller, C, Haedersdal, M, Malvehy, J, Middleton, Mr, Morton, Ca, Nagore, E, Stratigos, Aj, Szeimies, Rm, Tagliaferri, L, Trakatelli, M, Zalaudek, I, Eggermont, A, Grob, Jj, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC)., Peris K (ORCID:0000-0002-5237-0463), Tagliaferri L (ORCID:0000-0003-2308-0982), Zalaudek I, Peris, K, Fargnoli, Mc, Garbe, C, Kaufmann, R, Bastholt, L, Seguin, Nb, Bataille, V, Marmol, Vd, Dummer, R, Harwood, Ca, Hauschild, A, Höller, C, Haedersdal, M, Malvehy, J, Middleton, Mr, Morton, Ca, Nagore, E, Stratigos, Aj, Szeimies, Rm, Tagliaferri, L, Trakatelli, M, Zalaudek, I, Eggermont, A, Grob, Jj, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC)., Peris K (ORCID:0000-0002-5237-0463), Tagliaferri L (ORCID:0000-0003-2308-0982), and Zalaudek I

Abstract

Basal cell carcinoma (BCC) is the most common malignant tumour in white populations. Multidisciplinary experts from the European Dermatology Forum, the European Association of Dermato-Oncology and the European Organization of Research and Treatment of Cancer collaborated to develop recommendations on diagnosis and treatment of BCC. A new classification into 'easy-to-treat (common) BCC and 'difficult-to-treat' BCC is proposed. Diagnosis is based on clinicodermatoscopic features for 'easy-to-treat' BCCs. Histopathological confirmation is mandatory in ambiguous lesions and in BCCs located in high-risk areas. The first-line treatment of 'easy-to-treat' BCC is complete surgery. Microscopically controlled surgery shall be offered for high-risk BCC, recurrent BCC and BCC in critical anatomical sites. Topical therapies (5% imiquimod, 5% fluorouracil) and destructive approaches (curettage, electrocautery, cryotherapy, laser ablation) should be considered in patients with low-risk superficial BCC. Photodynamic therapy is an effective treatment for superficial BCC and thin nodular BCC. The therapy for a 'difficult-to-treat' BCC should preferentially be discussed by a multidisciplinary tumour board. Hedgehog inhibitors, vismodegib or sonidegib, should be offered to patients with locally advanced and metastatic BCCs. Immunotherapy with anti-programmed cell death 1 (PD-1) antibodies is a promising therapeutic option, currently being investigated in clinical trials. Radiotherapy represents a valid alternative to surgery for BCC on the face, especially in elderly patients. In patients with naevoid basal cell carcinoma syndrome (NBCCS), close surveillance and regular skin examinations are required to diagnose and treat BCCs at early stage. Long-term follow-up is recommended in patients with high-risk BCC subtypes, high-risk sites, multiple BCCs and NBCCS.

Published
2019

46. Moderate-to-severe plaque psoriasis, described by PASI ≥10%, can be associated with higher cardiovascular risk according to seven risk algorithms: Results of a 10-year single-center retrospective study and clinical management of psoriatic patients with cardiovascular risk

Author

Conforti C., Currado D., Navarini L., Retrosi C., Giuffrida R., Zelin E., Afeltra A., di Meo N., Dianzani C., Zalaudek I., Conforti, C., Currado, D., Navarini, L., Retrosi, C., Giuffrida, R., Zelin, E., Afeltra, A., di Meo, N., Dianzani, C., and Zalaudek, I.

Subjects
cardiovascular risk, heart disease, Severity of Illness Index, Algorithms, Heart Disease Risk Factors, Humans, Retrospective Studies, Risk Factors, Treatment Outcome, Cardiovascular Diseases, Psoriasis, psoriasis, psoriasi
Abstract

N/A

Published
2020

48. Étude de phase 3 (PIVOTAL) sur le daromun intralésionnel néoadjuvant comparé à une chirurgie immédiate dans le mélanome entièrement résécable avec métastases cutanées régionales et/ou ganglionnaires

Author

Robert, C., Hassel, J.C., Ziemer, M., Rutkowski, P., Meier, F.E., Flatz, L., Gaudy-Marqueste, C., Santinami, M., Russano, F., Von, W.I., Eigentler, T., Maio, M., Zalaudek, I., Haferkamp, S., Quaglino, P., Ascierto, P.A., Garbe, C., Schadendorf, D., Kaehler, K.C., and Hauschild, A.

Abstract

PIVOTAL (NCT02938299) est un essai ouvert, randomisé, multicentrique de phase 3 évaluant le daromun comme traitement (Tx) intralésionnel néoadjuvant pour le mélanome localement avancé, résécable, de stade III. Le daromun, une combinaison de deux fusions anticorps-cytokines (L19IL2, L19TNF) a montré son efficacité dans une étude de phase 2 (NCT02076633) chez des patients (pts) atteints de mélanome non résécable.

Published
2024
Full Text
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