38 results on '"Turchini Laura"'
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2. Transition from intravenous to subcutaneous biological therapies in inflammatory bowel disease: An online survey of patients
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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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3. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease
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Gornet, Jean-Marc, Beaugerie, Laurent, Shaji, Sebastian, Peyrin-Biroulet, Laurent, Reimund, Jean-Marie, Hebuterne, Xavier, Amiot, Aurélien, Armelao, Franco, Blanc, Pierre, Papi, Claudio, De Chambrun, Guillaume Pineton, Roblin, Xavier, Chu, Karmiris, Konstantinos, Shariq, Sohail, Viazis, Nikolaos, Limdi, Jimmy, Eder H, Piotr, Michalopoulos, Georgios, Bell, Andrew, Biancone, Livia, Dewitte, Marie, Mazhar, Zia, Franchimont, Denis, Nancey, Stephane, Macaigne, Gilles, Principi, Maria Beatrice, Fumery, Mathurin, Parkes, Gareth, Valats, Jean-Christophe, Doherty, Glen, Bouguen, Guillaume, Molnar, Tamás, Tsai, Hersin, Gangi, Mohsin, Pedersen, Natalia, Heluwaert, Frédéric, Shenderey, Richard, Zeissig, Sebastian, Butterworth, Jeffrey, Castiglione, Fabiana, Corless, Lynsey, Zallot, Camille, Baert, Filip, Singh, Salil, Sonwalkar, Sunil, Clayton, Elizabeth, Rahier, Jean-François, Vani, Deven, Bellaiche, Guy, De Vos, Martine, Kirchgesner, Julien, Kopylov, Uri, Lobaton, Triana, Locher, Christophe, Mantzaris, Gerassimos, Abouda, George, Smith, Katie, Sprakes, Michael, Theodoropoulou, Angeliki, Wesley, Emma, Bonnet, Joëlle, Elphick, David, Gilletta, Cyrielle, Gordon, John, Laharie, David, Nakad, Antoine, Orlando, Ambrogio, Dubois, Patrick, Hasselblatt, Peter, Michiels, Christophe, Preston, Cathryn, Staicu, Anca, Vuitton, Lucine, Kaassis, Mehdi, Speight, Ally, Ghosh, Deb, Löwenberg, Mark, Mathieu, Nicolas, Pelletier, Anne-Laure, Phillips, Anne, Magro, Fernando, Altwegg, Romain, Avni, Irit, biron, Landy, Jonathon, Nachury, Maria, Shenoy, Achuth, Trang, Caroline, Abitbol, Vered, Bamias, Georgios, Farkas, Klaudia, Maaser, Christian, Shitrit, Ariella, Siegmund, Britta, Filippi, Jérôme, O'morain, Colm, Yanai, Henit, Costes, Laurent, Hobday, David, Szepes, Zoltán, Calabrese, Emma, Dallal, Helen, Fung, Michael, Ramadas, Arvind, Baburajan, Bijay, Koss, Konrad, Barberis, Christophe, Buisson, Anthony, Amil, Morgane, Balestrieri, Paola, Johnson, Matthew, Tzouvala, Maria, Viennot, Stéphanie, Nagy, Ferenc, Thompson, Nick, Alric, Laurent, Samuel, Sunil, Bourrier, Anne, Chanteloup, Elise, Del Tedesco, Emilie, Harbord, Marcus, Lobo, Alan, Myers, Sally, Pollok, Richard, Ahmad, Tariq, Chaudhary, Rakesh, Karakoidas, Christos, Soliman, Ashraf, Stefanescu, Carmen, Theocharis, Georgios, Branden, Stijn Vanden, Beltran, Belén, Bouhnik, Yoram, Bourreille, Arnaud, Branco, Joana, Colleypriest, Ben, Eliakim, Rami, Knight, Paul, O'toole, Aoibhlinn, Robles, Virgina, Triantafyllou, Konstantinos, Bosca, Marta Maia, Lambrecht, Guy, Mosquera, Lucia Marquez, Panter, Simon, Pappa, Aikaterini, Simon, Marion, Sivaji, Ganesh, Bellanger, Christophe, Belle, Arthur, Borruel, Natalia, Egan, Laurence, Peeters, Harald, Sharpstone, Daniel, Arasaradnam, Ramesh, Benitez, José Manuel, Dahlerup, Jens Frederik, Giouleme, Olga, Gisbert, Javier P., Helwig, Ulf, Minguez, Miguel, Tsironi, Eftychia, Variola, Angela, Allen, Patrick, Boivineau, Lucille, Cole, Andy, Dib, Nina, Gomollon, Fernando, Johnston, Richard, Katsanos, Konstantinos, Kennedy, Nick, Kiszka-Kanowitz, Marianne, Marin-Jimenez, Ignacio, Miheller, Pál, Nos, Pilar, Saraj, Othman, Vinter-Jensen, Lars, Zittan, Eran, Baudry, Clotilde, Calvet, Xavier, Cazelles-Boudier, Marie-Christine, Coenegrachts, Jean-Louis, Cullen, Garret, Daperno, Marco, Dhar, Anjan, Gerard, Romain, Jensen, Nanna, Maharshak, Nitsan, Mcalindon, Mark, Mcloughlin, Simon, Parkes, Miles, Patel, Kamal, Peixoto, Armando, Polymeros, Dimitrios, Portela, Francisco, Rocca, Rodolfo, Seksik, Philippe, Subramanian, Sreedhar, Tennenbaum, Ruth, Atreya, Raja, Bachmann, Oliver, Berger, Arthur, Bor, Renáta, Buckley, Maire, Carpio, Daniel, Chaparro, María, Costa, Francesco, Domenech, Eugeni, Esteve, Maria, Foley, Stephen, Guardiola, Jordi, Koutroubakis, Ioannis, Kuehbacher, Tanja, Landman, Cécilia, Lavagna, Alessandro, Manceñido, Noemí, Mañosa, Míriam, Martín-Arranz, Maria Dolores, Plastaras, Laurianne, Scribano, Maria Lia, Sengupta, Subhasish, Teich, Nils, Tran-Minh, My-Linh, Zampeli, Evanthia, Amininejad, Leila, Arroyo, Teresa, Attar, Alain, Backman, Ann-Sofie, Bálint, Anita, Beckly, John, Ben Horin, Shomron, Bernardo, Sónia, Caillo, Ludovic, Caron, Bénédicte, Shanika de Silva, María, FábiáN, Anna, Fiorino, Gionata, Gutierrez, Ana, Lahat, Adi, Masmoudi, Mohamed, Mendolaro, Marco, Muls, Vinciane, Poullenot, Florian, Probert, Christopher, Reenaers, Catherine, Rutka, Mariann, Sarwari, Zaman, Sayer, Joanne, Sicilia, Beatriz, Sousa, Helena, van Kemseke, Catherine, Zabana, Yamile, Astegiano, Marco, Banim, Paul, Bettenworth, Dominik, Boualit, Médina, Brodersen, Jacob Broder, Christidou, Angeliki, Cooney, Rachel, Pinto, João Cortez, Cravo, Portugal Marília, Cremer, Anneline, Danese, Silvio, di Sabatino, Antonio, Fallingborg, Jan, Ferronato, Antonio, Planella, Esther Garcia, Gupta, Sanjay, Halfvarson, Jonas, Israeli, Eran, Kestenbaum, Samantha, Larsen, Lone, Macken, Elisabeth, Mathou, Nicoletta, Milassin, Ágnes, Pofelski, Joanna, Ricci, Chiara, Rodriguez-Moranta, Francisco, Schmidt-Lauber, Martin, Shaw, Ian, Soares, Marta, Soliman, Heithem, Triantos, Christos, Zografos, Konstantinos, Agrawal, Anurag, Armuzzi, Alessandro, Aubourg, Alexandre, Acosta, Manuel Barreiro-de, Barrio, Jesús, Bergemalm, Daniel, Bermejo, Fernando, Bodini, Giorgia, Bohr, Johan, Bossuyt, Peter, Christodoulou, Dimitrios, Claessens, Christophe, Collins, Paul, de Francisco, Ruth, Garcia, Santiago, Georgopoulos, Sotirios, Goutorbe, Felix, Kalantzis, Chrisostomos, Kourikou, Anastasia, Mace, Vincent, Malamut, Georgia, Ministro, Paula, Larmurier, Isabelle Nion, Ricart, Elena, Serrero, Mélanie, Sheridan, Juliette, Weimers, Petra, Andersen, Vibeke, Arroja, Bruno, Bokemeyer, Bernd, Bujanda, Luis, Degand, Thibault, Eriksson, Carl, Garceau, Cécile, Glerup, Henning, Goren, Idan, Jackson, Lucina, Koch, Stéphane, Mesonero, Francisco, Ordas, Ingrid, Riviere, Pauline, Saibeni, Simone, Soares, João, Tavernier, Noémie, Theede, Klaus, Ungar, Bella, Bästlein, Elke, Gasbarrini, Antonio, Protopapas, Andreas, Reindl, Wolfgang, Bossa, Fabrizio, Hart, Ailsa, Heil, Franz-Josef, O'Connor, Anthony, Oldenburg, Bas, Pastorelli, Luca, Stephen patchett, Ramakrishnan, Subramaniam, de Caestecker, John, Echarri, Ana, Kevans, David, Büning, Jürgen, Coelho, Rosa, Jansen, Jeroen, Koslowski, Benjamin, Wells, Christopher, Ceballos, Daniel, König, Ingrid, Padmanabhan, Hari, Patani, Timi, Qureshi, Raheel, Zagorowicz, Edyta, Allez, Matthieu, Archavlis, Emmanouil, Bonnet, Delphine, Guidi, Luisa, Mcnamara, Deirdre, Vernia, Piero, Weidenhiller, Michael, Alon, Lang, Boysen, Trine, Delattre, Charlotte, Farrell, Richard, Krüger, Rolf-Achim, Paupard, Thierry, Vind, Ida, Caprioli, Flavio, Gancho, Vladimir, Quentin, Vincent, Avidan, Benjamin, D’Haens, Geert, Mccarthy, Jane, Snook, Jonathon, Soufleris, Konstantinos, Zerbib, Frank, Carter, Dan, Depla, Annekatrien, Eisenbach, Thomas, Fries, Walter, Grammatikos, Nikolaos, Ilegems, Saskia, Lopez-Sanroman, Antonio, Moreau, Jacques, Riegler, Gabriele, Rietdijk, Svend, Rocha, Marta, Rosa, Isabelle, Ryan, Barbara, Yeremenko, Yelena, Boruchowicz, Arnaud, Damião, Filipe, Laoudi, Foteini, Lügering, Andreas, Macarri, Giampiero, Thomopoulos, Konstantinos, Barros, Luísa, Blixt, Thomas, Garros, Aurélien, Khorrami, Sam, Sokol, Harry, Sturm, Andreas, Livovsky, Dan, Maul, Jochen, Miks, Heinrich, Papadopoulos, Vasileios, Schmidt, Carsten, Snir, Yifat, Svenningsen, Lise, Ahmed, Wafaa, Broitman, Yelena, Cuillerier, Emmanuel, Kant, Prashant, Leyden, Jan, Lichtenstein, Lev, Lopes, Susana, Martineau, Chloé, Mulcahy, Hugh, Schweitzer, Axel, Van Schaik, Fiona, Banai, Hagar, Danion, Pauline, Dulery, Charlotte, Fidder, Herma, Gay, Claire, Hagege, Hervé, Harnois, Florence, Jørgensen, Søren Peter, Müller-Ziehm, Jens, Oikonomou, Michail, Palmela, Carolina, Schulze/Röske, Jörg, Smith, Mark, Thurm, Tamar, Bresso, Francesca, Brixi, Hedia, Jones, John, Macmathuna, Padraig, Painchart, Claire, Ron, Yulia, Vester-Andersen, Marianne, Alexandrino, Gonçalo, Börner, Norbert, Cardoso, Mariana, Chagas, Cristina, Dignaß, Axel, Dotan, Iris, Hedin, Charlotte, Karatzas, Pantelis, Kasapidis, Panagiotis, Palatka, Károly, Sakizlis, Georgios, Wilson, Ana, Bosanko, Nick, Caldeira, Paulo, Gagniere, Charlotte, Libier, Louise, Meunier, Camille, Moog, Gero, Pasquion, Audrey, Pica, Roberta, Akbar, Ayesha, Arab, Nadia, Cadiot, Guillaume, Carvalho, João, Charpignon, Claire, Fellermann, Laus, Fishman, Sigal, Fraser, Gerald, Gluck, Nathan, Hoesl, Mark, Kierkus, Jarosław, Klopocka, Maria, Arranz, Eduardo Martin, Menchen, Luis, Nikolaus, Susanna, Petrache, Anca, Ponsioen, Cyriel, Riestra, Sabino, Robledo, Pilar, Rodriguez, Cristina, Samer, Misheal, Tischer, Matthias, Wypych, Joanna, Baudon, Julien, Bezzio, Cristina, Boschetti, Gilles, Burisch, Johan, Creed, Tom, Demarzo, Maria Giulia, Festa, Stefano, Figueroa, Andrés, Julsgaard, Mette, Navarro, Pablo, Perez-Galindo, Pablo, Rouillon, Cléa, Sablich, Emanuele, Tosca, Joan, Vidon, Mathias, Vidon, Marine, Vitte, René-Louis, Wampach, Anne, Baumann, Cédric, Urmes, Isabelle Clerc, Rousseau, Hélène, Borie, Marc, Uzzan, Mathieu, Chatten, Kelly, Peter, Rimmer, Tariq, Iqbal, Cossignani, Marta, Cañete, Fiorella, Holvoet, Tom, Krasz, Susanne, Dias, Sandra, Abalia, Hadas, Abaza, Aziza, Abramovich, Gal, Ackzell, Ingrid, Adams, Carol, Addleton, Catherine, Alfambra, Erika, Algaba, Alicia, Allcock, Clare, Allison, Joanna, Amouriaux, Karine, Anderson, Julie, Anderson, Emma, Appelmans, Saskia, Armstrong, Lisa, Atkins, Stacey, Attaran-Bandarabadi, Masoumeh, Bailey, Yvonne, Bardot, Stephanie, Beck, Natasha, Bennett, Lillie, Bergfeld, Jonathan Phil, Berkane, Ramdane, Boey, Hanne, Bowlas, Louise, Bradley-Potts, Joanne, Brear, Tracy, Bretlander-Peters, Nicole, Brown, Ellen, Brown, Johanna, Buckingham, Elizabeth, Buellens, Katrien, Bull, Rhian, Burke, Maura, Burns, Leighanne, Burton, Julie, Bwalya, Agness, Cabanas, Karine, Callaghan, Muriel, Camou, Océane, Campbell, Debbie, Capoferro, Elvira, Carnahan, Mandy, Carnio, Cornelia, Carter, Anne, Clack, Concetta Casali, Chedouba, Leïla, Cipriano, Bessie, Claeys, Sophie, Closset, Manon, Coban, Dilek, Cococcia, Sara, Coe, Carolann, Cole, Helen, Collet, Emilie, Collins, Kayleigh, Combes, Isabelle, Connor, Emma, Constantin, Kathryn, Cooke, Susan, Cornet, Nathanaëlle, Corrihons, Estelle, Corsino, Pilar, Cortaville, Rosie, Cotterill, Donna, Cowton, Amanda, Cox, Harriet, Cripps, Viktoria, Crowder, Amanda, Cukier, Tzufit, Daniel, Amelia, Dawe, Chris, de Haan, Jose, Croix, Rosanna de la, Dejonckheere, Evva, Villanegro, Juan Delare, Delaval, Guillaume, Delliponti, Mariangela, Delommez, Aude, Detry, Emilie, Dhanaratne, Melanie, Galan, Laura Diez, Dodel, Marie, Dooks, Emma, Du Cheyron, Joseph, Duane, Linda, Vulgo Cochran, Jennifer Dulling, Dyer, Simona, Dymond, Harvey, Ekblad, Charlotte, Elliott, Kerry, Emmerson, Ingrid, Eugene-Jolchine, Irène, Fleming, Lorna, Fletcher, Eve, Ford, Sarah, Forshaw, Greg, Foulds, Angela, Francois, Caroline, Fuge, Nicole, Gafni, Gal, Ganon, Miri, Nuñez, Olga Garcia, Ramirez, Laura Garcia, Gelder, Sophie, Gettkowski, Raimonda, Gilardi, Daniela, Giuffrida, Paolo, Gobert, Vincent, Godden, Jo, Godwin, Nuala, Goulden, Kay, Graham, Sharon, Green, Charlotte, Green, Marie, Gueye, Aboubakar, Guler, Tuba, Gustavsson, Ida, Hadjisavvas, Helena, Hammonds, Fiona, Hantzi, Christina, Hauke, Marion, Haydock, Julie, Hayes, Orla, Nislev, Lizette Helbo, Hochstodter, Jessica, Hogg, Ashleigh, Hölbing, Manuela, Holland, Maureen, Holsbergen, Maartje, Howard, Linda, Hoyda, Aviya, Hull, Robert, Irish, Jane, Jackson, Wendy, Janssen, Wendy, Jeffrey, Lesley, Jourdan, Sofia, Jutrowska, Izabela, Kaniel, Chava, Karezos, Theofilos, Kelly, Niamh, Kelly, Jessica, Kennedy, Mary, Kennedy, Una, Kibaru, Joyce, Kirkman, Gemma, Klaproth, Janine, Kneese, Corinna, Koch, Andrea, Kokke, Kathleen, Koppelow, Martha, Krause, Sabine, Krauspe, Sabine, Kwakkenbos, Petra, Labarile, Nunzia, Lang, Hannah, Lassailly, Marianne, Leconte, Martine, Lepczynski, Linda, Levell, Emma, Levhar, Nina, Lindhort, Kerstin, Lisle, Jessica, Cauce, Beatriz Lopez, Lorenz, Gabriele, Lovati, Ambra, Lowry, Tracey, Lund, Margareta, Vorderbrügge, Anne Lutz, Maansson, Suzanne, Madapathage, Videsheka, Cheviakoff, Maelys, Magness, Alison, Manley, Orla, Manyoni, Catherine, Marg, Ingke, Marra, Antonella, Martins, Carole, Massella, Arianna, Mathias, Aurore, Mervyn, Danielle, Minsart, Charlotte, Mitchell, Sally, Monks, Kathleen, Montero, Mélanie, Moore, Alson, Moser, Maren, Moss, Alison, Mullen, Angela, Murciano, M. Francisca, Naylor, Deanna, Nehus, Ansgar, Nicholson, Anne, Nöding, Sarah, Nolan, Sinead, Nörenberg, Janet, Northcott, Clare, O'Connell, Jim, O’Kelly, Alison, Orbach-Zingboim, Noam, Orobitg, Judit, Otieno, Charlene, Owen, Charlotte, Patch, Sarah, Pauker, Maor, Pauli, Renate, Pearson, Harriet, Peggy, Falgon, Petit, Séverine, Petrissans, Christine, Piergallini, Simona, Pippard, Lucy, Pitt, Laura, Pócsik, Gabriella, Poher, Yoann, Pomes, Chloé, Pritchard, Lucy, Puchades, Laura, Quaid, Sheena, Rana, Aleem, Raynard, Dana, Reilly, Mykla, Reinert, Sonja, Reinknecht, Manuela, Renner, Baerbel, Reynolds, Rob, Rizzuto, Giulia, Robinson, Matthew, Robrechts, Joke, Rodriguez, Eva M., Rosenblum, Efrat, Russel, Tamlyn, Sadare, Ibiyemi, Salama, Noa, Schakel, Toos, Schauer, Anja, Schiavoni, Elisa, Shaw, Caroline, Shelton, Sarah, Sicart, Virginie, Siouville, Elodie, Smith, Orla, Soude, Théo, Stephenson, Sophie, Stephenson, Elaine, Steppe, Marjan, Sterkx, An, Stickley, Jo, Sugrue, Kathleen, Swietec, Natalia, Tasiaux, Charlotte, Thamu, Bhavneet, Thomas, Susane, Tobi, Ogwa, Touabi, Kahina, Tovi, Shifra, Tregonning, Julie, Turchini, Laura, Unkhoff, Julia, Unruh, Olesya, Uzun, Nurcan, Van Aert, Frauke, Bergh, Sandrine Vanden, Vandenbroucke, Louise, Vansteenkiste, Laura, Vardit, Shay, Vergriete, Valentin, Walker, Elaine, Warner, Eleanor, Watchorn, Olivia, Watson, Ekaterina, Wauthier, Marie-Claire, Weetman, Belgium Maria, Weston, Margaret, West-Petroschka, Wiebke, Wienecke, Susann, Wierling, Kerstin, Wiestler, Miriam, Wilcox, Rebecca, Wilhelmsen, Elva, Williams, Angharad, Williamson, Georgina, Wilson, Deborah, Wistance, Kate, Wortmann, Nicolas, Wurie, Subie, Yadgar, Karin, Young, Gail, Young, Megan, Aucouturier, Julien, Bertin, Marie- Jo, Bougrine, Hasnae, Coisnon, Marie, Defrance, Antoine, Gutierrez, Kati, Harouz, Amel, Jerber, Laure, Khlifi, Aida, Kirati, Amina, Liworo, Nasaladjine, Logoltat, Maude, Mailhat, Charlotte, M'Bayi, Chancely, Medane, Yasmina, Merkhoufa, Dalal, Elhad, Saouda Mohamed, Monthe, Bertille, Moyon, Fanny, Rabiega, Pascaline, Sekela, Jennifer, Thilloy, Charlotte, Hamamouche, Naima, Partisotti, Frederic, Blandin, Patrick, Mokhtari, Hocine, Coutard, Laure, and Doherty, Glen A.
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- 2023
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4. The gut–brain axis in irritable bowel syndrome and inflammatory bowel disease
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Ancona, Angela, Petito, Claudia, Iavarone, Irene, Petito, Valentina, Galasso, Linda, Leonetti, Alessia, Turchini, Laura, Belella, Daniela, Ferrarrese, Daniele, Addolorato, Giovanni, Armuzzi, Alessandro, Gasbarrini, Antonio, and Scaldaferri, Franco
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- 2021
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5. Faecal Transplantation for Ulcerative Colitis From Diet Conditioned Donors Followed by Dietary Intervention Results in Favourable Gut Microbial Profile Compared to Faecal Transplantation Alone.
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Leibovitzh, Haim, Shabat, Chen Sarbagili, Hirsch, Ayal, Zittan, Eran, Mentella, Maria Chiara, Petito, Valentina, Cohen, Nathaniel Aviv, Ron, Yulia, Isakov, Naomi Fliss, Pfeffer, Jorge, Yaakov, Michal, Fanali, Caterina, Turchini, Laura, Masucci, Luca, Quaranta, Gianluca, Kolonimos, Nitzan, Godneva, Anastasia, Weinberger, Adina, Scaldaferri, Franco, and Maharshak, Nitsan
- Abstract
Background and Aims Several faecal microbial transplantation [FMT] approaches for ulcerative colitis [UC] have been investigated with conflicting results. We have recently published the clinical outcomes from the CRAFT UC Trial using FMT with the UC Exclusion Diet [UCED], compared with FMT alone. Here we aimed to compare the two FMT strategies in terms of microbial profile and function. Methods Subjects recruited to the CRAFT UC study with available pre- and post-intervention faecal samples were included. Donors received diet conditioning for 14 days based on the UCED principles. Group 1 received single FMT by colonoscopy [Day 1] and enemas [Days 2 and 14] without donors' dietary conditioning [ N = 11]. Group 2 received FMT but with donors' dietary pre-conditioning and UCED for the patients [ N = 10]. Faecal samples were assessed by DNA shotgun metagenomic sequencing. Results Following diet conditioning, donors showed depletion in metabolic pathways involved in biosynthesis of sulphur-containing amino acids. Only Group 2 showed significant shifts towards the donors' microbial composition [ADONIS: R
2 = 0.15, p = 0.008] and significantly increased Eubacterium AF228LB post-intervention [β-coefficient 2.66, 95% confidence interval 2.1–3.3, q < 0.05] which was inversely correlated with faecal calprotectin [rho = −0.52, p = 0.035]. Moreover, pathways involved in gut inflammation and barrier function including branched chain amino acids were enriched post-intervention in Group 2 and were significantly inversely correlated with faecal calprotectin. Conclusion FMT from diet conditioned donors followed by the UCED led to microbial alterations associated with favourable microbial profiles which correlated with decreased faecal calprotectin. Our findings support further exploration of the additive benefit of dietary intervention for both donors and patients undergoing FMT as a potential treatment of UC. [ABSTRACT FROM AUTHOR]- 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
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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
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- 2023
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7. Clinical Trial IBD Unit: The Role of the Study Nurse in Conduction of Trials and Patients' Care.
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Turchini, Laura, Amatucci, Valeria, Scaldaferri, Franco, and Laterza, Lucrezia
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MEDICAL personnel as patients , *MEDICAL personnel , *PATIENT-professional relations , *PATIENTS' attitudes , *INFLAMMATORY bowel diseases - Abstract
This document consists of two articles that discuss the role of clinical trial nurses in oncology research. The first article highlights the importance of clinical trial nurses in the field of oncology and their contributions to the success of clinical trials. The second article focuses on the evolving role of clinical trial nurses as they transition from providing direct patient care to coordinating and managing clinical research. Both articles provide valuable insights into the vital role that clinical trial nurses play in advancing oncology research. [Extracted from the article]
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- 2024
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8. Ecology and Machine Learning-Based Classification Models of Gut Microbiota and Inflammatory Markers May Evaluate the Effects of Probiotic Supplementation in Patients Recently Recovered from COVID-19
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Laterza, Lucrezia, Putignani, Lorenza, Settanni, Carlo Romano, Petito, Valentina, Varca, Simone, De Maio, Flavio, Macari, Gabriele, Guarrasi, Valerio, Gremese, Elisa, Tolusso, Barbara, Wlderk, Giulia, Pirro, Maria Antonia, Fanali, Caterina, Scaldaferri, Franco, Turchini, Laura, Amatucci, Valeria, Sanguinetti, Maurizio, Gasbarrini, Antonio, Gremese, Elisa (ORCID:0000-0002-2248-1058), Tolusso, Barbara (ORCID:0000-0002-9108-6609), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Laterza, Lucrezia, Putignani, Lorenza, Settanni, Carlo Romano, Petito, Valentina, Varca, Simone, De Maio, Flavio, Macari, Gabriele, Guarrasi, Valerio, Gremese, Elisa, Tolusso, Barbara, Wlderk, Giulia, Pirro, Maria Antonia, Fanali, Caterina, Scaldaferri, Franco, Turchini, Laura, Amatucci, Valeria, Sanguinetti, Maurizio, Gasbarrini, Antonio, Gremese, Elisa (ORCID:0000-0002-2248-1058), Tolusso, Barbara (ORCID:0000-0002-9108-6609), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)
- Abstract
Gut microbiota (GM) modulation can be investigated as possible solution to enhance recovery after COVID-19. An open-label, single-center, single-arm, pilot, interventional study was performed by enrolling twenty patients recently recovered from COVID-19 to investigate the role of a mixed probiotic, containing Lactobacilli, Bifidobacteria and Streptococcus thermophilus, on gastrointestinal symptoms, local and systemic inflammation, intestinal barrier integrity and GM profile. Gastrointestinal Symptom Rating Scale, cytokines, inflammatory, gut permeability, and integrity markers were evaluated before (T-0) and after 8 weeks (T-1) of probiotic supplementation. GM profiling was based on 16S-rRNA targeted-metagenomics and QIIME 2.0, LEfSe and PICRUSt computational algorithms. Multiple machine learning (ML) models were trained to classify GM at T-0 and T-1. A statistically significant reduction of IL-6 (p < 0.001), TNF-a (p < 0.001) and IL-12RA (p < 0.02), citrulline (p value < 0.001) was reported at T-1. GM global distribution and microbial biomarkers strictly reflected probiotic composition, with a general increase in Bifidobacteria at T-1. Twelve unique KEGG orthologs were associated only to T-0, including tetracycline resistance cassettes. ML classified the GM at T-1 with 100% score at phylum level. Bifidobacteriaceae and Bifidobacterium spp. inversely correlated to reduction of citrulline and inflammatory cytokines. Probiotic supplementation during post-COVID-19 may trigger anti-inflammatory effects though Bifidobacteria and related-metabolism enhancement.
- Published
- 2023
9. Gut Microbiota Signatures Are Associated With Psychopathological Profiles in Patients With Ulcerative Colitis: Results From an Italian Tertiary IBD Center
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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)
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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
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- 2023
10. Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study
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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)
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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
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- 2023
11. Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission
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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)
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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.
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- 2023
12. Ecology and Machine Learning-Based Classification Models of Gut Microbiota and Inflammatory Markers May Evaluate the Effects of Probiotic Supplementation in Patients Recently Recovered from COVID-19
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Laterza, Lucrezia, primary, Putignani, Lorenza, additional, Settanni, Carlo Romano, additional, Petito, Valentina, additional, Varca, Simone, additional, De Maio, Flavio, additional, Macari, Gabriele, additional, Guarrasi, Valerio, additional, Gremese, Elisa, additional, Tolusso, Barbara, additional, Wlderk, Giulia, additional, Pirro, Maria Antonia, additional, Fanali, Caterina, additional, Scaldaferri, Franco, additional, Turchini, Laura, additional, Amatucci, Valeria, additional, Sanguinetti, Maurizio, additional, and Gasbarrini, Antonio, additional
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- 2023
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13. 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
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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
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- 2022
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14. Innovative, complementary and alternative therapy in inflammatory bowel diseases: A broad 2020s update
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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
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- 2022
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15. 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
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Tursi, Antonio, Mocci, G., Allegretta, L., Aragona, G., Bianco, M. A., Colucci, R., Cuomo, A., Della Valle, N., Ferronato, A., Forti, G., Gaiani, F., Graziani, M. G., Lorenzetti, R., Luzza, F., Paese, P., Penna, A., Pica, R., Pranzo, G., Rodino, S., Scarcelli, A., Zampaletta, C., Brozzi, L., Cicerone, C., Cocco, A., De' Angelis, G., Donnarumma, L., Fiorella, S., Iannelli, C., Larussa, T., Le Grazie, M., Luppino, I., Meucci, C., Faggiani, R., Pagnini, C., Perazzo, P., Rodriguez-Castro, K. I., Sacco, R., Sebkova, L., Serio, M., De Monti, A., Picchio, M., Napolitano, Daniele, Schiavoni, Elisa, Turchini, Laura, Scaldaferri, Franco, Pugliese, Daniela, Guidi, Luisa, Laterza, Lucrezia, Privitera, G., Pizzoferrato, M., Lopetuso, Loris Riccardo, Armuzzi, Alessandro, Elisei, W., Maconi, G., Papa, Alfredo, Tursi A., Napolitano D., Schiavoni E., Turchini L., Scaldaferri F. (ORCID:0000-0001-8334-7541), Pugliese D., Guidi L. (ORCID:0000-0003-3320-7094), Laterza L., Lopetuso L. R., Armuzzi A. (ORCID:0000-0003-1572-0118), Papa A. (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, G., Allegretta, L., Aragona, G., Bianco, M. A., Colucci, R., Cuomo, A., Della Valle, N., Ferronato, A., Forti, G., Gaiani, F., Graziani, M. G., Lorenzetti, R., Luzza, F., Paese, P., Penna, A., Pica, R., Pranzo, G., Rodino, S., Scarcelli, A., Zampaletta, C., Brozzi, L., Cicerone, C., Cocco, A., De' Angelis, G., Donnarumma, L., Fiorella, S., Iannelli, C., Larussa, T., Le Grazie, M., Luppino, I., Meucci, C., Faggiani, R., Pagnini, C., Perazzo, P., Rodriguez-Castro, K. I., Sacco, R., Sebkova, L., Serio, M., De Monti, A., Picchio, M., Napolitano, Daniele, Schiavoni, Elisa, Turchini, Laura, Scaldaferri, Franco, Pugliese, Daniela, Guidi, Luisa, Laterza, Lucrezia, Privitera, G., Pizzoferrato, M., Lopetuso, Loris Riccardo, Armuzzi, Alessandro, Elisei, W., Maconi, G., Papa, Alfredo, Tursi A., Napolitano D., Schiavoni E., Turchini L., Scaldaferri F. (ORCID:0000-0001-8334-7541), Pugliese D., Guidi L. (ORCID:0000-0003-3320-7094), Laterza L., Lopetuso L. R., Armuzzi A. (ORCID:0000-0003-1572-0118), and Papa A. (ORCID:0000-0002-4186-7298)
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- 2022
16. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial
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Shabat, C. S., Scaldaferri, Franco, Zittan, E., Hirsch, A., Mentella, Maria Chiara, Musca, Tania, Cohen, N. A., Ron, Y., Isakov, N. F., Pfeffer, J., Yaakov, M., Fanali, Chiara, Turchini, Laura, Masucci, Luca, Quaranta, Gianluca, Kolonimos, N., Godneva, A., Weinberger, A., Kopylov, U., Levine, A., Maharshak, N., Scaldaferri F. (ORCID:0000-0001-8334-7541), Mentella M. C. (ORCID:0000-0003-4552-3932), Musca T., Fanali C., Turchini L., Masucci L. (ORCID:0000-0002-8358-6726), Quaranta G., Shabat, C. S., Scaldaferri, Franco, Zittan, E., Hirsch, A., Mentella, Maria Chiara, Musca, Tania, Cohen, N. A., Ron, Y., Isakov, N. F., Pfeffer, J., Yaakov, M., Fanali, Chiara, Turchini, Laura, Masucci, Luca, Quaranta, Gianluca, Kolonimos, N., Godneva, A., Weinberger, A., Kopylov, U., Levine, A., Maharshak, N., Scaldaferri F. (ORCID:0000-0001-8334-7541), Mentella M. C. (ORCID:0000-0003-4552-3932), Musca T., Fanali C., Turchini L., Masucci L. (ORCID:0000-0002-8358-6726), and Quaranta G.
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Background: We evaluated whether integration of novel diets for donors and patients, in addition to faecal transplantation [FT], could increase FT remission rate in refractory ulcerative colitis [UC]. Methods: This was a blinded, randomised, controlled trial in adults with active UC, defined by a simple clinical colitis activity index [SCCAI] of ≥5 and ≤11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on Day 1and rectal enemas on Days 2 and 14 without dietary conditioning of the donor. Group 2 received FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet [UCED] for the patients. Group 3 received the UCED alone. The primary endpoint was Week 8 clinical steroid-free remission, defined as SCCAI <3. Results: Of 96 planned patients, 62 were enrolled. Remission Week 8 Group 1 was 2/17 [11.8%], Group 2 was 4/19 [21.1%], Group 3 was 6/15 [40%] [non-significant]. Endoscopic remission Group 1 was 2/17 [12%], Group 2 was 3/19 [16%], Group 3 was 4/15 [27%] [Group 1 vs 3 p = 0.38]. Mucosal healing [Mayo 0] was achieved only in Group 3 [3/15, 20%] vs 0/36 FT patients [p = 0.022]. Exacerbation of disease occurred in 3/17 [17.6%] of Group 1, 4/19 [21.1%] of Group 2, and 1/15 [6.7%] of Group 3 [Group 2 vs 3, p = 0.35]. Conclusions: UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.
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- 2022
17. The role of inflammatory bowel disease nurses for patients on biologic therapy during the COVID-19 pandemic
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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)
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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.
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- 2022
18. 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
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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)
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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.
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- 2022
19. Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study
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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
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- 2022
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20. The role of inflammatory bowel disease nurses for patients on biologic therapy during the COVID-19 pandemic
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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
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- 2022
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21. 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
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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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22. One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy
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Chiappetta, Michele Francesco, primary, Viola, Anna, additional, Mastronardi, Mauro, additional, Turchini, Laura, additional, Carparelli, Sonia, additional, Orlando, Adele, additional, Biscaglia, Giuseppe, additional, Miranda, Agnese, additional, Guida, Laura, additional, Costantino, Giuseppe, additional, Scaldaferri, Franco, additional, Bossa, Fabrizio, additional, Renna, Sara, additional, Cappello, Maria, additional, Alibrandi, Angela, additional, Orlando, Ambrogio, additional, Armuzzi, Alessandro, additional, and Fries, Walter, additional
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- 2021
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23. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial
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Sarbagili Shabat, Chen, primary, Scaldaferri, Franco, additional, Zittan, Eran, additional, Hirsch, Ayal, additional, Mentella, Maria Chiara, additional, Musca, Tania, additional, Cohen, Nathaniel Aviv, additional, Ron, Yulia, additional, Fliss Isakov, Naomi, additional, Pfeffer, Jorge, additional, Yaakov, Michal, additional, Fanali, Caterina, additional, Turchini, Laura, additional, Masucci, Luca, additional, Quaranta, Gianluca, additional, Kolonimos, Nitzan, additional, Godneva, Anastasia, additional, Weinberger, Adina, additional, Kopylov, Uri, additional, Levine, Arie, additional, and Maharshak, Nitsan, additional
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- 2021
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24. The educational role of IBD nurses in Italy in vaccinations: do not miss the moment for COVID-19
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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
25. One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy
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Chiappetta, M. F., Viola, A., Mastronardi, M., Turchini, Laura, Carparelli, S., Orlando, Antonio, Biscaglia, G., Miranda, A., Guida, L., Costantino, Angela Giusy, Scaldaferri, Franco, Bossa, F., Renna, S., Cappello, M., Alibrandi, A., Armuzzi, Alessandro, Fries, W., Turchini L., Orlando A., Costantino G., Scaldaferri F. (ORCID:0000-0001-8334-7541), Armuzzi A. (ORCID:0000-0003-1572-0118), Chiappetta, M. F., Viola, A., Mastronardi, M., Turchini, Laura, Carparelli, S., Orlando, Antonio, Biscaglia, G., Miranda, A., Guida, L., Costantino, Angela Giusy, Scaldaferri, Franco, Bossa, F., Renna, S., Cappello, M., Alibrandi, A., Armuzzi, Alessandro, Fries, W., Turchini L., Orlando A., Costantino G., Scaldaferri F. (ORCID:0000-0001-8334-7541), and Armuzzi A. (ORCID:0000-0003-1572-0118)
- Abstract
Background: Efficacy and safety of ustekinumab for the treatment of ulcerative colitis (UC) has been demonstrated in clinical trials, but few real-world data are available so far. The aim of this study was to assess effectiveness and safety of ustekinumab in a cohort of refractory UC patients. Methods: Data of patients with moderate to severe UC treated with ustekinumab were retrospectively collected. Primary endpoint was steroid-free clinical remission at weeks 24 and 52 of therapy. Secondary endpoints were treatment response, endoscopic remission, treatment persistence at 12 months and safety. Results: A total of 68 patients [males 63%; median (range) age 42 (16–72) years] were included. Almost all patients (97%) were biologics experienced. At weeks 24 and 52, 31% and 50% of patients achieved steroid-free clinical remission, 84% and 82% had clinical response, respectively. At the end of follow-up, there was a significant reduction of pMS from baseline (p < 0.001) and of steroid use (p < 0.001). At week 52, 22% of the available endoscopies (18/38) showed mucosal healing. The probability to persist in therapy at week 52 was 87%. Only one adverse event occurred. Conclusions: Data from our real-life cohort of refractory UC patients suggest satisfactory effectiveness and a good safety of ustekinumab.
- Published
- 2021
26. The gut–brain axis in irritable bowel syndrome and inflammatory bowel disease
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Ancona, A., Petito, C., Iavarone, I., Petito, Valentina, Galasso, Linda, Leonetti, A., Turchini, Laura, Belella, D., Ferrarrese, D., Addolorato, Giovanni, Armuzzi, Alessandro, Gasbarrini, Antonio, Scaldaferri, Franco, Petito V., Galasso L., Turchini L., Addolorato G. (ORCID:0000-0002-1522-9946), Armuzzi A. (ORCID:0000-0003-1572-0118), Gasbarrini A. (ORCID:0000-0002-7278-4823), Scaldaferri F. (ORCID:0000-0001-8334-7541), Ancona, A., Petito, C., Iavarone, I., Petito, Valentina, Galasso, Linda, Leonetti, A., Turchini, Laura, Belella, D., Ferrarrese, D., Addolorato, Giovanni, Armuzzi, Alessandro, Gasbarrini, Antonio, Scaldaferri, Franco, Petito V., Galasso L., Turchini L., Addolorato G. (ORCID:0000-0002-1522-9946), Armuzzi A. (ORCID:0000-0003-1572-0118), Gasbarrini A. (ORCID:0000-0002-7278-4823), and Scaldaferri F. (ORCID:0000-0001-8334-7541)
- Abstract
Research increasingly demonstrates the bidirectional communication between gut microbiota and the brain, enhancing the role of gut microbiota modulation in the treatment of central nervous system (CNS) disorders. The first five years of life are extremely important as it affects the development of gut microbiota, immune system and, consequently, the onset of psychometric alterations, particularly in genetically predisposed individuals. In this review, we focus on the link between specific microbial genera, gastrointestinal (GI) disorders, anxiety and depression and on the effects of different therapeutic strategies for mood disorders on gut microbiota.
- Published
- 2021
27. 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
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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
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- 2020
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28. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial.
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Shabat, Chen Sarbagili, Scaldaferri, Franco, Zittan, Eran, Hirsch, Ayal, Mentella, Maria Chiara, Musca, Tania, Cohen, Nathaniel Aviv, Ron, Yulia, Isakov, Naomi Fliss, Pfeffer, Jorge, Yaakov, Michal, Fanali, Caterina, Turchini, Laura, Masucci, Luca, Quaranta, Gianluca, Kolonimos, Nitzan, Godneva, Anastasia, Weinberger, Adina, Kopylov, Uri, and Levine, Arie
- Abstract
Background We evaluated whether integration of novel diets for donors and patients, in addition to faecal transplantation [FT], could increase FT remission rate in refractory ulcerative colitis [UC]. Methods This was a blinded, randomised, controlled trial in adults with active UC, defined by a simple clinical colitis activity index [SCCAI] of ≥5 and ≤11 and endoscopic Mayo score 2–3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on Day 1and rectal enemas on Days 2 and 14 without dietary conditioning of the donor. Group 2 received FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet [UCED] for the patients. Group 3 received the UCED alone. The primary endpoint was Week 8 clinical steroid-free remission, defined as SCCAI <3. Results Of 96 planned patients, 62 were enrolled. Remission Week 8 Group 1 was 2/17 [11.8%], Group 2 was 4/19 [21.1%], Group 3 was 6/15 [40%] [non-significant]. Endoscopic remission Group 1 was 2/17 [12%], Group 2 was 3/19 [16%], Group 3 was 4/15 [27%] [Group 1 vs 3 p = 0.38]. Mucosal healing [Mayo 0] was achieved only in Group 3 [3/15, 20%] vs 0/36 FT patients [ p = 0.022]. Exacerbation of disease occurred in 3/17 [17.6%] of Group 1, 4/19 [21.1%] of Group 2, and 1/15 [6.7%] of Group 3 [Group 2 vs 3, p = 0.35]. Conclusions UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board. [ABSTRACT FROM AUTHOR]
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- 2022
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29. The awareness of the IBD nurse position among patients from an Italian tertiary IBD centre
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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
30. 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
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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
31. Characterization of Sarcopenia in an IBD Population Attending an Italian Gastroenterology Tertiary Center
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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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32. Characterization of Sarcopenia in an IBD Population Attending an Italian Gastroenterology Tertiary Center
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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
33. Nursing‐sensitive outcomes in adult inflammatory bowel disease: A systematic review.
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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]
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- 2021
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34. Gut Microbiota Signatures Are Associated With Psychopathological Profiles in Patients With Ulcerative Colitis: Results From an Italian Tertiary IBD Center.
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Scaldaferri F, D'Onofrio AM, Calia R, Di Vincenzo F, Ferrajoli GF, Petito V, Maggio E, Pafundi PC, Napolitano D, Masi L, Schiavoni E, Fanali C, Puca P, Turchini L, Lopetuso LR, Del Chierico F, Putignani L, Gasbarrini A, and Camardese AG
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- Humans, Longitudinal Studies, Prospective Studies, Quality of Life, Bacteria, Colitis, Ulcerative pathology, Gastrointestinal Microbiome, Depressive Disorder, Major complications
- Abstract
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 bacteria (Enterobacteriaceae, Streptococcus, Veillonella, Klebsiella, and Clostridiaceae) as potential markers of an altered gut-brain axis in these patients., (© 2023 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)
- Published
- 2023
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35. 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
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Tursi A, Mocci G, Allegretta L, Aragona G, Bianco MA, Colucci R, Cuomo A, Della Valle N, Ferronato A, Forti G, Gaiani F, Giorgetti G, Graziani MG, Lofano K, Lorenzetti R, Larussa T, Penna A, Pica R, Pranzo G, Rodino' S, Scarcelli A, Zampaletta C, Bassotti G, Cazzato AI, Chiri S, Clemente V, Cocco A, De' Angelis G, Donnarumma L, Faggiani R, Graziosi C, Le Grazie M, Luzza F, Meucci C, Monterubbianesi R, Pagnini C, Perazzo P, Picchio M, Sacco R, Sebkova L, Serio M, Napolitano D, Pugliese D, Scaldaferri F, Schiavoni E, Turchini L, Armuzzi A, Elisei W, Maconi G, and Papa A
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- Humans, Adalimumab therapeutic use, Retrospective Studies, Treatment Outcome, Biosimilar Pharmaceuticals therapeutic use, Inflammatory Bowel Diseases drug therapy, Colitis, Ulcerative drug therapy, Crohn Disease drug therapy
- 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, ABP501, 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., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2023
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36. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial.
- Author
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Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, and Maharshak N
- Subjects
- Adult, Colonoscopy, Diet, Humans, Remission Induction, Colitis, Ulcerative drug therapy, Colitis, Ulcerative surgery, Fecal Microbiota Transplantation adverse effects
- Abstract
Background: We evaluated whether integration of novel diets for donors and patients, in addition to faecal transplantation [FT], could increase FT remission rate in refractory ulcerative colitis [UC]., Methods: This was a blinded, randomised, controlled trial in adults with active UC, defined by a simple clinical colitis activity index [SCCAI] of ≥5 and ≤11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on Day 1and rectal enemas on Days 2 and 14 without dietary conditioning of the donor. Group 2 received FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet [UCED] for the patients. Group 3 received the UCED alone. The primary endpoint was Week 8 clinical steroid-free remission, defined as SCCAI <3., Results: Of 96 planned patients, 62 were enrolled. Remission Week 8 Group 1 was 2/17 [11.8%], Group 2 was 4/19 [21.1%], Group 3 was 6/15 [40%] [non-significant]. Endoscopic remission Group 1 was 2/17 [12%], Group 2 was 3/19 [16%], Group 3 was 4/15 [27%] [Group 1 vs 3 p = 0.38]. Mucosal healing [Mayo 0] was achieved only in Group 3 [3/15, 20%] vs 0/36 FT patients [p = 0.022]. Exacerbation of disease occurred in 3/17 [17.6%] of Group 1, 4/19 [21.1%] of Group 2, and 1/15 [6.7%] of Group 3 [Group 2 vs 3, p = 0.35]., Conclusions: UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board., (© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)
- Published
- 2022
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37. 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
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Tursi A, Mocci G, Allegretta L, Aragona G, Bianco MA, Colucci R, Cuomo A, Della Valle N, Ferronato A, Forti G, Gaiani F, Graziani MG, Lorenzetti R, Luzza F, Paese P, Penna A, Pica R, Pranzo G, Rodinò S, Scarcelli A, Zampaletta C, Brozzi L, Cicerone C, Cocco A, De' Angelis G, Donnarumma L, Fiorella S, Iannelli C, Larussa T, Le Grazie M, Luppino I, Meucci C, FaggianI R, Pagnini C, Perazzo P, Rodriguez-Castro KI, Sacco R, Sebkova L, Serio M, De Monti A, Picchio M, Napolitano D, Schiavoni E, Turchini L, Scaldaferri F, Pugliese D, Guidi L, Laterza L, Privitera G, Pizzoferrato M, Lopetuso LR, Armuzzi A, Elisei W, Maconi G, and Papa A
- Subjects
- Antibodies, Monoclonal, Gastrointestinal Agents adverse effects, Humans, Infliximab therapeutic use, Italy, Prospective Studies, Retrospective Studies, Treatment Outcome, Biosimilar Pharmaceuticals adverse effects, Colitis, Ulcerative drug therapy, Inflammatory Bowel Diseases drug therapy
- Abstract
Background: To 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 Methods: Three 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., Results: 197 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)., Conclusion: This first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.
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- 2022
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38. The awareness of the IBD nurse position among patients from an Italian tertiary IBD centre.
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Napolitano D, Martella P, Schiavoni E, Turchini L, Amatucci V, Armuzzi A, Cocchieri A, Zega M, Scaldaferri F, and Gasbarrini A
- Subjects
- Humans, Italy, Nurse's Role, Surveys and Questionnaires, Inflammatory Bowel Diseases, Quality of Life
- Abstract
Background: Inflammatory Bowel Disease (IBD) is a chronic condition characterized by acute relapses which have an important impact on the quality of life of patients, both physically and psychologically. In the personalized care of IBD patients, a key role is covered by the IBD nurse, who provides psychological and educational support, as well as a source of contact for all patients., Aim: Aim of the present study was to assess the perception of IBD patients about roles, competences and abilities of the IBD nurses in a specialized center. This is the base for further programs aiming to improve quality of care., Methods: A questionnaire composed of 15 statements regarding the role of the IBD nurse in their treatment was offered to all patients attending this IBD center over a 3-month period. Results were showed comparing those of patients currently receiving treatment with a biologic therapy to those receiving non-biologic therapy., Results: Patients in this center have a poor awareness of the IBD nurse role, particularly those not receiving biologic treatment. Although most patients are aware that they can use the IBD nurse as a point of contact, the majority are not aware of the qualifications of the IBD nurse to discuss their treatment options and provide psychological support., Conclusion: Our survey shows that the figure of the IBD nurse is still poorly recognised by patients, with a likely resultant underutilisation of the services of a highly skilled and educated professional. Several key issues for improvement for the IBD nurse service have been raised by this study and warrant similar investigation in other centres.
- Published
- 2020
- Full Text
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