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1. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial

Author

Rocca, Rodolfo, Lopes, Susana, Caprioli, Flavio, Ardizzone, Sandro, Echarri Piudo, Ana, Gionchetti, Paolo, Roblin, Xavier, Seidler, Ursula, Andersson, David, Patel, Kamal, Desreumaux, Pierre, Saibeni, Simone, From, Gustav, Fedurco, Miroslav, Gregus, Milos, Bouhnik, Yoram, Luegering, Andreas, Cosintino, Rocco, Bunganic, Ivan, Ramos, Jaime, Aguas Peris, Mariam, Dewit, Olivier, Principi, Mariabeatrice, Wesley, Emma, Lago, Paula, Nancey, Stephane, Martín Arranz, María Dolores, Hindryckx, Pieter, Orlando, Ambrogio, Geccherle, Andrea, Annunziata, Maria Laura, Hayee, Bu'hussain, Balaz, Jozef, Portela, Francisco, Gilletta, Cyrielle, Kucharzik, Torsten, Mínguez, Miguel, Gisbert, Javier Pérez, Casbas, Ana Gutiérrez, Louis, Edouard, Marino, Marco, Parkes, Gareth, Cummings, Fraser, Jharap, Bindia, Kjeldsen, Jens, Correia, Luís, Ministro, Paula, Ebert, Matthias, Hertervig, Erik, Staessen, Dirk, Dutré, Joris, Colard, Arnaud, Morrison, Graham, Glerup, Henning, Dahlerup, Jens Frederik, Wolfhagen, Frank, Batovsky, Marian, Molnar, Martin, Kadleckova, Barbora, Caldeira, Paulo, Laharie, David, Hebuterne, Xavier, Bonaz, Bruno, Allez, Matthieu, Fischer, Andreas, Hinojosa Del Val, Joaquín Ernesto, Ciria, Miriam Mañosa, Herrera Justiniano, Jose Manuel, Soderman, Charlotte, Chandy, Rajiv, Mowat, Craig, Irving, Peter, Fallingborg, Jan, Matous, Jan, Douda, Tomas, Altwegg, Romain, Benitez, Jose Manuel, Arroyo Villarino, María Teresa, Capón, Jordi Guardiola, Vicenc, Daniel Ginard, Dewint, Pieter, Almer, Sven, Kindt, Sebastien, Danese, Silvio, Vermeire, Severine, D'Haens, Geert, Panés, Julian, Dignass, Axel, Magro, Fernando, Nazar, Maciej, Le Bars, Manuela, Lahaye, Marjolein, Ni, Lioudmila, Bravata, Ivana, Lavie, Frederic, Daperno, Marco, Lukáš, Milan, Armuzzi, Alessandro, Löwenberg, Mark, Gaya, Daniel R, and Peyrin-Biroulet, Laurent

Published
2022
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2. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Aguilar, Humberto, Ahmad, Tariq, Akriviadis, Evangelos, Aldeguer Mante, Xavier, Allez, Matthieu, Altorjay, Istvan, Ananthakrishnan, Ashwin, Andersen, Vibeke, Andreu Garcia, Montserrat, Armuzzi, Alessandro, Aumais, Guy, Avni-Biron, Irit, Axler, Jeffrey, Ayub, Kamran, Jr., Baert, Filip, Bafutto, Mauro, Bamias, George, Bassan, Isaac, Baum, Curtis, Beaugerie, Laurent, Behm, Brian, Bekal, Pradeep, Bennett, Michael, Bermejo San Jose, Fernando, Bernstein, Charles, Bettenworth, Dominik, Bhaskar, Sudhir, Biancone, Livia, Bilir, Bahri, Blaeker, Michael, Bloom, Stuart, Bohman, Verle, Jr., Bosques Padilla, Francisco Javier, Bossuyt, Peter, Bouhnik, Yoram, Bouma, Gerd, Bourdages, Raymond, Brand, Stephan, Bressler, Brian, Brückner, Markus, Buening, Carsten, Carbonnel, Franck, Caves, Thomas, Chapman, Jonathon, Cheon, Jae Hee, Chiba, Naoki, Chioncel, Camelia, Christodoulou, Dimitrios, Clodi, Martin, Cohen, Albert, Corazza, Gino Roberto, Corlin, Richard, Cosintino, Rocco, Cummings, Fraser, Dalal, Robin, Danese, Silvio, De Maeyer, Marc, De Magalhães Francesconi, Carlos Fernando, De Silva, Aminda, Debinski, Henry, Desreumaux, Pierre, Dewit, Olivier, D'Haens, Geert, Di Felice Boratto, Sandra, Ding, John Nik, Dixon, Tyler, Dryden, Gerald, Jr., Du Vall, George Aaron, Ebert, Matthias, Echarri Piudo, Ana, Ehehalt, Robert, Elkhashab, Magdy, Ennis, Craig, Etzel, Jason, Fallingborg, Jan, Feagan, Brian, Fejes, Roland, Ferraz de Campos Mazo, Daniel, Ferreira de Almeida Borges, Valéria, Fischer, Andreas, Fixelle, Alan, Fleisher, Mark, Fowler, Sharyle, Freilich, Bradley, Friedenberg, Keith, Fries, Walter, Fulop, Csaba, Fumery, Mathurin, Fuster, Sergio, G Kiss, Gyula, Garcia Lopez, Santiago, Gassner, Sonja, Gill, Kanwar, Gilletta de Saint Joseph, Cyrielle, Ginsburg, Philip, Gionchetti, Paolo, Goldin, Eran, Goldis, Adrian-Eugen, Gomez Jaramillo, Hector Alejandro, Gonciarz, Maciej, Gordon, Glenn, Green, Daniel, Grimaud, Jean-Charles, Guajardo Rodriguez, Rogelio, Gurzo, Zoltan, Gutierrez, Alexandra, Gyökeres, Tibor, Hahm, Ki Baik, Hanauer, Stephen, Hanson, John, Harlan III, William, Hasselblatt, Peter, Hayee, Buhussain, Hebuterne, Xavier, Hendy, Peter, Heyman, Melvin, Higgins, Peter, Hilal, Raouf, Hindryckx, Pieter, Hoentjen, Frank, Hoffmann, Peter, Holtkamp-Endemann, Frank, Holtmann, Gerald, Horvat, Gyula, Howaldt, Stefanie, Huber, Samuel, Ibegbu, Ikechukwu, Iborra Colomino, Maria Isabel, Irving, Peter, Isaacs, Kim, Jagarlamudi, Kiran, Jain, Rajesh, Jankiel Miszputen, Sender, Jansen, Jeroen, Jones, Jennifer, Juillerat, Pascal, Karagiannis, John, Karyotakis, Nicholas, Kaser, Arthur, Katz, Lior, Katz, Seymour, Katz, Leo, Kaur, Nirmal, Kazenaite, Edita, Khanna, Reena, Khurana, Sunil, Kim, Joo Sung, Kim, Young-Ho, Kim, Sung Kook, Kim, Dongwoo, Klaus, Jochen, Kleczkowski, Dariusz, Kohout, Pavel, Korczowski, Bartosz, Kouklakis, Georgios, Koutroubakis, Ioannis, Krause, Richard, Kristof, Tunde, Kronborg, Ian, Krummenerl, Annette, Kupcinskas, Limas, Laborda Molteni, Jorge, Laharie, David, Lahat-zok, Adi, Lee, Jonghun, Lee, Kang-Moon, Leong, Rupert, Levine, Henry, Limdi, Jimmy, Lindsay, James, Lodhia, Nilesh, Loftus, Edward, Longman, Randy, Lopez Serrano, Pilar, Louis, Edouard, Louzada Pereira, Maria Helena, Lowe, John, Lueth, Stefan, Lukas, Milan, Maconi, Giovanni, Macrae, Finlay, Madi-Szabo, Laszlo, Mahadevan-Velayos, Uma, Malluta, Everson Fernando, Mana, Fazia, Mannon, Peter, Mantzaris, Gerasimos, Marin Jimenez, Ignacio, Martin Arranz, Maria Dolores, Mateescu, Radu-Bogdan, Mazzoleni, Felipe, Meder, Agnieszka, Melzer, Ehud, Mertens, Jessica, Mimidis, Konstantinos, Mitchell, Brent, Molnar, Tamas, Moore, Gregory, Morales Garza, Luis Alonso, Mountifield, Reme, Muls, Vinciane, Murray, Charles, Nagy, Bela, Neurath, Markus, Nguyen, Augustin, Panaccione, Remo, Pandak, William, Panes Diaz, Julian, Park, Jihye, Pastorelli, Luca, Patel, Bhaktasharan, Peck-Radosavljevic, Markus, Pecsi, Gyula, Peerani, Farhad, Perez Gisbert, Javier, Pesta, Martin, Petryka, Robert, Peyrin-Biroulet, Laurent, Phillips, Raymond, Pierik, Marieke, Pratha, Vijayalakshmi, Prochazka, Vlastimil, Racz, Istvan, Radford-Smith, Graham, Ramos Castañeda, Daniel, Ramos Júnior, Odery, Regula, Jaroslaw, Reimund, Jean-Marie, Robbins, Bryan, Roblin, Xavier, Rogai, Francesca, Rogler, Gerhard, Rozciecha, Jerzy, Rubin, David, Ruiz Flores, Azalia Yuriria, Rupinski, Maciej, Rydzewska, Grazyna, Saha, Sumona, Saibeni, Simone, Salamon, Agnes, Sallo, Zoltan, Salzberg, Bruce, Samuel, Douglas, Samuel, Sunil, Sandborn, William, Savarino, Edoardo Vincenzo, Schirbel, Anja, Schnabel, Robert, Schreiber, Stefan, Scott, John, Sedghi, Shahriar, Seibold, Frank, Seidelin, Jakob, Seidler, Ursula, Shaban, Ahmad, Shafran, Ira, Sheikh, Aasim, Sherman, Alex, Shirin, Haim, Smolinski, Patryk, Song, Geun Am, Soufleris, Konstantinos, Speight, Alexander, Staessen, Dirk, Stallmach, Andreas, Staun, Michael, Stein, Daniel, Steinhart, Hillary, Stifft, Jonathas, Stokesberry, David, Sturm, Andreas, Sultan, Keith, Szekely, Gyorgy, Tagore, Kuldeep, Tanno, Hugo, Thin, Lena, Thiwan, Syed, Thomas, Carlton, Tichy, Michal, Toth, Gabor Tamas, Tulassay, Zsolt, Ulbrych, Jan, Valentine, John, Varga, Marta, Vasconcellos, Eduardo, Vaughn, Byron, Velasco, Brenda, Velazquez, Francisco, Vermeire, Severine, Villa, Erica, Vincze, Aron, Vogelsang, Harald, Volfova, Miroslava, Vuitton, Lucine, Vyhnalek, Petr, Wahab, Peter, Walldorf, Jens, Waterman, Mattitiahu, Weber, John, Weiss, L. Michael, Wiechowska-Kozlowska, Anna, Wiesner, Elise, Witthoeft, Thomas, Wohlman, Robert, Wozniak-Stolarska, Barbara, Yacyshyn, Bruce, Ye, Byong-Duk, Younes, Ziad, Yukie Sassaki, Lígia, Zaltman, Cyrla, Zeuzem, Stefan, Hart, Ailsa, Long, Millie, Loftus, Edward V, Jr, Ostad-Saffari, Elham, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Pulley, Jennifer, Lacey, Stuart, and Sandborn, William J

Published
2022
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3. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study

Author

Aboo, Nazimuddin, Ahmad, Tariq, Aldeguer Mante, Xavier, Allez, Matthieu, Almer, Sven, Altwegg, Romain, Andreu Garcia, Montserrat, Arasaradnam, Ramesh, Ardizzone, Sandro, Armuzzi, Alessandro, Arnott, Ian, Aumais, Guy, Avni-Biron, Irit, Barrow, Peter, Beales, Ian, Bermejo San Jose, Fernando, Bezuidenhout, Abraham, Biancone, Livia, Blaeker, Michael, Bloom, Stuart, Bokemeyer, Bernd, Bossa, Fabrizio, Bossuyt, Peter, Bouguen, Guillaume, Bouhnik, Yoram, Bouma, Gerd, Bourdages, Raymond, Bourreille, Arnaud, Boustiere, Christian, Brabec, Tomas, Brand, Stephan, Buening, Carsten, Buisson, Anthony, Cadiot, Guillaume, Calvet Calvo, Xavier, Carbonnel, Franck, Carpio, Daniel, Cheon, Jae Hee, Chiba, Naoki, Chioncel, Camelia, Cimpoeru, Nicoleta-Claudia, Clodi, Martin, Corazza, Gino Roberto, Cosintino, Rocco, Cotter, Jose, Creed, Thomas, Cummings, Fraser, Danese, Silvio, de' Angelis, Gian Luigi, De Maeyer, Marc, Desai, Milind, Desilets, Etienne, Desreumaux, Pierre, Dewit, Olivier, D'Haens, Geert, Dinter, Johanna, Dobru, Ecaterina Daniela, Douda, Tomas, Dumitrascu, Dan Lucian, Ebert, Matthias, Echarri Piudo, Ana, Elkhashab, Magdy, Eun, Chang Soo, Feagan, Brian, Fejes, Roland, Fidalgo, Catarina, Fishman, Sigal, Flourié, Bernard, Fowler, Sharyle, Fries, Walter, Fulop, Csaba, Fumery, Mathurin, G Kiss, Gyula, Gassner, Sonja, Gaya, Daniel, Germanà, Bastianello, Gheorghe, Liliana Simona, Gilletta de Saint Joseph, Cyrielle, Gionchetti, Paolo, Goldis, Adrian-Eugen, Gonçalves, Raquel, Grimaud, Jean-Charles, Gyökeres, Tibor, Hagege, Herve, Haidar, Andrei, Hartmann, Heinz, Hasselblatt, Peter, Hayee, Buhussain, Hebuterne, Xavier, Hellström, Per, Hindryckx, Pieter, Hlavova, Helena, Hoentjen, Frank, Howaldt, Stefanie, Hrdlicka, Ludek, Huh, Kyu Chan, Iborra Colomino, Maria Isabel, Ionita-Radu, Florentina, Irving, Peter, Jahnsen, Jørgen, Jang, ByungIk, Jansen, Jeroen, Jeon, Seong Woo, Jover Martinez, Rodrigo, Juillerat, Pascal, Karlén, Per, Kaser, Arthur, Keil, Radan, Kejariwal, Deepak, Keret, Dan, Khanna, Reena, Kim, Dongwoo, Kim, Duk Hwan, Kim, Hyo-Jong, Kim, Hyun-Soo, Kim, Joo Sung, Kim, Kueongok, Kim, Kyung-Jo, Kim, Sung Kook, Kim, Young-Ho, Klaus, Jochen, Kohn, Anna, Kojecky, Vladimir, Koo, Ja Seol, Kozak, Robert, Kremer, Milan, Kristof, Tunde, Kruger, Frederik, Laharie, David, Lahat-zok, Adi, Landa, Evgeny, Lee, Jonghun, Lee, Kang-Moon, Lee, Kook Lae, Lee, YooJin, Lenze, Frank, Lim, Wee Chian, Limdi, Jimmy, Lindsay, James, Lopez Serrano, Pilar, Louis, Edouard, Lueth, Stefan, Lukas, Milan, Maconi, Giovanni, Mana, Fazia, Mann, Steven, Mansfield, John, Marchi, Santino, Marino, Marco, Marshall, John, Martin Arranz, Maria Dolores, Mateescu, Radu-Bogdan, McLaughlin, John, McLaughlin, Simon, Melzer, Ehud, Mertens, Jessica, Mitrut, Paul, Molnar, Tamas, Muls, Vinciane, Munuswamy, Pushpakaran, Murray, Charles, Naftali, Timna, Naidoo, Visvakuren, Nanabhay, Yusuf, Negreanu, Lucian, Nguyen, Augustin, Ochsenkuehn, Thomas, Orlando, Ambrogio, Panaccione, Remo, Panes Diaz, Julian, Paritsky, Maya, Park, Dong Il, Park, Jihye, Pastorelli, Luca, Peck-Radosavljevic, Markus, Peerani, Farhad, Perez Gisbert, Javier, Peyrin-Biroulet, Laurent, Picon, Laurence, Pierik, Marieke, Ponich, Terry, Portela, Francisco, Prins, Maartens Jeroen, Racz, Istvan, Rahman, Khan Fareed, Reimund, Jean-Marie, Reinshagen, Max, Roblin, Xavier, Rocca, Rodolfo, Rogai, Francesca, Rogler, Gerhard, Salamon, Agnes, Salazar, Ennaliza, Sallo, Zoltan, Samuel, Sunil, Sans Cuffi, Miquel de los Santos, Savarino, Edoardo Vincenzo, Savarino, Vincenzo, Savoye, Guillaume, Schreiber, Stefan, Seicean, Andrada, Selinger, Christian, Serra, David Martins, Shim, Hang Hock, Shin, SungJae, Siegmund, Britta, Siffledeen, Jesse, Simmonds, Wayne, Smid, Jan, Sollano, Jose, Song, Geun Am, Speight, Alexander, Sporea, Ioan, Staessen, Dirk, Stancu, George, Steel, Alan, Stepek, David, Stoica, Victor, Sturm, Andreas, Szekely, Gyorgy, Tan, Teck Kiang, Taxonera Samso, Carlos, Thomson, John, Tichy, Michal, Toth, Gabor Tamas, Tulassay, Zsolt, Vangeli, Marcello, Varga, Marta, Vieira, Ana, Viennot, Stephanie, Villa, Erica, Vitek, Petr, Vogelsang, Harald, Vyhnalek, Petr, Wahab, Peter, Walldorf, Jens, Ye, Byong Duk, Ziady, Christopher, Colombel, Jean-Frederic, Gisbert, Javier P, Hayee, Bu'hussain, Reinisch, Walter, Tyrrell, Helen, Oh, Young S, Tole, Swati, Chai, Akiko, Chamberlain-James, Kirsten, and Tang, Meina Tao

Published
2022
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4. Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Author

Leone, Salvatore, Previtali, Enrica, Aloi, Marina, Alvisi, Patrizia, Antonelli, Elisabetta, Ardizzone, Sandro, Astegiano, Marco, Baldoni, Monia, Beltrami, Marina, Biancone, Livia, Bodini, Giorgia, Buda, Andrea, Bossa, Fabrizio, Bracci, Fiammetta, Calabrese, Emma, Cappello, Maria, Castiglione, Fabiana, Ciacci, Carolina, Cicala, Michele, Ciccocioppo, Rachele, Comberlato, Michele, Cortelezzi, Claudio Camillo, Cosintino, Rocco, Costa, Francesco, Costantino, Giuseppe, Cucchiara, Salvatore, Cuomo, Antonio, D’Incà, Renata, Di Paolo, Maria Carla, Di Sabatino, Antonio, Di Sario, Antonio, Frieri, Giuseppe, Fries, Walter, Gasbarrini, Antonio, Geccherle, Andrea, Gionchetti, Paolo, Graziani, Maria Giovanna, Grossi, Laurino, Guidi, Luisa, Imperiali, Gianni, Latella, Giovanni, Lionetti, Paolo, Inserra, Gaetano, Maconi, Giovanni, Manguso, Francesco, Marino, Marco, Mastronardi, Mauro, Mazzuoli, Silvia, Meucci, Gianmichele, Mendolaro, Marco, Milla, Monica, Mocci, Giammarco, Monteleone, Giovanni, Bortoluzzi, Francesco Neri, Pagnini, Cristiano, Pastorelli, Luca, Pica, Roberta, Piergallini, Simona, Privitera, Antonello, Renna, Sara, Ribaldone, Davide Giuseppe, Ricci, Chiara, Rispo, Antonio, Rocca, Rodolfo, Romano, Claudio, Romano, Marco, Russo, Giovanni, Sablich, Renato, Saibeni, Simone, Savarino, Edoardo, Scribano, Maria Lia, Spagnuolo, Rocco, Stasi, Elisa, Terpin, Maria Maddalena, Testa, Anna, Valpiani, Daniela, Variola, Angela, Vernia, Piero, Vitale, Giovanna, Zoli, Giorgio, Fiorino, Gionata, Caprioli, Flavio, Daperno, Marco, Mocciaro, Filippo, Principi, Mariabeatrice, Viscido, Angelo, Fantini, Massimo Claudio, Orlando, Ambrogio, Papi, Claudio, Annese, Vito, Danese, Silvio, Vecchi, Maurizio, Rizzello, Fernando, and Armuzzi, Alessandro

Published
2019
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8. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST):an open-label, multicentre, randomised phase 3b trial

Author

Danese, Silvio, Vermeire, Severine, D'Haens, Geert, Panés, Julian, Dignass, Axel, Magro, Fernando, Nazar, Maciej, Le Bars, Manuela, Lahaye, Marjolein, Ni, Lioudmila, Bravata, Ivana, Lavie, Frederic, Daperno, Marco, Lukáš, Milan, Armuzzi, Alessandro, Löwenberg, Mark, Gaya, Daniel R., Peyrin-Biroulet, Laurent, Rocca, Rodolfo, Lopes, Susana, Caprioli, Flavio, Ardizzone, Sandro, Echarri Piudo, Ana, Gionchetti, Paolo, Roblin, Xavier, Seidler, Ursula, Andersson, David, Patel, Kamal, Desreumaux, Pierre, Saibeni, Simone, From, Gustav, Fedurco, Miroslav, Gregus, Milos, Bouhnik, Yoram, Luegering, Andreas, Cosintino, Rocco, Bunganic, Ivan, Ramos, Jaime, Aguas Peris, Mariam, Dewit, Olivier, Principi, Mariabeatrice, Wesley, Emma, Lago, Paula, Nancey, Stephane, Martín Arranz, María Dolores, Hindryckx, Pieter, Orlando, Ambrogio, Geccherle, Andrea, Annunziata, Maria Laura, Danese, Silvio, Vermeire, Severine, D'Haens, Geert, Panés, Julian, Dignass, Axel, Magro, Fernando, Nazar, Maciej, Le Bars, Manuela, Lahaye, Marjolein, Ni, Lioudmila, Bravata, Ivana, Lavie, Frederic, Daperno, Marco, Lukáš, Milan, Armuzzi, Alessandro, Löwenberg, Mark, Gaya, Daniel R., Peyrin-Biroulet, Laurent, Rocca, Rodolfo, Lopes, Susana, Caprioli, Flavio, Ardizzone, Sandro, Echarri Piudo, Ana, Gionchetti, Paolo, Roblin, Xavier, Seidler, Ursula, Andersson, David, Patel, Kamal, Desreumaux, Pierre, Saibeni, Simone, From, Gustav, Fedurco, Miroslav, Gregus, Milos, Bouhnik, Yoram, Luegering, Andreas, Cosintino, Rocco, Bunganic, Ivan, Ramos, Jaime, Aguas Peris, Mariam, Dewit, Olivier, Principi, Mariabeatrice, Wesley, Emma, Lago, Paula, Nancey, Stephane, Martín Arranz, María Dolores, Hindryckx, Pieter, Orlando, Ambrogio, Geccherle, Andrea, and Annunziata, Maria Laura

Abstract

Background: A treat-to-target strategy, in which strictly defined treatment targets facilitate decision making in clinical practice, is advocated as an optimised management approach for some chronic disorders. The aim of the STARDUST trial was to assess whether a treat-to-target strategy with early endoscopy, regular biomarker and clinical symptom monitoring, and dose intensification for persistent inflammatory activity, was more successful in achieving endoscopic improvement at week 48 than a clinically driven maintenance strategy in patients with moderate-to-severe active Crohn's disease receiving ustekinumab. Methods: This open-label, multicentre, randomised phase 3b trial included adults with active, moderate-to-severe Crohn's disease (Crohn's Disease Activity Index [CDAI] 220–450 and Simple Endoscopic Score in Crohn's Disease [SES-CD] ≥3) for whom conventional therapy or one biologic therapy, or both, had failed. Patients received intravenous ustekinumab approximating 6 mg/kg at baseline and subcutaneous ustekinumab 90 mg at week 8. At week 16, patients with a CDAI improvement of 70 or more points from baseline were randomly assigned (1:1) to receive standard-of-care or treat-to-target maintenance treatment through week 48. Randomisation was balanced by using randomly permuted blocks and was stratified by biologic history status and baseline SES-CD score. All patients who signed informed consent, who were not screening failures, and who received at least one dose of study treatment were included in week 16 analyses. All patients included in week 16 analyses and randomly assigned to one of the maintenance treatment regimens were included in the week 48 efficacy and safety analyses (ie, on an intention-to-treat basis). Patients assigned to the treat-to-target arm received ustekinumab every 12 weeks or every 8 weeks based on SES-CD improvement from baseline and could escalate to every 4 weeks through week 48 if prespecified targets were missed. Patients assigne

Published
2022

9. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial

Author

Danese, Silvio, primary, Vermeire, Severine, additional, D'Haens, Geert, additional, Panés, Julian, additional, Dignass, Axel, additional, Magro, Fernando, additional, Nazar, Maciej, additional, Le Bars, Manuela, additional, Lahaye, Marjolein, additional, Ni, Lioudmila, additional, Bravata, Ivana, additional, Lavie, Frederic, additional, Daperno, Marco, additional, Lukáš, Milan, additional, Armuzzi, Alessandro, additional, Löwenberg, Mark, additional, Gaya, Daniel R, additional, Peyrin-Biroulet, Laurent, additional, Rocca, Rodolfo, additional, Lopes, Susana, additional, Caprioli, Flavio, additional, Ardizzone, Sandro, additional, Echarri Piudo, Ana, additional, Gionchetti, Paolo, additional, Roblin, Xavier, additional, Seidler, Ursula, additional, Andersson, David, additional, Patel, Kamal, additional, Desreumaux, Pierre, additional, Saibeni, Simone, additional, From, Gustav, additional, Fedurco, Miroslav, additional, Gregus, Milos, additional, Bouhnik, Yoram, additional, Luegering, Andreas, additional, Cosintino, Rocco, additional, Bunganic, Ivan, additional, Ramos, Jaime, additional, Aguas Peris, Mariam, additional, Dewit, Olivier, additional, Principi, Mariabeatrice, additional, Wesley, Emma, additional, Lago, Paula, additional, Nancey, Stephane, additional, Martín Arranz, María Dolores, additional, Hindryckx, Pieter, additional, Orlando, Ambrogio, additional, Geccherle, Andrea, additional, Annunziata, Maria Laura, additional, Hayee, Bu'hussain, additional, Balaz, Jozef, additional, Portela, Francisco, additional, Gilletta, Cyrielle, additional, Kucharzik, Torsten, additional, Mínguez, Miguel, additional, Gisbert, Javier Pérez, additional, Casbas, Ana Gutiérrez, additional, Louis, Edouard, additional, Marino, Marco, additional, Parkes, Gareth, additional, Cummings, Fraser, additional, Jharap, Bindia, additional, Kjeldsen, Jens, additional, Correia, Luís, additional, Ministro, Paula, additional, Ebert, Matthias, additional, Hertervig, Erik, additional, Staessen, Dirk, additional, Dutré, Joris, additional, Colard, Arnaud, additional, Morrison, Graham, additional, Glerup, Henning, additional, Dahlerup, Jens Frederik, additional, Wolfhagen, Frank, additional, Batovsky, Marian, additional, Molnar, Martin, additional, Kadleckova, Barbora, additional, Caldeira, Paulo, additional, Laharie, David, additional, Hebuterne, Xavier, additional, Bonaz, Bruno, additional, Allez, Matthieu, additional, Fischer, Andreas, additional, Hinojosa Del Val, Joaquín Ernesto, additional, Ciria, Miriam Mañosa, additional, Herrera Justiniano, Jose Manuel, additional, Soderman, Charlotte, additional, Chandy, Rajiv, additional, Mowat, Craig, additional, Irving, Peter, additional, Fallingborg, Jan, additional, Matous, Jan, additional, Douda, Tomas, additional, Altwegg, Romain, additional, Benitez, Jose Manuel, additional, Arroyo Villarino, María Teresa, additional, Capón, Jordi Guardiola, additional, Vicenc, Daniel Ginard, additional, Dewint, Pieter, additional, Almer, Sven, additional, and Kindt, Sebastien, additional

Published
2022
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10. sj-docx-1-tag-10.1177_17562848211072412 ��� Supplemental material for Effectiveness of ustekinumab in patients with refractory Crohn���s disease: a multicentre real-life study in Italy

Author

Scribano, Maria Lia, Aratari, Annalisa, Neri, Benedetto, Bezzio, Cristina, Balestrieri, Paola, Baccolini, Valentina, Falasco, Giuliano, Camastra, Caterina, Pantanella, Paolo, Monterubbianesi, Rita, Tullio, Alessandro, Saibeni, Simone, Papi, Claudio, Biancone, Livia, Cosintino, Rocco, and Faggiani, Roberto

Subjects
FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-1-tag-10.1177_17562848211072412 for Effectiveness of ustekinumab in patients with refractory Crohn���s disease: a multicentre real-life study in Italy by Maria Lia Scribano, Annalisa Aratari, Benedetto Neri, Cristina Bezzio, Paola Balestrieri, Valentina Baccolini, Giuliano Falasco, Caterina Camastra, Paolo Pantanella, Rita Monterubbianesi, Alessandro Tullio, Simone Saibeni, Claudio Papi, Livia Biancone, Rocco Cosintino and Roberto Faggiani in Therapeutic Advances in Gastroenterology

Published
2022
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11. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Peyrin-Biroulet, Laurent, primary, Hart, Ailsa, additional, Bossuyt, Peter, additional, Long, Millie, additional, Allez, Matthieu, additional, Juillerat, Pascal, additional, Armuzzi, Alessandro, additional, Loftus, Edward V, additional, Ostad-Saffari, Elham, additional, Scalori, Astrid, additional, Oh, Young S, additional, Tole, Swati, additional, Chai, Akiko, additional, Pulley, Jennifer, additional, Lacey, Stuart, additional, Sandborn, William J, additional, Aguilar, Humberto, additional, Ahmad, Tariq, additional, Akriviadis, Evangelos, additional, Aldeguer Mante, Xavier, additional, Altorjay, Istvan, additional, Ananthakrishnan, Ashwin, additional, Andersen, Vibeke, additional, Andreu Garcia, Montserrat, additional, Aumais, Guy, additional, Avni-Biron, Irit, additional, Axler, Jeffrey, additional, Ayub, Kamran, additional, Baert, Filip, additional, Bafutto, Mauro, additional, Bamias, George, additional, Bassan, Isaac, additional, Baum, Curtis, additional, Beaugerie, Laurent, additional, Behm, Brian, additional, Bekal, Pradeep, additional, Bennett, Michael, additional, Bermejo San Jose, Fernando, additional, Bernstein, Charles, additional, Bettenworth, Dominik, additional, Bhaskar, Sudhir, additional, Biancone, Livia, additional, Bilir, Bahri, additional, Blaeker, Michael, additional, Bloom, Stuart, additional, Bohman, Verle, additional, Bosques Padilla, Francisco Javier, additional, Bouhnik, Yoram, additional, Bouma, Gerd, additional, Bourdages, Raymond, additional, Brand, Stephan, additional, Bressler, Brian, additional, Brückner, Markus, additional, Buening, Carsten, additional, Carbonnel, Franck, additional, Caves, Thomas, additional, Chapman, Jonathon, additional, Cheon, Jae Hee, additional, Chiba, Naoki, additional, Chioncel, Camelia, additional, Christodoulou, Dimitrios, additional, Clodi, Martin, additional, Cohen, Albert, additional, Corazza, Gino Roberto, additional, Corlin, Richard, additional, Cosintino, Rocco, additional, Cummings, Fraser, additional, Dalal, Robin, additional, Danese, Silvio, additional, De Maeyer, Marc, additional, De Magalhães Francesconi, Carlos Fernando, additional, De Silva, Aminda, additional, Debinski, Henry, additional, Desreumaux, Pierre, additional, Dewit, Olivier, additional, D'Haens, Geert, additional, Di Felice Boratto, Sandra, additional, Ding, John Nik, additional, Dixon, Tyler, additional, Dryden, Gerald, additional, Du Vall, George Aaron, additional, Ebert, Matthias, additional, Echarri Piudo, Ana, additional, Ehehalt, Robert, additional, Elkhashab, Magdy, additional, Ennis, Craig, additional, Etzel, Jason, additional, Fallingborg, Jan, additional, Feagan, Brian, additional, Fejes, Roland, additional, Ferraz de Campos Mazo, Daniel, additional, Ferreira de Almeida Borges, Valéria, additional, Fischer, Andreas, additional, Fixelle, Alan, additional, Fleisher, Mark, additional, Fowler, Sharyle, additional, Freilich, Bradley, additional, Friedenberg, Keith, additional, Fries, Walter, additional, Fulop, Csaba, additional, Fumery, Mathurin, additional, Fuster, Sergio, additional, G Kiss, Gyula, additional, Garcia Lopez, Santiago, additional, Gassner, Sonja, additional, Gill, Kanwar, additional, Gilletta de Saint Joseph, Cyrielle, additional, Ginsburg, Philip, additional, Gionchetti, Paolo, additional, Goldin, Eran, additional, Goldis, Adrian-Eugen, additional, Gomez Jaramillo, Hector Alejandro, additional, Gonciarz, Maciej, additional, Gordon, Glenn, additional, Green, Daniel, additional, Grimaud, Jean-Charles, additional, Guajardo Rodriguez, Rogelio, additional, Gurzo, Zoltan, additional, Gutierrez, Alexandra, additional, Gyökeres, Tibor, additional, Hahm, Ki Baik, additional, Hanauer, Stephen, additional, Hanson, John, additional, Harlan III, William, additional, Hasselblatt, Peter, additional, Hayee, Buhussain, additional, Hebuterne, Xavier, additional, Hendy, Peter, additional, Heyman, Melvin, additional, Higgins, Peter, additional, Hilal, Raouf, additional, Hindryckx, Pieter, additional, Hoentjen, Frank, additional, Hoffmann, Peter, additional, Holtkamp-Endemann, Frank, additional, Holtmann, Gerald, additional, Horvat, Gyula, additional, Howaldt, Stefanie, additional, Huber, Samuel, additional, Ibegbu, Ikechukwu, additional, Iborra Colomino, Maria Isabel, additional, Irving, Peter, additional, Isaacs, Kim, additional, Jagarlamudi, Kiran, additional, Jain, Rajesh, additional, Jankiel Miszputen, Sender, additional, Jansen, Jeroen, additional, Jones, Jennifer, additional, Karagiannis, John, additional, Karyotakis, Nicholas, additional, Kaser, Arthur, additional, Katz, Lior, additional, Katz, Seymour, additional, Katz, Leo, additional, Kaur, Nirmal, additional, Kazenaite, Edita, additional, Khanna, Reena, additional, Khurana, Sunil, additional, Kim, Joo Sung, additional, Kim, Young-Ho, additional, Kim, Sung Kook, additional, Kim, Dongwoo, additional, Klaus, Jochen, additional, Kleczkowski, Dariusz, additional, Kohout, Pavel, additional, Korczowski, Bartosz, additional, Kouklakis, Georgios, additional, Koutroubakis, Ioannis, additional, Krause, Richard, additional, Kristof, Tunde, additional, Kronborg, Ian, additional, Krummenerl, Annette, additional, Kupcinskas, Limas, additional, Laborda Molteni, Jorge, additional, Laharie, David, additional, Lahat-zok, Adi, additional, Lee, Jonghun, additional, Lee, Kang-Moon, additional, Leong, Rupert, additional, Levine, Henry, additional, Limdi, Jimmy, additional, Lindsay, James, additional, Lodhia, Nilesh, additional, Loftus, Edward, additional, Longman, Randy, additional, Lopez Serrano, Pilar, additional, Louis, Edouard, additional, Louzada Pereira, Maria Helena, additional, Lowe, John, additional, Lueth, Stefan, additional, Lukas, Milan, additional, Maconi, Giovanni, additional, Macrae, Finlay, additional, Madi-Szabo, Laszlo, additional, Mahadevan-Velayos, Uma, additional, Malluta, Everson Fernando, additional, Mana, Fazia, additional, Mannon, Peter, additional, Mantzaris, Gerasimos, additional, Marin Jimenez, Ignacio, additional, Martin Arranz, Maria Dolores, additional, Mateescu, Radu-Bogdan, additional, Mazzoleni, Felipe, additional, Meder, Agnieszka, additional, Melzer, Ehud, additional, Mertens, Jessica, additional, Mimidis, Konstantinos, additional, Mitchell, Brent, additional, Molnar, Tamas, additional, Moore, Gregory, additional, Morales Garza, Luis Alonso, additional, Mountifield, Reme, additional, Muls, Vinciane, additional, Murray, Charles, additional, Nagy, Bela, additional, Neurath, Markus, additional, Nguyen, Augustin, additional, Panaccione, Remo, additional, Pandak, William, additional, Panes Diaz, Julian, additional, Park, Jihye, additional, Pastorelli, Luca, additional, Patel, Bhaktasharan, additional, Peck-Radosavljevic, Markus, additional, Pecsi, Gyula, additional, Peerani, Farhad, additional, Perez Gisbert, Javier, additional, Pesta, Martin, additional, Petryka, Robert, additional, Peyrin-Biroulet, Laurent, additional, Phillips, Raymond, additional, Pierik, Marieke, additional, Pratha, Vijayalakshmi, additional, Prochazka, Vlastimil, additional, Racz, Istvan, additional, Radford-Smith, Graham, additional, Ramos Castañeda, Daniel, additional, Ramos Júnior, Odery, additional, Regula, Jaroslaw, additional, Reimund, Jean-Marie, additional, Robbins, Bryan, additional, Roblin, Xavier, additional, Rogai, Francesca, additional, Rogler, Gerhard, additional, Rozciecha, Jerzy, additional, Rubin, David, additional, Ruiz Flores, Azalia Yuriria, additional, Rupinski, Maciej, additional, Rydzewska, Grazyna, additional, Saha, Sumona, additional, Saibeni, Simone, additional, Salamon, Agnes, additional, Sallo, Zoltan, additional, Salzberg, Bruce, additional, Samuel, Douglas, additional, Samuel, Sunil, additional, Sandborn, William, additional, Savarino, Edoardo Vincenzo, additional, Schirbel, Anja, additional, Schnabel, Robert, additional, Schreiber, Stefan, additional, Scott, John, additional, Sedghi, Shahriar, additional, Seibold, Frank, additional, Seidelin, Jakob, additional, Seidler, Ursula, additional, Shaban, Ahmad, additional, Shafran, Ira, additional, Sheikh, Aasim, additional, Sherman, Alex, additional, Shirin, Haim, additional, Smolinski, Patryk, additional, Song, Geun Am, additional, Soufleris, Konstantinos, additional, Speight, Alexander, additional, Staessen, Dirk, additional, Stallmach, Andreas, additional, Staun, Michael, additional, Stein, Daniel, additional, Steinhart, Hillary, additional, Stifft, Jonathas, additional, Stokesberry, David, additional, Sturm, Andreas, additional, Sultan, Keith, additional, Szekely, Gyorgy, additional, Tagore, Kuldeep, additional, Tanno, Hugo, additional, Thin, Lena, additional, Thiwan, Syed, additional, Thomas, Carlton, additional, Tichy, Michal, additional, Toth, Gabor Tamas, additional, Tulassay, Zsolt, additional, Ulbrych, Jan, additional, Valentine, John, additional, Varga, Marta, additional, Vasconcellos, Eduardo, additional, Vaughn, Byron, additional, Velasco, Brenda, additional, Velazquez, Francisco, additional, Vermeire, Severine, additional, Villa, Erica, additional, Vincze, Aron, additional, Vogelsang, Harald, additional, Volfova, Miroslava, additional, Vuitton, Lucine, additional, Vyhnalek, Petr, additional, Wahab, Peter, additional, Walldorf, Jens, additional, Waterman, Mattitiahu, additional, Weber, John, additional, Weiss, L. Michael, additional, Wiechowska-Kozlowska, Anna, additional, Wiesner, Elise, additional, Witthoeft, Thomas, additional, Wohlman, Robert, additional, Wozniak-Stolarska, Barbara, additional, Yacyshyn, Bruce, additional, Ye, Byong-Duk, additional, Younes, Ziad, additional, Yukie Sassaki, Lígia, additional, Zaltman, Cyrla, additional, and Zeuzem, Stefan, additional

Published
2022
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12. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study

Author

Danese, Silvio, primary, Colombel, Jean-Frederic, additional, Lukas, Milan, additional, Gisbert, Javier P, additional, D'Haens, Geert, additional, Hayee, Bu'hussain, additional, Panaccione, Remo, additional, Kim, Hyun-Soo, additional, Reinisch, Walter, additional, Tyrrell, Helen, additional, Oh, Young S, additional, Tole, Swati, additional, Chai, Akiko, additional, Chamberlain-James, Kirsten, additional, Tang, Meina Tao, additional, Schreiber, Stefan, additional, Aboo, Nazimuddin, additional, Ahmad, Tariq, additional, Aldeguer Mante, Xavier, additional, Allez, Matthieu, additional, Almer, Sven, additional, Altwegg, Romain, additional, Andreu Garcia, Montserrat, additional, Arasaradnam, Ramesh, additional, Ardizzone, Sandro, additional, Armuzzi, Alessandro, additional, Arnott, Ian, additional, Aumais, Guy, additional, Avni-Biron, Irit, additional, Barrow, Peter, additional, Beales, Ian, additional, Bermejo San Jose, Fernando, additional, Bezuidenhout, Abraham, additional, Biancone, Livia, additional, Blaeker, Michael, additional, Bloom, Stuart, additional, Bokemeyer, Bernd, additional, Bossa, Fabrizio, additional, Bossuyt, Peter, additional, Bouguen, Guillaume, additional, Bouhnik, Yoram, additional, Bouma, Gerd, additional, Bourdages, Raymond, additional, Bourreille, Arnaud, additional, Boustiere, Christian, additional, Brabec, Tomas, additional, Brand, Stephan, additional, Buening, Carsten, additional, Buisson, Anthony, additional, Cadiot, Guillaume, additional, Calvet Calvo, Xavier, additional, Carbonnel, Franck, additional, Carpio, Daniel, additional, Cheon, Jae Hee, additional, Chiba, Naoki, additional, Chioncel, Camelia, additional, Cimpoeru, Nicoleta-Claudia, additional, Clodi, Martin, additional, Corazza, Gino Roberto, additional, Cosintino, Rocco, additional, Cotter, Jose, additional, Creed, Thomas, additional, Cummings, Fraser, additional, Danese, Silvio, additional, de' Angelis, Gian Luigi, additional, De Maeyer, Marc, additional, Desai, Milind, additional, Desilets, Etienne, additional, Desreumaux, Pierre, additional, Dewit, Olivier, additional, Dinter, Johanna, additional, Dobru, Ecaterina Daniela, additional, Douda, Tomas, additional, Dumitrascu, Dan Lucian, additional, Ebert, Matthias, additional, Echarri Piudo, Ana, additional, Elkhashab, Magdy, additional, Eun, Chang Soo, additional, Feagan, Brian, additional, Fejes, Roland, additional, Fidalgo, Catarina, additional, Fishman, Sigal, additional, Flourié, Bernard, additional, Fowler, Sharyle, additional, Fries, Walter, additional, Fulop, Csaba, additional, Fumery, Mathurin, additional, G Kiss, Gyula, additional, Gassner, Sonja, additional, Gaya, Daniel, additional, Germanà, Bastianello, additional, Gheorghe, Liliana Simona, additional, Gilletta de Saint Joseph, Cyrielle, additional, Gionchetti, Paolo, additional, Goldis, Adrian-Eugen, additional, Gonçalves, Raquel, additional, Grimaud, Jean-Charles, additional, Gyökeres, Tibor, additional, Hagege, Herve, additional, Haidar, Andrei, additional, Hartmann, Heinz, additional, Hasselblatt, Peter, additional, Hayee, Buhussain, additional, Hebuterne, Xavier, additional, Hellström, Per, additional, Hindryckx, Pieter, additional, Hlavova, Helena, additional, Hoentjen, Frank, additional, Howaldt, Stefanie, additional, Hrdlicka, Ludek, additional, Huh, Kyu Chan, additional, Iborra Colomino, Maria Isabel, additional, Ionita-Radu, Florentina, additional, Irving, Peter, additional, Jahnsen, Jørgen, additional, Jang, ByungIk, additional, Jansen, Jeroen, additional, Jeon, Seong Woo, additional, Jover Martinez, Rodrigo, additional, Juillerat, Pascal, additional, Karlén, Per, additional, Kaser, Arthur, additional, Keil, Radan, additional, Kejariwal, Deepak, additional, Keret, Dan, additional, Khanna, Reena, additional, Kim, Dongwoo, additional, Kim, Duk Hwan, additional, Kim, Hyo-Jong, additional, Kim, Joo Sung, additional, Kim, Kueongok, additional, Kim, Kyung-Jo, additional, Kim, Sung Kook, additional, Kim, Young-Ho, additional, Klaus, Jochen, additional, Kohn, Anna, additional, Kojecky, Vladimir, additional, Koo, Ja Seol, additional, Kozak, Robert, additional, Kremer, Milan, additional, Kristof, Tunde, additional, Kruger, Frederik, additional, Laharie, David, additional, Lahat-zok, Adi, additional, Landa, Evgeny, additional, Lee, Jonghun, additional, Lee, Kang-Moon, additional, Lee, Kook Lae, additional, Lee, YooJin, additional, Lenze, Frank, additional, Lim, Wee Chian, additional, Limdi, Jimmy, additional, Lindsay, James, additional, Lopez Serrano, Pilar, additional, Louis, Edouard, additional, Lueth, Stefan, additional, Maconi, Giovanni, additional, Mana, Fazia, additional, Mann, Steven, additional, Mansfield, John, additional, Marchi, Santino, additional, Marino, Marco, additional, Marshall, John, additional, Martin Arranz, Maria Dolores, additional, Mateescu, Radu-Bogdan, additional, McLaughlin, John, additional, McLaughlin, Simon, additional, Melzer, Ehud, additional, Mertens, Jessica, additional, Mitrut, Paul, additional, Molnar, Tamas, additional, Muls, Vinciane, additional, Munuswamy, Pushpakaran, additional, Murray, Charles, additional, Naftali, Timna, additional, Naidoo, Visvakuren, additional, Nanabhay, Yusuf, additional, Negreanu, Lucian, additional, Nguyen, Augustin, additional, Ochsenkuehn, Thomas, additional, Orlando, Ambrogio, additional, Panes Diaz, Julian, additional, Paritsky, Maya, additional, Park, Dong Il, additional, Park, Jihye, additional, Pastorelli, Luca, additional, Peck-Radosavljevic, Markus, additional, Peerani, Farhad, additional, Perez Gisbert, Javier, additional, Peyrin-Biroulet, Laurent, additional, Picon, Laurence, additional, Pierik, Marieke, additional, Ponich, Terry, additional, Portela, Francisco, additional, Prins, Maartens Jeroen, additional, Racz, Istvan, additional, Rahman, Khan Fareed, additional, Reimund, Jean-Marie, additional, Reinshagen, Max, additional, Roblin, Xavier, additional, Rocca, Rodolfo, additional, Rogai, Francesca, additional, Rogler, Gerhard, additional, Salamon, Agnes, additional, Salazar, Ennaliza, additional, Sallo, Zoltan, additional, Samuel, Sunil, additional, Sans Cuffi, Miquel de los Santos, additional, Savarino, Edoardo Vincenzo, additional, Savarino, Vincenzo, additional, Savoye, Guillaume, additional, Seicean, Andrada, additional, Selinger, Christian, additional, Serra, David Martins, additional, Shim, Hang Hock, additional, Shin, SungJae, additional, Siegmund, Britta, additional, Siffledeen, Jesse, additional, Simmonds, Wayne, additional, Smid, Jan, additional, Sollano, Jose, additional, Song, Geun Am, additional, Speight, Alexander, additional, Sporea, Ioan, additional, Staessen, Dirk, additional, Stancu, George, additional, Steel, Alan, additional, Stepek, David, additional, Stoica, Victor, additional, Sturm, Andreas, additional, Szekely, Gyorgy, additional, Tan, Teck Kiang, additional, Taxonera Samso, Carlos, additional, Thomson, John, additional, Tichy, Michal, additional, Toth, Gabor Tamas, additional, Tulassay, Zsolt, additional, Vangeli, Marcello, additional, Varga, Marta, additional, Vieira, Ana, additional, Viennot, Stephanie, additional, Villa, Erica, additional, Vitek, Petr, additional, Vogelsang, Harald, additional, Vyhnalek, Petr, additional, Wahab, Peter, additional, Walldorf, Jens, additional, Ye, Byong Duk, additional, and Ziady, Christopher, additional

Published
2022
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13. Effectiveness of ustekinumab in patients with refractory Crohn’s disease: a multicentre real-life study in Italy

Author

Scribano, Maria Lia, primary, Aratari, Annalisa, additional, Neri, Benedetto, additional, Bezzio, Cristina, additional, Balestrieri, Paola, additional, Baccolini, Valentina, additional, Falasco, Giuliano, additional, Camastra, Caterina, additional, Pantanella, Paolo, additional, Monterubbianesi, Rita, additional, Tullio, Alessandro, additional, Saibeni, Simone, additional, Papi, Claudio, additional, Biancone, Livia, additional, Cosintino, Rocco, additional, and Faggiani, Roberto, additional

Published
2022
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14. Long‐term outcomes of acute severe ulcerative colitis in the rescue therapy era: A multicentre cohort study

Author

Festa, Stefano, primary, Scribano, Maria L., additional, Pugliese, Daniela, additional, Bezzio, Cristina, additional, Principi, Mariabeatrice, additional, Ribaldone, Davide G., additional, Allocca, Mariangela, additional, Mocci, Giammarco, additional, Bodini, Giorgia, additional, Spagnuolo, Rocco, additional, Vernia, Piero, additional, Mazzuoli, Silvia, additional, Costa, Francesco, additional, Barberio, Brigida, additional, Cosintino, Rocco, additional, Zerboni, Giulia, additional, Aratari, Annalisa, additional, Armuzzi, Alessandro, additional, and Papi, Claudio, additional

Published
2021
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15. Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Author

Fiorino, Gionata, primary, Caprioli, Flavio, additional, Daperno, Marco, additional, Mocciaro, Filippo, additional, Principi, Mariabeatrice, additional, Viscido, Angelo, additional, Fantini, Massimo Claudio, additional, Orlando, Ambrogio, additional, Papi, Claudio, additional, Annese, Vito, additional, Danese, Silvio, additional, Vecchi, Maurizio, additional, Rizzello, Fernando, additional, Armuzzi, Alessandro, additional, Leone, Salvatore, additional, Previtali, Enrica, additional, Aloi, Marina, additional, Alvisi, Patrizia, additional, Antonelli, Elisabetta, additional, Ardizzone, Sandro, additional, Astegiano, Marco, additional, Baldoni, Monia, additional, Beltrami, Marina, additional, Biancone, Livia, additional, Bodini, Giorgia, additional, Buda, Andrea, additional, Bossa, Fabrizio, additional, Bracci, Fiammetta, additional, Calabrese, Emma, additional, Cappello, Maria, additional, Castiglione, Fabiana, additional, Ciacci, Carolina, additional, Cicala, Michele, additional, Ciccocioppo, Rachele, additional, Comberlato, Michele, additional, Cortelezzi, Claudio Camillo, additional, Cosintino, Rocco, additional, Costa, Francesco, additional, Costantino, Giuseppe, additional, Cucchiara, Salvatore, additional, Cuomo, Antonio, additional, D’Incà, Renata, additional, Di Paolo, Maria Carla, additional, Di Sabatino, Antonio, additional, Di Sario, Antonio, additional, Frieri, Giuseppe, additional, Fries, Walter, additional, Gasbarrini, Antonio, additional, Geccherle, Andrea, additional, Gionchetti, Paolo, additional, Graziani, Maria Giovanna, additional, Grossi, Laurino, additional, Guidi, Luisa, additional, Imperiali, Gianni, additional, Latella, Giovanni, additional, Lionetti, Paolo, additional, Inserra, Gaetano, additional, Maconi, Giovanni, additional, Manguso, Francesco, additional, Marino, Marco, additional, Mastronardi, Mauro, additional, Mazzuoli, Silvia, additional, Meucci, Gianmichele, additional, Mendolaro, Marco, additional, Milla, Monica, additional, Mocci, Giammarco, additional, Monteleone, Giovanni, additional, Bortoluzzi, Francesco Neri, additional, Pagnini, Cristiano, additional, Pastorelli, Luca, additional, Pica, Roberta, additional, Piergallini, Simona, additional, Privitera, Antonello, additional, Renna, Sara, additional, Ribaldone, Davide Giuseppe, additional, Ricci, Chiara, additional, Rispo, Antonio, additional, Rocca, Rodolfo, additional, Romano, Claudio, additional, Romano, Marco, additional, Russo, Giovanni, additional, Sablich, Renato, additional, Saibeni, Simone, additional, Savarino, Edoardo, additional, Scribano, Maria Lia, additional, Spagnuolo, Rocco, additional, Stasi, Elisa, additional, Terpin, Maria Maddalena, additional, Testa, Anna, additional, Valpiani, Daniela, additional, Variola, Angela, additional, Vernia, Piero, additional, Vitale, Giovanna, additional, and Zoli, Giorgio, additional

Published
2019
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16. Training Programs on Endoscopic Scoring Systems for Inflammatory Bowel Disease Lead to a Significant Increase in Interobserver Agreement Among Community Gastroenterologists

Author

Daperno, Marco, Comberlato, Michele, Bossa, Fabrizio, Armuzzi, Alessandro, Biancone, Livia, Bonanomi, Andrea G., Cosintino, Rocco, Lombardi, Giovanni, Mangiarotti, Roberto, Papa, Alfredo, Pica, Roberta, Grassano, Luca, Pagana, Guido, D'Incà, Renata, Orlando, Ambrogio, Rizzello, Fernando, Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Papa, Alfredo (ORCID:0000-0002-4186-7298), Daperno, Marco, Comberlato, Michele, Bossa, Fabrizio, Armuzzi, Alessandro, Biancone, Livia, Bonanomi, Andrea G., Cosintino, Rocco, Lombardi, Giovanni, Mangiarotti, Roberto, Papa, Alfredo, Pica, Roberta, Grassano, Luca, Pagana, Guido, D'Incà, Renata, Orlando, Ambrogio, Rizzello, Fernando, Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), and Papa, Alfredo (ORCID:0000-0002-4186-7298)

Abstract

Background and Aims: Endoscopic outcomes are increasingly used in clinical trials and in routine practice for inflammatory bowel disease [IBD] in order to reach more objective patient evaluations than possible using only clinical features. However, reproducibility of endoscopic scoring systems used to categorize endoscopic activity has been reported to be suboptimal. The aim of this study was to analyse the inter-rated agreement of non-dedicated gastroenterologists on IBD endoscopic scoring systems, and to explore the effects of a dedicated training programme on agreement.Methods: A total of 237 physicians attended training courses on IBD endoscopic scoring systems, and they independently scored a set of IBD endoscopic videos for ulcerative colitis [with Mayo endoscopic subscore], post-operative Crohn's disease [with Rutgeerts score] and luminal Crohn's disease (with the Simple Endoscopic Score for Crohn's Disease [SESCD] and Crohn's Endoscopic Index of Severity [CDEIS]). A second round of scoring was collected after discussion about determinants of discrepancy. Interobserver agreement was measured by means of the Fleiss' kappa [kappa] or intraclass correlation coefficient [ICC] as appropriate.Results: The inter-rater agreement increased from kappa 0.51 (95% confidence interval [95% CI] 0.48-0.55) to 0.76 [95% CI 0.72-0.79] for the Mayo endoscopic subscore, and from 0.45 [95% CI 0.40-0.50] to 0.79 [0.74-0.83] for the Rutgeerts score before and after the training programme, respectively, and both differences were significant [P < 0.0001]. The ICC was 0.77 [95% CI 0.56-0.96] for SESCD and 0.76 [0.54- 0.96] for CDEIS, respectively, with only one measurement.Discussion: The basal inter-rater agreement of inexperienced gastroenterologists focused on IBD management is moderate; however, a dedicated training programme can significantly impact on inter-rater agreement, increasing it to levels expected among expert central reviewers.

Published
2017

17. Tu1938 Endoscopic Training Leads to a Significant Increase in Agreement of Endoscopic Scoring for Inflammatory Bowel Disease (IBD): Final Results of the Igibdendo Educational Project

Author

Daperno, Marco, primary, Comberlato, Michele, additional, Bossa, Fabrizio, additional, Biancone, Livia, additional, Bonanomi, Andrea G., additional, Cosintino, Rocco, additional, Lombardi, Giovanni, additional, Mangiarotti, Roberto, additional, Papa, Alfredo, additional, Pica, Roberta, additional, Rabagliati, Matteo, additional, Grassano, Luca, additional, Gasparini, Mauro, additional, Pagana, Guido, additional, D'Inca, Renata, additional, Orlando, Ambrogio, additional, and Rizzello, Fernando, additional

Published
2016
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19. Sa1221 Increasing Interobserver Agreement on IBD Endoscopic Scoring Systems: Results From the IGIBDEndo Educational Program

Author

Daperno, Marco, primary, Comberlato, Michele, additional, Bossa, Fabrizio, additional, Bonanomi, Andrea G., additional, Lombardi, Giovanni, additional, Biancone, Livia, additional, Cosintino, Rocco, additional, D'Inca, Renata, additional, Cassinotti, Andrea, additional, Mangiarotti, Roberto, additional, Papa, Alfredo, additional, Pica, Roberta, additional, Rizzello, Fernando, additional, Armuzzi, Alessandro, additional, and Orlando, Ambrogio, additional

Published
2014
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20. Su1917 Interobserver Agreement in IBD Endoscopic Scoring: Preliminary Results of an Ongoing IG-IBD Study

Author

Daperno, Marco, primary, Comberlato, Michele, additional, Bossa, Fabrizio, additional, Biancone, Livia, additional, Bonanomi, Andrea G., additional, Cassinotti, Andrea, additional, Cosintino, Rocco, additional, Lombardi, Giovanni, additional, Mangiarotti, Roberto, additional, Papi, Claudio, additional, Pica, Roberta, additional, Rizzello, Fernando, additional, and D'Incà, Renata, additional

Published
2012
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23. Mucosal Healing With Thalidomide in Refractory Crohn’s Disease Patients Intolerant of Anti-TNF- Drugs

Author

Scribano, Maria Lia, Cantoro, Laura, Marrollo, Marzia, Cosintino, Rocco, and Kohn, Anna

Abstract

Thalidomide is an oral immunomodulatory and anti-inflammatory drug with antitumor necrosis factor- (TNF-) activity. Several case reports and some clinical trials have demonstrated its efficacy in the treatment of refractory Crohn’s disease (CD). We report the effect and tolerability of thalidomide in 3 patients with moderate-to-severe CD who were not responsive to anti-TNF- therapies, and review the relevant literature. The first case is of a 28-year-old female affected by Crohn’s colitis complicated by a severe fistulizing perianal disease; she was treated with infliximab, adalimumab, and certolizumab pegol, which were stopped because of intolerance. The second case is of a 39-year-old female with fistulizing ileocolitis complicated by severe arthralgias and perianal disease with loss of response to infliximab and intolerance of certolizumab pegol. The third case is of a 39-year-old male with gastric and ileocolonic CD refractory to immunosuppressors and intolerant of infliximab. All the 3 cases achieved complete clinical remission and endoscopic healing of mucosal lesions at a low dose of thalidomide (50 to 150 mgd). In our CD patients who experienced loss of response or were unable to tolerate anti-TNF- drugs, thalidomide was an effective and well-tolerated therapy for inducing and maintaining long-term remission.

Published
2014
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24. Long-term outcomes of acute severe ulcerative colitis in the rescue therapy era: A multicentre cohort study

Author

Festa, Stefano, Scribano, Maria L, Pugliese, Daniela, Bezzio, Cristina, Principi, Mariabeatrice, Ribaldone, Davide G, Allocca, Mariangela, Mocci, Giammarco, Bodini, Giorgia, Spagnuolo, Rocco, Vernia, Piero, Mazzuoli, Silvia, Costa, Francesco, Barberio, Brigida, Cosintino, Rocco, Zerboni, Giulia, Aratari, Annalisa, Armuzzi, Alessandro, and Papi, Claudio

Abstract

Background The long-term course of ulcerative colitis after a severe attack is poorly understood. Second-line rescue therapy with cyclosporine or infliximab is effective for reducing short-term colectomy but the impact in the long-term is controversial.Objective The purpose of this study was to evaluate the long-term course of acute severe ulcerative colitis patients who avoid early colectomy either because of response to steroids or rescue therapy.Methods This was a multicentre retrospective cohort study of adult patients with acute severe ulcerative colitis admitted to Italian inflammatory bowel disease referral centres from 2005–2017. All patients received intravenous steroids, and those who did not respond received either rescue therapy or colectomy. For patients who avoided early colectomy (within three months from the index attack), we recorded the date of colectomy, last follow-up visit or death. The primary end-point was long-term colectomy rate in patients avoiding early colectomy.Results From the included 372 patients with acute severe ulcerative colitis, 337 (90.6%) avoided early colectomy. From those, 60.5% were responsive to steroids and 39.5% to the rescue therapy. Median follow-up was 44 months (interquartile range, 21–85). Colectomy-free survival probability was 93.5%, 81.5% and 79.4% at one, three and five years, respectively. Colectomy risk was higher among rescue therapy users than in steroid-responders (log-rank test, p?=?0.02). At multivariate analysis response to steroids was independently associated with a lower risk of long-term colectomy (adjusted odds ratio?=?0.5; 95% confidence interval, 0.2–0.8), while previous exposure to anti-tumour necrosis factor alpha agents was associated with an increased risk (adjusted odds ratio?=?3.0; 95% confidence interval, 1.5–5.7). Approximately 50% of patients required additional therapy or new hospitalization within five years due to a recurrent flare. Death occurred in three patients (0.9%).Conclusions Patients with acute severe ulcerative colitis avoiding early colectomy are at risk of long-term colectomy, especially if previously exposed to anti-tumour necrosis factor alpha agents or if rescue therapy during the acute attack was required because of steroid refractoriness.

Published
2020
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25. Training Programs on Endoscopic Scoring Systems for Inflammatory Bowel Disease Lead to a Significant Increase in Interobserver Agreement Among Community Gastroenterologists.

Author

Daperno M, Comberlato M, Bossa F, Armuzzi A, Biancone L, Bonanomi AG, Cassinotti A, Cosintino R, Lombardi G, Mangiarotti R, Papa A, Pica R, Grassano L, Pagana G, D'Incà R, Orlando A, and Rizzello F

Subjects
Colitis, Ulcerative diagnosis, Colitis, Ulcerative pathology, Crohn Disease diagnosis, Crohn Disease pathology, Education, Medical, Continuing methods, Gastroenterologists statistics & numerical data, Humans, Inflammatory Bowel Diseases pathology, Observer Variation, Colonoscopy education, Gastroenterologists education, Inflammatory Bowel Diseases diagnosis
Abstract

Background and Aims: Endoscopic outcomes are increasingly used in clinical trials and in routine practice for inflammatory bowel disease [IBD] in order to reach more objective patient evaluations than possible using only clinical features. However, reproducibility of endoscopic scoring systems used to categorize endoscopic activity has been reported to be suboptimal. The aim of this study was to analyse the inter-rated agreement of non-dedicated gastroenterologists on IBD endoscopic scoring systems, and to explore the effects of a dedicated training programme on agreement., Methods: A total of 237 physicians attended training courses on IBD endoscopic scoring systems, and they independently scored a set of IBD endoscopic videos for ulcerative colitis [with Mayo endoscopic subscore], post-operative Crohn's disease [with Rutgeerts score] and luminal Crohn's disease (with the Simple Endoscopic Score for Crohn's Disease [SESCD] and Crohn's Endoscopic Index of Severity [CDEIS]). A second round of scoring was collected after discussion about determinants of discrepancy. Interobserver agreement was measured by means of the Fleiss' kappa [kappa] or intraclass correlation coefficient [ICC] as appropriate., Results: The inter-rater agreement increased from kappa 0.51 (95% confidence interval [95% CI] 0.48-0.55) to 0.76 [95% CI 0.72-0.79] for the Mayo endoscopic subscore, and from 0.45 [95% CI 0.40-0.50] to 0.79 [0.74-0.83] for the Rutgeerts score before and after the training programme, respectively, and both differences were significant [P < 0.0001]. The ICC was 0.77 [95% CI 0.56-0.96] for SESCD and 0.76 [0.54- 0.96] for CDEIS, respectively, with only one measurement., Discussion: The basal inter-rater agreement of inexperienced gastroenterologists focused on IBD management is moderate; however, a dedicated training programme can significantly impact on inter-rater agreement, increasing it to levels expected among expert central reviewers., (Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com)

Published
2017
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