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1. Dual targeting of lymphocyte homing and retention through α4β7 and αEβ7 inhibition in inflammatory bowel disease.

Author

Dai, Bingbing, Hackney, Jason A, Ichikawa, Ryan, Nguyen, Allen, Elstrott, Justin, Orozco, Luz D, Sun, Kai-Hui, Modrusan, Zora, Gogineni, Alvin, Scherl, Alexis, Gubatan, John, Habtezion, Aida, Deswal, Monika, Somsouk, Ma, Faubion, William A, Chai, Akiko, Sharafali, Zaineb, Hassanali, Azra, Oh, Young S, Tole, Swati, McBride, Jacqueline, Keir, Mary E, and Yi, Tangsheng

Subjects
T cell entry and retention, etrolizumab, inflammatory bowel disease, α4β7, αEβ7
Abstract

Anti-integrins are therapeutically effective for inflammatory bowel disease, yet the relative contribution of α4β7 and αEβ7 to gut lymphocyte trafficking is not fully elucidated. Here, we evaluate the effect of α4β7 and αEβ7 blockade using a combination of murine models of gut trafficking and longitudinal gene expression analysis in etrolizumab-treated patients with Crohn's disease (CD). Dual blockade of α4β7 and αEβ7 reduces CD8+ T cell accumulation in the gut to a greater extent than blockade of either integrin alone. Anti-αEβ7 reduces epithelial:T cell interactions and promotes egress of activated T cells from the mucosa into lymphatics. Inflammatory gene expression is greater in human intestinal αEβ7+ T cells. Etrolizumab-treated patients with CD display a treatment-specific reduction in inflammatory and cytotoxic intraepithelial lymphocytes (IEL) genes. Concurrent blockade of α4β7 and αEβ7 promotes reduction of cytotoxic IELs and inflammatory T cells in the gut mucosa through a stepwise inhibition of intestinal tissue entry and retention.

Published
2021

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. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

Rustem, Abdulkhakov, Norasiah, Abu Bakar, Humberto, Aguilar, Diego, Aizenberg, Hale, Akpinar, Evangelos, Akriviadis, Olga, Alexeeva, Bagdadi, Alikhanov, Andres, Alvarisqueta, Ashwin, Ananthakrishnan, Jane, Andrews, Tomasz, Arlukowicz, Nathan, Atkinson, Ozlen, Atug, Mauro, Bafutto, Jozef, Balaz, George, Bamias, Marko, Banic, Andrey, Baranovsky, Guerino, Barbalaco Neto, Metin, Basaranoglu, Curtis, Baum, Stefan, Baydanov, William, Bennetts, Fatih, Besisik, Sudhir, Bhaskar, Andrzej, Bielasik, Leonid, Bilianskyi, Bahri, Bilir, Pavol, Blaha, Verle, Bohman, Julia, Borissova, Vladimir, Borzan, Francisco, Bosques-Padilla, Yoram, Bouhnik, James, Brooker, Tetiana, Budko, Igor, Budzak, Ivan, Bunganic, Jonathon, Chapman, Azlida, Che' Aun, Tatiana, Chernykh, Michael, Chiorean, Ivan, Chopey, Dimitrios, Christodoulou, Pui Shan, Chu, Galina, Chumakova, Andrew, Cummins, Robert, Cunliffe, Mirjana, Cvetkovic, Ulku, Dagli, Wit Cezary, Danilkiewicz, Olena, Datsenko, Carlos Fernando, de Magalhães Francesconi, Henry, Debinski, Elena, Deminova, Jelena, Derova, John Nik, Ding, Julia, Dmitrieva, Oleg, Dolgikh, Tomas, Douda, Piotr, Drobinski, Gerald, Dryden, Pedro, Duarte Gaburri, George Aaron, DuVall, Mikhail, Dvorkin, Craig, Ennis, Yusuf, Erzin, Galyna, Fadieienko, Oleksandr, Fediv, Olga, Fedorishina, Miroslav, Fedurco, Roland, Fejes, Jorge, Fernandez, Monica Lorena, Fernandez, Lucky, Flores, Bradley, Freilich, Keith, Friedenberg, Sergio, Fuster, Beata, Gawdis-Wojnarska, Fabio Leonel, Gil Parada, Edgardo Daniel, Gimenez, Nataliia, Golovchenko, Oleksandr, Golovchenko, Maciej, Gonciarz, Can, Gonen, Glenn, Gordon, Milos, Gregus, Vladimir, Grinevich, Rogelio, Guajardo Rodriguez, Stephen, Hall, John, Hanson, Marek, Hartleb, Xavier, Hebuterne, Peter, Hendy, Robert, Herring, David, Hetzel, Peter, Higgins, Raouf, Hilal, Ida Normiha, Hilmi, Tibor, Hlavaty, Richard, Holman, Gerald, Holtmann, John, Hong, Frantisek, Horvath, Ihor, Hospodarskyy, Irena, Hrstic, Sadettin, Hulagu, Luis Alberto, Ibarra Verdugo, Ikechukwu, Ibegbu, Stephen, Inns, Vladimir, Ivashkin, James, Izanec, Rajesh, Jain, Zofia, Jamrozik-Kruk, Victor, Kamburov, John, Karagiannis, Tarkan, Karakan, Marek, Karczewski, Irina, Kasherininova, Seymour, Katz, Barry, Kaufman, Edita, Kazenaite, Irina, Kholina, Sunil, Khurana, Jaroslaw, Kierkus, Anzela, Kiselevska, Dariusz, Kleczkowski, Volodymyr, Klymenko, Slavko, Knezevic, Malgorzata, Kondusz-Szklarz, Natalya, Korablina, Bartosz, Korczowski, Lyubomir, Kosturkov, Iskren, Kotzev, Georgios, Kouklakis, Ioannis, Koutroubakis, Richard, Krause, Ian, Kronborg, Miodrag, Krstic, Zeljko, Krznaric, Mikolaj, Krzyzanowski, Grazyna, Kulig, Karin, Kull, Limas, Kupcinskas, Mark, Lamet, Tatjana, Latinovic Radakovic, Rupert, Leong, Wai Keung, Leung, Henry, Levine, Michael Kin Kong, Li, Lúcia, Libanez Bessa Campelo Braga, Maria, Livzan, Tetiana, Lohdanidi, Maria Helena, Louzada Pereira, John, Lowe, Kresimir, Luetic, Milan, Lukas, Yurii, Lymar, Finlay, Macrae, Anu, Mäelt, Igor, Maev, Arkadiusz, Mamos, Gerasimos, Mantzaris, Benno, Margus, Ivanka, Marinova, Inna, Markevych, Mario, Markov, Srdjan, Markovic, Juan Ricardo, Marquez Velasquez, Felipe, Mazzoleni, Konstantinos, Mimidis, Brent, Mitchell, Gregory, Moore, Luis Alonso, Morales Garza, Salvatore, Moscatello, Yuriy, Mostovoy, Reme, Mountifield, Aleksandar, Nagorni, Viacheslav, Neshta, Andrey, Obrezan, Oleksandr, Oliinyk, Genoile, Oliveira Santana Silva, Maria, Orzeszko, Vladimir, Pavlenko, Dimitar, Pavlov, Mariana, Penkova, Sasa, Peric, Plamen, Petkov, Asen, Petrov, Plamen, Petrov, Michaela, Petrova, Raymond, Phillips, Sergio, Pintor Chacon, Igor, Polianskyi, Ludmyla, Prystupa, Mykhailo, Pugach, Ana Teresa, Pugas Carvalho, Aldis, Pukitis, Jiri, Pumprla, Volodymyr, Pyrogovskyy, Istvan, Racz, Graham, Radford-Smith, Raja Affendi, Raja Ali, Daniel, Ramos Castañeda, Odery, Ramos Júnior, David, Rausher, Andrey, Rebrov, Jaroslaw, Regula, Amir, Rezk, Viktoriia, Reznikova, Iaroslava, Rishko, Xavier, Roblin, Grigory, Rodoman, Carlos Arturo, Rojas Rodriguez, Jerzy, Rozciecha, David, Rubin, Maciej, Rupinski, Jacek, Rzucidlo, Oleg, Sablin, Halil, Sahin, Rosemi, Salleh, Douglas, Samuel, Antonio, Scafuto Scotton, Robert, Schnabel, Michael, Schulman, Michael, Schultz, John, Scott, Shahriar, Sedghi, Ahmad, Shaban, Marina, Shapina, Natalia, Shaposhnikova, Oksana, Shchukina, Alex, Sherman, Irina, Shumikhina, Vladimir, Simanenkov, Vladislav, Simonov, Giedrius, Simulionis, Igor, Skrypnyk, Zbigniew, Sliwowski, Jan, Smid, Mahmood, Solaiman, Najm, Soofi, Konstantinos, Soufleris, Zoia, Spassova, Mykola, Stanislavchuk, Krystyna, Stec-Michalska, Jonathas, Stifft, Simeon, Stoinov, Girgina, Stoyanova, Keith, Sultan, Lindsey, Surace, Dimitar, Takov, Jaak, Tälli, Ludmila, Tankova, Hugo, Tanno, Dino, Tarabar, Elias, Tarakji, Konstantin, Tchernev, Hoi Poh, Tee, Lena, Thin, Carlton, Thomas, Irina, Tishaeva, Tsveta, Todorova, Oleksandr, Tokarenko, Ivars, Tolmanis, Ratko, Tomasevic, Vasiliy, Trofimov, Zsolt, Tulassay, Belkis, Unsal, Alma, Uzunova-Genova, John, Valentine, Ekaterina, Valuyskikh, Eduardo, Vasconcellos, Galina, Vasileva, Sergiy, Vasylyuk, Byron, Vaughn, Francisco, Velazquez, Vadym, Vizir, Borislav, Vladimirov, Miroslava, Volfova, Petr, Vyhnalek, Ian, Wallace, Marek, Waluga, William, Watkins, John, Weber, Anna, Wiechowska-Kozlowska, Nathaniel, Winstead, Pawel, Wojtkiewicz, Barbara, Wozniak-Stolarska, Bruce, Yacyshyn, Alexey, Yakovlev, Ziad, Younes, Lígia, Yukie Sassaki, Ilhami, Yuksel, Jan, Zachar, Cyrla, Zaltman, Natasa, Zdravkovic Petrovic, Vyacheslav, Zhdan, Maryna, Zinchenko, Maciej, Zymla, Rubin, David T, Dotan, Iris, DuVall, Aaron, Bouhnik, Yoram, Radford-Smith, Graham, Higgins, Peter D R, Mishkin, Daniel S, Arrisi, Pablo, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Chamberlain-James, Kirsten, Lacey, Stuart, McBride, Jacqueline, and Panés, Julian

Published
2022
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5. Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study

Author

Abraham, Philip, Acir Crippa Júnior, Mauro, Aguilar, Humberto, Ahmed, Tasneem, Altorjay, Istvan, Andersen, Vibeke, Arai, Ronen, Arnold, Hays, Ausk, Karlee, Axler, Jeffrey, Ayub, Kamran, Balekuduru, Avinash, Barbalaco Neto, Guerino, Bassan, Isaac, Behm, Brian, Bekal, Pradeep, Bhatia, Shobna, Bod, Barnabas, Brandão Mello, Carlos Eduardo, Brandeburova, Julia, Breedt, Johannes, Bressler, Brian, Chopey, Ivan, Connor, Michael, Corlin, Richard, Cortez Hernandez, Carlos Alejandro, De, Arijit, de Sá Rolim, Alexander, Di Felice Boratto, Sandra, Dixon, Tyler, Dourado Poli, Debora, Dresner, David, Du Vall, George Aaron, Ebert, Matthias, Ehehalt, Robert, Ertan, Atilla, Escarcega Valencia, Ruben, Etzel, Jason, Fallingborg, Jan, Feagan, Brian, Fedurco, Miroslav, Fernandez Castro, Enrique, Ferreira de Almeida Borges, Valéria, Finklestein, Mark, Fischer, Andreas, Fleisher, Mark, Flores Rendon, Angel Ricardo, Fogel, Ronald, Franceschi Junior, Osvaldo, Freedland, Curtis, Gatof, David, Gill, Kanwar, Glerup, Henning, Gokak, Vardaraj, Goldin, Eran, Gomez Jaramillo, Hector Alejandro, Gupta, Nitin, Gurzo, Zoltan, Gyrina, Olga, Habeeb, Mohammed Aejaz, Hanauer, Stephen, Hardi, Robert, Harlan, William, Hemaidan, Ammar, Heyman, Melvin, Hoffmann, Peter, Holderman, William, Holtkamp-Endemann, Frank, Horvat, Gyula, Isaacs, Kim, Israeli, Eran, Jankiel Miszputen, Sender, Jensen, Søren, Johnson, Kenneth, Jones, Jennifer, Junior, Osvaldo, Kadleckova, Barbora, Kalla, Mukesh, Kallo, Zsuzsanna, Karyotakis, Nicholas, Katz, Lior, Katz, Leo, Kaur, Nirmal, Khanna, Reena, Kohout, Pavel, Lakatos, Peter, Larriva de los Reyes, Emmanuel, Lee, Robert, Leman, Bernard, Levchenko, Olena, Levine, Henry, Libanez Bessa Campelo Braga, Lúcia, Loftus, Edward, Lohdanidi, Tetiana, Longman, Randy, Lozano, Josefina, Maaser, Christian, Madi-Szabo, Laszlo, Malluta, Everson Fernando, Marshall, John, Martinez Silva, Francisca, Maynard, Kenneth, Meder, Agnieszka, Mehta, Chetan, Minarik, Peter, Mueller, Joachim, Mukewar, Shrikant, Nagy, Bela, Neiko, Vasyl, Neurath, Markus, Nichol, Brian, Novick, James, Pai, Nitin, Pandak, William, Panigrahi, Sarat, Pape, Ulrich-Frank, Paraná, Raymundo, Parekh, Nimisha, Patel, Bhaktasharan, Pecsi, Gyula, Peralta, Sergio, Pesta, Martin, Peterfai, Eva, Petruzzellis, Carlo, Petryka, Robert, Pica, Roberta, Piniella, Carlos, Pratha, Vijayalakshmi, Prochazka, Vlastimil, Prokopchuk, Sergey, Prystupa, Ludmyla, Puri, Amarender, Rainis, Tova, Ramesh Kumar, Bhashyakarla, Ramos Júnior, Odery, Rishko, Iaroslava, Ritter, Timothy, Robbins, Bryan, Rock, Elizabeth, Rodrigues Borba, Marcelo, Rodriguez, Miguel, Rozciecha, Jerzy, Ruiz Flores, Azalia Yuriria, Rydzewska, Grazyna, Safadi, Rifaat, Saibeni, Simone, Schirbel, Anja, Schmiegel, Wolff, Schnabel, Róbert, Schneider, Herbert, Segui, Armando, Seidelin, Jakob, Seidler, Ursula, Sellin, Joseph, Shafran, Ira, Shah, Saumin, Sheikh, Aasim, Sherman, Alex, Shirin, Haim, Shukla, Akash, Siddiqui, Firdous, Sike, Robert, Sood, Ajit, Stallmach, Andreas, Stanislavchuk, Mykola, Staun, Michael, Stein, Daniel, Steinberg, Alon, Steinhart, Hillary, Stifft, Jonathas, Tandon, Rakesh, Tantry, Vishwanath, Thiwan, Syed, Treiber, Matthias, Ulbrych, Jan, Valentine, John, Vasudeva, Rajeev, Vaughn, Byron, Velasco, Brenda, Vincze, Aron, Volfova, Miroslava, Waterman, Mattitiahu, Weiss, L. Michael, Wiesner, Elise, Williams, Alonzo, Witthoeft, Thomas, Wohlman, Robert, Wright, John, Yamamoto Furusho, Jesus Kazuo, Younes, Ziad, Yousuf, Khurshid, Zborivskyy, Yaroslav, Zeuzem, Stefan, Zhdan, Vyacheslav, Vermeire, Severine, Lakatos, Peter L, Kadva, Alysha, Tyrrell, Helen, Oh, Young S, Tole, Swati, Chai, Akiko, Pulley, Jennifer, Eden, Christopher, Zhang, Wenhui, and Feagan, Brian G

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2022
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6. A phase 2 study of the BH3 mimetic BCL2 inhibitor navitoclax (ABT-263) with or without rituximab, in previously untreated B-cell chronic lymphocytic leukemia

Author

Kipps, Thomas J, Eradat, Herbert, Grosicki, Sebastian, Catalano, John, Cosolo, Walter, Dyagil, Iryna S, Yalamanchili, Sreeni, Chai, Akiko, Sahasranaman, Srikumar, Punnoose, Elizabeth, Hurst, Deborah, and Pylypenko, Halyna

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Lymphoma, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Rare Diseases, Hematology, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Female, Humans, Kaplan-Meier Estimate, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Proto-Oncogene Proteins c-bcl-2, Rituximab, Sulfonamides, Treatment Outcome, B-cell, BH3, chronic lymphocytic leukemia, rituximab, clinical trial, ABT-263, BCL2, navitoclax, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

We evaluated the safety and biologic activity of the BH3 mimetic protein, navitoclax, combined with rituximab, in comparison to rituximab alone. One hundred and eighteen patients with chronic lymphocytic leukemia (CLL) were randomized to receive eight weekly doses of rituximab (arm A), eight weekly doses of rituximab plus daily navitoclax for 12 weeks (arm B) or eight weekly doses of rituximab plus daily navitoclax until disease progression or unacceptable toxicity (arm C). Investigator-assessed overall response rates (complete [CR] and partial [PR]) were 35% (arm A), 55% (arm B, p = 0.19 vs. A) and 70% (arm C, p = 0.0034 vs. A). Patients with del(17p) or high levels of BCL2 had significantly better clinical responses when treated with navitoclax. Navitoclax in combination with rituximab was well tolerated as initial therapy for patients with CLL, yielded higher response rates than rituximab alone and resulted in prolonged progression-free survival with treatment beyond 12 weeks.

Published
2015

8. 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, Colombel, Jean-Frederic, Lukas, Milan, Gisbert, Javier P, D'Haens, Geert, Hayee, Bu'hussain, Panaccione, Remo, Kim, Hyun-Soo, Reinisch, Walter, Tyrrell, Helen, Oh, Young S, Tole, Swati, Chai, Akiko, Chamberlain-James, Kirsten, Tang, Meina Tao, and Schreiber, Stefan

Subjects
610 Medicine & health
Abstract

BACKGROUND Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis. METHODS We conducted a randomised, double-blind, double-dummy, parallel-group, phase 3 study (GARDENIA) across 114 treatment centres worldwide. We included adults (age 18-80 years) with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. Patients were required to have had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. Participants were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks or intravenous infliximab 5 mg/kg at 0, 2, and 6 weeks and every 8 weeks thereafter for 52 weeks. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All participants and study site personnel were masked to treatment assignment. The primary endpoint was the proportion of patients who had both clinical response at week 10 (MCS ≥3-point decrease and ≥30% reduction from baseline, plus ≥1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) and clinical remission at week 54 (MCS ≤2, with individual subscores ≤1); efficacy was analysed using a modified intention-to-treat population (all randomised patients who received at least one dose of study drug). GARDENIA was designed to show superiority of etrolizumab over infliximab for the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT02136069, and is now closed to recruitment. FINDINGS Between Dec 24, 2014, and June 23, 2020, 730 patients were screened for eligibility and 397 were enrolled and randomly assigned to etrolizumab (n=199) or infliximab (n=198). 95 (48%) patients in the etrolizumab group and 103 (52%) in the infliximab group completed the study through week 54. At week 54, 37 (18·6%) of 199 patients in the etrolizumab group and 39 (19·7%) of 198 in the infliximab group met the primary endpoint (adjusted treatment difference -0·9% [95% CI -8·7 to 6·8]; p=0·81). The number of patients reporting one or more adverse events was similar between treatment groups (154 [77%] of 199 in the etrolizumab group and 151 [76%] of 198 in the infliximab group); the most common adverse event in both groups was ulcerative colitis (55 [28%] patients in the etrolizumab group and 43 [22%] in the infliximab group). More patients in the etrolizumab group reported serious adverse events (including serious infections) than did those in the infliximab group (32 [16%] vs 20 [10%]); the most common serious adverse event was ulcerative colitis (12 [6%] and 11 [6%]). There was one death during follow-up, in the infliximab group due to a pulmonary embolism, which was not considered to be related to study treatment. INTERPRETATION To our knowledge, this trial is the first phase 3 maintenance study in moderately to severely active ulcerative colitis to use infliximab as an active comparator. Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint. FUNDING F Hoffmann-La Roche.

Published
2022
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9. 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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10. 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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11. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

Rubin, David T, primary, Dotan, Iris, additional, DuVall, Aaron, additional, Bouhnik, Yoram, additional, Radford-Smith, Graham, additional, Higgins, Peter D R, additional, Mishkin, Daniel S, additional, Arrisi, Pablo, additional, Scalori, Astrid, additional, Oh, Young S, additional, Tole, Swati, additional, Chai, Akiko, additional, Chamberlain-James, Kirsten, additional, Lacey, Stuart, additional, McBride, Jacqueline, additional, Panés, Julian, additional, Rustem, Abdulkhakov, additional, Norasiah, Abu Bakar, additional, Humberto, Aguilar, additional, Diego, Aizenberg, additional, Hale, Akpinar, additional, Evangelos, Akriviadis, additional, Olga, Alexeeva, additional, Bagdadi, Alikhanov, additional, Andres, Alvarisqueta, additional, Ashwin, Ananthakrishnan, additional, Jane, Andrews, additional, Tomasz, Arlukowicz, additional, Nathan, Atkinson, additional, Ozlen, Atug, additional, Mauro, Bafutto, additional, Jozef, Balaz, additional, George, Bamias, additional, Marko, Banic, additional, Andrey, Baranovsky, additional, Guerino, Barbalaco Neto, additional, Metin, Basaranoglu, additional, Curtis, Baum, additional, Stefan, Baydanov, additional, William, Bennetts, additional, Fatih, Besisik, additional, Sudhir, Bhaskar, additional, Andrzej, Bielasik, additional, Leonid, Bilianskyi, additional, Bahri, Bilir, additional, Pavol, Blaha, additional, Verle, Bohman, additional, Julia, Borissova, additional, Vladimir, Borzan, additional, Francisco, Bosques-Padilla, additional, Yoram, Bouhnik, additional, James, Brooker, additional, Tetiana, Budko, additional, Igor, Budzak, additional, Ivan, Bunganic, additional, Jonathon, Chapman, additional, Azlida, Che' Aun, additional, Tatiana, Chernykh, additional, Michael, Chiorean, additional, Ivan, Chopey, additional, Dimitrios, Christodoulou, additional, Pui Shan, Chu, additional, Galina, Chumakova, additional, Andrew, Cummins, additional, Robert, Cunliffe, additional, Mirjana, Cvetkovic, additional, Ulku, Dagli, additional, Wit Cezary, Danilkiewicz, additional, Olena, Datsenko, additional, Carlos Fernando, de Magalhães Francesconi, additional, Henry, Debinski, additional, Elena, Deminova, additional, Jelena, Derova, additional, John Nik, Ding, additional, Julia, Dmitrieva, additional, Oleg, Dolgikh, additional, Tomas, Douda, additional, Piotr, Drobinski, additional, Gerald, Dryden, additional, Pedro, Duarte Gaburri, additional, George Aaron, DuVall, additional, Mikhail, Dvorkin, additional, Craig, Ennis, additional, Yusuf, Erzin, additional, Galyna, Fadieienko, additional, Oleksandr, Fediv, additional, Olga, Fedorishina, additional, Miroslav, Fedurco, additional, Roland, Fejes, additional, Jorge, Fernandez, additional, Monica Lorena, Fernandez, additional, Lucky, Flores, additional, Bradley, Freilich, additional, Keith, Friedenberg, additional, Sergio, Fuster, additional, Beata, Gawdis-Wojnarska, additional, Fabio Leonel, Gil Parada, additional, Edgardo Daniel, Gimenez, additional, Nataliia, Golovchenko, additional, Oleksandr, Golovchenko, additional, Maciej, Gonciarz, additional, Can, Gonen, additional, Glenn, Gordon, additional, Milos, Gregus, additional, Vladimir, Grinevich, additional, Rogelio, Guajardo Rodriguez, additional, Stephen, Hall, additional, John, Hanson, additional, Marek, Hartleb, additional, Xavier, Hebuterne, additional, Peter, Hendy, additional, Robert, Herring, additional, David, Hetzel, additional, Peter, Higgins, additional, Raouf, Hilal, additional, Ida Normiha, Hilmi, additional, Tibor, Hlavaty, additional, Richard, Holman, additional, Gerald, Holtmann, additional, John, Hong, additional, Frantisek, Horvath, additional, Ihor, Hospodarskyy, additional, Irena, Hrstic, additional, Sadettin, Hulagu, additional, Luis Alberto, Ibarra Verdugo, additional, Ikechukwu, Ibegbu, additional, Stephen, Inns, additional, Vladimir, Ivashkin, additional, James, Izanec, additional, Rajesh, Jain, additional, Zofia, Jamrozik-Kruk, additional, Victor, Kamburov, additional, John, Karagiannis, additional, Tarkan, Karakan, additional, Marek, Karczewski, additional, Irina, Kasherininova, additional, Seymour, Katz, additional, Barry, Kaufman, additional, Edita, Kazenaite, additional, Irina, Kholina, additional, Sunil, Khurana, additional, Jaroslaw, Kierkus, additional, Anzela, Kiselevska, additional, Dariusz, Kleczkowski, additional, Volodymyr, Klymenko, additional, Slavko, Knezevic, additional, Malgorzata, Kondusz-Szklarz, additional, Natalya, Korablina, additional, Bartosz, Korczowski, additional, Lyubomir, Kosturkov, additional, Iskren, Kotzev, additional, Georgios, Kouklakis, additional, Ioannis, Koutroubakis, additional, Richard, Krause, additional, Ian, Kronborg, additional, Miodrag, Krstic, additional, Zeljko, Krznaric, additional, Mikolaj, Krzyzanowski, additional, Grazyna, Kulig, additional, Karin, Kull, additional, Limas, Kupcinskas, additional, Mark, Lamet, additional, Tatjana, Latinovic Radakovic, additional, Rupert, Leong, additional, Wai Keung, Leung, additional, Henry, Levine, additional, Michael Kin Kong, Li, additional, Lúcia, Libanez Bessa Campelo Braga, additional, Maria, Livzan, additional, Tetiana, Lohdanidi, additional, Maria Helena, Louzada Pereira, additional, John, Lowe, additional, Kresimir, Luetic, additional, Milan, Lukas, additional, Yurii, Lymar, additional, Finlay, Macrae, additional, Anu, Mäelt, additional, Igor, Maev, additional, Arkadiusz, Mamos, additional, Gerasimos, Mantzaris, additional, Benno, Margus, additional, Ivanka, Marinova, additional, Inna, Markevych, additional, Mario, Markov, additional, Srdjan, Markovic, additional, Juan Ricardo, Marquez Velasquez, additional, Felipe, Mazzoleni, additional, Konstantinos, Mimidis, additional, Brent, Mitchell, additional, Gregory, Moore, additional, Luis Alonso, Morales Garza, additional, Salvatore, Moscatello, additional, Yuriy, Mostovoy, additional, Reme, Mountifield, additional, Aleksandar, Nagorni, additional, Viacheslav, Neshta, additional, Andrey, Obrezan, additional, Oleksandr, Oliinyk, additional, Genoile, Oliveira Santana Silva, additional, Maria, Orzeszko, additional, Vladimir, Pavlenko, additional, Dimitar, Pavlov, additional, Mariana, Penkova, additional, Sasa, Peric, additional, Plamen, Petkov, additional, Asen, Petrov, additional, Plamen, Petrov, additional, Michaela, Petrova, additional, Raymond, Phillips, additional, Sergio, Pintor Chacon, additional, Igor, Polianskyi, additional, Ludmyla, Prystupa, additional, Mykhailo, Pugach, additional, Ana Teresa, Pugas Carvalho, additional, Aldis, Pukitis, additional, Jiri, Pumprla, additional, Volodymyr, Pyrogovskyy, additional, Istvan, Racz, additional, Graham, Radford-Smith, additional, Raja Affendi, Raja Ali, additional, Daniel, Ramos Castañeda, additional, Odery, Ramos Júnior, additional, David, Rausher, additional, Andrey, Rebrov, additional, Jaroslaw, Regula, additional, Amir, Rezk, additional, Viktoriia, Reznikova, additional, Iaroslava, Rishko, additional, Xavier, Roblin, additional, Grigory, Rodoman, additional, Carlos Arturo, Rojas Rodriguez, additional, Jerzy, Rozciecha, additional, David, Rubin, additional, Maciej, Rupinski, additional, Jacek, Rzucidlo, additional, Oleg, Sablin, additional, Halil, Sahin, additional, Rosemi, Salleh, additional, Douglas, Samuel, additional, Antonio, Scafuto Scotton, additional, Robert, Schnabel, additional, Michael, Schulman, additional, Michael, Schultz, additional, John, Scott, additional, Shahriar, Sedghi, additional, Ahmad, Shaban, additional, Marina, Shapina, additional, Natalia, Shaposhnikova, additional, Oksana, Shchukina, additional, Alex, Sherman, additional, Irina, Shumikhina, additional, Vladimir, Simanenkov, additional, Vladislav, Simonov, additional, Giedrius, Simulionis, additional, Igor, Skrypnyk, additional, Zbigniew, Sliwowski, additional, Jan, Smid, additional, Mahmood, Solaiman, additional, Najm, Soofi, additional, Konstantinos, Soufleris, additional, Zoia, Spassova, additional, Mykola, Stanislavchuk, additional, Krystyna, Stec-Michalska, additional, Jonathas, Stifft, additional, Simeon, Stoinov, additional, Girgina, Stoyanova, additional, Keith, Sultan, additional, Lindsey, Surace, additional, Dimitar, Takov, additional, Jaak, Tälli, additional, Ludmila, Tankova, additional, Hugo, Tanno, additional, Dino, Tarabar, additional, Elias, Tarakji, additional, Konstantin, Tchernev, additional, Hoi Poh, Tee, additional, Lena, Thin, additional, Carlton, Thomas, additional, Irina, Tishaeva, additional, Tsveta, Todorova, additional, Oleksandr, Tokarenko, additional, Ivars, Tolmanis, additional, Ratko, Tomasevic, additional, Vasiliy, Trofimov, additional, Zsolt, Tulassay, additional, Belkis, Unsal, additional, Alma, Uzunova-Genova, additional, John, Valentine, additional, Ekaterina, Valuyskikh, additional, Eduardo, Vasconcellos, additional, Galina, Vasileva, additional, Sergiy, Vasylyuk, additional, Byron, Vaughn, additional, Francisco, Velazquez, additional, Vadym, Vizir, additional, Borislav, Vladimirov, additional, Miroslava, Volfova, additional, Petr, Vyhnalek, additional, Ian, Wallace, additional, Marek, Waluga, additional, William, Watkins, additional, John, Weber, additional, Anna, Wiechowska-Kozlowska, additional, Nathaniel, Winstead, additional, Pawel, Wojtkiewicz, additional, Barbara, Wozniak-Stolarska, additional, Bruce, Yacyshyn, additional, Alexey, Yakovlev, additional, Ziad, Younes, additional, Lígia, Yukie Sassaki, additional, Ilhami, Yuksel, additional, Jan, Zachar, additional, Cyrla, Zaltman, additional, Natasa, Zdravkovic Petrovic, additional, Vyacheslav, Zhdan, additional, Maryna, Zinchenko, additional, and Maciej, Zymla, additional

Published
2022
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12. Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study

Author

Vermeire, Severine, primary, Lakatos, Peter L, additional, Ritter, Timothy, additional, Hanauer, Stephen, additional, Bressler, Brian, additional, Khanna, Reena, additional, Isaacs, Kim, additional, Shah, Saumin, additional, Kadva, Alysha, additional, Tyrrell, Helen, additional, Oh, Young S, additional, Tole, Swati, additional, Chai, Akiko, additional, Pulley, Jennifer, additional, Eden, Christopher, additional, Zhang, Wenhui, additional, Feagan, Brian G, additional, Abraham, Philip, additional, Acir Crippa Júnior, Mauro, additional, Aguilar, Humberto, additional, Ahmed, Tasneem, additional, Altorjay, Istvan, additional, Andersen, Vibeke, additional, Arai, Ronen, additional, Arnold, Hays, additional, Ausk, Karlee, additional, Axler, Jeffrey, additional, Ayub, Kamran, additional, Balekuduru, Avinash, additional, Barbalaco Neto, Guerino, additional, Bassan, Isaac, additional, Behm, Brian, additional, Bekal, Pradeep, additional, Bhatia, Shobna, additional, Bod, Barnabas, additional, Brandão Mello, Carlos Eduardo, additional, Brandeburova, Julia, additional, Breedt, Johannes, additional, Chopey, Ivan, additional, Connor, Michael, additional, Corlin, Richard, additional, Cortez Hernandez, Carlos Alejandro, additional, De, Arijit, additional, de Sá Rolim, Alexander, additional, Di Felice Boratto, Sandra, additional, Dixon, Tyler, additional, Dourado Poli, Debora, additional, Dresner, David, additional, Du Vall, George Aaron, additional, Ebert, Matthias, additional, Ehehalt, Robert, additional, Ertan, Atilla, additional, Escarcega Valencia, Ruben, additional, Etzel, Jason, additional, Fallingborg, Jan, additional, Feagan, Brian, additional, Fedurco, Miroslav, additional, Fernandez Castro, Enrique, additional, Ferreira de Almeida Borges, Valéria, additional, Finklestein, Mark, additional, Fischer, Andreas, additional, Fleisher, Mark, additional, Flores Rendon, Angel Ricardo, additional, Fogel, Ronald, additional, Franceschi Junior, Osvaldo, additional, Freedland, Curtis, additional, Gatof, David, additional, Gill, Kanwar, additional, Glerup, Henning, additional, Gokak, Vardaraj, additional, Goldin, Eran, additional, Gomez Jaramillo, Hector Alejandro, additional, Gupta, Nitin, additional, Gurzo, Zoltan, additional, Gyrina, Olga, additional, Habeeb, Mohammed Aejaz, additional, Hardi, Robert, additional, Harlan, William, additional, Hemaidan, Ammar, additional, Heyman, Melvin, additional, Hoffmann, Peter, additional, Holderman, William, additional, Holtkamp-Endemann, Frank, additional, Horvat, Gyula, additional, Israeli, Eran, additional, Jankiel Miszputen, Sender, additional, Jensen, Søren, additional, Johnson, Kenneth, additional, Jones, Jennifer, additional, Junior, Osvaldo, additional, Kadleckova, Barbora, additional, Kalla, Mukesh, additional, Kallo, Zsuzsanna, additional, Karyotakis, Nicholas, additional, Katz, Lior, additional, Katz, Leo, additional, Kaur, Nirmal, additional, Kohout, Pavel, additional, Lakatos, Peter, additional, Larriva de los Reyes, Emmanuel, additional, Lee, Robert, additional, Leman, Bernard, additional, Levchenko, Olena, additional, Levine, Henry, additional, Libanez Bessa Campelo Braga, Lúcia, additional, Loftus, Edward, additional, Lohdanidi, Tetiana, additional, Longman, Randy, additional, Lozano, Josefina, additional, Maaser, Christian, additional, Madi-Szabo, Laszlo, additional, Malluta, Everson Fernando, additional, Marshall, John, additional, Martinez Silva, Francisca, additional, Maynard, Kenneth, additional, Meder, Agnieszka, additional, Mehta, Chetan, additional, Minarik, Peter, additional, Mueller, Joachim, additional, Mukewar, Shrikant, additional, Nagy, Bela, additional, Neiko, Vasyl, additional, Neurath, Markus, additional, Nichol, Brian, additional, Novick, James, additional, Pai, Nitin, additional, Pandak, William, additional, Panigrahi, Sarat, additional, Pape, Ulrich-Frank, additional, Paraná, Raymundo, additional, Parekh, Nimisha, additional, Patel, Bhaktasharan, additional, Pecsi, Gyula, additional, Peralta, Sergio, additional, Pesta, Martin, additional, Peterfai, Eva, additional, Petruzzellis, Carlo, additional, Petryka, Robert, additional, Pica, Roberta, additional, Piniella, Carlos, additional, Pratha, Vijayalakshmi, additional, Prochazka, Vlastimil, additional, Prokopchuk, Sergey, additional, Prystupa, Ludmyla, additional, Puri, Amarender, additional, Rainis, Tova, additional, Ramesh Kumar, Bhashyakarla, additional, Ramos Júnior, Odery, additional, Rishko, Iaroslava, additional, Robbins, Bryan, additional, Rock, Elizabeth, additional, Rodrigues Borba, Marcelo, additional, Rodriguez, Miguel, additional, Rozciecha, Jerzy, additional, Ruiz Flores, Azalia Yuriria, additional, Rydzewska, Grazyna, additional, Safadi, Rifaat, additional, Saibeni, Simone, additional, Schirbel, Anja, additional, Schmiegel, Wolff, additional, Schnabel, Róbert, additional, Schneider, Herbert, additional, Segui, Armando, additional, Seidelin, Jakob, additional, Seidler, Ursula, additional, Sellin, Joseph, additional, Shafran, Ira, additional, Sheikh, Aasim, additional, Sherman, Alex, additional, Shirin, Haim, additional, Shukla, Akash, additional, Siddiqui, Firdous, additional, Sike, Robert, additional, Sood, Ajit, additional, Stallmach, Andreas, additional, Stanislavchuk, Mykola, additional, Staun, Michael, additional, Stein, Daniel, additional, Steinberg, Alon, additional, Steinhart, Hillary, additional, Stifft, Jonathas, additional, Tandon, Rakesh, additional, Tantry, Vishwanath, additional, Thiwan, Syed, additional, Treiber, Matthias, additional, Ulbrych, Jan, additional, Valentine, John, additional, Vasudeva, Rajeev, additional, Vaughn, Byron, additional, Velasco, Brenda, additional, Vincze, Aron, additional, Volfova, Miroslava, additional, Waterman, Mattitiahu, additional, Weiss, L. Michael, additional, Wiesner, Elise, additional, Williams, Alonzo, additional, Witthoeft, Thomas, additional, Wohlman, Robert, additional, Wright, John, additional, Yamamoto Furusho, Jesus Kazuo, additional, Younes, Ziad, additional, Yousuf, Khurshid, additional, Zborivskyy, Yaroslav, additional, Zeuzem, Stefan, additional, and Zhdan, Vyacheslav, additional

Published
2022
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13. Using prednisolone and cortisol assays to assess adherence in oral corticosteroid dependant asthma: An analysis of test-retest repeatability

Author

Busby, John, primary, Holweg, Cecile, additional, Chai, Akiko, additional, Bradding, Peter, additional, Chaudhuri, Rekha, additional, Mansur, Adel, additional, Matthews, John G., additional, Menzies-Gow, Andrew, additional, Lordan, James, additional, Niven, Rob, additional, and Heaney, Liam G., additional

Published
2020
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15. Change in type-2 biomarkers and related cytokines with prednisolone in uncontrolled severe oral corticosteroid dependent asthmatics: an interventional open-label study

Author

Busby, John, primary, Holweg, Cecile T J, additional, Chai, Akiko, additional, Bradding, Peter, additional, Cai, Fang, additional, Chaudhuri, Rekha, additional, Mansur, Adel H, additional, Lordan, James Laurence, additional, Matthews, John G, additional, Menzies-Gow, Andrew, additional, Niven, Robert, additional, Staton, Tracy, additional, and Heaney, Liam G, additional

Published
2019
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16. Concurrent Oral 1 - Rheumatoid Arthritis: Treatment [OP4-OP9]: OP4. Inhibition of Radiographic Progression and Improvements in Physical Function at 2 Years, with Increasing Clinical Efficacy Over Time, in Rheumatoid Arthritis (Ra) Patients Treated with Tocilizumab (Tcz): The Lithe Study

Author

Fleischmann, R., Burgos-Vargas, R., Ambs, P., Alecock, E., Kremer, J., Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah P., Hyrich, Kimme L., Tak, Paul P., Rigby, William, Rubbert, Andrea, Peterfy, Charles, van Vollenhoven, Ronald F., Stohl, William, Hessey, Eva, Chen, Annie, Tyrrell, Helen, Shaw, Tim, Genovese, Mark C., Breedveld, Ferdinand C., Emery, Paul, Cohen, Stanley B., Keystone, Edward C., Matteson, Eric L., Burke, Laura S., Chai, Akiko, Reiss, William G., Sweetser, Marianne T., Shaw, Tim M., Owen, Sally A., Eyre, Stephen, Martin, Paul, Hider, Samantha, Bruce, Ian N., Barton, Anne, Thomson, Wendy, Jones, G., Gomez-Reino, J. J., Lowenstein, M. B., Tornero, J., Sebba, A., Guarin, E., Genovese, M., Fleischmann, R., Burgos-Vargas, R., Ambs, P., Alecock, E., Kremer, J., Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah P., Hyrich, Kimme L., Tak, Paul P., Rigby, William, Rubbert, Andrea, Peterfy, Charles, van Vollenhoven, Ronald F., Stohl, William, Hessey, Eva, Chen, Annie, Tyrrell, Helen, Shaw, Tim, Genovese, Mark C., Breedveld, Ferdinand C., Emery, Paul, Cohen, Stanley B., Keystone, Edward C., Matteson, Eric L., Burke, Laura S., Chai, Akiko, Reiss, William G., Sweetser, Marianne T., Shaw, Tim M., Owen, Sally A., Eyre, Stephen, Martin, Paul, Hider, Samantha, Bruce, Ian N., Barton, Anne, Thomson, Wendy, Jones, G., Gomez-Reino, J. J., Lowenstein, M. B., Tornero, J., Sebba, A., Guarin, E., and Genovese, M.

Abstract

Background: Patients with moderate to severe RA who remained on methotrexate (MTX) despite inadequate response were treated with TCZ in a double-blind, randomized, controlled phase 3 trial. Results of a 2-year planned analysis from this study are presented. Methods: Patients were randomized to treatment with TCZ 4 mg/kg + MTX (TCZ4), TCZ 8 mg/kg + MTX (TCZ8) or placebo + MTX (CON) every 4 weeks. If patients failed to respond (<20% improvement in swollen and tender joint count; SJC and TJC) then stepwise rescue therapy could begin at week 16. Patients with ≥ 70% improvement in SJC and TJC could continue the blinded therapy at the end of year 1 to week 104. For all other patients, open-label TCZ8 was initiated at week 52. Change from baseline in Genant-modified total Sharp score (GmTSS) and physical function (AUC of change from baseline in HAQ-DI) were the primary 2-year end points. Linear extrapolation (GmTSS) or standardization (change in HAQ-DI) was used for missing data. The impact of 2 years of treatment was examined by assessing efficacy end points over time for patients randomized to TCZ8, with the last observation carried forward for SJC and TJC in patients who received rescue therapy or withdrew. Results: The intention to treat population consisted of 398 TCZ8, 399 TCZ4 and 393 CON patients. At 2 years, exposure rates in patient-years (PY) were 1320.0, 521.9 and 284.8 in TCZ8, TCZ4 and CON patients, respectively. At year 2, patients in the TCZ8 group had 81% less radiographic progression vs CON patients (based on linear extrapolation of mean change in GmTSS). Significantly more TCZ8 patients had no radiographic progression vs CON patients (P ≤ 0.0001). AUC of change from baseline in HAQ-DI showed significant improvement in physical function in TCZ4 and in TCZ8 vs CON patients (P ≤ 0.0025). In patients initially randomized to TCZ8, a low disease activity score (LDAS; DAS28 < 3.2) was seen in > 60% of patients and the DAS28 remission (DAS28 < 2.6) rate was 48%

Published
2017

17. Rheumatoid arthritis - treatment: 180. Utility of Body Weight Classified Low-Dose Leflunomide in Japanese Rheumatoid Arthritis

Author

Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, Venables, Patrick, Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, and Venables, Patrick

Abstract

Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient die

Published
2017

20. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study

Author

Sehn, Laurie H., primary, Goy, Andre, additional, Offner, Fritz C., additional, Martinelli, Giovanni, additional, Caballero, M. Dolores, additional, Gadeberg, Ole, additional, Baetz, Tara, additional, Zelenetz, Andrew D., additional, Gaidano, Gianluca, additional, Fayad, Luis E., additional, Buckstein, Rena, additional, Friedberg, Jonathan W., additional, Crump, Michael, additional, Jaksic, Branimir, additional, Zinzani, Pier Luigi, additional, Padmanabhan Iyer, Swaminathan, additional, Sahin, Deniz, additional, Chai, Akiko, additional, Fingerle-Rowson, Günter, additional, and Press, Oliver W., additional

Published
2015
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23. Preliminary results of a phase II randomized study (ROMULUS) of polatuzumab vedotin (PoV) or pinatuzumab vedotin (PiV) plus rituximab (RTX) in patients (Pts) with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).

Author

Morschhauser, Franck, primary, Flinn, Ian, additional, Advani, Ranjana H., additional, Sehn, Laurie Helen, additional, Kolibaba, Kathryn S., additional, Press, Oliver W., additional, Salles, Gilles A., additional, Magid Diefenbach, Catherine S., additional, Tilly, Herve, additional, Assouline, Sarit E., additional, Chen, Andrew Tzong-Yow, additional, Dreyling, Martin H., additional, Hagenbeek, Anton, additional, Zinzani, Pier Luigi, additional, Cheson, Bruce D., additional, Yalamanchili, Sreenivasu, additional, Lu, Dan, additional, Chai, Akiko, additional, Chu, Yu-Waye, additional, and Sharman, Jeff Porter, additional

Published
2014
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24. Phase III safety study of rituximab administered as a 90-minute infusion in patients with previously untreated diffuse large B-cell and follicular lymphoma

Author

Dakhil, Shaker, primary, Hermann, Robert, additional, Schreeder, Marshall T., additional, Gregory, Stephanie A., additional, Monte, Marc, additional, Windsor, Kevin S., additional, Hurst, Deborah, additional, Chai, Akiko, additional, Brewster, Michael, additional, and Richards, Paul, additional

Published
2014
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25. Final Results Of a Phase I Study Of The Anti-CD22 Antibody-Drug Conjugate (ADC) DCDT2980S With Or Without Rituximab (RTX) In Patients (Pts) With Relapsed Or Refractory (R/R) B-Cell Non-Hodgkin’s Lymphoma (NHL)

Author

Advani, Ranjana, primary, Chen, Andy I., additional, Lebovic, Daniel, additional, Brunvand, Mark W., additional, Goy, Andre, additional, Chang, Julie E., additional, Hochberg, Ephraim, additional, Yalamanchili, Sreeni, additional, Kahn, Robert, additional, Lu, Dan, additional, Chai, Akiko, additional, Chu, Yu-Waye, additional, and Cheson, Bruce D., additional

Published
2013
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26. Final Results Of a Phase I Study Of The Anti-CD79b Antibody-Drug Conjugate DCDS4501A In Relapsed Or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (NHL)

Author

Palanca-Wessels, Maria Corinna, primary, Salles, Gilles Andre, additional, Czuczman, Myron S., additional, Assouline, Sarit E., additional, Flinn, Ian W., additional, Sehn, Laurie H., additional, Patel, Manish, additional, Sangha, Randeep, additional, Tilly, Herve, additional, Advani, Ranjana, additional, Casasnovas, Olivier, additional, Press, Oliver W., additional, Yalamanchili, Sreeni, additional, Kahn, Robert, additional, Lu, Dan, additional, Chai, Akiko, additional, Chu, Yu-Waye, additional, and Morschhauser, Franck, additional

Published
2013
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34. Rheumatoid arthritis - treatment: 180. Utility of Body Weight Classified Low-Dose Leflunomide in Japanese Rheumatoid Arthritis

Author

Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, Venables, Patrick, Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, and Venables, Patrick

Abstract

Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient die

35. Concurrent Oral 1 - Rheumatoid Arthritis: Treatment [OP4-OP9]: OP4. Inhibition of Radiographic Progression and Improvements in Physical Function at 2 Years, with Increasing Clinical Efficacy Over Time, in Rheumatoid Arthritis (Ra) Patients Treated with Tocilizumab (Tcz): The Lithe Study

Author

Fleischmann, R., Burgos-Vargas, R., Ambs, P., Alecock, E., Kremer, J., Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah P., Hyrich, Kimme L., Tak, Paul P., Rigby, William, Rubbert, Andrea, Peterfy, Charles, van Vollenhoven, Ronald F., Stohl, William, Hessey, Eva, Chen, Annie, Tyrrell, Helen, Shaw, Tim, Genovese, Mark C., Breedveld, Ferdinand C., Emery, Paul, Cohen, Stanley B., Keystone, Edward C., Matteson, Eric L., Burke, Laura S., Chai, Akiko, Reiss, William G., Sweetser, Marianne T., Shaw, Tim M., Owen, Sally A., Eyre, Stephen, Martin, Paul, Hider, Samantha, Bruce, Ian N., Barton, Anne, Thomson, Wendy, Jones, G., Gomez-Reino, J. J., Lowenstein, M. B., Tornero, J., Sebba, A., Guarin, E., Genovese, M., Fleischmann, R., Burgos-Vargas, R., Ambs, P., Alecock, E., Kremer, J., Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah P., Hyrich, Kimme L., Tak, Paul P., Rigby, William, Rubbert, Andrea, Peterfy, Charles, van Vollenhoven, Ronald F., Stohl, William, Hessey, Eva, Chen, Annie, Tyrrell, Helen, Shaw, Tim, Genovese, Mark C., Breedveld, Ferdinand C., Emery, Paul, Cohen, Stanley B., Keystone, Edward C., Matteson, Eric L., Burke, Laura S., Chai, Akiko, Reiss, William G., Sweetser, Marianne T., Shaw, Tim M., Owen, Sally A., Eyre, Stephen, Martin, Paul, Hider, Samantha, Bruce, Ian N., Barton, Anne, Thomson, Wendy, Jones, G., Gomez-Reino, J. J., Lowenstein, M. B., Tornero, J., Sebba, A., Guarin, E., and Genovese, M.

Abstract

Background: Patients with moderate to severe RA who remained on methotrexate (MTX) despite inadequate response were treated with TCZ in a double-blind, randomized, controlled phase 3 trial. Results of a 2-year planned analysis from this study are presented. Methods: Patients were randomized to treatment with TCZ 4 mg/kg + MTX (TCZ4), TCZ 8 mg/kg + MTX (TCZ8) or placebo + MTX (CON) every 4 weeks. If patients failed to respond (<20% improvement in swollen and tender joint count; SJC and TJC) then stepwise rescue therapy could begin at week 16. Patients with ≥ 70% improvement in SJC and TJC could continue the blinded therapy at the end of year 1 to week 104. For all other patients, open-label TCZ8 was initiated at week 52. Change from baseline in Genant-modified total Sharp score (GmTSS) and physical function (AUC of change from baseline in HAQ-DI) were the primary 2-year end points. Linear extrapolation (GmTSS) or standardization (change in HAQ-DI) was used for missing data. The impact of 2 years of treatment was examined by assessing efficacy end points over time for patients randomized to TCZ8, with the last observation carried forward for SJC and TJC in patients who received rescue therapy or withdrew. Results: The intention to treat population consisted of 398 TCZ8, 399 TCZ4 and 393 CON patients. At 2 years, exposure rates in patient-years (PY) were 1320.0, 521.9 and 284.8 in TCZ8, TCZ4 and CON patients, respectively. At year 2, patients in the TCZ8 group had 81% less radiographic progression vs CON patients (based on linear extrapolation of mean change in GmTSS). Significantly more TCZ8 patients had no radiographic progression vs CON patients (P ≤ 0.0001). AUC of change from baseline in HAQ-DI showed significant improvement in physical function in TCZ4 and in TCZ8 vs CON patients (P ≤ 0.0025). In patients initially randomized to TCZ8, a low disease activity score (LDAS; DAS28 < 3.2) was seen in > 60% of patients and the DAS28 remission (DAS28 < 2.6) rate was 48%

36. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study

Author

Jonathan W. Friedberg, Michael Crump, Ole V. Gadeberg, Oliver W. Press, Pier Luigi Zinzani, Akiko Chai, Laurie H. Sehn, Swaminathan Padmanabhan Iyer, Tara Baetz, Günter Fingerle-Rowson, Gianluca Gaidano, M. Dolores Caballero, Andre Goy, Andrew D. Zelenetz, Rena Buckstein, Giovanni Martinelli, Deniz Sahin, Luis Fayad, Branimir Jakšić, Fritz Offner, Sehn, Laurie H, Goy, Andre, Offner, Fritz C, Martinelli, Giovanni, Caballero, M Dolore, Gadeberg, Ole, Baetz, Tara, Zelenetz, Andrew D, Gaidano, Gianluca, Fayad, Luis E, Buckstein, Rena, Friedberg, Jonathan W, Crump, Michael, Jaksic, Branimir, Zinzani, Pier Luigi, Padmanabhan Iyer, Swaminathan, Sahin, Deniz, Chai, Akiko, Fingerle-Rowson, Günter, and Press, Oliver W

Subjects
Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Lymphoma, B-Cell, Chronic lymphocytic leukemia, Follicular lymphoma, Lymphoma, B-Cell/drug therapy, Antineoplastic Agents, Antibodies, Monoclonal, Humanized, Disease-Free Survival, Drug Administration Schedule, Antigens, CD20/biosynthesis, Rituximab/administration & dosage, chemistry.chemical_compound, Maintenance therapy, Obinutuzumab, immune system diseases, Internal medicine, hemic and lymphatic diseases, follicular lymphoma, Obinutuzumab, GA101, anti-CD20 monoclonal antibody, non-Hodgkin lymphoma, relapsed/refractory non-Hodgkin lymphoma, obinutuzumab with rituximab, relapsed indolent lymphoma, medicine, Humans, Prospective Studies, Infusions, Intravenous, Aged, CD20, Aged, 80 and over, biology, business.industry, CHRONIC LYMPHOCYTIC-LEUKEMIA MONOCLONAL-ANTIBODY THERAPY ADVANCED FOLLICULAR LYMPHOMA PROGRESSION-FREE SURVIVAL LOW-GRADE SIGNIFICANTLY INCREASES MAINTENANCE TREATMENT ANTI-CD20 ANTIBODY PROLONGS SURVIVAL CYCLOPHOSPHAMIDE, ORIGINAL REPORTS, Middle Aged, medicine.disease, Antigens, CD20, Lymphoma, Surgery, Antineoplastic Agents/administration & dosage, chemistry, biology.protein, B-Cell Non-Hodgkin Lymphoma, Rituximab, Female, business, medicine.drug, Antibodies, Monoclonal, Humanized/administration & dosage
Abstract

Purpose Obinutuzumab (GA101), a novel glycoengineered type II anti-CD20 monoclonal antibody, demonstrated responses in single-arm studies of patients with relapsed/refractory non-Hodgkin lymphoma. This is the first prospective, randomized study comparing safety and efficacy of obinutuzumab with rituximab in relapsed indolent lymphoma. The primary end point of this study was the overall response rate (ORR) in patients with follicular lymphoma after induction and safety in patients with indolent lymphoma. Patients and Methods A total of 175 patients with relapsed CD20+ indolent lymphoma requiring therapy and with previous response to a rituximab-containing regimen were randomly assigned (1:1) to four once-per-week infusions of either obinutuzumab (1,000 mg) or rituximab (375 mg/m2). Patients without evidence of disease progression after induction therapy received obinutuzumab or rituximab maintenance therapy every 2 months for up to 2 years. Results Among patients with follicular lymphoma (n = 149), ORR seemed higher for obinutuzumab than rituximab (44.6% v 33.3%; P = .08). This observation was also demonstrated by a blinded independent review panel that measured a higher ORR for obinutuzumab (44.6% v 26.7%; P = .01). However, this difference did not translate into an improvement in progression-free survival. No new safety signals were observed for obinutuzumab, and the incidence of adverse events was balanced between arms, with the exception of infusion-related reactions and cough, which were higher in the obinutuzumab arm. Conclusion Obinutuzumab demonstrated a higher ORR without appreciable differences in safety compared with rituximab. However, the clinical benefit of obinutuzumab in this setting remains unclear and should be evaluated within phase III trials.

Published
2015

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