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1. Transition from intravenous to subcutaneous biological therapies in inflammatory bowel disease: An online survey of patients

Author: Napolitano, Daniele, Settanni, Carlo Romano, Parisio, Laura, Orgiana, Nicoletta, Poscia, Andrea, Schiavoni, Elisa, Turchini, Laura, Cascio, Alessio Lo, Germini, Francesco, Sblendorio, Elena, Milani, Alessandra, Patteril, Christopher, Laterza, Lucrezia, Lopetuso, Loris Riccardo, Pugliese, Daniela, Papa, Alfredo, Gasbarrini, Antonio, and Scaldaferri, Franco
Published: 2024
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2. Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study

Author: Ribaldone, Davide Giuseppe, Parisio, Laura, Variola, Angela, Bossa, Fabrizio, Castiglione, Fabiana, Marzo, Manuela, Piazza, Nicole, Aratari, Annalisa, Savarino, Edoardo Vincenzo, Bodini, Giorgia, Mastronardi, Mauro, Micheli, Federica, Mazzuoli, Silvia, Ascolani, Marta, Viganò, Chiara, Cappello, Maria, Bezzio, Cristina, Ciccocioppo, Rachele, Scardino, Giulia, Sarli, Ennio, Pugliese, Daniela, Scaldaferri, Franco, Napolitano, Daniele, Todeschini, Alessia, Geccherle, Andrea, Colaci, Nicoletta, Guerra, Maria, Annese, Monica, Testa, Anna, Caiazzo, Anna, Conforti, Francesco Simone, Festa, Stefano, Lorenzon, Greta, Marra, Antonella, Magiotta, Ambra, Baccini, Flavia, Amato, Arnaldo, Poshnjari, Anxhela, Vernero, Marta, Caprioli, Flavio, and Caviglia, Gian Paolo
Published: 2024
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3. Clinical research coordinators: Key components of an efficient clinical trial unit

Author: Vincenzina Mora, Stefania Colantuono, Caterina Fanali, Alessia Leonetti, Giulia Wlderk, Maria Antonia Pirro, Francesca Maria Calà Palmarino, Roberta Savini, Gianluca Ianiro, Antonio Gasbarrini, Pirozzoli Maria Celeste, Giannone Luciana, Spataro Cristina, Graziani Cristina, Capodrossi Anna, Teberino Maria Anna, Tolusso Barbara, Di Ciurcio Marica, Verdirosi Diana, Rotunno Serena, Finotti Ludovica, Turchini Laura, Amatucci Valeria, Schiavoni Elisa, Napolitano Daniele, Durini Eleonora, Strazzeri Martina, Lombardi Maria Teresa, and Schifano Elisabetta
Subjects: Medicine (General), R5-920
Published: 2023
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4. Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study

Author: Tursi, Antonio, Mocci, Giammarco, Scaldaferri, Franco, Napolitano, Daniele, Maresca, Rossella, Pugliese, Daniela, Semprucci, Gianluca, Savarino, Edoardo, Cuomo, Antonio, Donnarumma, Laura, Bodini, Giorgia, Pasta, Andrea, Maconi, Giovanni, Cataletti, Giovanni, Pranzo, Giuseppe, Rodinò, Stefano, Sebkova, Ladislava, Costa, Francesco, Ferronato, Antonio, Gaiani, Federica, Marzo, Manuela, Luppino, Ileana, Fabiano, Giulia, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Grossi, Laurino, Serio, Mariaelena, Scarcelli, Antonella, Lorenzetti, Roberto, Allegretta, Leonardo, Chiri, Stefania, Grasso, Giuseppina, Antonelli, Elisabetta, Bassotti, Gabrio, Spagnuolo, Rocco, Luzza, Francesco, Fanigliulo, Libera, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Rocchi, Chiara, Bolognini, Laura, Bendia, Emanuele, Bianco, Maria Antonia, Capone, Pietro, Meucci, Costantino, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Della Valle, Nicola, Felice, Carla, Pica, Roberta, Cocco, Andrea, Forti, Giacomo, Onidi, Francesca Maria, Usai Satta, Paolo, Checchin, Davide, Gravina, Antonietta Gerarda, Pellegrino, Raffaele, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Scaldaferri, Franco, Napolitano, Daniele, Maresca, Rossella, Pugliese, Daniela, Semprucci, Gianluca, Savarino, Edoardo, Cuomo, Antonio, Donnarumma, Laura, Bodini, Giorgia, Pasta, Andrea, Maconi, Giovanni, Cataletti, Giovanni, Pranzo, Giuseppe, Rodinò, Stefano, Sebkova, Ladislava, Costa, Francesco, Ferronato, Antonio, Gaiani, Federica, Marzo, Manuela, Luppino, Ileana, Fabiano, Giulia, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Grossi, Laurino, Serio, Mariaelena, Scarcelli, Antonella, Lorenzetti, Roberto, Allegretta, Leonardo, Chiri, Stefania, Grasso, Giuseppina, Antonelli, Elisabetta, Bassotti, Gabrio, Spagnuolo, Rocco, Luzza, Francesco, Fanigliulo, Libera, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Rocchi, Chiara, Bolognini, Laura, Bendia, Emanuele, Bianco, Maria Antonia, Capone, Pietro, Meucci, Costantino, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Della Valle, Nicola, Felice, Carla, Pica, Roberta, Cocco, Andrea, Forti, Giacomo, Onidi, Francesca Maria, Usai Satta, Paolo, Checchin, Davide, Gravina, Antonietta Gerarda, Pellegrino, Raffaele, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: BackgroundUstekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting.Research design and methodsThis is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, <= 1) and the safety of UST. Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and fecal calprotectin (FC) reduction at week 24.ResultsWe included 256 consecutive patients with UC (M/F 139/117, median age 52). The clinical remission and clinical response rates at eight weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p = 0.0004) and 24 (p = 0.038). At eight weeks, patients naive or with one previous biologic treatment showed higher remission (p = 0.002) and clinical response rates (p = 0.018) than patients previously treated with >= 2. Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy.ConclusionThis real-world study shows that UST effectively and safely treats patients with UC.
Published: 2024

5. Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study

Author: Tursi, Antonio, primary, Mocci, Giammarco, additional, Scaldaferri, Franco, additional, Napolitano, Daniele, additional, Maresca, Rossella, additional, Pugliese, Daniela, additional, Semprucci, Gianluca, additional, Savarino, Edoardo, additional, Cuomo, Antonio, additional, Donnarumma, Laura, additional, Bodini, Giorgia, additional, Pasta, Andrea, additional, Maconi, Giovanni, additional, Cataletti, Giovanni, additional, Pranzo, Giuseppe, additional, Rodinò, Stefano, additional, Sebkova, Ladislava, additional, Costa, Francesco, additional, Ferronato, Antonio, additional, Gaiani, Federica, additional, Marzo, Manuela, additional, Luppino, Ileana, additional, Fabiano, Giulia, additional, Paese, Pietro, additional, Elisei, Walter, additional, Monterubbianesi, Rita, additional, Faggiani, Roberto, additional, Grossi, Laurino, additional, Serio, Mariaelena, additional, Scarcelli, Antonella, additional, Lorenzetti, Roberto, additional, Allegretta, Leonardo, additional, Chiri, Stefania, additional, Grasso, Giuseppina, additional, Antonelli, Elisabetta, additional, Bassotti, Gabrio, additional, Spagnuolo, Rocco, additional, Luzza, Francesco, additional, Fanigliulo, Libera, additional, Rocco, Giulia, additional, Sacchi, Carlotta, additional, Zampaletta, Costantino, additional, Rocchi, Chiara, additional, Bolognini, Laura, additional, Bendia, Emanuele, additional, Bianco, Maria Antonia, additional, Capone, Pietro, additional, Meucci, Costantino, additional, Colucci, Raffaele, additional, Tonti, Paolo, additional, Neve, Viviana, additional, Della Valle, Nicola, additional, Felice, Carla, additional, Pica, Roberta, additional, Cocco, Andrea, additional, Forti, Giacomo, additional, Onidi, Francesca Maria, additional, Usai Satta, Paolo, additional, Checchin, Davide, additional, Gravina, Antonietta Gerarda, additional, Pellegrino, Raffaele, additional, Picchio, Marcello, additional, and Papa, Alfredo, additional
Published: 2024
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6. Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission

Author: Parisio, Laura, primary, Settanni, Carlo Romano, primary, Varca, Simone, primary, Laterza, Lucrezia, primary, Lopetuso, Loris Riccardo, primary, Napolitano, Daniele, primary, Schiavoni, Elisa, primary, Turchini, Laura, primary, Fanali, Caterina, primary, Alfieri, Norma, primary, Pizzoferrato, Marco, primary, Papa, Alfredo, primary, Pafundi, Pia Clara, primary, Armuzzi, Alessandro, primary, Gasbarrini, Antonio, primary, Pugliese, Daniela, primary, and Scaldaferri, Franco, primary
Published: 2023
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7. Serial Fecal Microbiota Infusions via Colonoscopy for Active Ulcerative Colitis: A Feasibility, Safety, and Translational Monocentric Italian Study

Author: Lopetuso, Loris Riccardo, primary, Laterza, Lucrezia, additional, Petito, Valentina, additional, Pecere, Silvia, additional, Quaranta, Gianluca, additional, Del Chierico, Federica, additional, Puca, Pierluigi, additional, Schiavoni, Elisa, additional, Napolitano, Daniele, additional, Poscia, Andrea, additional, Ianiro, Gianluca, additional, Pugliese, Daniela, additional, Putignani, Lorenza, additional, Sanguinetti, Maurizio, additional, Armuzzi, Alessandro, additional, Masucci, Luca, additional, Gasbarrini, Antonio, additional, Cammarota, Giovanni, additional, and Scaldaferri, Franco, additional
Published: 2023
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8. Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study

Author: Ribaldone, Davide Giuseppe, primary, Parisio, Laura, additional, Variola, Angela, additional, Bossa, Fabrizio, additional, Castiglione, Fabiana, additional, Marzo, Manuela, additional, Piazza, Nicole, additional, Aratari, Annalisa, additional, Savarino, Edoardo Vincenzo, additional, Bodini, Giorgia, additional, Mastronardi, Mauro, additional, Micheli, Federica, additional, Mazzuoli, Silvia, additional, Ascolani, Marta, additional, Viganò, Chiara, additional, Cappello, Maria, additional, Bezzio, Cristina, additional, Ciccocioppo, Rachele, additional, Scardino, Giulia, additional, Sarli, Ennio, additional, Pugliese, Daniela, additional, Scaldaferri, Franco, additional, Napolitano, Daniele, additional, Todeschini, Alessia, additional, Geccherle, Andrea, additional, Colaci, Nicoletta, additional, Guerra, Maria, additional, Annese, Monica, additional, Testa, Anna, additional, Caiazzo, Anna, additional, Conforti, Francesco Simone, additional, Festa, Stefano, additional, Lorenzon, Greta, additional, Marra, Antonella, additional, Magiotta, Ambra, additional, Baccini, Flavia, additional, Amato, Arnaldo, additional, Poshnjari, Anxhela, additional, Vernero, Marta, additional, Caprioli, Flavio, additional, and Caviglia, Gian Paolo, additional
Published: 2023
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9. Use of tofacitinib as first or second-line therapy is associated with better outcomes in patients with ulcerative colitis: data from a real-world study

Author: Tursi, Antonio, primary, Mocci, Giammarco, additional, Cingolani, Linda, additional, Savarino, Edoardo, additional, Pica, Roberta, additional, Cocco, Andrea, additional, Zippi, Maddalena, additional, Napolitano, Daniele, additional, Schiavoni, Elisa, additional, Pugliese, Daniela, additional, Scaldaferri, Franco, additional, Costa, Francesco, additional, Marzo, Manuela, additional, Serio, Mariaelena, additional, Scarcelli, Antonella, additional, Bolognini, Laura, additional, Bendia, Emanuele, additional, Maconi, Giovanni, additional, Cannatelli, Rosanna, additional, Piergallini, Simona, additional, Bodini, Giorgia, additional, Calabrese, Francesco, additional, Ferronato, Antonio, additional, Pranzo, Giuseppe, additional, Elisei, Walter, additional, Monterubbianesi, Rita, additional, Faggiani, Roberto, additional, Rodinò, Stefano, additional, Sebkova, Ladislava, additional, Grossi, Laurino, additional, Gaiani, Federica, additional, dè Angelis, Gianluigi, additional, Lorenzetti, Roberto, additional, Allegretta, Leonardo, additional, Cazzato, Alessia Immacolata, additional, Scorza, Stefano, additional, Della Valle, Nicola, additional, Sacco, Rodolfo, additional, Forti, Giacomo, additional, Colucci, Raffaele, additional, Tonti, Paolo, additional, Neve, Viviana, additional, Rocco, Giulia, additional, Sacchi, Carlotta, additional, Zampaletta, Costantino, additional, Pagnini, Cristiano, additional, Graziani, Maria Giovanna, additional, Di Paolo, Maria Carla, additional, Onidi, Francesca Maria, additional, Usai Satta, Paolo, additional, Picchio, Marcello, additional, and Papa, Alfredo, additional
Published: 2023
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10. The inflammatory bowel disease care manager: Italian state of the art.

Author: Napolitano, Daniele, Di Vincenzo, Federica, Orgiana, Nicoletta, Schiavoni, Elisa, Germini, Francesco, Pugliese, Daniela, and Scaldaferri, Franco
Subjects: *INFLAMMATORY bowel diseases, *ITALIAN art, *PREGNANT women, *TEAM nursing, *BEHAVIORAL assessment, *EXECUTIVE ability (Management), *GASTROENTEROLOGISTS
Abstract: Background In the inflammatory bowel disease (IBD) multidisciplinary team, a key figure is the IBD care manager, usually an independent practice nurse, responsible for evidence-based assessment, care planning, treatment evaluation, and provision of practical information, health education, and emotional support to patients. The objective of this study was to evaluate the profile of this figure in Italy. Methods A team of experienced nurses created a questionnaire based on the Second N-ECCO declaration, which was administered to nurses who worked in an IBD unit for a period of at least 3 years. A definition of IBD care manager was provided to every participant. The questionnaire consisted of 3 sections: behavioral, knowledge and managerial skills that an IBD care manager should exhibit. Results were studied in relation to the benefits for the patient, organizational advantages, clinical advantages and Italian state of the art. Results Fifty-five nurses participated in the study, from 28 Italian centers. In the evaluation of behavioral skills of IBD care managers, "management and support of the pregnant patient" was the lowest scored item, while "patient privacy" obtained higher scores. In the evaluation of knowledge, "knowledge of intimacy and sexuality" obtained the lowest scores, while "knowledge of psychophysical and social impact of the disease" obtained a higher score. In managerial skills "management of pain" obtained the lowest scores. Conclusion Our study confirmed that IBD care managers are invaluable nursing figures within the multidisciplinary team that cares for IBD patients, providing benefits to both patients' clinics and management. [ABSTRACT FROM AUTHOR]
Published: 2024
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11. Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn’s disease: results from an Italian multicenter study

Author: Mocci, Giammarco, primary, Tursi, Antonio, additional, Maconi, Giovanni, additional, Cataletti, Giovanni, additional, Mantia, Beatrice, additional, Serio, Mariaelena, additional, Scarcelli, Antonella, additional, Pagnini, Cristiano, additional, Graziani, Maria Giovanna, additional, Di Paolo, Maria Carla, additional, Pranzo, Giuseppe, additional, Luppino, Ileana, additional, Paese, Pietro, additional, Elisei, Walter, additional, Monterubbianesi, Rita, additional, Faggiani, Roberto, additional, Ferronato, Antonio, additional, Perini, Barbara, additional, Savarino, Edoardo, additional, Onidi, Francesca Maria, additional, Binaghi, Laura, additional, Usai Satta, Paolo, additional, Schiavoni, Elisa, additional, Napolitano, Daniele, additional, Scaldaferri, Franco, additional, Pugliese, Daniela, additional, Pica, Roberta, additional, Cocco, Andrea, additional, Zippi, Maddalena, additional, Rodino, Stefano, additional, Sebkova, Ladislava, additional, Rocco, Giulia, additional, Sacchi, Carlotta, additional, Zampaletta, Costantino, additional, Gaiani, Federica, additional, De Angelis, Gianluigi, additional, Kayali, Stefano, additional, Fanigliulo, Libera, additional, Lorenzetti, Roberto, additional, Allegretta, Leonardo, additional, Scorza, Stefano, additional, Cuomo, Antonio, additional, Donnarumma, Laura, additional, Della Valle, Nicola, additional, Sacco, Rodolfo, additional, Forti, Giacomo, additional, Antonelli, Elisabetta, additional, Bassotti, Gabrio, additional, Iannelli, Chiara, additional, Luzza, Francesco, additional, Aragona, Giovanni, additional, Perazzo, Patrizia, additional, Lauria, Angelo, additional, Piergallini, Simona, additional, Colucci, Raffaele, additional, Bianco, Maria Antonia, additional, Meucci, Costantino, additional, Giorgetti, Gianmarco, additional, Clemente, Valeria, additional, Fiorella, Serafina, additional, Penna, Antonio, additional, De Medici, Antonio, additional, Picchio, Marcello, additional, and Papa, Alfredo, additional
Published: 2023
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12. Gut Microbiota Signatures Are Associated With Psychopathological Profiles in Patients With Ulcerative Colitis: Results From an Italian Tertiary IBD Center

Author: Scaldaferri, Franco, D'Onofrio, Antonio Maria, Calia, Rosaria, Di Vincenzo, Federica, Ferrajoli, Gaspare Filippo, Petito, Valentina, Maggio, Eleonora, Pafundi, Pia Clara, Napolitano, Daniele, Masi, Letizia, Schiavoni, Elisa, Fanali, Caterina, Puca, Pierluigi, Turchini, Laura, Lopetuso, Loris Riccardo, Del Chierico, Federica, Putignani, Lorenza, Gasbarrini, Antonio, Camardese, Giovanni, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Calia, Rosaria (ORCID:0000-0003-1060-7554), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Camardese, Giovanni (ORCID:0000-0002-8139-9230), Scaldaferri, Franco, D'Onofrio, Antonio Maria, Calia, Rosaria, Di Vincenzo, Federica, Ferrajoli, Gaspare Filippo, Petito, Valentina, Maggio, Eleonora, Pafundi, Pia Clara, Napolitano, Daniele, Masi, Letizia, Schiavoni, Elisa, Fanali, Caterina, Puca, Pierluigi, Turchini, Laura, Lopetuso, Loris Riccardo, Del Chierico, Federica, Putignani, Lorenza, Gasbarrini, Antonio, Camardese, Giovanni, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Calia, Rosaria (ORCID:0000-0003-1060-7554), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Camardese, Giovanni (ORCID:0000-0002-8139-9230)
Abstract: Lay Summary Psychiatric disorders are more prevalent in IBD patients than in general population. In this prospective cohort study, we found a correlation between active UC, peculiar psychiatric distress (anxiety and depression above all), and specific taxonomic gut microbiota signatures.Background Several patients with ulcerative colitis (UC) suffer from psychiatric disorders, such as major depressive disorder, anxiety, or bipolar disorder, and show specific personality traits. Despite this, there are few data about personality profiles' characterization in UC patients and about correlation of their psychopathological profile with their intestinal microbiota. The aim of our study is to analyze the psychopathological and personality profile of UC patients and correlate it with specific signatures of their gut microbiota. Methods This is a prospective interventional longitudinal cohort study. We enrolled consecutive patients affected by UC attending to the IBD Unit of Center for Digestive Disease of "A. Gemelli" IRCCS Hospital in Rome and a group of healthy subjects, matched for specific characteristics. Each patient was evaluated by a gastroenterologist and a psychiatrist. Moreover, all participants underwent psychological tests and a collection of stool samples. Results We recruited 39 UC patients and 37 healthy subjects. Most patients showed high level of alexithymia, anxiety symptoms, depressive symptoms, as well as neuroticism and hypochondria, with obsessive-compulsive features at the behavioral level, which significantly impaired their quality of life and abilities at work. Gut microbiota analysis in UC patients demonstrated an increase in actinobacteria, Proteobacteria and Saccharibacteria (TM7), with a reduction in verrucomicrobia, euryarchaeota and tenericutes. Conclusions Our study confirmed the presence of high levels of psycho-emotional distress in UC patients, alongside alterations of the intestinal microbiota, and highlighted some families and genera of
Published: 2023

13. Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn's disease: results from an Italian multicenter study

Author: Mocci, Giammarco, Tursi, Antonio, Maconi, Giovanni, Cataletti, Giovanni, Mantia, Beatrice, Serio, Mariaelena, Scarcelli, Antonella, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Pranzo, Giuseppe, Luppino, Ileana, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Ferronato, Antonio, Perini, Barbara, Savarino, Edoardo, Onidi, Francesca Maria, Binaghi, Laura, Usai Satta, Paolo, Schiavoni, Elisa, Napolitano, Daniele, Scaldaferri, Franco, Pugliese, Daniela, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Rodino, Stefano, Sebkova, Ladislava, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Gaiani, Federica, De Angelis, Gianluigi, Kayali, Stefano, Fanigliulo, Libera, Lorenzetti, Roberto, Allegretta, Leonardo, Scorza, Stefano, Cuomo, Antonio, Donnarumma, Laura, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Antonelli, Elisabetta, Bassotti, Gabrio, Iannelli, Chiara, Luzza, Francesco, Aragona, Giovanni, Perazzo, Patrizia, Lauria, Angelo, Piergallini, Simona, Colucci, Raffaele, Bianco, Maria Antonia, Meucci, Costantino, Giorgetti, Gianmarco, Clemente, Valeria, Fiorella, Serafina, Penna, Antonio, De Medici, Antonio, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Mocci, Giammarco, Tursi, Antonio, Maconi, Giovanni, Cataletti, Giovanni, Mantia, Beatrice, Serio, Mariaelena, Scarcelli, Antonella, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Pranzo, Giuseppe, Luppino, Ileana, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Ferronato, Antonio, Perini, Barbara, Savarino, Edoardo, Onidi, Francesca Maria, Binaghi, Laura, Usai Satta, Paolo, Schiavoni, Elisa, Napolitano, Daniele, Scaldaferri, Franco, Pugliese, Daniela, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Rodino, Stefano, Sebkova, Ladislava, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Gaiani, Federica, De Angelis, Gianluigi, Kayali, Stefano, Fanigliulo, Libera, Lorenzetti, Roberto, Allegretta, Leonardo, Scorza, Stefano, Cuomo, Antonio, Donnarumma, Laura, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Antonelli, Elisabetta, Bassotti, Gabrio, Iannelli, Chiara, Luzza, Francesco, Aragona, Giovanni, Perazzo, Patrizia, Lauria, Angelo, Piergallini, Simona, Colucci, Raffaele, Bianco, Maria Antonia, Meucci, Costantino, Giorgetti, Gianmarco, Clemente, Valeria, Fiorella, Serafina, Penna, Antonio, De Medici, Antonio, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: BackgroundVedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn's disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ.Research design and methods Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.Results729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6(th) month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6(th) month of treatment (p=0.001) and being naive to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016).ConclusionWe found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug's longterm efficacy.
Published: 2023

14. Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Author: Tursi, Antonio, Mocci, Giammarco, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Cuomo, Antonio, Della Valle, Nicola, Ferronato, Antonio, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Pica, Roberta, Pranzo, Giuseppe, Rodino', Stefano, Scarcelli, Antonella, Zampaletta, Costantino, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De' Angelis, Gianluigi, Donnarumma, Laura, Faggiani, Roberto, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Picchio, Marcello, Sacco, Rodolfo, Sebkova, Ladislava, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Scaldaferri, Franco, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Elisei, Walter, Maconi, Giovanni, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Cuomo, Antonio, Della Valle, Nicola, Ferronato, Antonio, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Pica, Roberta, Pranzo, Giuseppe, Rodino', Stefano, Scarcelli, Antonella, Zampaletta, Costantino, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De' Angelis, Gianluigi, Donnarumma, Laura, Faggiani, Roberto, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Picchio, Marcello, Sacco, Rodolfo, Sebkova, Ladislava, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Scaldaferri, Franco, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Elisei, Walter, Maconi, Giovanni, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.Lay Summary We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive p
Published: 2023

15. Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission

Author: Parisio, Laura, Settanni, Carlo Romano, Varca, Simone, Laterza, Lucrezia, Lopetuso, Loris Riccardo, Napolitano, Daniele, Schiavoni, Elisa, Turchini, Laura, Fanali, Caterina, Alfieri, Norma, Pizzoferrato, Marco, Papa, Alfredo, Pafundi, Pia Clara, Armuzzi, Alessandro, Gasbarrini, Antonio, Pugliese, Daniela, Scaldaferri, Franco, Papa, Alfredo (ORCID:0000-0002-4186-7298), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Parisio, Laura, Settanni, Carlo Romano, Varca, Simone, Laterza, Lucrezia, Lopetuso, Loris Riccardo, Napolitano, Daniele, Schiavoni, Elisa, Turchini, Laura, Fanali, Caterina, Alfieri, Norma, Pizzoferrato, Marco, Papa, Alfredo, Pafundi, Pia Clara, Armuzzi, Alessandro, Gasbarrini, Antonio, Pugliese, Daniela, Scaldaferri, Franco, Papa, Alfredo (ORCID:0000-0002-4186-7298), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Scaldaferri, Franco (ORCID:0000-0001-8334-7541)
Abstract: Background & Aims: Subcutaneous vedolizumab formulation has been shown to be as effective and safe as the intravenous one in randomized control trials. Real-life data are limited especially for patients receiving long-term intravenous therapy. This study aimed to evaluate the safety and effectiveness of switching from intravenous to subcutaneous vedolizumab in a large cohort of patients with stable clinical remission.Methods: In this prospective cohort study, we enrolled consecutive patients attending our center between September 2021 and April 2022. The baseline demographic characteristics, 12- and 24-weeks follow-up clinical activity, C-reactive protein levels, and adverse events were recorded. The primary endpoint was to assess combined steroid-free clinical remission plus biochemical remission 24-week after the switch.Results: 93 patients (43 Crohn's disease, 50 ulcerative colitis), switched to subcutaneous vedolizumab after a median duration of intravenous treatment of 36 months [IQR 16-52]. At baseline, 80 patients (86%) had a combined remission. At 24-week, 89.2% (n=74) maintained combined steroid-free clinical remission plus biochemical remission. 25 adverse events were reported, mostly SARS-CoV-2 infections and injection site reactions, with a further four recurrence episodes. Twelve patients (12.9%) discontinued subcutaneous administration and restarted intravenous vedolizumab.Conclusions: Switching from intravenous to subcutaneous vedolizumab can be considered effective and safe for maintaining remission in patients with inflammatory bowel disease. In addition, this might reduce healthcare costs. However, large-scale real-life studies with long-term follow-up are necessary.
Published: 2023

16. Serial Fecal Microbiota Infusions via Colonoscopy for Active Ulcerative Colitis: A Feasibility, Safety, and Translational Monocentric Italian Study

Author: Lopetuso, Loris Riccardo, Laterza, Lucrezia, Petito, Valentina, Pecere, Silvia, Quaranta, Gianluca, Del Chierico, Federica, Puca, Pierluigi, Schiavoni, Elisa, Napolitano, Daniele, Poscia, Andrea, Ianiro, Gianluca, Pugliese, Daniela, Putignani, Lorenza, Sanguinetti, Maurizio, Armuzzi, Alessandro, Masucci, Luca, Gasbarrini, Antonio, Cammarota, Giovanni, Scaldaferri, Franco, Poscia, Andrea (ORCID:0000-0002-7616-3389), Ianiro, Gianluca (ORCID:0000-0002-8318-0515), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Masucci, Luca (ORCID:0000-0002-8358-6726), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cammarota, Giovanni (ORCID:0000-0002-3626-6148), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Lopetuso, Loris Riccardo, Laterza, Lucrezia, Petito, Valentina, Pecere, Silvia, Quaranta, Gianluca, Del Chierico, Federica, Puca, Pierluigi, Schiavoni, Elisa, Napolitano, Daniele, Poscia, Andrea, Ianiro, Gianluca, Pugliese, Daniela, Putignani, Lorenza, Sanguinetti, Maurizio, Armuzzi, Alessandro, Masucci, Luca, Gasbarrini, Antonio, Cammarota, Giovanni, Scaldaferri, Franco, Poscia, Andrea (ORCID:0000-0002-7616-3389), Ianiro, Gianluca (ORCID:0000-0002-8318-0515), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Masucci, Luca (ORCID:0000-0002-8358-6726), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cammarota, Giovanni (ORCID:0000-0002-3626-6148), and Scaldaferri, Franco (ORCID:0000-0001-8334-7541)
Abstract: The effectiveness of fecal microbiota transplantation (FMT) in ulcerative colitis (UC) remains unclear. This study aimed to investigate the feasibility and effectiveness of serial fecal infusions via colonoscopy in patients with active UC. Subjects with mild-to-moderate UC received three consecutive fecal infusions via colonoscopy. A control population with the same baseline features receiving Infliximab treatment was enrolled. Adverse events and clinical, endoscopic, and microbial outcomes were investigated. Nineteen patients with mildly-to-moderately active UC were enrolled. Clinical response was obtained in six patients at week 2, in eight at week 6, and in nine at week 12. Clinical response was maintained in eight patients at week 24. Endoscopic remission at week 12 was reached in six patients. In the control population, 13/19 patients achieved clinical response at week 6, and 10/19 patients maintained clinical response after 6 months. Microbiota richness was higher in responders compared with the non-responders. Peptostreptococcus, Lactobacillus, and Veillonella were higher in non-responders, while Parabacteroides, Bacteroides, Faecalibacterium, and Akkermansia were higher in responders at all timepoints. Serial FMT infusions appear to be feasible, safe, and effective in UC patients, with a potential role in inducing and maintaining clinical response. Specific bacteria predict the response to FMT.
Published: 2023

17. Use of tofacitinib as first or second-line therapy is associated with better outcomes in patients with ulcerative colitis: data from a real-world study

Author: Tursi, Antonio, Mocci, Giammarco, Cingolani, Linda, Savarino, Edoardo, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Napolitano, Daniele, Schiavoni, Elisa, Pugliese, Daniela, Scaldaferri, Franco, Costa, Francesco, Marzo, Manuela, Serio, Mariaelena, Scarcelli, Antonella, Bolognini, Laura, Bendia, Emanuele, Maconi, Giovanni, Cannatelli, Rosanna, Piergallini, Simona, Bodini, Giorgia, Calabrese, Francesco, Ferronato, Antonio, Pranzo, Giuseppe, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Rodinò, Stefano, Sebkova, Ladislava, Grossi, Laurino, Gaiani, Federica, dè Angelis, Gianluigi, Lorenzetti, Roberto, Allegretta, Leonardo, Cazzato, Alessia Immacolata, Scorza, Stefano, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Onidi, Francesca Maria, Usai Satta, Paolo, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Cingolani, Linda, Savarino, Edoardo, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Napolitano, Daniele, Schiavoni, Elisa, Pugliese, Daniela, Scaldaferri, Franco, Costa, Francesco, Marzo, Manuela, Serio, Mariaelena, Scarcelli, Antonella, Bolognini, Laura, Bendia, Emanuele, Maconi, Giovanni, Cannatelli, Rosanna, Piergallini, Simona, Bodini, Giorgia, Calabrese, Francesco, Ferronato, Antonio, Pranzo, Giuseppe, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Rodinò, Stefano, Sebkova, Ladislava, Grossi, Laurino, Gaiani, Federica, dè Angelis, Gianluigi, Lorenzetti, Roberto, Allegretta, Leonardo, Cazzato, Alessia Immacolata, Scorza, Stefano, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Onidi, Francesca Maria, Usai Satta, Paolo, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: BackgroundData regarding the real-world (RW) use of tofacitinib (TOF) in patients with ulcerative colitis (UC) are limited. We aimed to investigate TOF's RW efficacy and safety in Italian UC patients.Research design and methodsA retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of TOF.ResultsWe enrolled 166 patients with a median follow-up of 24 (IQR 8-36) weeks. Clinical remission was achieved in 61/166 (36.7%) and 75/166 (45.2%) patients at 8-week and 24-week follow-ups, respectively. The optimization was requested in 27 (16.3%) patients. Clinical remission was achieved more frequently when TOF was used as a first/second line rather than a third/fourth line treatment (p = 0.007). Mucosal healing was reported in 46% of patients at the median follow-up time. Colectomy occurred in 8 (4.8%) patients. Adverse events occurred in 12 (5.4%) patients and severe in 3 (1.8%). One case of simple Herpes Zoster and one of renal vein thrombosis were recorded.ConclusionsOur RW data confirm that TOF is effective and safe in UC patients. It performs remarkably better when used as the first/second line of treatment.
Published: 2023

18. The inflammatory bowel disease care manager: Italian state of the art

Author: Napolitano, Daniele, primary
Published: 2023
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19. Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

Author: Tursi, Antonio, primary, Mocci, Giammarco, primary, Cuomo, Antonio, primary, Ferronato, Antonio, primary, Elisei, Walter, primary, Picchio, Marcello, primary, Maconi, Giovanni, primary, Scaldaferri, Franco, primary, Papa, Alfredo, primary, Italian group for switch of biologics, -, primary, Allegretta, Leonardo, primary, Aragona, Giovanni, primary, Bianco, Maria Antonia, primary, Colucci, Raffaele, primary, Della Valle, Nicola, primary, Faggiani, Roberto, primary, Forti, Giacomo, primary, Gaiani, Federica, primary, Giorgetti, GianMarco, primary, Graziani, Maria Giovanna, primary, Lofano, Katia, primary, Lorenzetti, Roberto, primary, Larussa, Tiziana, primary, Penna, Antonio, primary, Bassotti, Gabrio, primary, Cazzato, Alessia Immacolata, primary, Chiri, Stefania, primary, Clemente, Valeria, primary, Cocco, Andrea, primary, De’ Angelis, Gianluigi, primary, Donnarumma, Laura, primary, Graziosi, Camilla, primary, Le Grazie, Marco, primary, Luzza, Francesco, primary, Meucci, Costantino, primary, Monterubbianesi, Rita, primary, Pagnini, Cristiano, primary, Perazzo, Patrizia, primary, Pica, Roberta, primary, Pranzo, Giuseppe, primary, Rodino’, Stefano, primary, Sacco, Rodolfo, primary, Sebkova, Ladislava, primary, Scarcelli, Antonella, primary, Serio, Mariaelena, primary, Napolitano, Daniele, primary, Pugliese, Daniela, primary, Schiavoni, Elisa, primary, Turchini, Laura, primary, Armuzzi, Alessandro, primary, and Zampaletta, Costantino, primary
Published: 2022
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20. Nurse Practitioners in Inflammatory Bowel Disease: The Emerging Role of the IBD Care Manager

Author: Napolitano, Daniele, primary, Schiavoni, Elisa, primary, and Scaldaferri, Franco, primary
Published: 2022
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21. Oltre il ring. come da una palestra di pugilato si può riqualificare una borgata

Author: Napolitano, Daniele
Abstract: Tracce urbane. Rivista italiana transdisciplinare di studi urbani, V. 8 N. 12 (2022): Sguardi critici sulla rigenerazione urbana dal basso. Pratiche, retoriche ed effetti di cambiamento per un’alternativa di città
Published: 2022
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22. Evaluation of factors associated with trust in telemedicine in patients with inflammatory bowel disease during COVID-19 pandemic: a multicenter cross-sectional survey

Author: Bossa, F, Valvano, Mr, Vetrone, Lm, Guerra, M, Lopetuso, Loris Riccardo, Carparelli, S, Mignini, Irene, Cocomazzi, F, Napolitano, Daniele, Costantino, A, Caprioli, F, Gasbarrini, Antonio, Perri, F, and Papa, Alfredo
Subjects: Cross-Sectional Studies, Telemon-itoring, Settore MED/12 - GASTROENTEROLOGIA, Chronic Disease, Humans, COVID-19, Trust, Inflammatory Bowel Diseases, Pandemics, Leukocyte L1 Antigen Complex, Inflammatory bowel disease, Telemedicine, Infor-mation and communication technologies
Abstract: Telemedicine (TM) has had a powerful impact in recent years, particularly on managing chronic diseases such as inflammatory bowel disease (IBD). Knowing patients' expectations and concerns is essential to increase their confidence in this mode of medical care.We interviewed a large cohort of IBD patients enrolled at two Italian tertiary referral centers to investigate their trust in TM.A total of 376 patients completed the survey and were included in the study: 293 (77.9%) considered TM valuable for managing their disease, and 307 (85%) wanted to have TM service at their center. However, only 99 patients (26.3%) believed that TM guarantees the same level of care as the in-person visit. Among the socio-demographic variables, those independently associated with trust in TM were the higher education qualification (p=0.02) and the level of competence in information and communication technologies (ICT) (p=0.03).Our findings highlighted the importance of equipping IBD patients with basic ICT skills to utilize TM services and increase their confidence in ICT with the help of caregivers. Additionally, to improve the perceived value of TM, it will be helpful to use additional tools such as telemonitoring of disease activity using patients' reported outcomes or remote measurement of fecal calprotectin.
Published: 2022

23. Knowledge of perianal Crohn's disease among nurses in an Italian tertiary centre

Author: Napolitano, Daniele, primary, Cioffi, Federica, additional, Marocchini, Giannina, additional, Bernabei, Tiziana, additional, Leonetti, Alessia, additional, Fanali, Caterina, additional, Orgiana, Nicoletta, additional, Amatucci, Valeria, additional, Gasbarrini, Antonio, additional, Ratto, Carlo, additional, Litta, Francesco, additional, and Scaldaferri, Franco, additional
Published: 2022
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24. Innovative, complementary and alternative therapy in inflammatory bowel diseases: A broad 2020s update

Author: Masi, Letizia, primary, Ciuffini, Cristina, additional, Petito, Valentina, additional, Pisani, Laura Francesca, additional, Lopetuso, Loris Riccardo, additional, Graziani, Cristina, additional, Pugliese, Daniela, additional, Laterza, Lucrezia, additional, Puca, Pierluigi, additional, Di Vincenzo, Federica, additional, Pizzoferrato, Marco, additional, Napolitano, Daniele, additional, Turchini, Laura, additional, Amatucci, Valeria, additional, Schiavoni, Elisa, additional, Privitera, Giuseppe, additional, Minordi, Laura Maria, additional, Mentella, Maria Chiara, additional, Papa, Alfredo, additional, Armuzzi, Alessandro, additional, Gasbarrini, Antonio, additional, and Scaldaferri, Franco, additional
Published: 2022
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25. Knowledge of perianal Crohn's disease among nurses in an Italian tertiary centre

Author: Napolitano, Daniele, Cioffi, F., Marocchini, G., Bernabei, T., Leonetti, Arianna, Fanali, Caterina, Orgiana, N., Amatucci, V., Gasbarrini, Antonio, Ratto, Carlo, Litta, Francesco, Scaldaferri, Franco, Napolitano D., Cioffi F., Marocchini G., Bernabei T., Leonetti A. (ORCID:0000-0001-9163-417X), Fanali C., Orgiana N., Amatucci V., Gasbarrini A. (ORCID:0000-0002-7278-4823), Ratto C. (ORCID:0000-0002-0556-0037), Litta F., Scaldaferri F. (ORCID:0000-0001-8334-7541), Napolitano, Daniele, Cioffi, F., Marocchini, G., Bernabei, T., Leonetti, Arianna, Fanali, Caterina, Orgiana, N., Amatucci, V., Gasbarrini, Antonio, Ratto, Carlo, Litta, Francesco, Scaldaferri, Franco, Napolitano D., Cioffi F., Marocchini G., Bernabei T., Leonetti A. (ORCID:0000-0001-9163-417X), Fanali C., Orgiana N., Amatucci V., Gasbarrini A. (ORCID:0000-0002-7278-4823), Ratto C. (ORCID:0000-0002-0556-0037), Litta F., and Scaldaferri F. (ORCID:0000-0001-8334-7541)
Abstract: Background: Patients with Crohn s disease can develop anal and perianal lesions, such as fistulas, ulcers, skin tags, perianal abscesses and strictures. Perianal Crohn s disease (PCD) is a condition that has a major impact on patients quality of life. The multidisciplinary team includes a nurse who manages the patient according to evidence-based medicine. Clinical practice and post-registration training are the way forward for nurses to acquire the skills needed to deliver quality care. Aims: This study explored the assessment of nurses knowledge of PCD. A cross-sectional survey was used to look at the nurses knowledge. Methods: The questionnaire was administered over 2 months, between September and October 2019. The questionnaire was anonymous, validated by a panel of experts in the field and consisted of 30 questions to assess knowledge and two questions to assess the need for training. It was directed to 120 clinical nurses in the departments of medicine and abdominal surgery. Results: There were 120 nurses enrolled, and 64.2% of nurses had cared for patients with PCD at least once. The survey showed a fairly low level of knowledge of the diagnostic and therapeutic care pathways for patients affected by PCD. On the other hand, a high need for training and in-depth study of the subject emerged. Conclusion: The nurse, an integral part of the multidisciplinary team, plays an important role in the education of these patients. Nurses present level of knowledge can certainly be improved thanks to their willingness to undertake training courses or to use information tools.
Published: 2022

26. The role of inflammatory bowel disease nurses for patients on biologic therapy during the COVID-19 pandemic

Author: Napolitano, Daniele, Galasso, Linda, Privitera, Giuseppe, Morana, G., Bardelli, A., Sinatora, R., Onidi, M. F., Lombardi, M. T., Orgiana, N., Amatucci, V., Strazzeri, M., Schiavoni, Elisa, Turchini, Laura, Guarini, Antonella, Settanni, Carlo Romano, Armuzzi, Alessandro, Scaldaferri, Franco, Napolitano D., Galasso L., Privitera G., Schiavoni E., Turchini L., Guarini A., Settanni C. R., Armuzzi A. (ORCID:0000-0003-1572-0118), Scaldaferri F. (ORCID:0000-0001-8334-7541), Napolitano, Daniele, Galasso, Linda, Privitera, Giuseppe, Morana, G., Bardelli, A., Sinatora, R., Onidi, M. F., Lombardi, M. T., Orgiana, N., Amatucci, V., Strazzeri, M., Schiavoni, Elisa, Turchini, Laura, Guarini, Antonella, Settanni, Carlo Romano, Armuzzi, Alessandro, Scaldaferri, Franco, Napolitano D., Galasso L., Privitera G., Schiavoni E., Turchini L., Guarini A., Settanni C. R., Armuzzi A. (ORCID:0000-0003-1572-0118), and Scaldaferri F. (ORCID:0000-0001-8334-7541)
Abstract: Background: During the COVID-19 pandemic, many inflammatory bowel disease (IBD) centres had to reorganise their work, and multidisciplinary teams, including IBD nurses, have had to try to deliver services to patients as safely as possible. Aims: This survey aimed to assess the thoughts, opinions and feelings of IBD patients on biologics regarding the efforts of IBD nurses to organise care during the COVID-19 pandemic. Methods: An evaluation survey based on an anonymous questionnaire was distributed to IBD nurses in five Italian IBD centres, in parallel. Findings: Of 306 participants, 55.6% had Crohn’s disease and 44.4% had ulcerative colitis. Most (79.1%) were aware of the specialist IBD nurse role, and 75.8% could distinguish it from generalist nurses. Of patients, 99.7% felt IBD nurses were competent to care for their condition and 91.2% felt that IBD nurses could provide valid scientific information. Meanwhile, 81.4% had a good or excellent relationship with their IBD nurse. Patients reported that most nurses wore personal protective equipment (94.4%), promoted self-care (91.8%), asked about presence of fever or cough (84.3%), asked about patient health status (83.7%) and covered pandemic safety and social distancing rules (69.3%), but fewer spoke about patient mood (44.4%) or relevant benefits, rules and exemptions (26.8%). Most participants (77.8%) faced pandemic-related issues for infusions. Nearly all (97.4%) knew immunosuppressed people were vulnerable to COVID-19, but only 42.8% spoke to their nurse about it. Some 61.8% of patients were concerned about COVID-19, but only 39.2% raised this with the IBD nurse. However, many more patients spoke to a nurse about concerns regarding biologics (41.8%) and worsening IBD symptoms (46.4%) in the pandemic than the actual number experiencing these issues (13.7% and 4.3%, respectively). Conclusion: The results show that IBD patients appreciate the role of the specialist nurse in their care.
Published: 2022

27. Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

Author: Tursi, Antonio, Mocci, Giammarco, Cuomo, Antonio, Ferronato, Antonio, Elisei, Walter, Picchio, Marcello, Maconi, Giovanni, Scaldaferri, Franco, Papa, Alfredo, Italian group for switch of biologics,, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Della Valle, Nicola, Faggiani, Roberto, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De’ Angelis, Gianluigi, Donnarumma, Laura, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Pica, Roberta, Pranzo, Giuseppe, Rodino’, Stefano, Sacco, Rodolfo, Sebkova, Ladislava, Scarcelli, Antonella, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Zampaletta, Costantino, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Cuomo, Antonio, Ferronato, Antonio, Elisei, Walter, Picchio, Marcello, Maconi, Giovanni, Scaldaferri, Franco, Papa, Alfredo, Italian group for switch of biologics,, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Della Valle, Nicola, Faggiani, Roberto, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De’ Angelis, Gianluigi, Donnarumma, Laura, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Pica, Roberta, Pranzo, Giuseppe, Rodino’, Stefano, Sacco, Rodolfo, Sebkova, Ladislava, Scarcelli, Antonella, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Zampaletta, Costantino, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: Background & Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason.Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars.Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild.Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.
Published: 2022

28. Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Author: Tursi, Antonio, primary, Mocci, Giammarco, additional, Allegretta, Leonardo, additional, Aragona, Giovanni, additional, Bianco, Maria Antonia, additional, Colucci, Raffaele, additional, Cuomo, Antonio, additional, Della Valle, Nicola, additional, Ferronato, Antonio, additional, Forti, Giacomo, additional, Gaiani, Federica, additional, Giorgetti, GianMarco, additional, Graziani, Maria Giovanna, additional, Lofano, Katia, additional, Lorenzetti, Roberto, additional, Larussa, Tiziana, additional, Penna, Antonio, additional, Pica, Roberta, additional, Pranzo, Giuseppe, additional, Rodino’, Stefano, additional, Scarcelli, Antonella, additional, Zampaletta, Costantino, additional, Bassotti, Gabrio, additional, Cazzato, Alessia Immacolata, additional, Chiri, Stefania, additional, Clemente, Valeria, additional, Cocco, Andrea, additional, de’ Angelis, Gianluigi, additional, Donnarumma, Laura, additional, Faggiani, Roberto, additional, Graziosi, Camilla, additional, Le Grazie, Marco, additional, Luzza, Francesco, additional, Meucci, Costantino, additional, Monterubbianesi, Rita, additional, Pagnini, Cristiano, additional, Perazzo, Patrizia, additional, Picchio, Marcello, additional, Sacco, Rodolfo, additional, Sebkova, Ladislava, additional, Serio, Mariaelena, additional, Napolitano, Daniele, additional, Pugliese, Daniela, additional, Scaldaferri, Franco, additional, Schiavoni, Elisa, additional, Turchini, Laura, additional, Armuzzi, Alessandro, additional, Elisei, Walter, additional, Maconi, Giovanni, additional, and Papa, Alfredo, additional
Published: 2022
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29. Impact of SARS-CoV-2 Infection on the Course of Inflammatory Bowel Disease in Patients Treated with Biological Therapeutic Agents: A Case-Control Study

Author: Papa, Alfredo, primary, Scaldaferri, Franco, additional, Covino, Marcello, additional, Tursi, Antonio, additional, Furfaro, Federica, additional, Mocci, Giammarco, additional, Lopetuso, Loris Riccardo, additional, Maconi, Giovanni, additional, Bibbò, Stefano, additional, Fiorani, Marcello, additional, Laterza, Lucrezia, additional, Mignini, Irene, additional, Napolitano, Daniele, additional, Parisio, Laura, additional, Pizzoferrato, Marco, additional, Privitera, Giuseppe, additional, Pugliese, Daniela, additional, Schepis, Tommaso, additional, Schiavoni, Elisa, additional, Settanni, Carlo Romano, additional, Vetrone, Lorenzo Maria, additional, Armuzzi, Alessandro, additional, Danese, Silvio, additional, and Gasbarrini, Antonio, additional
Published: 2022
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30. The role of inflammatory bowel disease nurses for patients on biologic therapy during the COVID-19 pandemic

Author: Napolitano, Daniele, primary, Galasso, Linda, additional, Privitera, Giuseppe, additional, Morana, Giuseppe, additional, Bardelli, Arianna, additional, Sinatora, Rita, additional, Onidi, Maria Francesca, additional, Lombardi, Maria Teresa, additional, Orgiana, Nicoletta, additional, Amatucci, Valeria, additional, Strazzeri, Martina, additional, Schiavoni, Elisa, additional, Turchini, Laura, additional, Guarini, Alessandra, additional, Settanni, Carlo Romano, additional, Armuzzi, Alessandro, additional, and Scaldaferri, Franco, additional
Published: 2022
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31. Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy

Author: Tursi, Antonio, primary, Mocci, Giammarco, additional, Allegretta, Leonardo, additional, Aragona, Giovanni, additional, Bianco, Maria Antonia, additional, Colucci, Raffaele, additional, Cuomo, Antonio, additional, Della Valle, Nicola, additional, Ferronato, Antonio, additional, Forti, Giacomo, additional, Gaiani, Federica, additional, Graziani, Maria Giovanna, additional, Lorenzetti, Roberto, additional, Luzza, Francesco, additional, Paese, Pietro, additional, Penna, Antonio, additional, Pica, Roberta, additional, Pranzo, Giuseppe, additional, Rodinò, Stefano, additional, Scarcelli, Antonella, additional, Zampaletta, Costantino, additional, Brozzi, Lorenzo, additional, Cicerone, Clelia, additional, Cocco, Andrea, additional, De’ Angelis, Gianluigi, additional, Donnarumma, Laura, additional, Fiorella, Serafina, additional, Iannelli, Chiara, additional, Larussa, Tiziana, additional, Le Grazie, Marco, additional, Luppino, Ileana, additional, Meucci, Costantino, additional, FaggianI, Roberto, additional, Pagnini, Cristiano, additional, Perazzo, Patrizia, additional, Rodriguez-Castro, Kryssia Isabel, additional, Sacco, Rodolfo, additional, Sebkova, Ladislava, additional, Serio, Mariaelena, additional, De Monti, Alberta, additional, Picchio, Marcello, additional, Napolitano, Daniele, additional, Schiavoni, Elisa, additional, Turchini, Laura, additional, Scaldaferri, Franco, additional, Pugliese, Daniela, additional, Guidi, Luisa, additional, Laterza, Lucrezia, additional, Privitera, Giuseppe, additional, Pizzoferrato, Marco, additional, Lopetuso, Loris R., additional, Armuzzi, Alessandro, additional, Elisei, Walter, additional, Maconi, Giovanni, additional, and Papa, Alfredo, additional
Published: 2021
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32. Changes in admissions, and hospitalization outcomes of IBD patients in an Italian tertiary referral center over a 13-year period

Author: Scaldaferri, Franco, Papa, Alfredo, Napolitano, Daniele, Rizzatti, Gianenrico, Pistone, M. T., Poscia, Andrea, Volpe, Massimo, Lopetuso, Loris Riccardo, Schiavoni, Elisa, Guidi, Luisa, Gaetani, Eleonora, Holleran, G., Cammarota, Giovanni, Rapaccini, Gian Ludovico, Pugliese, Daniela, Ojetti, Veronica, Franceschi, Francesco, Armuzzi, Alessandro, and Gasbarrini, Antonio
Subjects: Hospitalizations, Settore MED/12 - GASTROENTEROLOGIA, Healthcare organization, Inflammatory bowel disease, Biologic therapy
Published: 2021

33. The educational role of IBD nurses in Italy in vaccinations: do not miss the moment for COVID-19

Author: Napolitano, Daniele, Privitera, Giuseppe, Schiavoni, Elisa, Turchini, Laura, Amatucci, V., Pugliese, Daniela, Gasbarrini, Antonio, Scaldaferri, Franco, and Armuzzi, Alessandro
Subjects: Settore MED/12 - GASTROENTEROLOGIA, SARS CoV-2, Biologics, Vaccine, Inflammatory bowel disease
Published: 2021

34. Knowledge of Diagnostic and Therapeutic Aspects of IBD Among Nurses Working in Digestive Endoscopy: A Nationwide Italian Survey

Author: Napolitano, Daniele, Scaldaferri, Franco, Fiorino, Gionata, Spagnuolo, Rocco, Leonetti, Alessia, Lopetuso, Loris Riccardo, Cocchieri, Antonello, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Cocchieri, Antonello (ORCID:0000-0002-7694-4986), Napolitano, Daniele, Scaldaferri, Franco, Fiorino, Gionata, Spagnuolo, Rocco, Leonetti, Alessia, Lopetuso, Loris Riccardo, Cocchieri, Antonello, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Cocchieri, Antonello (ORCID:0000-0002-7694-4986)
Abstract: The importance of inflammatory bowel disease (IBD) dedicated nurses in endoscopy services is poorly explored. Non-IBD healthcare professionals who work in endoscopy units may underestimate the discomfort and the secondary psychological distress that endoscopic procedures cause in IBD patients. We performed a nationwide survey to evaluate nurses' level of knowledge working in endoscopy facilities throughout Italy related to IBD patients' needs undergoing endoscopic procedures. A non-validate 45 items questionnaire divided into six sections was assembled by a group of experts and supervised by nurses and IBD physicians as part of the board of IGIBD, ANOTE-ANIGEA, and AGGEI. The questionnaire was sent to 397 nurses of which 335 (84.4%) responded to the questionnaire. The median level of knowledge registered was 29 ± 12, corresponding to a medium level of knowledge based on the scores described in the method section. One hundred eighty-three nurses (54.6%) reported a high score, 113 (33.7%) a medium score, and 39 (11.6%) a low score. The majority of nurses worked in high-volume endoscopy centers, where 48% were educated in IBD management. A low level of knowledge was recorded regarding disease severity definition, bowel preparation strategies in severe colitis, and evaluation of perianal fistula. This nationwide survey clearly shows that there is a need for endoscopic nurses to acquire specific knowledge in the IBD field. Dedicated pathways for IBD management in endoscopy, continuous educational programs for nurses, and further studies to improve nurse education are needed.
Published: 2021

35. Knowledge of Diagnostic and Therapeutic Aspects of IBD Among Nurses Working in Digestive Endoscopy

Author: Napolitano, Daniele, primary, Scaldaferri, Franco, additional, Fiorino, Gionata, additional, Spagnuolo, Rocco, additional, Leonetti, Alessia, additional, Lopetuso, Loris Riccardo, additional, and Cocchieri, Antonello, additional
Published: 2021
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36. The awareness of the IBD nurse position among patients from an Italian tertiary IBD centre

Author: Napolitano, Daniele, Martella, P., Schiavoni, Elisa, Turchini, Laura, Amatucci, V., Armuzzi, Alessandro, Cocchieri, Antonello, Zega, Maurizio, Scaldaferri, Franco, and Gasbarrini, Antonio
Subjects: tertiary, position, Settore MED/12 - GASTROENTEROLOGIA, IBD, Settore MED/09 - MEDICINA INTERNA
Published: 2020

37. Impact of COVID-19 pandemic on the daily management of biotechnological therapy in inflammatory bowel disease patients: Reorganisational response in a high-volume Italian inflammatory bowel disease centre

Author: Scaldaferri, Franco, Pugliese, Daniela, Privitera, Giuseppe, Onali, Sebastiano, Lopetuso, Loris Riccardo, Rizzatti, Gianenrico, Settanni, Carlo Romano, Pizzoferrato, Marco, Schiavoni, Elisa, Turchini, Laura, Amatucci, V., Napolitano, Daniele, Bernabei, T., Mora, Vincenzina, Laterza, Lucrezia, Papa, Alfredo, Guidi, Luisa, Rapaccini, Gian Ludovico, Gasbarrini, Antonio, Armuzzi, Alessandro, Scaldaferri F. (ORCID:0000-0001-8334-7541), Pugliese D., Privitera G., Onali S., Lopetuso L. R., Rizzatti G. (ORCID:0000-0003-1876-7587), Settanni C. R., Pizzoferrato M., Schiavoni E., Turchini L., Napolitano D., Mora V., Laterza L., Papa A. (ORCID:0000-0002-4186-7298), Guidi L. (ORCID:0000-0003-3320-7094), Rapaccini G. L. (ORCID:0000-0002-6467-857X), Gasbarrini A. (ORCID:0000-0002-7278-4823), Armuzzi A. (ORCID:0000-0003-1572-0118), Scaldaferri, Franco, Pugliese, Daniela, Privitera, Giuseppe, Onali, Sebastiano, Lopetuso, Loris Riccardo, Rizzatti, Gianenrico, Settanni, Carlo Romano, Pizzoferrato, Marco, Schiavoni, Elisa, Turchini, Laura, Amatucci, V., Napolitano, Daniele, Bernabei, T., Mora, Vincenzina, Laterza, Lucrezia, Papa, Alfredo, Guidi, Luisa, Rapaccini, Gian Ludovico, Gasbarrini, Antonio, Armuzzi, Alessandro, Scaldaferri F. (ORCID:0000-0001-8334-7541), Pugliese D., Privitera G., Onali S., Lopetuso L. R., Rizzatti G. (ORCID:0000-0003-1876-7587), Settanni C. R., Pizzoferrato M., Schiavoni E., Turchini L., Napolitano D., Mora V., Laterza L., Papa A. (ORCID:0000-0002-4186-7298), Guidi L. (ORCID:0000-0003-3320-7094), Rapaccini G. L. (ORCID:0000-0002-6467-857X), Gasbarrini A. (ORCID:0000-0002-7278-4823), and Armuzzi A. (ORCID:0000-0003-1572-0118)
Abstract: The coronavirus disease 2019 (COVID-19) pandemic is having a major clinical as well as organisational impact on the national health-care system in Italy, particularly in high-volume hospitals which are usually active for many essential clinical needs, including inflammatory bowel disease (IBD). Here, we report major clinical and organisational challenges at a high-volume Italian IBD centre one month after the start of the Italian government’s restrictions due to the COVID-19 pandemic. All routine follow-up IBD visits of patients in remission were cancelled or rescheduled for 8–12 weeks’ time. However, access to the hospital for therapy or for unstable/relapsing patients was not considered postponable. Everyone attending the centre (e.g. physicians, nurses, administrative personnel and patients) were advised to respect the general recommended rules for hand hygiene and social distancing, to disclose if they had a fever or cough or flu-like symptoms and to wear a surgical mask and gloves. At the entrance of the therapy area, a control station was set up in order to double-check all patients with a clinical interview and conduct thermal scanning. A total of 1451 IBD patients under biotechnological or experimental therapy actively followed in the CEMAD IBD centre were included in the study. About 65% of patients maintained their appointment schedules without major problems, while in 20% of cases planned infusions were delayed because of the patient’s decision or practical issues. About 10% of patients receiving subcutaneous therapy were allowed to collect their medicine without a follow-up visit. Finally, 10% of patients living outside the Lazio region requested access to their therapy at a local centre closer to their home. At present, five patients have been found to be positive for SARS-CoV-2 infection but with minimal symptoms, 22 are in ‘quarantine’ for contact considered to be ‘at risk’ for the infection. Up to now, none of them has experienced significant symptom
Published: 2020

38. Mo1753 MULTIPARAMETRIC ASSESSMENT OF IBD AND SPA-IBD PATIENTS TO EXPLORE DISEASE BIOMARKERS AND RESPONSE PREDICTORS

Author: Privitera, Giuseppe, Parisio, Laura, Perniola, Simone, Alivernini, Stefano, Tolusso, Barbara, Petito, Valentina, Napolitano, Daniele, Schiavoni, Elisa, Scaldaferri, Franco, Armuzzi, Alessandro, Gremese, Elisa, and Pugliese, Daniela
Published: 2023
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39. Impact of COVID‐19 pandemic on the daily management of biotechnological therapy in inflammatory bowel disease patients: Reorganisational response in a high‐volume Italian inflammatory bowel disease centre

Author: Scaldaferri, Franco, primary, Pugliese, Daniela, additional, Privitera, Giuseppe, additional, Onali, Sara, additional, Lopetuso, Loris Riccardo, additional, Rizzatti, Gianenrico, additional, Settanni, Carlo Romano, additional, Pizzoferrato, Marco, additional, Schiavoni, Elisa, additional, Turchini, Laura, additional, Amatucci, Valeria, additional, Napolitano, Daniele, additional, Bernabei, Tiziana, additional, Mora, Vincenzina, additional, Laterza, Lucrezia, additional, Papa, Alfredo, additional, Guidi, Luisa, additional, Rapaccini, Gian Lodovico, additional, Gasbarrini, Antonio, additional, and Armuzzi, Alessandro, additional
Published: 2020
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40. Nursing Communication as a Tool for Patient Satisfaction. A Single Hospital Survey

Author: Barilaro, Anna, primary, Conidi, Arianna, additional, Ligarò, Sabrina, additional, Licata, Francesca, additional, Marinaro, Maria Anna, additional, Ventura, Saverio, additional, Varano, Anna, additional, Zangari, Iolanda, additional, Pagliuso, Caterina, additional, Pagnotta, Raffaele, additional, Garieri, Pietro, additional, Papaleo, Anna, additional, Grande, Laura, additional, Manduci, Elena, additional, Napolitano, Daniele, additional, Aida, Bianco, additional, De Filippo, Caterina, additional, and Spagnuolo, Rocco, additional
Published: 2019
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41. Characterization of Sarcopenia in an IBD Population Attending an Italian Gastroenterology Tertiary Center

Author: Pizzoferrato, Marco, de Sire, Roberto, Ingravalle, Fabio, Mentella, Maria Chiara, Petito, Valentina, Martone, Anna Maria, Landi, Francesco, Miggiano, Giacinto Abele Donato, Mele, Maria Cristina, Lopetuso, Loris Riccardo, Schiavoni, Elisa, Napolitano, Daniele, Turchini, Laura, Poscia, Andrea, Nicolotti, Nicola, Papa, Alfredo, Armuzzi, Alessandro, Scaldaferri, Franco, Gasbarrini, Antonio, Mentella, Maria Chiara (ORCID:0000-0003-4552-3932), Landi, Francesco (ORCID:0000-0002-3472-1389), Miggiano, Giacinto Abele Donato (ORCID:0000-0002-8627-5528), Mele, Maria Cristina (ORCID:0000-0003-0153-5819), Poscia, Andrea (ORCID:0000-0002-7616-3389), Papa, Alfredo (ORCID:0000-0002-4186-7298), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Pizzoferrato, Marco, de Sire, Roberto, Ingravalle, Fabio, Mentella, Maria Chiara, Petito, Valentina, Martone, Anna Maria, Landi, Francesco, Miggiano, Giacinto Abele Donato, Mele, Maria Cristina, Lopetuso, Loris Riccardo, Schiavoni, Elisa, Napolitano, Daniele, Turchini, Laura, Poscia, Andrea, Nicolotti, Nicola, Papa, Alfredo, Armuzzi, Alessandro, Scaldaferri, Franco, Gasbarrini, Antonio, Mentella, Maria Chiara (ORCID:0000-0003-4552-3932), Landi, Francesco (ORCID:0000-0002-3472-1389), Miggiano, Giacinto Abele Donato (ORCID:0000-0002-8627-5528), Mele, Maria Cristina (ORCID:0000-0003-0153-5819), Poscia, Andrea (ORCID:0000-0002-7616-3389), Papa, Alfredo (ORCID:0000-0002-4186-7298), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)
Abstract: N/A
Published: 2019

42. Characterization of Sarcopenia in an IBD Population Attending an Italian Gastroenterology Tertiary Center

Author: Pizzoferrato, Marco, primary, de Sire, Roberto, additional, Ingravalle, Fabio, additional, Mentella, Maria Chiara, additional, Petito, Valentina, additional, Martone, Anna Maria, additional, Landi, Francesco, additional, Miggiano, Giacinto Abele Donato, additional, Mele, Maria Cristina, additional, Lopetuso, Loris Riccardo, additional, Schiavoni, Elisa, additional, Napolitano, Daniele, additional, Turchini, Laura, additional, Poscia, Andrea, additional, Nicolotti, Nicola, additional, Papa, Alfredo, additional, Armuzzi, Alessandro, additional, Scaldaferri, Franco, additional, and Gasbarrini, Antonio, additional
Published: 2019
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43. Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy

Author: Tursi, Antonio, Mocci, Giammarco, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Cuomo, Antonio, Della Valle, Nicola, Ferronato, Antonio, Forti, Giacomo, Gaiani, Federica, Graziani, Maria Giovanna, Lorenzetti, Roberto, Luzza, Francesco, Paese, Pietro, Penna, Antonio, Pica, Roberta, Pranzo, Giuseppe, Rodinò, Stefano, Scarcelli, Antonella, Zampaletta, Costantino, Brozzi, Lorenzo, Cicerone, Clelia, Cocco, Andrea, De’ Angelis, Gianluigi, Donnarumma, Laura, Fiorella, Serafina, Iannelli, Chiara, Larussa, Tiziana, Le Grazie, Marco, Luppino, Ileana, Meucci, Costantino, FaggianI, Roberto, Pagnini, Cristiano, Perazzo, Patrizia, Rodriguez-Castro, Kryssia Isabel, Sacco, Rodolfo, Sebkova, Ladislava, Serio, Mariaelena, De Monti, Alberta, Picchio, Marcello, Napolitano, Daniele, Schiavoni, Elisa, Turchini, Laura, Scaldaferri, Franco, Pugliese, Daniela, Guidi, Luisa, Laterza, Lucrezia, Privitera, Giuseppe, Pizzoferrato, Marco, Lopetuso, Loris R., Armuzzi, Alessandro, Elisei, Walter, Maconi, Giovanni, and Papa, Alfredo
Abstract: ABSTRACTBackgroundTo compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy.Research Design and MethodsThree hundred and eighty IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint.Results197 patients with Ulcerative Colitis (UC) and 183 patients with Crohn’s Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6–36) months were compared: 230 (60.5%) were naïve to anti-TNFα, 20 (5.26%) were switched from IFX originator or from IFX CT-P13 to IFX SB2. Clinical remission was achieved in 133 (67.5%) UC patients and in 164 (89.6%) CD patients (p < 0.000), with no differences between CT-P13 and SB2 in the rate of remission in UC (p = 0.667) and CD (p = 0.286). Clinical response, steroid-free remission, rate of surgery, mucosal healing (MH) in UC, switching from IFX originator or from other biosimilar, and safety were similar. Higher MH rate was obtained in CD patients treated with CT-P13 (p = 0.004).ConclusionThis first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.
Published: 2022
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44. Nursing‐sensitive outcomes in adult inflammatory bowel disease: A systematic review.

Author: Spagnuolo, Rocco, Corea, Alessandro, Napolitano, Daniele, Nisticò, Eleonora, Pagnotta, Raffaele, Pagliuso, Caterina, Schiavoni, Elisa, Turchini, Laura, Fiorino, Gionata, Radice, Simona, Armuzzi, Alessandro, and Doldo, Patrizia
Subjects: NURSING audit, EVALUATION of medical care, ONLINE information services, CINAHL database, PSYCHOLOGY information storage & retrieval systems, OCCUPATIONAL roles, INFLAMMATORY bowel diseases, MEDICAL information storage & retrieval systems, MEDICAL databases, INFORMATION storage & retrieval systems, NURSING, SYSTEMATIC reviews, PATIENT satisfaction, MEDICAL care use, SELF-efficacy, NURSES, DESCRIPTIVE statistics, MEDLINE, ODDS ratio, PATIENT compliance, ADULTS
Abstract: Aims: To evaluate nursing activity through outcomes that are affected, provided, and/or influenced by nurses and defined as nursing‐sensitive outcomes in adult IBD patients. Design: Systematic review without meta‐analysis. Data Sources: PubMed, Embase, CINAHL, PsycINFO, and the Cochrane Library databases on August 2019. Review Methods: Peer‐reviewed articles published between 2000–2020 were reviewed. The outcome measures were contextualized and presented by OMERACT Filter 2.0. Results: Twenty‐four studies were included. Eighteen nursing‐sensitive outcomes were identified. These outcomes defined eight domains for health intervention, fitting into three core areas (resource use/economic impact, life impact, pathophysiological manifestations). Fifty‐three measurement instruments were identified. Conclusions: Through 53 measurement tools, with use of OMERACT framework, 18 nursing‐sensitive outcomes in the main 3 core areas were identified, highlighting the multidimensional role of nursing. Further insights are to be carried out to define nursing outcomes included in IBD nursing intervention studies. Impact: These results could serve as a cornerstone for further investigations and validation by a panel of experts to standardizing nursing activity in a multidisciplinary context. [ABSTRACT FROM AUTHOR]
Published: 2021
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45. WASTE HEAT RECOVERY FOR EAF

Author: Schwelberger, Jorg, additional, Trunner, Paul, additional, Steinparzer, Thomas, additional, Napolitano, Daniele, additional, Tagesson, Martin, additional, and Keplinger, Thomas, additional
Published: 2018
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46. Eigenvalue-based signal detector for an automatic modulation classifier

Author: De Vito, Luca, primary, Napolitano, Daniele Domenico, additional, Rapuano, Sergio, additional, and Villanacci, Maurizio, additional
Published: 2010
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47. L'uocchie vuoste!

Author: Matt Testa, Napolitano, Daniele, Matt Testa, and Napolitano, Daniele
Abstract: Manuscript score of song for voice and piano, with music by Daniele Napolitano and words by Riccardo Cordiferro.

48. Industrializzazione banco prova componenti oleodinamici

Author: Napolitano, Daniele, thesis supervisor: Francia, Daniela, Napolitano, Daniele, and thesis supervisor: Francia, Daniela
Abstract: Il percorso ha inizio con una prima parte prettamente teorica che ha come obiettivo quello di far apprendere i concetti base, sia dei componenti che dei circuiti ovvero degli elementi cardine di un impianto. La parte finale di questa prima fase è stata quella di analizzare ed interpretare schemi idraulici inerenti banchi di collaudo già esistenti. La parte pratica vera e propria è iniziata, in base a quanto appreso, dall’analisi critica dello schema idraulico di un banco di collaudo già esistente da reingegnerizzare. In particolare, l’obiettivo principale era quello di aumentare la produttività riducendo al contempo quelli che sono i rischi sulla salute e sicurezza per l’operatore. Come vedremo per realizzare una modifica strutturale di tale banco, è stato necessario intervenire a priori sullo schema idraulico ed in base a quello si è potuto scegliere la soluzione costruttiva migliore per ottenere i risultati cercati. La successiva fase di ingegnerizzazione del prodotto è prettamente tecnica poiché ha visto la modifica e realizzazione ex novo di gruppi (morsa) e particolari meccanici; pertanto, non solo è stata richiesta una buona conoscenza teorica ma anche l’utilizzo di strumenti informatici a cui fa affidamento l’azienda.

49. Monitoring the psychopathological profile of inflammatory bowel disease patients treated with biological agents: a pilot study.

Author: D'Onofrio AM, Balzoni LM, Ferrajoli GF, DI Vincenzo F, Napolitano D, Schiavoni E, Kotzalidis GD, Simonetti A, Mazza M, Rosa I, Pettorruso M, Sani G, Gasbarrini A, Scaldaferri F, and Camardese G
Abstract: Background: Biological agents were found to alter the psychopathological profile of a small subgroup of patients treated for a variety of conditions, including inflammatory bowel disease (IBD) and psychiatric disorders. The association between the administration of biological agents and psychopathology needs to be further investigated., Methods: In this naturalistic prospective cohort study, patients with IBD were assigned to two treatment groups, i.e., a biological agent (which also included tofacitinib) or conventional therapy. Clinician-administered scales were used to assess psychosomatic symptoms (Hamilton Depression Rating Scale [Ham-D], Hamilton Anxiety Rating Scale [Ham-A], Young Mania Rating Scale [YMRS], and Brief Psychiatric Rating Scale [BPRS]) and disease activity (Mayo Score and Harvey-Bradshaw Index [HBI]) at baseline, after one, three, and six months of treatment. Each group was assessed for the course of their scores during the observation period at each assessment point., Results: Patients on biological drugs who completed three months of treatment (N.=32) and six months of treatment (N.=20) scored significantly lower on the Mayo compared to baseline. Patients on conventional treatment obtained significant drops from baseline on the HBI after one and three months of treatment (N.=30) and also at the six-month endpoint (N.=11). Both groups showed no improvement or worsening on the psychiatric rating scales., Conclusions: In this study, we found no evidence of psychiatric symptom worsening, as some literature would suggest. Our data suggest that the use of biological agents in IBD is safe.
Published: 2024
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50. Self-care in patients affected by inflammatory bowel disease and caregiver contribution to self-care (IBD-SELF): a protocol for a longitudinal observational study.

Author: Napolitano D, Vellone E, Iovino P, Scaldaferri F, and Cocchieri A
Subjects: Humans, Longitudinal Studies, Depression epidemiology, Depression psychology, Male, Female, Italy epidemiology, Anxiety epidemiology, Anxiety psychology, Severity of Illness Index, Adult, Research Design, Observational Studies as Topic, Self Care psychology, Caregivers psychology, Caregivers statistics & numerical data, Quality of Life psychology, Inflammatory Bowel Diseases psychology, Inflammatory Bowel Diseases therapy
Abstract: Introduction: Supporting patient self-care and the contribution of their caregivers is crucial in chronic illness care. Inflammatory bowel disease (IBD) is a chronic condition whose prevalence is expected to double, especially in Western countries. IBD symptoms can negatively impact patients' well-being, causing high anxiety, depression, stress and reduced quality of life. These symptoms also affect the health of family members and friends, who often take on caregiving roles during exacerbations. Knowledge about self-care in IBD (IBD-SELF) is limited, and few studies have explored this context. This paper outlines a research protocol for a multicentre longitudinal study to investigate patient self-care and caregiver contributions to IBD-SELF., Methods and Analysis: A sample of 250 consecutive patients diagnosed with IBD and their caregivers will be recruited from 9 dedicated IBD units in northern, central and southern Italy during outpatient visits. Data collection will occur at baseline, 6 and 12 months after enrolment. Multivariable regressions, path analyses and structural equation models will identify predictors (eg, health literacy, caregiver burden and depression) and outcomes (use of healthcare services, disease severity and quality of life) of self-care and caregiver contributions. Dyadic analyses will control for the interdependence of dyad members., Ethics and Dissemination: Ethical approval was obtained from the Territorial Ethics Committee (Lazio 3) N. 0023486/23 and registered on ClinicalTrials.gov (Identifier number: NCT06015789). This study will enhance our understanding of the self-care process in the patient-caregiver dyad in IBD, aiding the design of future educational interventions and promoting greater patient and caregiver involvement in the care pathway., Trial Registration Number: ClinicalTrials.gov: NCT06015789., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2024
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