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2. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study

Author

Abrahamovych, Orest, Afanasieva, Halyna, Aitova, Lilia, Altintas, Engin, Altwegg, Romain, Andreev, Pavel, Aomatsu, Kazuki, Augustyn, Monika, Balestrieri, Paola, Begun, Jakob, Brunatto, Luciana, Bulgheroni, Diego, Bunkova, Elena, Cabello, Mercedes, Cao, Qian, Caprioli, Flavio, Cerqueira, Rute, Chen, Baili, Chen, Chou-Chen, Chen, Chou-Pin, Chiu, Cheng-Tang, Choi, Chang Hwan, Cicala, Michele, Datsenko, Olena, Dewint, Pieter, Domenech, Eugeni, Dutré, Joris, Duvall, George, Fernandez, Juan, Filip, Rafal, Fogel, Ronald, Fowler, Sharyle, Fujii, Toshimitsu, Fukata, Masayuki, Furumoto, Yohei, Gasbarrini, Antonio, Gawdis-Wojnarska, Beata, Gilletta, Cyrielle, Gionchetti, Paolo, Goldin, Eran, Golovchenko, Oleksandr, Gonciarz, Maciej, Gonen, Can, Segura, Gaston Gonzalez, Gridnyev, Oleksii, Gyokeres, Tibor, Hébuterne, Xavier, Hedin, Charlotte, Hellström, Per, Hilmi, Ida Normiha, Horný, Ivo, Horvat, Gyula, Hoshi, Namiko, Hrdlicka, Ludek, Ishihara, Shunji, Ivanishyn, Olha, Jang, Byung Ik, Junior, Odery, Kagaya, Takashi, Kanmura, Shuji, Karakina, Marina, Katsuhiko, Nakai, Kierkus, Jaroslaw, Kim, Hyo Jong, Kim, Tae-Oh, Kim, Young-Ho, Kiss, Gyula G., Klaus, Jochen, Kleczkowski, Dariusz, Klopocka, Maria, Kobayashi, Taku, Kobielusz-Gembala, Iwona, Koo, Ja Seol, Kopon, Adam, Kravchenko, Tetiana, Kudo, Masatoshi, Kwon, Kwang An, Lago, Paula, Laharie, David, Lawrance, Ian, Leszczyszyn, Jaroslaw, Li, Yan, Lukas, Milan, Maaser, Christian, Maemoto, Atsuo, Marusawa, Hiroyuki, McBride, Matthew, Mendu, Shoba, Miheller, Pal, Miyabayashi, Hideharu, Mohl, Wolfgang, Moore, Gregory, Motoya, Satoshi, Murali, Narayanachar, Naem, Mohammed, Nakajima, Koichi, Nakamoto, Yasunari, Nancey, Stéphane, Neto, Joaquim, Onizawa, Michio, Ono, Yohei, Osada, Taro, Osipenko, Marina, Owczarek, Danuta, Patel, Bhaktasharan, Patel, Kamal, Petrova, Elina, Poroshina, Elena, Portela, Francisco, Prystupa, Lyudmyla, Rivero, Monserrat, Roblin, Xavier, Romatowski, Jacek, Rydzewska, Grazyna, Saibeni, Simone, Sakuraba, Hirotake, Samaan, Mark, Schultz, Michael, Schulze, Joerg, Sedghi, Shahriar, Seidler, Ursula, Shin, Sung Jae, Stanislavchuk, Mykola, Stokesberry, David, Suzuki, Takayoshi, Taguchi, Hiroki, Tankova, Lyudmila, Thin, Lena, Tkachev, Alexander, Torrealba, Leyanira, Tsarynna, Nataliia, Tulassay, Zsolt, Ueo, Tetsuya, Valuyskikh, Ekaterina, Vasilevskaya, Olga, Viamonte, Manuel, Wei, Shu-Chen, Weisshof, Roni, Wojcik, Katarzyna, Ye, Byong Duk, Yen, Hsu-Heng, Yoon, Hyuk, Yoshida, Kosuke, Yurkiv, Andriy, Zaha, Osamu, Zhan, Qiang, Peyrin-Biroulet, Laurent, Allegretti, Jessica R., Rubin, David T., Bressler, Brian, Germinaro, Matthew, Huang, Kuan-Hsiang (Gary), Shipitofsky, Nicole, Zhang, Hongyan, Wilson, Rebbecca, Han, Chenglong, Feagan, Brian G., Sandborn, William J., Panés, Julian, Hisamatsu, Tadakazu, Lichtenstein, Gary R., Sands, Bruce E., and Dignass, Axel

Published
2023
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3. Higher Anti-tumor Necrosis Factor-α Levels Correlate With Improved Radiologic Outcomes in Crohn’s Perianal Fistulas

Author

De Gregorio, Michael, Lee, Tanya, Krishnaprasad, Krupa, Amos, Gregory, An, Yoon-Kyo, Bastian-Jordan, Matthew, Begun, Jakob, Borok, Nira, Brown, Dougal J.M., Cheung, Wa, Connor, Susan J., Gerstenmaier, Jan, Gilbert, Lauren E., Gilmore, Robert, Gu, Bonita, Kutaiba, Numan, Lee, Allan, Mahy, Gillian, Srinivasan, Ashish, Thin, Lena, Thompson, Alexander J., Welman, Christopher J., Yong, Eric X.Z., De Cruz, Peter, van Langenberg, Daniel, Sparrow, Miles P., and Ding, Nik S.

Published
2022
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4. 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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5. High Technical Success Rate of Endoscopic Balloon Dilatation Reduces Surgical Requirement for Patients With Stricturing Crohn’s Disease

Author

Lim, Emily, primary, Thai, Maxter, additional, An, Yoon-Kyo, additional, Hendy, Peter, additional, Alchlaihawi, Mahmoud, additional, Leong, Rupert, additional, Connor, Susan, additional, Ng, Watson, additional, Gu, Bonita, additional, Thin, Lena, additional, Sparrow, Miles, additional, Gilmore, Robert, additional, Taylor, Kirstin, additional, Sallis, Olivia, additional, Andrews, Jane M., additional, Daker, Charlotte, additional, Gearry, Richard B., additional, Wark, Gabrielle, additional, Ghaly, Simon, additional, Begun, Matt, additional, Krishnaprasad, Krupa, additional, Wu, Tianhong, additional, Ruddick-Collins, Leonie, additional, Schreiber, Veronika, additional, Okano, Satomi, additional, Radford-Smith, Graham, additional, Schulberg, Julien, additional, van Langenberg, Daniel, additional, and Begun, Jakob, additional

Published
2024
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7. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study

Author

Peyrin-Biroulet, Laurent, primary, Allegretti, Jessica R., additional, Rubin, David T., additional, Bressler, Brian, additional, Germinaro, Matthew, additional, Huang, Kuan-Hsiang (Gary), additional, Shipitofsky, Nicole, additional, Zhang, Hongyan, additional, Wilson, Rebbecca, additional, Han, Chenglong, additional, Feagan, Brian G., additional, Sandborn, William J., additional, Panés, Julian, additional, Hisamatsu, Tadakazu, additional, Lichtenstein, Gary R., additional, Sands, Bruce E., additional, Dignass, Axel, additional, Abrahamovych, Orest, additional, Afanasieva, Halyna, additional, Aitova, Lilia, additional, Altintas, Engin, additional, Altwegg, Romain, additional, Andreev, Pavel, additional, Aomatsu, Kazuki, additional, Augustyn, Monika, additional, Balestrieri, Paola, additional, Begun, Jakob, additional, Brunatto, Luciana, additional, Bulgheroni, Diego, additional, Bunkova, Elena, additional, Cabello, Mercedes, additional, Cao, Qian, additional, Caprioli, Flavio, additional, Cerqueira, Rute, additional, Chen, Baili, additional, Chen, Chou-Chen, additional, Chen, Chou-Pin, additional, Chiu, Cheng-Tang, additional, Choi, Chang Hwan, additional, Cicala, Michele, additional, Datsenko, Olena, additional, Dewint, Pieter, additional, Domenech, Eugeni, additional, Dutré, Joris, additional, Duvall, George, additional, Fernandez, Juan, additional, Filip, Rafal, additional, Fogel, Ronald, additional, Fowler, Sharyle, additional, Fujii, Toshimitsu, additional, Fukata, Masayuki, additional, Furumoto, Yohei, additional, Gasbarrini, Antonio, additional, Gawdis-Wojnarska, Beata, additional, Gilletta, Cyrielle, additional, Gionchetti, Paolo, additional, Goldin, Eran, additional, Golovchenko, Oleksandr, additional, Gonciarz, Maciej, additional, Gonen, Can, additional, Segura, Gaston Gonzalez, additional, Gridnyev, Oleksii, additional, Gyokeres, Tibor, additional, Hébuterne, Xavier, additional, Hedin, Charlotte, additional, Hellström, Per, additional, Hilmi, Ida Normiha, additional, Horný, Ivo, additional, Horvat, Gyula, additional, Hoshi, Namiko, additional, Hrdlicka, Ludek, additional, Ishihara, Shunji, additional, Ivanishyn, Olha, additional, Jang, Byung Ik, additional, Junior, Odery, additional, Kagaya, Takashi, additional, Kanmura, Shuji, additional, Karakina, Marina, additional, Katsuhiko, Nakai, additional, Kierkus, Jaroslaw, additional, Kim, Hyo Jong, additional, Kim, Tae-Oh, additional, Kim, Young-Ho, additional, Kiss, Gyula G., additional, Klaus, Jochen, additional, Kleczkowski, Dariusz, additional, Klopocka, Maria, additional, Kobayashi, Taku, additional, Kobielusz-Gembala, Iwona, additional, Koo, Ja Seol, additional, Kopon, Adam, additional, Kravchenko, Tetiana, additional, Kudo, Masatoshi, additional, Kwon, Kwang An, additional, Lago, Paula, additional, Laharie, David, additional, Lawrance, Ian, additional, Leszczyszyn, Jaroslaw, additional, Li, Yan, additional, Lukas, Milan, additional, Maaser, Christian, additional, Maemoto, Atsuo, additional, Marusawa, Hiroyuki, additional, McBride, Matthew, additional, Mendu, Shoba, additional, Miheller, Pal, additional, Miyabayashi, Hideharu, additional, Mohl, Wolfgang, additional, Moore, Gregory, additional, Motoya, Satoshi, additional, Murali, Narayanachar, additional, Naem, Mohammed, additional, Nakajima, Koichi, additional, Nakamoto, Yasunari, additional, Nancey, Stéphane, additional, Neto, Joaquim, additional, Onizawa, Michio, additional, Ono, Yohei, additional, Osada, Taro, additional, Osipenko, Marina, additional, Owczarek, Danuta, additional, Patel, Bhaktasharan, additional, Patel, Kamal, additional, Petrova, Elina, additional, Poroshina, Elena, additional, Portela, Francisco, additional, Prystupa, Lyudmyla, additional, Rivero, Monserrat, additional, Roblin, Xavier, additional, Romatowski, Jacek, additional, Rydzewska, Grazyna, additional, Saibeni, Simone, additional, Sakuraba, Hirotake, additional, Samaan, Mark, additional, Schultz, Michael, additional, Schulze, Joerg, additional, Sedghi, Shahriar, additional, Seidler, Ursula, additional, Shin, Sung Jae, additional, Stanislavchuk, Mykola, additional, Stokesberry, David, additional, Suzuki, Takayoshi, additional, Taguchi, Hiroki, additional, Tankova, Lyudmila, additional, Thin, Lena, additional, Tkachev, Alexander, additional, Torrealba, Leyanira, additional, Tsarynna, Nataliia, additional, Tulassay, Zsolt, additional, Ueo, Tetsuya, additional, Valuyskikh, Ekaterina, additional, Vasilevskaya, Olga, additional, Viamonte, Manuel, additional, Wei, Shu-Chen, additional, Weisshof, Roni, additional, Wojcik, Katarzyna, additional, Ye, Byong Duk, additional, Yen, Hsu-Heng, additional, Yoon, Hyuk, additional, Yoshida, Kosuke, additional, Yurkiv, Andriy, additional, Zaha, Osamu, additional, and Zhan, Qiang, additional

Published
2023
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8. Prevalence and risk factors for early medical and surgical complications following an admission for acute severe ulcerative colitis.

Author

Li, Angel, Coote, Matthew, and Thin, Lena

Subjects
SURGICAL complications, ULCERATIVE colitis, PREOPERATIVE risk factors, COLECTOMY, SERUM albumin
Abstract

Background: Risk factors for colectomy following an episode of acute severe ulcerative colitis (ASUC) have been well studied, but data examining the early complications following an episode is limited. Objectives: We aimed to evaluate the prevalence and risk factors for medical and surgical complications within 90 days of an ASUC admission and determine if a high-intensity induction infliximab dose is associated with these complications. Design: Retrospective analysis. Methods: We conducted a retrospective study of ASUC admissions between January 2015 and July 2021 at a tertiary hospital. The primary outcome was the prevalence of total, medical and surgical complications within 90 days following an ASUC admission. Multivariate linear regression analysis assessed for factors associated with the prevalence of complications. Results: A total of 150 patients had 186 hospital admissions for ASUC. In total, 101/186 (54.3%) admissions required rescue medical therapy. Standard infliximab induction occurred in 65/100 admissions, accelerated infliximab induction in 35/100 and cyclosporine in 1/100 of admissions. In total, 117 complications, including 74/117 (63.2%) medical and 43/117 (36.8%) surgical complications, arose. Low serum albumin was independently associated with a higher incidence of total [β = −0.08 (95% confidence interval (CI): −0.15, −0.01), p = 0.03] and surgical complications [β = −0.1 (95% CI: −0.18, −0.001), p = 0.047], while an increased age was associated with increased incidence of surgical complications [β = 0.06 (95% CI: 0.01, 0.12), p = 0.02]. A higher Charlson score was associated with increased medical complications [β = 0.12 (95% CI: 0.01, 0.24), p = 0.03]. Infliximab induction dose intensity was not associated with an increased incidence of any complications. Conclusion: Early complications following an ASUC admission is prevalent although the majority are not serious. Risk factors associated with complications include low serum albumin, older age and a higher comorbidity score. Induction infliximab dose intensity, however, is not a risk factor. [ABSTRACT FROM AUTHOR]

Published
2023
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11. sj-docx-1-tag-10.1177_17562848231167280 – Supplemental material for The yield of dysplasia and serrated lesions in a single-centre tertiary inflammatory bowel disease cohort

Author

Yeaman, Fiona and Thin, Lena

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

Supplemental material, sj-docx-1-tag-10.1177_17562848231167280 for The yield of dysplasia and serrated lesions in a single-centre tertiary inflammatory bowel disease cohort by Fiona Yeaman and Lena Thin in Therapeutic Advances in Gastroenterology

Published
2023
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12. 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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14. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

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

Subjects
Ulcerative Colitis Flare, Adult, Male, medicine.medical_specialty, Adolescent, Population, Placebo, Antibodies, Monoclonal, Humanized, Gastroenterology, Severity of Illness Index, Placebos, Young Adult, Double-Blind Method, Gastrointestinal Agents, Internal medicine, Adalimumab, Medicine, Humans, Adverse effect, education, Aged, education.field_of_study, Hepatology, business.industry, Remission Induction, Colonoscopy, Induction Chemotherapy, Middle Aged, medicine.disease, Symptom Flare Up, Ulcerative colitis, Concomitant, Etrolizumab, Colitis, Ulcerative, Female, business, medicine.drug
Abstract

Summary Background Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis. Methods HIBISCUS I and HIBISCUS II were identically designed, multicentre, phase 3, randomised, double-blind, placebo-controlled and active-controlled studies of etrolizumab, adalimumab, and placebo in adult (18–80 years) patients 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. All patients 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. In both studies, patients were randomly assigned (2:2:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks; subcutaneous adalimumab 160 mg on day 1, 80 mg at week 2, and 40 mg at weeks 4, 6, and 8; or placebo. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All patients and study site personnel were masked to treatment assignment. The primary endpoint was induction of remission at week 10 (defined as MCS of 2 or lower, with individual subscores of 1 or lower, and rectal bleeding subscore of 0) with etrolizumab compared with placebo. Pooled analyses of both studies comparing etrolizumab and adalimumab were examined for several clinical and endoscopic endpoints. Efficacy was analysed using a modified intent-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. These trials are registered with ClinicalTrials.gov , NCT02163759 (HIBISCUS I), NCT02171429 (HIBISCUS II). Findings Between Nov 4, 2014, and May 25, 2020, each study screened 652 patients (HIBISCUS I) and 613 patients (HIBISCUS II). Each study enrolled and randomly assigned 358 patients (HIBISCUS I etrolizumab n=144, adalimumab n=142, placebo n=72; HIBISCUS II etrolizumab n=143; adalimumab n=143; placebo n=72). In HIBISCUS I, 28 (19·4%) of 144 patients in the etrolizumab group and five (6·9%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 12·3% (95% CI 1·6 to 20·6; p=0·017) in favour of etrolizumab. In HIBISCUS II, 26 (18·2%) of 143 patients in the etrolizumab group and eight (11·1%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 7·2% (95% CI –3·8 to 16·1; p=0·17). In the pooled analysis, etrolizumab was not superior to adalimumab for induction of remission, endoscopic improvement, clinical response, histological remission, or endoscopic remission; however, similar numerical results were observed in both groups. In HIBISCUS I, 50 (35%) of 144 patients in the etrolizumab group reported any adverse event, compared with 61 (43%) of 142 in the adalimumab group and 26 (36%) of 72 in the placebo group. In HIBISCUS II, 63 (44%) of 143 patients in the etrolizumab group reported any adverse event, as did 62 (43%) of 143 in the adalimumab group and 33 (46%) in the placebo group. The most common adverse event in all groups was ulcerative colitis flare. The incidence of serious adverse events in the pooled patient population was similar for etrolizumab (15 [5%] of 287) and placebo (seven [5%] of 144) and lower for adalimumab (six [2%] of 285). Two patients in the etrolizumab group died; neither death was deemed to be treatment related. Interpretation Etrolizumab was superior to placebo for induction of remission in HIBISCUS I, but not in HIBISCUS II. Etrolizumab was well tolerated in both studies. Funding F Hoffmann-La Roche.

Published
2021

15. Su437 HIGHER ANTI-TUMOUR NECROSIS FACTOR-ALPHA DRUG LEVELS ARE ASSOCIATED WITH IMPROVED RADIOLOGICAL OUTCOMES IN PATIENTS WITH PERIANAL FISTULISING CROHN'S DISEASE: A MULTICENTRE CROSS-SECTIONAL RETROSPECTIVE STUDY

Author

De Gregorio, Michael, primary, Lee, Tanya, additional, Krishnaprasad, Krupa, additional, Amos, Gregory, additional, An, Yoon-Kyo, additional, Bastian-Jordan, Matthew, additional, Begun, Jakob, additional, Borok, Nira, additional, Brown, Dougal J., additional, Cheung, Wa, additional, Connor, Susan J., additional, Gerstenmaier, Jan F., additional, Gilbert, Lauren, additional, Gilmore, Robert, additional, Gu, Bonita, additional, Kutaiba, Numan, additional, Lee, Allan, additional, Mahy, Gillian, additional, Srinivasan, Ashish, additional, Thin, Lena, additional, Thompson, Alexander, additional, Welman, Christopher J., additional, Yong, Eric, additional, De Cruz, Peter, additional, Van Langenberg, Daniel R., additional, Sparrow, Miles, additional, and Ding, Nik S., additional

Published
2021
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17. Tu1749 POST-USTEKINUMAB INDUCTION IL-12, IL-23, AND USTEKINUMAB LEVELS ARE ASSOCIATED WITH CLINICAL RESPONSE IN A MULTICENTRE PROSPECTIVE COHORT STUDY OF CROHN'S DISEASE PATIENTS: RESULTS FROM THE AURORA STUDY

Author

An, Yoon-Kyo, Lindsay, Niamh, Allan, Natalie, Khoo, Emi, Fernandes, Richard, Amiss, Anna, Pham, Hai, Wong, Kam Fai, Ooi, Soong-Yuan, Thin, Lena, Lightowler, Daniel, Connor, Susan J., Williams, Astrid-Jane, De Cruz, Peter, Suen, Christopher Li Wai, Kariyawasam, Viraj C., Mitrev, Nikola, Ghaly, Dr Simon, Andrews, Jane M., Christensen, Britt, Sparrow, Miles, White, Lauren S., Bryant, Robert V., Ding, Nik S., Leong, Rupert, Van Langenberg, Daniel R., Seltenreich, Hansjoerg, Subramaniam, Kavitha, Radford-Smith, Graham L., and Begun, Jakob

Published
2023
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20. Su1733 BASELINE CYTOKINE LEVELS AND MICROBIOME SIGNATURES ARE ASSOCITED WITH CLINICAL RESPONSE FOLLOWING USTEKINUMAB INDUCTION IN A MULTI-CENTRE PROSPECTIVE COHORT STUDY OF CROHN'S DISEASE PATIENTS: RESULTS FROM THE AURORA STUDY

Author

An, Yoon-Kyo, Lindsay, Niamh, Allan, Natalie, Khoo, Emi, Fernandes, Richard, Amiss, Anna, Pham, Hai, Giri, Rabina, Ooi, Soong-Yuan, Thin, Lena, Lightowler, Daniel, Connor, Susan J., Williams, Astrid-Jane, De Cruz, Peter, Suen, Christopher Li Wai, Kariyawasam, Viraj C., Mitrev, Nikola, Ghaly, Dr Simon, Andrews, Jane M., Christensen, Britt, Sparrow, Miles, White, Lauren S., Bryant, Robert V., Ding, Nik S., Leong, Rupert, Van Langenberg, Daniel R., Seltenreich, Hansjoerg, Subramaniam, Kavitha, Radford-Smith, Graham L., and Begun, Jakob

Published
2023
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24. Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford

Author

Pulusu, Samba Siva Reddy, primary, Srinivasan, Ashish, additional, Krishnaprasad, Krupa, additional, Cheng, Daniel, additional, Begun, Jakob, additional, Keung, Charlotte, additional, Langenberg, Daniel Van, additional, Thin, Lena, additional, Mogilevski, Tamara, additional, Cruz, Peter De, additional, Radford-Smith, Graham, additional, Flanagan, Emma, additional, Bell, Sally, additional, Kashkooli, Soleiman, additional, Sparrow, Miles, additional, Ghaly, Simon, additional, Bampton, Peter, additional, Sawyer, Elise, additional, Connor, Susan, additional, Rizvi, Quart-ul-ain, additional, Andrews, Jane M, additional, Mahy, Gillian, additional, Chivers, Paola, additional, Travis, Simon, additional, and Lawrance, Ian Craig, additional

Published
2020
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27. 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, 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, Panés, Julian, Abdulkhakov, Rustem, Abu Bakar, Norasiah, Aguilar, Humberto, Aizenberg, Diego, Akpinar, Hale, Akriviadis, Evangelos, Alexeeva, Olga, Alikhanov, Bagdadi, Alvarisqueta, Andres, Ananthakrishnan, Ashwin, Andrews, Jane, Arlukowicz, Tomasz, Atkinson, Nathan, Atug, Ozlen, Bafutto, Mauro, Balaz, Jozef, Bamias, George, Banic, Marko, Baranovsky, Andrey, Barbalaco Neto, Guerino, Basaranoglu, Metin, Baum, Curtis, Baydanov, Stefan, Bennetts, William, Besisik, Fatih, Bhaskar, Sudhir, Bielasik, Andrzej, Bilianskyi, Leonid, Bilir, Bahri, Blaha, Pavol, Bohman, Verle, Borissova, Julia, Borzan, Vladimir, Bosques-Padilla, Francisco, Bouhnik, Yoram, Brooker, James, Budko, Tetiana, Budzak, Igor, Bunganic, Ivan, Chapman, Jonathon, Che' Aun, Azlida, Chernykh, Tatiana, Chiorean, Michael, Chopey, Ivan, Christodoulou, Dimitrios, Chu, Pui Shan, Chumakova, Galina, Cummins, Andrew, Cunliffe, Robert, Cvetkovic, Mirjana, Dagli, Ulku, Danilkiewicz, Wit Cezary, Datsenko, Olena, de Magalhães Francesconi, Carlos Fernando, Debinski, Henry, Deminova, Elena, Derova, Jelena, Ding, John Nik, Dmitrieva, Julia, Dolgikh, Oleg, Douda, Tomas, Drobinski, Piotr, Dryden, Gerald, Duarte Gaburri, Pedro, DuVall, George Aaron, Dvorkin, Mikhail, Ennis, Craig, Erzin, Yusuf, Fadieienko, Galyna, Fediv, Oleksandr, Fedorishina, Olga, Fedurco, Miroslav, Fejes, Roland, Fernandez, Jorge, Fernandez, Monica Lorena, Flores, Lucky, Freilich, Bradley, Friedenberg, Keith, Fuster, Sergio, Gawdis-Wojnarska, Beata, Gil Parada, Fabio Leonel, Gimenez, Edgardo Daniel, Golovchenko, Nataliia, Golovchenko, Oleksandr, Gonciarz, Maciej, Gordon, Glenn, Gregus, Milos, Grinevich, Vladimir, Guajardo Rodriguez, Rogelio, Hall, Stephen, Hanson, John, Hartleb, Marek, Hebuterne, Xavier, Hendy, Peter, Herring, Robert, Higgins, Peter, Hilal, Raouf, Hilmi, Ida Normiha, Hlavaty, Tibor, Holman, Richard, Holtmann, Gerald, Hong, John, Horvath, Frantisek, Hospodarskyy, Ihor, Hrstic, Irena, Hulagu, Sadettin, Ibarra Verdugo, Luis Alberto, Ibegbu, Ikechukwu, Inns, Stephen, Ivashkin, Vladimir, Izanec, James, Jain, Rajesh, Jamrozik-Kruk, Zofia, Kamburov, Victor, Karagiannis, John, Karakan, Tarkan, Karczewski, Marek, Kasherininova, Irina, Katz, Seymour, Kaufman, Barry, Kazenaite, Edita, Kholina, Irina, Khurana, Sunil, Kiselevska, Anzela, Kleczkowski, Dariusz, Klymenko, Volodymyr, Knezevic, Slavko, Kondusz-Szklarz, Malgorzata, Korablina, Natalya, Korczowski, Bartosz, Kosturkov, Lyubomir, Kotzev, Iskren, Kouklakis, Georgios, Koutroubakis, Ioannis, Krause, Richard, Kronborg, Ian, Krstic, Miodrag, Krznaric, Zeljko, Krzyzanowski, Mikolaj, Kulig, Grazyna, Kull, Karin, Kupcinskas, Limas, Lamet, Mark, Latinovic Radakovic, Tatjana, Leong, Rupert, Leung, Wai Keung, Levine, Henry, Li, Michael Kin Kong, Libanez Bessa Campelo Braga, Lúcia, Livzan, Maria, Lohdanidi, Tetiana, Louzada Pereira, Maria Helena, Lowe, John, Luetic, Kresimir, Lukas, Milan, Lymar, Yurii, Macrae, Finlay, Mäelt, Anu, Maev, Igor, Mamos, Arkadiusz, Mantzaris, Gerasimos, Margus, Benno, Marinova, Ivanka, Markevych, Inna, Markov, Mario, Markovic, Srdjan, Marquez Velasquez, Juan Ricardo, Mazzoleni, Felipe, Mimidis, Konstantinos, Mitchell, Brent, Moore, Gregory, Morales Garza, Luis Alonso, Moscatello, Salvatore, Mostovoy, Yuriy, Mountifield, Reme, Nagorni, Aleksandar, Neshta, Viacheslav, Obrezan, Andrey, Oliinyk, Oleksandr, Oliveira Santana Silva, Genoile, Orzeszko, Maria, Pavlenko, Vladimir, Pavlov, Dimitar, Penkova, Mariana, Peric, Sasa, Petkov, Plamen, Petrov, Asen, Petrov, Plamen, Petrova, Michaela, Phillips, Raymond, Pintor Chacon, Sergio, Polianskyi, Igor, Prystupa, Ludmyla, Pugach, Mykhailo, Pukitis, Aldis, Pumprla, Jiri, Pyrogovskyy, Volodymyr, Racz, Istvan, Radford-Smith, Graham, Raja Ali, Raja Affendi, Ramos Castañeda, Daniel, Ramos Júnior, Odery, Rausher, David, Rebrov, Andrey, Regula, Jaroslaw, Rezk, Amir, Reznikova, Viktoriia, Rishko, Iaroslava, Roblin, Xavier, Rodoman, Grigory, Rojas Rodriguez, Carlos Arturo, Rozciecha, Jerzy, Rubin, David, Rupinski, Maciej, Rzucidlo, Jacek, Sablin, Oleg, Sahin, Halil, Samuel, Douglas, Scafuto Scotton, Antonio, Schnabel, Robert, Schulman, Michael, Schultz, Michael, Scott, John, Sedghi, Shahriar, Shaban, Ahmad, Shapina, Marina, Shaposhnikova, Natalia, Shchukina, Oksana, Sherman, Alex, Shumikhina, Irina, Simanenkov, Vladimir, Simonov, Vladislav, Simulionis, Giedrius, Skrypnyk, Igor, Sliwowski, Zbigniew, Smid, Jan, Solaiman, Mahmood, Soofi, Najm, Soufleris, Konstantinos, Spassova, Zoia, Stanislavchuk, Mykola, Stec-Michalska, Krystyna, Stifft, Jonathas, Stoinov, Simeon, Stoyanova, Girgina, Sultan, Keith, Surace, Lindsey, Takov, Dimitar, Tälli, Jaak, Tankova, Ludmila, Tanno, Hugo, Tarabar, Dino, Tarakji, Elias, Tchernev, Konstantin, Thin, Lena, Thomas, Carlton, Tishaeva, Irina, Todorova, Tsveta, Tokarenko, Oleksandr, Tolmanis, Ivars, Tomasevic, Ratko, Trofimov, Vasiliy, Tulassay, Zsolt, Unsal, Belkis, Uzunova-Genova, Alma, Valentine, John, Valuyskikh, Ekaterina, Vasconcellos, Eduardo, Vasileva, Galina, Vasylyuk, Sergiy, Vaughn, Byron, Velazquez, Francisco, Vizir, Vadym, Vladimirov, Borislav, Volfova, Miroslava, Vyhnalek, Petr, Wallace, Ian, Waluga, Marek, Watkins, William, Weber, John, Wiechowska-Kozlowska, Anna, Winstead, Nathaniel, Wojtkiewicz, Pawel, Wozniak-Stolarska, Barbara, Yacyshyn, Bruce, Yakovlev, Alexey, Younes, Ziad, Yukie Sassaki, Lígia, Yuksel, Ilhami, Zachar, Jan, Zaltman, Cyrla, Zdravkovic Petrovic, Natasa, Zhdan, Vyacheslav, Zinchenko, Maryna, and Zymla, Maciej

Abstract

Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis.

Published
2022
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28. Switching Australian patients with moderate to severe inflammatory bowel disease from originator to biosimilar infliximab: a multicentre, parallel cohort study.

Author

Haifer, Craig, Srinivasan, Ashish, An, Yoon‐Kyo, Picardo, Sherman, Langenberg, Daniel, Menon, Shankar, Begun, Jakob, Ghaly, Simon, and Thin, Lena

Abstract

Objective: To examine whether non‐medical switching of patients with inflammatory bowel disease (IBD) from originator infliximab to a biosimilar (CT‐P13, Inflectra) is safe and clinically non‐inferior to continued treatment with originator infliximab. Design: Prospective, open label, multicentre, parallel cohort, non‐inferiority study in seven Australian hospitals over 48 weeks, May 2017 – October 2019. Participants: Adults (18 years or older) with IBD receiving maintenance originator infliximab (Remicade) who had been in steroid‐free clinical remission for at least 12 weeks. Intervention: Managed program for switching patients in four hospitals from originator to biosimilar infliximab (CT‐P13); patients in three other hospitals continued to receive originator infliximab (control). Main outcome measures: Clinical disease worsening requiring infliximab dose escalation or change in therapy. Results: The switch group included 204 patients, the control group 141 patients with IBD. Ten patients in the control group (7%) and 16 patients switched to CT‐P13 (8%) experienced clinical deterioration; the adjusted risk difference (control v switch group) was –1.1 percentage points (95% CI, –6.1 to 8.2 percentage points), within our pre‐specified non‐inferiority margin of 15 percentage points. Serious adverse events leading to infliximab discontinuation were infrequent in both the switch (six, 3%) and control (six, 4%) groups. Conclusion: Switching patients with IBD from originator to biosimilar infliximab is safe and non‐inferior to continuing treatment with originator infliximab. Moreover, the introduction of biosimilar infliximab, by increasing market competition, has resulted in substantial cost savings for the Pharmaceutical Benefits Scheme. [ABSTRACT FROM AUTHOR]

Published
2021
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31. Entyvio lengthen dose-interval study: lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease

Author

Chan, Webber, primary, Lynch, Nicole, additional, Bampton, Peter, additional, Chang, Jeff, additional, Chung, Alvin, additional, Florin, Timothy, additional, Hetzel, David J., additional, Jakobovits, Simon, additional, Moore, Gregory, additional, Pavli, Paul, additional, Radford-Smith, Graham, additional, Thin, Lena, additional, Baraty, Brandon, additional, Haifer, Craig, additional, Yau, Yunki, additional, and Leong, Rupert W.L., additional

Published
2018
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32. Mo1879 - Vedolizumab(VDZ) Real World Outcomes in Ulcerative Colitis (UC)

Author

Pulusu, Samba Siva Reddy, primary, Srinivasan, Ashish, additional, Krishnaprasad, Krupa, additional, Cheng, Daniel, additional, Mogilevski, Tamara, additional, Flanagan, Emma, additional, Keung, Charlotte, additional, Wu, Yang, additional, Prosser, Ruth, additional, Sawyer, Elise A., additional, Rizvi, Quart-Ul-Ain, additional, Su, Heidi Y., additional, Leung, Wai K., additional, Edmundson, Aleksandra, additional, Cooke, Sharon, additional, Mahy, Gillian, additional, Thin, Lena, additional, Radford-Smith, Graham L., additional, Sparrow, Miles, additional, Andrews, Jane M., additional, Connor, Susan J., additional, Bampton, Peter A., additional, Simon, Ghaly, additional, van Langenberg, Daniel R., additional, Bell, Sally, additional, De Cruz, Peter, additional, Begun, Jakob, additional, Ng, Siew C., additional, Travis, Simon P., additional, and Lawrance, Ian, additional

Published
2018
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35. Distribution of Serum Testosterone Concentrations in IBD Males and Associations With Inflammatory Bowel Disease Activity.

Author

Judge C, Lightowler D, Singh A, Yeap BB, and Thin L

Abstract

Background: An inverse relationship exists between inflammation and testosterone concentrations in non-inflammatory bowel disease (IBD) immune conditions but has not been objectively explored in the IBD male population. We aimed to characterize the distribution of testosterone concentrations in a cohort of males with IBD and identify any relationship between testosterone levels and disease activity., Methods: We conducted a prospective cross-sectional study of male IBD patients. Demographics, disease characteristics, sex-hormone concentration, gonadotropins, C-reactive protein, fecal calprotectin, and patient-reported outcomes on quality of life and erectile function were collected. Relationships between disease activity, biomarkers, patient-reported outcome scores, and testosterone levels were analyzed using univariate and multivariate linear regression analyses., Results: A total of 85 male IBD patients were included with a mean age 44 ± 14.1 years, of which 49.4% had Crohn's disease. Mean testosterone concentration was 15.4 ± 5.2 nmol/L and 17.6% had a serum testosterone <10.4 nmol/L. Active disease was associated with lower testosterone concentrations in univariate analysis (β ± SE = -0.25 ± -1.99, P = .02) but not in multivariate analysis (β -0.18 ± 1.75, P = .06). Testosterone concentrations were independently associated with sex hormone-binding globulin levels (β ± SE = 0.45 ± 0.04, P < .0001) and a younger age (β ± SE = -0.32 ± 0.04, P <.0001). Erectile function scores (5-item International Index of Erectile Function) were lower in IBD patients with a longer duration of disease (β ± SE = -0.24 ± 0.006, P = .04)., Conclusions: Lower testosterone concentrations in men with IBD may reflect confounding from other factors and are not independently associated with disease activity. Greater awareness and screening for sexual dysfunction should occur in males with IBD, particularly in those with a longer disease duration., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Published
2024
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36. Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease (DISCUS-IBD): protocol for a multicentre randomised controlled trial.

Author

Little RD, McKenzie J, Srinivasan A, Hilley P, Gilmore RB, Chee D, Sandhu M, Saitta D, Chow E, Thin L, Walker GJ, Moore GT, Lynch K, Andrews J, An YK, Bryant RV, Connor SJ, Garg M, Wright EK, Hold G, Segal JP, Boussioutas A, De Cruz P, Ward MG, and Sparrow MP

Subjects
Adult, Female, Humans, Male, Administration, Intravenous, Australia, Drug Monitoring methods, Injections, Subcutaneous, Multicenter Studies as Topic, Prospective Studies, Gastrointestinal Agents administration & dosage, Gastrointestinal Agents therapeutic use, Inflammatory Bowel Diseases drug therapy, Infliximab administration & dosage, Infliximab therapeutic use, Infliximab pharmacokinetics
Abstract

Introduction: A substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement. Observational data suggest that subcutaneous infliximab may offer a convenient and safe alternative to maintain disease remission in patients requiring dose-intensified infliximab. A prospective, controlled trial is required to confirm that subcutaneous infliximab is as effective as dose-intensified intravenous infliximab, to identify predictors of disease flare and to establish the role of subcutaneous infliximab therapeutic drug monitoring., Methods and Analysis: The DISCUS-IBD trial is an investigator-initiated, prospective, multicentre, randomised, open-label non-inferiority study comparing the rate of disease flares in participants randomised to continue dose-intensified intravenous infliximab to those switched to subcutaneous infliximab after 48 weeks. Participants are adult patients with IBD in sustained corticosteroid-free remission on any regimen of dose-intensified infliximab up to a maximum of 10 mg/kg 4-weekly intravenously. Participants allocated to intravenous infliximab will continue infliximab at the same dose-intensified regimen they were receiving at study enrolment. Subcutaneous infliximab dosing will be stratified by prior intravenous infliximab dosing. Clinical (Harvey-Bradshaw Index, partial Mayo score), biochemical (C reactive protein, faecal calprotectin), pharmacokinetic (drug-level±antidrug antibodies) and qualitative data are collected 12-weekly until study conclusion at week 48. 13 sites across Australia will participate in recruitment to reach a calculated sample size of 120 participants., Ethics and Dissemination: Multisite ethics approval was obtained from the Health District Human Research Ethics Committee (HREC) at The Alfred Hospital under a National Mutual Acceptance (NMA) agreement (HREC/90559/Alfred-2022; Local Reference: Project 618/22, version 1.6, 2 March 2023). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. DISCUS-IBD was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) prior to commencing recruitment., Trial Registration Number: ACTRN12622001458729., Competing Interests: Competing interests: RDL has received conference fees from Janssen and Celltrion Healthcare. AS has received speaker fees from Sandoz and received research support and advisory fees from AbbVie, Pfizer, and Arrow Pharmaceuticals. GJW has served as a speaker, a consultant or an advisory board member for Janssen, Galapagos, AbbVie, Ferring, Dr Falk Pharma, Nova Labs and Sandoz. GTM has received educational grants or research support from GESA, The Gutsy Group, NHMRC, MRFF, AbbVie, Janssen, Pfizer, Shire and Takeda; speaker fees from AbbVie, Ferring, Janssen, Orphan, Pfizer, Roche, Sandoz, Shire and Takeda and has serve on advisory boards for AbbVie, Emerge, Eli-Lilly, Gilead, Hospira, Janssen, Orphan, MSD, Pfizer, Shire and Takeda. KL declares speaker fees, advisory Board fees and/or conference travel/registration support from AbbVie, Bristol Myers Squibb, Chiesi, Dr Falk, Ferring, Gilead, Guidepoint, Intercept Pharmaceuticals, Janssen-Cilag, MSD, Norgine, Pfizer, Sandoz, Takeda and the RAH Research Fund. JA has served as a speaker, a consultant and an advisory board member for, and has received research funding from, Abbott, AbbVie, Allergan, Anatara, AstraZeneca, Bayer, Celgene, Falk, Ferring, Gilead, Hospira, Immunic, ImmunsanT, Janssen, MSD, Nestle, Progenity, Pfizer, Sandoz, Shire, Takeda, Vifor, RAH Research Fund, The Hospital Research Fund with all monies received by her department for research support. YKA reports grants from Janssen, during the conduct of the study; has received speaking and consulting fees from AbbVie, Bristol Myers Squibb, Celltrion, Chiesi, Dr Falk, Ferring, Janssen, Pfizer, Sandoz, Shire and Takeda; served on advisory boards for AbbVie, Bristol Myers Squibb, Chiesi, Janssen, NPS Medicine wise, Microba and received research and educational funding from Abbvie, Celltrion, Dr Falk, Janssen, Pfizer, Sandoz and Takeda. RVB has received grant/research support/speaker fees from AbbVie, Ferring, Janssen, Shire, Takeda, Bristol Myer Squibb and Emerge Health; and is a shareholder in Biomebank. SC declares advisory board participation, speaker fees, educational support and/or research support for Liverpool Hospital, South Western Sydney Local Health District (SWSLHD) Academic Unit or Crohn’s Colitis Cure from: AbbVie, Amgen, BMS, Celltrion, Chiesi, Eli-Lilly, Dr Falk, Ferring, Fresenius Kabi, Gilead, GSK, Janssen, MSD, Novartis, Organon, Pfizer, Sandoz, Takeda and non-pharmacological research support from Agency for Clinical Innovation, Gastroenterological Society of Australia, The Leona M and Harry B Helmsley Charitable Trust, Medical Research Future Fund, SWSLHD, Sydney Partnership for Health, Research and Enterprise (SPHERE). MG has served on the advisory board of Pfizer and has received speaker fees, research or travel grants from AbbVie, Celltrion, Dr Falk, Janssen, Pfizer, Pharmacosmos, Takeda. EKW declares speaker and consulting fees from AbbVie, BMS, Celltrion, Falk, Ferring, Janssen, Pfizer and research funding/support from AbbVie, Ferring, Janssen. JPS has received conference fees from Janssen, BMS, Takeda, educational grants from Pfizer, speaker fees from AbbVie, Takeda and Pfizer and an unrestricted grant from Tillots. PDC has served as a consultant, an advisory board member or a speaker for AbbVie, Baxter, Ferring, Janssen, Celltrion, Emerge Health, Shire and Takeda and received research support from Ferring, Shire, Janssen, AbbVie, and Takeda. MGW has received educational grants and speakers fees from AbbVie, Takeda and Ferring; travel grants from Pfizer; and has served on advisory boards for AbbVie. MPS has received educational grants or research support from Ferring, Orphan and Gilead; speakers fees from Janssen, AbbVie, Ferring, Takeda, Pfizer and Shire; and has served on advisory boards for Janssen, Takeda, Pfizer, Celgene, AbbVie, MSD, Emerge Health, Gilead and BMS. JM, PH, RBG, DC, MS, EC, LT, GH and AB declare no relevant competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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37. A High Visceral-to-Skeletal Muscle Area Ratio on Cross-Sectional Imaging Is Associated With Failure of Standard Ustekinumab Doses: A Multicenter Study.

Author

Tan Z, Chin A, Welman CJ, and Thin L

Subjects
Humans, Female, Male, Middle Aged, Retrospective Studies, Adult, Body Composition drug effects, Tomography, X-Ray Computed, Ustekinumab administration & dosage, Ustekinumab therapeutic use, Muscle, Skeletal diagnostic imaging, Muscle, Skeletal drug effects, Muscle, Skeletal pathology, Intra-Abdominal Fat diagnostic imaging, Intra-Abdominal Fat drug effects, Crohn Disease drug therapy, Crohn Disease diagnostic imaging, Treatment Failure, Body Mass Index
Abstract

Introduction: Anti-interleukin 12/23 agents have shown greater durability in response compared with anti-tumor necrosis factor α agents. Data on the association between body composition (BC) or body mass index (BMI) and ustekinumab's therapeutic response is limited. We aimed to evaluate the impact of BC on time to failing standard doses of ustekinumab in patients with Crohn's disease (CD)., Method: Patients with CD aged 16 years and older from 2 tertiary centers were studied retrospectively. Included patients had abdominal imaging within 6 months of ustekinumab induction and were followed until April 30, 2022. An experienced abdominal radiologist blinded to the clinical information measured the area of visceral fat area and skeletal muscle area at the mid L3 vertebral level, with values corrected for height 2 to derive respective indices (visceral fat index [VFI], skeletal muscle index [SMI]) and the VFI:SMI ratio., Results: Ninety-nine patients met inclusion criteria. The mean age at ustekinumab induction was 46.6 (±1.6) years. The median BMI (interquartile range) was 26.5 (22.6-30.8). Twenty-four patients (24.2%) did not respond or lost response to standard doses of ustekinumab over the follow-up duration. A younger age (hazard ratio 0.96, 95% confidence interval 0.94-0.99, P = 0.01) and a VFI:SMI ratio >1.6 (hazard ratio 4.65, 95% confidence interval 1.73-12.45, P = 0.002) were both associated with a shorter time to failing ustekinumab at standard doses on multivariate analysis. BMI, notably, had no association with the primary outcome., Discussion: A high VFI:SMI ratio is associated with an increased risk of failing standard doses of ustekinumab. BC measurements derived from cross-sectional imaging at the start of ustekinumab therapy is a useful indicator for therapeutic durability., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Published
2024
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38. Acute graft-versus-host disease after liver transplant: novel use of etanercept and the role of tumor necrosis factor alpha inhibitors.

Author

Thin L, Macquillan G, Adams L, Garas G, Seow C, Cannell P, Augustson B, Mitchell A, Delriveire L, and Jeffrey G

Subjects
Acute Disease, Aged, Antifungal Agents therapeutic use, Aspergillosis chemically induced, Aspergillosis drug therapy, Carcinoma, Hepatocellular virology, Dermatomycoses chemically induced, Dermatomycoses drug therapy, Etanercept, Graft vs Host Disease etiology, Graft vs Host Disease immunology, Hepatitis B, Chronic complications, Humans, Immunoglobulin G adverse effects, Immunosuppressive Agents adverse effects, Liver Neoplasms virology, Male, Treatment Outcome, Carcinoma, Hepatocellular surgery, Graft vs Host Disease drug therapy, Hepatitis B, Chronic surgery, Immunoglobulin G therapeutic use, Immunosuppressive Agents therapeutic use, Liver Neoplasms surgery, Liver Transplantation adverse effects, Receptors, Tumor Necrosis Factor therapeutic use, Tumor Necrosis Factor-alpha antagonists & inhibitors
Abstract

Acute graft-versus-host disease following orthotopic liver transplantation is a rare but feared complication arising in 1% to 2% of cases with a dismal prognosis. It most often presents as fever, rash, and diarrhea with or without pancytopenia. Patients die from complications of marrow failure such as sepsis or bleeding. Because of its low incidence, there is no clear treatment protocol for this complication. Both increasing and withdrawing immunosuppression have been attempted with variable success. Although anti-tumor necrosis factor alpha therapy has been widely used for the treatment of steroid-resistant acute graft-versus-host disease in the hematopoietic stem cell transplant setting, there previously have been no reported cases of its use in liver transplantation. The aim of this report is to review a case of acute graft-versus-host disease and the use of etanercept to manage this complication. Etanercept has never previously been used in liver transplantation complicated by acute graft-versus-host disease. In the hematology literature, the success of its use is offset by significant rates of serious infectious (especially fungal) complications. However, preliminary results are encouraging and offer insight into its use as a potentially viable therapeutic option. We report the first successful use of etanercept in liver transplantation-associated graft-versus-host disease, albeit complicated by invasive aspergillosis, and recommend concurrent antifungal prophylaxis when the drug is used in this setting., (Copyright 2009 AASLD.)

Published
2009
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