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

Author

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

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

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

Published
2023

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

Author

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

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

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

Published
2024
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5. Full‐scale measurements of thunderstorm outflows in the Northern Mediterranean.

Author

Canepa, F., Repetto, M. P., and Burlando, M.

Subjects
ATMOSPHERIC sciences, DATABASES, REMOTE-sensing images, WIND speed, WIND pressure
Abstract

Downbursts are severe wind systems originating from thunderstorm clouds, and their strong horizontal outflows can pose serious hazards to natural and built environments. In the context of the activities of the European project THUNDERR—Detection, simulation, modelling and loading of thunderstorm outflows to design wind‐safer and cost‐efficient structures—a comprehensive database of full‐scale downburst measurements was built. All records were acquired by bi‐ or tri‐axial ultrasonic anemometers installed in the main ports of the High Tyrrhenian Sea, namely Genova, Livorno and La Spezia, within the European projects 'Wind and Ports' and 'Wind, Ports and Sea'. The very limited space and time structure of downburst outflows makes the available records in nature inadequate for developing models that could be used in the atmospheric science and engineering communities. The database described herein represents a step forward in attempting to fill this gap. The downburst nature of all events contained in the dataset was verified through detailed meteorological analyses, including comparisons with radar and satellite images and lightning recordings. The wind speed records associated with the events detected by the anemometric network are made publicly available through the online repository Zenodo and can be reused for multiple purposes. The dataset is expected to convey an important impulse towards the physical characterization and modelling of downburst winds and their codification into design tools for the assessment of wind loading and its effects on structures and infrastructure. Furthermore, it could serve as a promising, essential tool for researchers and risk‐related insurance companies. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Eczematous reactions in patients with plaque psoriasis receiving biological therapy: an observational study.

Author

BURLANDO, M., MEGNA, M., CALDAROLA, G., BERNARDINI, N., GIOFRÉ, C., GISONDI, P., DE SIMONE, C., and COZZANI, E.

Abstract

OBJECTIVE: The use of biologic agents, mainly tumor necrosis factor (TNF)-a and interleukin (IL)-17A inhibitors, was associated with cutaneous side effects, but the factors associated with eczematous reactions occurring during biologic treatments are not completely known. PATIENTS AND METHODS: An observational, retrospective, multicentre Italian study evaluated the clinical features and the management of eczematous eruptions in 54 patients with chronic plaque psoriasis who developed eczema after treatment with biological agents (anti-IL-17 or 23). RESULTS: Many of these patients had personal and family history of atopy. Eczematous reactions developed between a few days and 3 years after initiation of the biologic drug. The highest proportion of cases associated with eczematous reactions during biologic treatments was seen in patients on anti-IL-17 agents, including brodalumab. We observed that eczema rapidly remitted without relapse in all patients who switched to anti-IL-23 agents. Among our cases, fast responders to psoriasis therapy seem to have more persistent eczematous reactions. CONCLUSIONS: Patients with psoriasis and a history of atopic dermatitis should be treated with an IL-23 inhibitor due to its efficacy in psoriasis and the rarely reported eczematous reaction. [ABSTRACT FROM AUTHOR]

Published
2024

9. Efficacy and Safety of bimekizumab in elderly patients: real-world multicenter retrospective study - IL PSO (Italian Landscape Psoriasis)

Author

Orsini, D, Megna, M, Assorgi, C, Balato, A, Balestri, R, Bernardini, N, Bettacchi, A, Bianchelli, T, Bianchi, L, Buggiani, G, Burlando, M, Brunasso, A, Caldarola, G, Cameli, N, Campanati, A, Campione, E, Carugno, A, Chersi, K, Conti, A, Costanzo, A, Cozzani, E, Cuccia, A, D'Amico, D, Dal Bello, G, Dall'Olio, E, Dapavo, P, De Simone, C, Di Brizzi, E, Di Cesare, A, Dini, V, Esposito, M, Errichetti, E, Fargnoli, M, Fiorella, C, Foti, A, Fratton, Z, Gaiani, F, Gisondi, P, Giuffrida, R, Giunta, A, Guarneri, C, Legori, A, Loconsole, F, Malagoli, P, Narcisi, A, Paolinelli, M, Potestio, L, Prignano, F, Rech, G, Rossi, A, Skroza, N, Trovato, F, Venturini, M, Richetta, A, Pellacani, G, Dattola, A, Brunasso, Amg, Dall'Olio, E G, Di Brizzi, E V, Fargnoli, M C, Fiorella, C S, Gaiani, F M, Richetta, A G, Orsini, D, Megna, M, Assorgi, C, Balato, A, Balestri, R, Bernardini, N, Bettacchi, A, Bianchelli, T, Bianchi, L, Buggiani, G, Burlando, M, Brunasso, A, Caldarola, G, Cameli, N, Campanati, A, Campione, E, Carugno, A, Chersi, K, Conti, A, Costanzo, A, Cozzani, E, Cuccia, A, D'Amico, D, Dal Bello, G, Dall'Olio, E, Dapavo, P, De Simone, C, Di Brizzi, E, Di Cesare, A, Dini, V, Esposito, M, Errichetti, E, Fargnoli, M, Fiorella, C, Foti, A, Fratton, Z, Gaiani, F, Gisondi, P, Giuffrida, R, Giunta, A, Guarneri, C, Legori, A, Loconsole, F, Malagoli, P, Narcisi, A, Paolinelli, M, Potestio, L, Prignano, F, Rech, G, Rossi, A, Skroza, N, Trovato, F, Venturini, M, Richetta, A, Pellacani, G, Dattola, A, Brunasso, Amg, Dall'Olio, E G, Di Brizzi, E V, Fargnoli, M C, Fiorella, C S, Gaiani, F M, and Richetta, A G

Abstract

Purpose of the article: The aim of this multicenter observational study is to report data from real world on the use of bimekizumab in patients aged ≥ 65 years with moderate-to-severe plaque psoriasis. Elderly patients are poorly represented in clinical trials on bimekizumab for plaque psoriasis, and real-world studies are important to guide clinical choices. Materials and methods: A retrospective multicenter study was conducted in 33 dermatological outpatient clinics in Italy. Patients aged ≥ 65 years, with moderate-to-severe plaque psoriasis and treated with bimekizumab were enrolled. No exclusion criteria were applied. Bimekizumab was administered following the Italian Guidelines for the management of plaque psoriasis and according to the summary of product characteristics, in adult patients who were candidates for systemic treatments. Overall, 98 subjects were included, and received bimekizumab up to week 36. Clinical and demographic data were collected before the initiation of treatment with bimekizumab. At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation. Results: The mean PASI score was 16.6 ± 9.4 at baseline and significantly decreased to 4.3 ± 5.2 after 4 weeks (p < 0.001), and 1.1 ± 1.7 after 16 week (p < 0.001). This level of improvement was maintained after 36 weeks (p < 0.001). PASI ≤2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. PASI 100 at 16 or 36 weeks was not

Published
2024

10. Gender influence and bimekizumab treatment in moderate-to-severe psoriasis: a short term real-life multicenter experience

Author

Diotallevi, F, Richiardi, I, Shevchuk, A, Esposito, M, Vagnozzi, E, Concetta Fargnoli, M, Gisondi, P, Bellinato, F, Assorgi, C, Orsini, D, Brianti, P, Raffaele Mercuri, S, Burlando, M, Cozzani, E, Brunasso, G, Caccavale, S, Di Caprio, R, Balato, A, Caldarola, G, De Simone, C, Campione, E, Giunta, A, Calzavara Pinton, P, Venturini, M, Giovanni Carrera, C, Valerio Marzano, A, Carugno, A, Sena, P, Costanzo, A, Narcisi, A, Cusano, F, Dapavo, P, Quaglino, P, Dattola, A, Giovanni Richetta, A, Gaiani, F, Malagoli, P, Megna, M, Potestio, L, Mortato, E, Loconsole, F, Romano, F, Faragalli, A, Gesuita, R, Campanati, A, Diotallevi, Federico, Richiardi, Irene, Shevchuk, Anna, Esposito, Maria, Vagnozzi, Emanuele, Concetta Fargnoli, Maria, Gisondi, Paolo, Bellinato, Francesco, Assorgi, Chiara, Orsini, Diego, Brianti, Pina, Raffaele Mercuri, Santo, Burlando, Martina, Cozzani, Emanuele, Brunasso, Giovanna, Caccavale, Stefano, Di Caprio, Roberta, Balato, Anna, Caldarola, Giacomo, De Simone, Clara, Campione, Elena, Giunta, Alessandro, Calzavara Pinton, Piergiorgio, Venturini, Marina, Giovanni Carrera, Carlo, Valerio Marzano, Angelo, Carugno, Andrea, Sena, Paolo, Costanzo, Antonio, Narcisi, Alessandra, Cusano, Francesco, Dapavo, Paolo, Quaglino, Pietro, Dattola, Annunziata, Giovanni Richetta, Antonio, Gaiani, Francesca, Malagoli, Piergiorgio, Megna, Matteo, Potestio, Luca, Mortato, Edoardo, Loconsole, Francesco, Romano, Francesca, Faragalli, Andrea, Gesuita, Rosaria, Campanati, Anna, Diotallevi, F, Richiardi, I, Shevchuk, A, Esposito, M, Vagnozzi, E, Concetta Fargnoli, M, Gisondi, P, Bellinato, F, Assorgi, C, Orsini, D, Brianti, P, Raffaele Mercuri, S, Burlando, M, Cozzani, E, Brunasso, G, Caccavale, S, Di Caprio, R, Balato, A, Caldarola, G, De Simone, C, Campione, E, Giunta, A, Calzavara Pinton, P, Venturini, M, Giovanni Carrera, C, Valerio Marzano, A, Carugno, A, Sena, P, Costanzo, A, Narcisi, A, Cusano, F, Dapavo, P, Quaglino, P, Dattola, A, Giovanni Richetta, A, Gaiani, F, Malagoli, P, Megna, M, Potestio, L, Mortato, E, Loconsole, F, Romano, F, Faragalli, A, Gesuita, R, Campanati, A, Diotallevi, Federico, Richiardi, Irene, Shevchuk, Anna, Esposito, Maria, Vagnozzi, Emanuele, Concetta Fargnoli, Maria, Gisondi, Paolo, Bellinato, Francesco, Assorgi, Chiara, Orsini, Diego, Brianti, Pina, Raffaele Mercuri, Santo, Burlando, Martina, Cozzani, Emanuele, Brunasso, Giovanna, Caccavale, Stefano, Di Caprio, Roberta, Balato, Anna, Caldarola, Giacomo, De Simone, Clara, Campione, Elena, Giunta, Alessandro, Calzavara Pinton, Piergiorgio, Venturini, Marina, Giovanni Carrera, Carlo, Valerio Marzano, Angelo, Carugno, Andrea, Sena, Paolo, Costanzo, Antonio, Narcisi, Alessandra, Cusano, Francesco, Dapavo, Paolo, Quaglino, Pietro, Dattola, Annunziata, Giovanni Richetta, Antonio, Gaiani, Francesca, Malagoli, Piergiorgio, Megna, Matteo, Potestio, Luca, Mortato, Edoardo, Loconsole, Francesco, Romano, Francesca, Faragalli, Andrea, Gesuita, Rosaria, and Campanati, Anna

Published
2024

11. Bimekizumab for the Treatment of Plaque Psoriasis With Involvement of Genitalia: A 16-Week Multicenter Real-World Experience - IL PSO (Italian Landscape Psoriasis)

Author

Orsini, D, Malagoli, P, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Dini, V, Esposito, M, Fargnoli, M, Gaiani, F, Gargiulo, L, Gisondi, P, Giunta, A, Ibba, L, Lasagni, C, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Narcisi, A, Offidani, A, Paolino, G, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Assorgi, C, Costanzo, A, Orsini, Diego, Malagoli, Piergiorgio, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G, Carugno, Andrea, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Dini, Valentina, Esposito, Maria, Fargnoli, Maria C, Gaiani, Francesca M, Gargiulo, Luigi, Gisondi, Paolo, Giunta, Alessandro, Ibba, Luciano, Lasagni, Claudia, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V, Maurelli, Martina, Megna, Matteo, Mercuri, Santo R, Narcisi, Alessandra, Offidani, Annamaria, Paolino, Giovanni, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G, Romano, Francesca, Sena, Paolo, Venturini, Marina, Assorgi, Chiara, Costanzo, Antonio, Orsini, D, Malagoli, P, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Dini, V, Esposito, M, Fargnoli, M, Gaiani, F, Gargiulo, L, Gisondi, P, Giunta, A, Ibba, L, Lasagni, C, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Narcisi, A, Offidani, A, Paolino, G, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Assorgi, C, Costanzo, A, Orsini, Diego, Malagoli, Piergiorgio, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G, Carugno, Andrea, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Dini, Valentina, Esposito, Maria, Fargnoli, Maria C, Gaiani, Francesca M, Gargiulo, Luigi, Gisondi, Paolo, Giunta, Alessandro, Ibba, Luciano, Lasagni, Claudia, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V, Maurelli, Martina, Megna, Matteo, Mercuri, Santo R, Narcisi, Alessandra, Offidani, Annamaria, Paolino, Giovanni, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G, Romano, Francesca, Sena, Paolo, Venturini, Marina, Assorgi, Chiara, and Costanzo, Antonio

Abstract

Introduction: Genital involvement is observed in approximately 60% of patients with psoriasis, presenting clinicians with formidable challenges in treatment. While new biologic drugs have emerged as safe and effective options for managing psoriasis, their efficacy in challenging-to-treat areas remains inadequately explored. Intriguingly, studies have shown that interleukin (IL)-17 inhibitors exhibit effectiveness in addressing genital psoriasis. Objectives: We aimed to determine the effectiveness profile of bimekizumab in patients affected by moderate-to-severe plaque psoriasis with involvement of genitalia. Methods: Bimekizumab, a dual inhibitor of both IL-17A and IL-17F, was the focus of our 16-week study, demonstrating highly favorable outcomes for patients with genital psoriasis. The effectiveness of bimekizumab was evaluated in terms of improvement in Static Physician's Global Assessment of Genitalia (sPGA-G) and Psoriasis Area and Severity Index. Results: Sixty-five adult patients were enrolled. Remarkably, 98.4% of our participants achieved a clear sPGA-G score (s-PGA-g=0) within 16 weeks. Moreover, consistent improvements were observed in PASI scores, accompanied by a significant reduction in the mean Dermatology Life Quality Index (DLQI), signifying enhanced quality of life. Notably, none of the patients reported a severe impairment in their quality of life after 16 weeks of treatment. In our cohort of 65 patients, subgroup analyses unveiled that the effectiveness of bimekizumab remained unaffected by prior exposure to other biologics or by obesity. Conclusions: Our initial findings suggest that bimekizumab may serve as a valuable treatment option for genital psoriasis. Nevertheless, further research with larger sample sizes and longer-term follow-up is imperative to conclusively validate these results.

Published
2024

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

Author

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

Abstract

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

Published
2024

13. Profilo super responder in corso di trattamento con bimekizumab: studio retrospettivo multicentrico nella psoriasi moderato-grave

Author

Esposito, M, Vagnozzi, E, Di Caprio, R, Assorgi, C, Bellinato, F, Brianti, P, Burlando, M, Brunasso, G, Caccavale, S, Caldarola, G, Campione, E, Calzavara-Pinton, P, Campanati, A, Carrera, C, Carugno, A, Cozzani, E, Costanzo, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Diotallevi, F, Fargnoli, M, Gaiani, F, Giunta, A, Malagoli, P, Marzano, A, Megna, M, Mercuri, S, Mortato, E, Narcisi, A, Orsini, D, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Loconsole, F, Gisondi, P, Balato, A, Carrera, CG, Fargnoli, MC, Marzano, AV, Mercuri, SR, Richetta, AG, Esposito, M, Vagnozzi, E, Di Caprio, R, Assorgi, C, Bellinato, F, Brianti, P, Burlando, M, Brunasso, G, Caccavale, S, Caldarola, G, Campione, E, Calzavara-Pinton, P, Campanati, A, Carrera, C, Carugno, A, Cozzani, E, Costanzo, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Diotallevi, F, Fargnoli, M, Gaiani, F, Giunta, A, Malagoli, P, Marzano, A, Megna, M, Mercuri, S, Mortato, E, Narcisi, A, Orsini, D, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Loconsole, F, Gisondi, P, Balato, A, Carrera, CG, Fargnoli, MC, Marzano, AV, Mercuri, SR, and Richetta, AG

Abstract

Bimekizumab è un anticorpo monoclonale umanizzato, recentemente approvato per il trattamento della psoriasi a placche moderato-grave, inibitore selettivo delle isoforme dell’interleuchina-17A e F. Le esperienze real-life riguardanti l’utilizzo del farmaco sono limitate ed il profilo del paziente con riposta più elevata PASI100 cioè super responder SR non è stato analizzato. Presentiamo questo studio multicentrico, retrospettivo volto a disegnare il profilo del paziente che beneficia maggiormente del trattamento con bimekizumab, considerando come SR coloro che raggiungono PASI 100 alla settimana-4 e 16. Sono stati studiati pazienti adulti affetti da psoriasi moderato-grave, trattati con bimekizumab per almeno 16 settimane presso 21 centri dermatologici italiani, secondo regole di appropriatezza AIFA e in accordo con la scheda tecnica del farmaco. Endpoints di efficacia erano PASI75, PASI90 e PASI100 alla settimana 4 e 16, ed in particolare la percentuale di SR ai due tempi. I pazienti che non raggiungevano tale target venivano definiti come non-super responders NSRs. Sono stati studiati 137 pazienti con età media 52,47±15,56 anni, BMI medio 27,43±5,91 e PASI medio al basale di 16,00±9,29. Alla settimana 4 il 72% dei pazienti raggiungeva PASI75, il 50% PASI90, mentre il 43% otteneva PASI100, definendo la popolazione SR alla settimana 4. Alla settimana 16, il 93% dei pazienti raggiungeva PASI75, il 77% PASI90, il 70% dei pazienti risultava essere SR mentre solo il 7% non raggiungeva PASI 75. Sono emerse alcune differenze caratterizzanti pazienti con un più rapido raggiungimento dello stato di SRs alla settimana 4 rispetto alla settimana 16: età ≥46<65, coesistenza di <2 comorbidità e stato naïve a precedenti trattamenti biologici. Considerando alcune caratteristiche clinico-demografiche è stata condotta un’analisi univariata per valutare le differenze tra SR e NSRs. Lo stato di NSR è risultato associato significativamente alla settimana 4 con: BMI≥25 &

Published
2024

14. Experimental and Numerical Study of the Wind Tunnel Blockage Effects on the Behaviour of a Horizontal Axis Wind Turbine

Author

Eltayesh, A., Burlando, M., Castellani, F., Becchetti, M., di Prisco, Marco, Series Editor, Chen, Sheng-Hong, Series Editor, Vayas, Ioannis, Series Editor, Kumar Shukla, Sanjay, Series Editor, Sharma, Anuj, Series Editor, Kumar, Nagesh, Series Editor, Wang, Chien Ming, Series Editor, Ricciardelli, Francesco, editor, and Avossa, Alberto Maria, editor

Published
2019
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15. Wind Tunnel Experimentation on Stationary Downbursts at WindEEE Dome

Author

Burlando, M., Romanić, D., Hangan, H., Solari, G., di Prisco, Marco, Series Editor, Chen, Sheng-Hong, Series Editor, Vayas, Ioannis, Series Editor, Kumar Shukla, Sanjay, Series Editor, Sharma, Anuj, Series Editor, Kumar, Nagesh, Series Editor, Wang, Chien Ming, Series Editor, Ricciardelli, Francesco, editor, and Avossa, Alberto Maria, editor

Published
2019
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17. PsoBioVax: A multicentric Italian case–control study of the immunological response to anti‐SARS‐CoV‐2 vaccine among psoriatic patients under biological therapy

Author

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

Published
2023
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18. PsoBioVax: A multicentric Italian case–control study of the immunological response to anti‐SARS‐CoV‐2 vaccine among psoriatic patients under biological therapy.

Author

Sacchelli, L., Filippi, F., Balato, A., Balestri, R., Bellinato, F., Bernardini, N., Bianchi, L., Burlando, M., Campanati, A., Chessa, M. A., Corazza, M., Di Cesare, A., Di Lernia, V., Diotallevi, F., Esposito, M., Fargnoli, M. C., Gisondi, P., Giunta, A., Hansel, K., and Magnano, M.

Subjects
BIOTHERAPY, VACCINE effectiveness, CASE-control method, MEDICAL personnel
Abstract

A recent Italian study examined the immune response to the COVID-19 vaccine among psoriatic patients receiving biological therapy. The study included 346 psoriatic patients and 151 controls who received two doses of the vaccine and were tested for antibodies. The results showed that both groups had a strong antibody response, with no significant difference between patients and controls. Mild adverse events were reported by about one-fourth of participants, and no serious adverse events were reported. The study also found that the type of vaccine administered was associated with antibody levels, with higher levels observed in those vaccinated with Janssen and lower levels in those vaccinated with AstraZeneca. However, the number of subjects who received these vaccines was limited. The study suggests that COVID-19 vaccinations are effective and safe for psoriatic patients undergoing biological treatments. [Extracted from the article]

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

Author

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

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

Author

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

Subjects
PSORIASIS, PATIENT experience, PATIENTS' attitudes
Abstract

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

Published
2024
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25. Real-life experience with ixekizumab in plaque psoriasis: a multi-center, retrospective, 3-year study

Author

Caldarola, G, primary, Chiricozzi, A, additional, Megna, M, additional, Dapavo, P, additional, Giunta, A, additional, Burlando, M, additional, Malagoli, P, additional, Dini, V, additional, Mariani, M, additional, Fabbrocini, G, additional, Quaglino, P, additional, Bianchi, L, additional, Parodi, A, additional, Peris, K, additional, and De Simone, C, additional

Published
2023
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26. Real-life experience with ixekizumab in plaque psoriasis: a multi-center, retrospective, 3-year study

Author

Caldarola, Giacomo, Chiricozzi, Andrea, Megna, M, Dapavo, P, Giunta, A, Burlando, M, Malagoli, P, Dini, V, Mariani, Marco, Fabbrocini, G, Quaglino, P, Bianchi, L, Parodi, A, Peris, Ketty, De Simone, Clara, Caldarola, Giacomo (ORCID:0000-0002-8837-9232), Chiricozzi, A (ORCID:0000-0002-6739-0387), Mariani, M, Peris, K (ORCID:0000-0002-5237-0463), De Simone, C (ORCID:0000-0002-0898-0045), Caldarola, Giacomo, Chiricozzi, Andrea, Megna, M, Dapavo, P, Giunta, A, Burlando, M, Malagoli, P, Dini, V, Mariani, Marco, Fabbrocini, G, Quaglino, P, Bianchi, L, Parodi, A, Peris, Ketty, De Simone, Clara, Caldarola, Giacomo (ORCID:0000-0002-8837-9232), Chiricozzi, A (ORCID:0000-0002-6739-0387), Mariani, M, Peris, K (ORCID:0000-0002-5237-0463), and De Simone, C (ORCID:0000-0002-0898-0045)

Abstract

Background: Confirmatory data on the long-term effectiveness and safety of ixekizumab in psoriatic patients from real-world studies are needed. Objectives: The primary aim was to evaluate the 3-year drug survival of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis, in a multicenter real-world setting. The secondary aim was to assess the influence of predictive factors on the drug survival of ixekizumab. Methods: A retrospective analysis was performed on a cohort of patients with chronic plaque psoriasis, who received at least one dose of ixekizumab before December 2018. The drug survival analysis was performed and descriptively analyzed using Kaplan-Meier survival curves. Multivariable Cox regression analyses were carried out including variables considered to be of clinical importance. Results: A total of 306 patients were enrolled. The overall drug survival at 12, 24, and 36 months of treatment with ixekizumab was 92.11%, 83.85%, and 80.19%, respectively. A higher probability (HR 2.34) of drug withdrawal was found among patients who had already received an anti-IL-17 agent compared with bio-naive patients (p 0.017). Conclusions: We found that ixekizumab is a biological agent characterized by long-term effectiveness, not influenced by several clinical factors and associated with a good safety profile.

Published
2023

27. Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)

Author

Gargiulo, L, Narcisi, A, Ibba, L, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cristaudo, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Gaiani, F, Gisondi, P, Giunta, A, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Offidani, A, Orsini, D, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Malagoli, P, Costanzo, A, Gargiulo, Luigi, Narcisi, Alessandra, Ibba, Luciano, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G., Carugno, Andrea, Cristaudo, Antonio, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Gaiani, Francesca M., Gisondi, Paolo, Giunta, Alessandro, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V., Maurelli, Martina, Megna, Matteo, Mercuri, Santo R., Offidani, Annamaria, Orsini, Diego, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G., Romano, Francesca, Sena, Paolo, Venturini, Marina, Malagoli, Piergiorgio, Costanzo, Antonio, Gargiulo, L, Narcisi, A, Ibba, L, Balato, A, Bianchi, L, Brianti, P, Buononato, D, Burlando, M, Caldarola, G, Campanati, A, Campione, E, Carrera, C, Carugno, A, Cristaudo, A, Cusano, F, Dapavo, P, Dattola, A, De Simone, C, Gaiani, F, Gisondi, P, Giunta, A, Loconsole, F, Maione, V, Mortato, E, Marzano, A, Maurelli, M, Megna, M, Mercuri, S, Offidani, A, Orsini, D, Parodi, A, Pellacani, G, Potestio, L, Quaglino, P, Richetta, A, Romano, F, Sena, P, Venturini, M, Malagoli, P, Costanzo, A, Gargiulo, Luigi, Narcisi, Alessandra, Ibba, Luciano, Balato, Anna, Bianchi, Luca, Brianti, Pina, Buononato, Dario, Burlando, Martina, Caldarola, Giacomo, Campanati, Anna, Campione, Elena, Carrera, Carlo G., Carugno, Andrea, Cristaudo, Antonio, Cusano, Francesco, Dapavo, Paolo, Dattola, Annunziata, De Simone, Clara, Gaiani, Francesca M., Gisondi, Paolo, Giunta, Alessandro, Loconsole, Francesco, Maione, Vincenzo, Mortato, Edoardo, Marzano, Angelo V., Maurelli, Martina, Megna, Matteo, Mercuri, Santo R., Offidani, Annamaria, Orsini, Diego, Parodi, Aurora, Pellacani, Giovanni, Potestio, Luca, Quaglino, Pietro, Richetta, Antonio G., Romano, Francesca, Sena, Paolo, Venturini, Marina, Malagoli, Piergiorgio, and Costanzo, Antonio

Abstract

Introduction: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. Method: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. Results: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. Conclusion: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.

Published
2023

28. 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

29. Characteristics of Patients Experiencing a Flare of Generalized Pustular Psoriasis: A Multicenter Observational Study

Author

Bellinato, F, Gisondi, P, Marzano, A, Piaserico, S, De Simone, C, Damiani, G, Argenziano, G, Venturini, M, Dapavo, P, Costanzo, A, Megna, M, Prignano, F, Burlando, M, Satolli, F, Carugno, A, Pezzolo, E, Romanelli, M, Cuccia, A, Girolomoni, G, Bellinato, Francesco, Gisondi, Paolo, Marzano, Angelo Valerio, Piaserico, Stefano, De Simone, Clara, Damiani, Giovanni, Argenziano, Giuseppe, Venturini, Marina, Dapavo, Paolo, Costanzo, Antonio, Megna, Matteo, Prignano, Francesca, Burlando, Martina, Satolli, Francesca, Carugno, Andrea, Pezzolo, Elena, Romanelli, Marco, Cuccia, Aldo, Girolomoni, Giampiero, Bellinato, F, Gisondi, P, Marzano, A, Piaserico, S, De Simone, C, Damiani, G, Argenziano, G, Venturini, M, Dapavo, P, Costanzo, A, Megna, M, Prignano, F, Burlando, M, Satolli, F, Carugno, A, Pezzolo, E, Romanelli, M, Cuccia, A, Girolomoni, G, Bellinato, Francesco, Gisondi, Paolo, Marzano, Angelo Valerio, Piaserico, Stefano, De Simone, Clara, Damiani, Giovanni, Argenziano, Giuseppe, Venturini, Marina, Dapavo, Paolo, Costanzo, Antonio, Megna, Matteo, Prignano, Francesca, Burlando, Martina, Satolli, Francesca, Carugno, Andrea, Pezzolo, Elena, Romanelli, Marco, Cuccia, Aldo, and Girolomoni, Giampiero

Abstract

Background: Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease characterized by recurrent episodes of flares. Characteristics of patients experiencing a flare are hardly described in a real-life setting. The aim of the study is to investigate the clinical characteristics of patients experiencing a flare of GPP. Methods: Multicenter retrospective observational study on consecutive patients experiencing a flare of GPP between 2018 and 2022. Disease severity and quality of life were assessed by Generalized Pustular Psoriasis Area, Body Surface Area (BSA), and Severity Index (GPPASI), and Dermatology life quality index (DLQI) questionnaire, respectively. Visual analogue scale (VAS) of itch and pain, triggers, complications, comorbidities, pharmacological therapies, and outcome were collected. Results: A total of 66 patients, 45 (68.2%) females, mean age 58.1 ± 14.9 years, were included. The GPPASI, BSA, and DLQI were 22.9 ± 13.5 (mean ± standard deviation), 47.9 ± 29.1, and 21.0 ± 5.0, respectively. The VAS of itch and pain were 6.2 ± 3.3 and 6.2 ± 3.0, respectively. Fever (>38 °C) and leukocytosis (WBC > 12 × 109/L) were found in 26 (39.4%) and 39 (59.1%) patients, respectively. Precipitating triggers were identified in 24 (36.3%) and included infections (15.9%), drugs (10.6%), stressful life events (7.6%), and corticosteroids withdrawal (3.0%). Fourteen (21.2%) patients were hospitalized because of complications including infections in 9 (13.6%) leading to death in one case and hepatitis in 3 (4.5%). Conclusions: GPP flares can be severe and cause severe pain and itch with significant impact on the quality of life. In about one-third of patients the flare may have a persistent course and, with complications, lead to hospitalization.

Published
2023

30. Risankizumab: Daily Practice Experience of High Need Patients

Author

Brunasso, A. M. G., Burlando, M., Amoruso, F., Arancio, L., Malara, G., Manzo, R., Montesu, M. A., Caldarola, Giacomo, Caldarola G. (ORCID:0000-0002-8837-9232), Brunasso, A. M. G., Burlando, M., Amoruso, F., Arancio, L., Malara, G., Manzo, R., Montesu, M. A., Caldarola, Giacomo, and Caldarola G. (ORCID:0000-0002-8837-9232)

Abstract

Psoriasis is a chronic inflammatory disease which affects 29.5 million people worldwide and it can negatively impact quality of life, especially when it affects a special localization, such as nails, face, palms and soles, or intertriginous regions. Risankizumab is a humanized monoclonal antibody which targets the p19 subunit of interleukin-23 and it is currently licensed also as systemic therapy for moderate to severe plaque psoriasis. Here, we present eight cases of patients with moderate to severe psoriasis treated with risankizumab with a significant efficacy in the remission of the disease. Our cases represent a real-world clinical setting and provide a valuable adjunct to results obtained in the selected patients usually included in controlled clinical trials. In our cases, risankizumab rapidly improved clinical manifestations and relieved symptoms in patients with moderate to severe psoriasis, regardless of the presence of comorbidities or the location of the plaques in special sites, and without any safety concerns.

Published
2023

31. Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)

Author

Gargiulo, L., Narcisi, A., Ibba, L., Balato, A., Bianchi, L., Brianti, P., Buononato, D., Burlando, M., Caldarola, Giacomo, Campanati, A., Campione, E., Carrera, C. G., Carugno, A., Cristaudo, A., Cusano, F., Dapavo, P., Dattola, Carmelo Alberto, De Simone, Clara, Gaiani, F. M., Gisondi, P., Giunta, A., Loconsole, F., Maione, V., Mortato, E., Marzano, A. V., Maurelli, M., Megna, M., Mercuri, S. R., Offidani, A., Orsini, Diego, Parodi, A., Pellacani, G., Potestio, L., Quaglino, P., Richetta, A. G., Romano, Federica, Sena, P., Venturini, M., Malagoli, P., Costanzo, Rosa Maria Alba, Caldarola G. (ORCID:0000-0002-8837-9232), Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Orsini D., Romano F., Costanzo A., Gargiulo, L., Narcisi, A., Ibba, L., Balato, A., Bianchi, L., Brianti, P., Buononato, D., Burlando, M., Caldarola, Giacomo, Campanati, A., Campione, E., Carrera, C. G., Carugno, A., Cristaudo, A., Cusano, F., Dapavo, P., Dattola, Carmelo Alberto, De Simone, Clara, Gaiani, F. M., Gisondi, P., Giunta, A., Loconsole, F., Maione, V., Mortato, E., Marzano, A. V., Maurelli, M., Megna, M., Mercuri, S. R., Offidani, A., Orsini, Diego, Parodi, A., Pellacani, G., Potestio, L., Quaglino, P., Richetta, A. G., Romano, Federica, Sena, P., Venturini, M., Malagoli, P., Costanzo, Rosa Maria Alba, Caldarola G. (ORCID:0000-0002-8837-9232), Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Orsini D., Romano F., and Costanzo A.

Abstract

Introduction: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. Method: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. Results: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. Conclusion: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.

Published
2023

34. 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

35. Efficacy and Safety of Dimethyl Fumarate in Patients with Moderate-to-Severe Plaque Psoriasis: DIMESKIN-2, a Multicentre Single-Arm Phase IIIb Study

Author

Pellacani, G., Bigi, L., Parodi, A., Burlando, M., Lanna, C., Campione, E., Rongioletti, F., Mugheddu, C., Malara, G., Moretti, G., Stingeni, L., Hansel, K., Micali, G., Naldi, L., Pirro, Federico, Peris, Ketty, Pirro F., Peris K. (ORCID:0000-0002-5237-0463), Pellacani, G., Bigi, L., Parodi, A., Burlando, M., Lanna, C., Campione, E., Rongioletti, F., Mugheddu, C., Malara, G., Moretti, G., Stingeni, L., Hansel, K., Micali, G., Naldi, L., Pirro, Federico, Peris, Ketty, Pirro F., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

This open-label multicentre trial evaluated the efficacy and safety of oral dimethyl fumarate (DMF) in patients with moderate-to-severe plaque psoriasis in real-life clinical practice over 52 weeks. Disease severity and improvement were assessed using the psoriasis area severity index (PASI), body surface area (BSA) affected, and Physician Global Assessment (PGA). Quality of life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) questionnaire. The visual analogue scale (VAS) was used to quantify pruritus and measure treatment satisfaction. A total of 141 patients were included, being 66.7% male, aged 49.1 ± 14.7 years and with disease duration of 16 ± 12.1 years. After 52 weeks, mean PASI decreased from 15.9 ± 6.8 to 1.5 ± 2 and 87.7%, 56.9% and 24.6% of patients achieved PASI 75/90/100 response, respectively. BSA decreased from 26.5 ± 14.8% to 2.7 ± 3.5% at 52 weeks, and 81.5% of patients had a PGA 0-1. DLQI scores decreased from 9.4 ± 6.4 to 2.1 ± 3.3, and VAS of pruritus decreased from 53 ± 28.4 to 19.1 ± 26.2 at Week 52. VAS for treatment satisfaction was 79.4 ± 29.4 at Week 52. A total of 34.2% of patients had an AE leading to permanent discontinuation. These findings show that DMF can significantly improve indices of disease severity, pruritus and QoL, with high levels of patient satisfaction and similar safety profile to other fumarates.

Published
2022

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

Author

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

Abstract

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

Published
2022

37. Long-term clinical efficacy and safety of ixekizumab for psoriatic patients: a single-center experience.

Author

BURLANDO, M., SALVI, I., CASTELLI, R., HERZUM, A., COZZANI, E., and PARODI, A.

Abstract

OBJECTIVE: While clinical trials provide invaluable evidence, real-world data can offer further insight on the efficacy and safety of biologic drugs. This report aims to analyze the long-term efficacy and safety of ixekizumab in real-world clinical practice in our facility. PATIENTS AND METHODS: Patients with a diagnosis of psoriasis and who started treatment with ixekizumab were included in this retrospective study and followed for 156 weeks. The severity of cutaneous manifestations was evaluated using the PASI score at several time points and clinical efficacy was evaluated using PASI 75, -90 and -100 responses. RESULTS: Not only PASI 75, but also PASI 90 and 100 responses showed a favorable outcome after treatment with ixekizumab. Responses at week 12 were sustained through the following three years in the majority of patients. No statistically significant difference was found between bio-naive and bioswitch patients and weight and disease duration had no impact on the efficacy of the drug. Ixekizumab had a favorable safety profile, as we observed no major adverse events. Two cases of eczema were observed and led to drug discontinuation. CONCLUSIONS: This study confirms the efficacy and safety of ixekizumab in real-world clinical practice. [ABSTRACT FROM AUTHOR]

Published
2023

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

Author

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

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

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

Published
2021

39. 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, Marina, Galluzzo, Marco, Chiricozzi, Andrea, Quaglino, Pietro, Fabbrocini, Gabriella, Gisondi, Paolo, Marzano, Angelo Valerio, Potenza, Concetta, Conti, Andrea, Parodi, Aurora, Piaserico, Stefano, Bardazzi, Federico, Argenziano, Giuseppe, Rongioletti, Franco, Stingeni, Luca, Micali, Giuseppe, Loconsole, Francesco, Rossi, Maria Teresa, Bongiorno, Maria Rita, Feliciani, Claudio, Rubegni, Pietro, Amerio, Paolo, Fargnoli, Maria Concetta, Pigatto, Paolo, Savoia, Paola, Nisticò, Steven Paul, Giustini, Sandra, Carugno, Andrea, Cannavo', Serafinella Patrizia, Rech, Giulia, Prignano, Francesca, Offidani, Annamaria, Lombardo, Maurizio, Zalaudek, Iris, Bianchi, Luca, Peris, Ketty, PSO-BIO-COVID study group, Balestri R, Bernardini N, Belloni Fortini A, Burlando M, Caldarola G, Campione E, Cattaneo A, Dapavo P, Dastoli S, De Simone C, Di Nuzzo S, Diotallevi F, Fierro MT, Franchi C, Esposito M, Foti C, Gambini DM, Gambardella A, Girolomoni G, Giunta A, Guarneri C, Gualdi G, Hansel K, Megna M, Mugheddu C, Musumeci ML, Patrizi A, Pellacani G, Richetta AG, Rosi E, Sacchelli L, Tiberio R, Tilotta G, Trovato E, Venturini M, Vezzoni R, 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., Nistico, 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, Marina, Galluzzo, Marco, Chiricozzi, Andrea, Quaglino, Pietro, Fabbrocini, Gabriella, Gisondi, Paolo, Marzano, Angelo Valerio, Potenza, Concetta, Conti, Andrea, Parodi, Aurora, Piaserico, Stefano, Bardazzi, Federico, Argenziano, Giuseppe, Rongioletti, Franco, Stingeni, Luca, Micali, Giuseppe, Loconsole, Francesco, Rossi, Maria Teresa, Bongiorno, Maria Rita, Feliciani, Claudio, Rubegni, Pietro, Amerio, Paolo, Fargnoli, Maria Concetta, Pigatto, Paolo, Savoia, Paola, Nisticò, Steven Paul, Giustini, Sandra, Carugno, Andrea, Cannavo', Serafinella Patrizia, Rech, Giulia, Prignano, Francesca, Offidani, Annamaria, Lombardo, Maurizio, Zalaudek, Iri, Bianchi, Luca, Peris, Ketty, PSO-BIO-COVID study, Group, Balestri, R, Bernardini, N, Belloni Fortini, A, Burlando, M, Caldarola, G, Campione, E, Cattaneo, A, Dapavo, P, Dastoli, S, De Simone, C, Di Nuzzo, S, Diotallevi, F, Fierro, Mt, Franchi, C, Esposito, M, Foti, C, Gambini, Dm, Gambardella, A, Girolomoni, G, Giunta, A, Guarneri, C, Gualdi, G, Hansel, K, Megna, M, Mugheddu, C, Musumeci, Ml, Patrizi, A, Pellacani, G, Richetta, Ag, Rosi, E, Sacchelli, L, Tiberio, R, Tilotta, G, Trovato, E, Venturini, M, Vezzoni, R, 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., Nistico S.P., Giustini S., Carugno A., Cannavo' S.P., Rech G., Prignano F., Offidani A., Lombardo M., Zalaudek I., Bianchi L., and Peris K.

Subjects
0301 basic medicine, Male, Clinical Biochemistry, Disease, Cohort Studies, 0302 clinical medicine, Drug Discovery, Receptors, 80 and over, Medicine, Aged, 80 and over, education.field_of_study, Incidence (epidemiology), Incidence, Interleukin-17, psoriasis, Middle Aged, dermatology, sars-CoV-2, Italy, biological therapy, 030220 oncology & carcinogenesis, Cohort, Biological Product, COVID-19, Female, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Adult, Aged, Biological Products, Biological Therapy, Chronic Disease, Humans, Pandemics, Psoriasis, Receptors, Interleukin, Risk Assessment, Tumor Necrosis Factor-alpha, Young Adult, Cohort study, Human, medicine.medical_specialty, Population, 03 medical and health sciences, Settore MED/35, Internal medicine, education, Pharmacology, Psoriasi, Pandemic, business.industry, Biological product, Interleukin, medicine.disease, Clinical trial, 030104 developmental biology, SARS-CoV-2, Cohort Studie, business
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. For all confirmed or suspected cases of COVID-19, data about concomitant disease, ongoing therapies, and comorbidities were also reported. Results A total of 12,807 psoriatic patients were included in the PSO-BIO-COVID study. In this cohort twenty-six patients (0.2%) had a swab confirmation of SARS-CoV-2 infection. Eleven patients required hospitalization and two died. 125 of 12807 patients (1.0%) with exposure to a patient with COVID-19 under quarantine or active health surveillance, were reported. 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

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

Author

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

Published
2015
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43. Psoriasis patients' characteristics associated with high PASI response to tildrakizumab: an international dual center study.

Author

BURLANDO, M., MAUL, J.-T., SALVI, I., SIMIC, D., COZZANI, E., AK, M., BIRKENMAIER, I., and PARODI, A.

Abstract

OBJECTIVE: Heterogeneous real-world evidence can complement the more strictly regulated clinical trial data. A benefit of this is the wide range of backgrounds, comorbidities and characteristics that can give additional insights into treatments. Observational, retrospective studies can help to fill in the mosaic that makes up a treatments landscape. Tildrakizumab, an interleukin 23p19 inhibitor, is approved for the treatment of plaque psoriasis and has been shown to be a safe and efficacious therapy in clinical trials and emerging real-world evidence. We aimed at confirming the efficacy of tildrakizumab in patients with plaque psoriasis in a dual center setting and identifying patients' characteristics leading to better treatment response. PATIENTS AND METHODS: Patients with moderate to severe plaque psoriasis, eligible for systemic biological treatment, and treated with tildrakizumab were included in the study and the routine clinical parameters - Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and safety - were retrospectively analyzed. RESULTS: The combined cohorts included 89 patients, of which 64% were naïve to biologic therapies. At the time of analysis efficacy assessment was available for 39 patients after 12 months of treatment, 73 patients after 36 weeks, 79 patients after 16 weeks and 82 patients after 4 weeks. PASI and DLQI decreased significantly over time, with 52/73 (71.2%) patients achieving PASI 100 after 36 weeks. No severe side-effects were recorded in association with tildrakizumab. CONCLUSIONS: We confirmed the safety and efficacy of tildrakizumab in a real-world clinical setting. A higher proportion of patients naïve to biologics achieved a greater PASI response than patients who had previously been treated with biologics. The same was true for older patients and patients with a shorter history of disease. [ABSTRACT FROM AUTHOR]

Published
2022

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

Author

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

Abstract

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

Published
2021

45. Secukinumab 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

46. Impact of Body Mass Index on the Efficacy of Biological Therapies in Patients with Psoriasis: A Real-World Study

Author

Pirro, Federico, Caldarola, Giacomo, Chiricozzi, Andrea, Burlando, M., Mariani, M., Parodi, A., Peris, Ketty, De Simone, Clara, Pirro F., Caldarola G. (ORCID:0000-0002-8837-9232), Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), De Simone C. (ORCID:0000-0002-0898-0045), Pirro, Federico, Caldarola, Giacomo, Chiricozzi, Andrea, Burlando, M., Mariani, M., Parodi, A., Peris, Ketty, De Simone, Clara, Pirro F., Caldarola G. (ORCID:0000-0002-8837-9232), Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), and De Simone C. (ORCID:0000-0002-0898-0045)

Abstract

Background: The efficacy of biological therapies used for the treatment of chronic plaque psoriasis can be influenced by numerous variables including body mass index (BMI). Objective: This study aimed to evaluate the impact of BMI on the short-term and long-term efficacy of biological therapies in clinical practice and to identify the best therapeutic options in obese patients (BMI ≥ 30 kg/m2). Methods: A multicentric retrospective study was conducted in patients who initiated a biological therapy during the period January 2006–December 2019. The proportion of patients achieving a 90% improvement of baseline Psoriasis Area and Severity Index at weeks 12 and 24 was calculated also recording the 12- and 24-month drug survival as a measure of long-term efficacy, performing multivariate analyses to assess the impact of different variables. Results: Five hundred and four patients with psoriasis were included. After 12 and 24 weeks, the proportion of patients achieving a 90% improvement of baseline Psoriasis Area and Severity Index response was higher in patients with a BMI < 30 kg/m2 compared with those with a BMI ≥ 30 kg/m2 [54.90% vs 43.45% (p = 0.014) at week 12 and 66.84% vs 56.55% (p = 0.021) at week 24]. The Kaplan–Meier survival curves showed how obese patients had a higher probability of discontinuation due to a lack or loss of efficacy (p = 0.0192) compared with non-obese patients. The drug survival analysis also showed that BMI negatively affected the drug survival of secukinumab (odds ratio 1.27, p < 0.001) and ustekinumab (odds ratio 1.06, p = 0.050), while the long-term efficacy of adalimumab, etanercept, and ixekizumab was not influenced by BMI. Conclusions: Obesity (BMI ≥ 30 kg/m2) negatively affects the clinical response of biological drugs in psoriatic patients, with anti-interleukin drugs being more affected by BMI than anti-tumor necrosis

Published
2021

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

Author

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

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

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

Published
2019

49. 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

50. 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

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