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1. 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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2. 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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4. Role of endoscopic ultrasound in the characterization of solid pseudopapillary neoplasm of the pancreas

Author

Katarzyna M Pawlak, Nadeem Tehami, Ben Maher, Shujaath Asif, Krishn Kant Rawal, Daniel Vasile Balaban, Mohammed Tag-Adeen, Fahd Ghalim, Wael A Abbas, Elsayed Ghoneem, Khaled Ragab, Mahmoud El-Ansary, Shanil Kadir, Sunil Amin, Keith Siau, Anna Wiechowska-Kozlowska, Klaus Mönkemüller, Dalia Abdelfatah, Abeer Abdellatef, Sundeep Lakhtakia, and Hussein Hassan Okasha

Subjects
Critical Care Nursing, Pediatrics
Published
2023

6. OP40 PRA023 Demonstrated Efficacy and Favorable Safety as Induction Therapy for Moderately to Severely Active UC: Phase 2 ARTEMIS-UC Study Results

Author

B Sands, L Peyrin-Biroulet, S Danese, D T Rubin, S Vermeire, O Laurent, A Luo, D Nguyen, J D Lu, A Wiechowska-Kozlowska, J Leszczyszyn, R Kempinski, J Kierkus, C Ma, T Ritter, B G Feagan, and S Targan

Subjects
Gastroenterology, General Medicine
Abstract

Background Tumor necrosis factor-like cytokine 1A (TL1A) is an upstream regulator of pro-inflammatory cytokines and fibrosis signals. PRA023 is an anti-TL1A monoclonal antibody in development for multiple inflammatory/fibrotic diseases using a precision medicine approach with a companion diagnostic (CDx). This Phase 2 placebo-controlled, multi-center, double-blind study aimed to assess the efficacy and safety of PRA023 for induction treatment in adults with moderately to severely active ulcerative colitis (UC). Methods Key eligibility criteria included a modified Mayo Score of 4-9, a centrally read (with adjudication) endoscopy subscore of ≥ 2, a rectal bleeding subscore of ≥ 1, and a history of insufficient response, loss of response, and/or intolerance to conventional and/or advanced (approved biologics and JAK inhibitors/S1P modulators) therapies (≤ 4 advanced agents from ≤ 3 classes). Patients were stratified by prior biologic exposure status (yes/no) and CDx status (yes/no) and randomized 1:1 to placebo or intravenous PRA023 (1000mg on Day 1, 500mg at Weeks 2, 6, and 10). The primary endpoint was clinical remission at week 12. Analyses of all ranked secondary endpoints, the first being endoscopic improvement (endoscopy score of ≤ 1), were multiplicity controlled. Results Of the 135 patients in the full analysis data set, 60/67 (89.6%) in the placebo arm and 68/68 (100%) in the PRA023 arm completed the 12-week Induction Period. Baseline characteristics were similar with minor differences in the proportion of patients with baseline endoscopy score of 3 and prior exposure to ≥ 3 advanced therapies (Table 1). A significantly greater proportion of patients who received PRA023 achieved the primary endpoint of clinical remission (26.5% PRA023 vs. 1.5% placebo, ∆25.0%, p < 0.0001) at Week 12 (Table 2). In addition, substantially more patients who received PRA023 achieved the key secondary endpoint of endoscopic improvement (36.8% PRA023 vs. 6.0% placebo, ∆30.8%, p < 0.0001). All remaining ranked secondary endpoints were met (Table 2). The rates of treatment-emergent adverse events (AEs) were similar between the two arms with no serious AEs or AEs leading to study drug discontinuation in the PRA023 arm (Table 3). There were no safety signals identified from the study. Conclusion PRA023 was effective with favorable tolerability for the induction of clinical remission and endoscopic improvement in moderately to severely active UC. A Phase 3 study will be conducted to confirm these findings. Recruitment is ongoing for the CDx+ expansion cohort of the study to assess the effectiveness of the CDx, designed to select patients with a higher probability of responding to PRA023.

Published
2023

7. Role of endoscopic ultrasound in the characterization of solid pseudopapillary neoplasm of the pancreas

Author

Pawlak, Katarzyna M, primary, Tehami, Nadeem, additional, Maher, Ben, additional, Asif, Shujaath, additional, Rawal, Krishn Kant, additional, Balaban, Daniel Vasile, additional, Tag-Adeen, Mohammed, additional, Ghalim, Fahd, additional, Abbas, Wael A, additional, Ghoneem, Elsayed, additional, Ragab, Khaled, additional, El-Ansary, Mahmoud, additional, Kadir, Shanil, additional, Amin, Sunil, additional, Siau, Keith, additional, Wiechowska-Kozlowska, Anna, additional, Mönkemüller, Klaus, additional, Abdelfatah, Dalia, additional, Abdellatef, Abeer, additional, Lakhtakia, Sundeep, additional, and Okasha, Hussein Hassan, additional

Published
2023
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8. OP40 PRA023 Demonstrated Efficacy and Favorable Safety as Induction Therapy for Moderately to Severely Active UC: Phase 2 ARTEMIS-UC Study Results

Author

Sands, B, primary, Peyrin-Biroulet, L, additional, Danese, S, additional, Rubin, D T, additional, Vermeire, S, additional, Laurent, O, additional, Luo, A, additional, Nguyen, D, additional, Lu, J D, additional, Wiechowska-Kozlowska, A, additional, Leszczyszyn, J, additional, Kempinski, R, additional, Kierkus, J, additional, Ma, C, additional, Ritter, T, additional, Feagan, B G, additional, and Targan, S, additional

Published
2023
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9. A MicroRNA-Based Test Improves Endoscopic Ultrasound–Guided Cytologic Diagnosis of Pancreatic Cancer

Author

Brand, Randall E., Adai, Alex T., Centeno, Barbara A., Lee, Linda S., Rateb, George, Vignesh, Shivakumar, Menard, Charles, Wiechowska–Kozłowska, Anna, Bołdys, Hubert, Hartleb, Marek, Sanders, Michael K., Munding, Johanna B., Tannapfel, Andrea, Hahn, Stephan A., Stefańczyk, Ludomir, Tsongalis, Gregory J., Whitcomb, David C., Conwell, Darwin L., Morisset, Jean A., Gardner, Timothy B., Gordon, Stuart R., Suriawinata, Arief A., Lloyd, Maura B., Wylie, Dennis, Labourier, Emmanuel, Andruss, Bernard F., and Szafranska–Schwarzbach, Anna E.

Published
2014
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10. 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

Laurent Peyrin-Biroulet, Ailsa Hart, Peter Bossuyt, Millie Long, Matthieu Allez, Pascal Juillerat, Alessandro Armuzzi, Edward V Loftus, Elham Ostad-Saffari, Astrid Scalori, Young S Oh, Swati Tole, Akiko Chai, Jennifer Pulley, Stuart Lacey, William J Sandborn, Humberto Aguilar, Tariq Ahmad, Evangelos Akriviadis, Xavier Aldeguer Mante, Istvan Altorjay, Ashwin Ananthakrishnan, Vibeke Andersen, Montserrat Andreu Garcia, Guy Aumais, Irit Avni-Biron, Jeffrey Axler, Kamran Ayub, Filip Baert, Mauro Bafutto, George Bamias, Isaac Bassan, Curtis Baum, Laurent Beaugerie, Brian Behm, Pradeep Bekal, Michael Bennett, Fernando Bermejo San Jose, Charles Bernstein, Dominik Bettenworth, Sudhir Bhaskar, Livia Biancone, Bahri Bilir, Michael Blaeker, Stuart Bloom, Verle Bohman, Francisco Javier Bosques Padilla, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Stephan Brand, Brian Bressler, Markus Brückner, Carsten Buening, Franck Carbonnel, Thomas Caves, Jonathon Chapman, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Dimitrios Christodoulou, Martin Clodi, Albert Cohen, Gino Roberto Corazza, Richard Corlin, Rocco Cosintino, Fraser Cummings, Robin Dalal, Silvio Danese, Marc De Maeyer, Carlos Fernando De Magalhães Francesconi, Aminda De Silva, Henry Debinski, Pierre Desreumaux, Olivier Dewit, Geert D'Haens, Sandra Di Felice Boratto, John Nik Ding, Tyler Dixon, Gerald Dryden, George Aaron Du Vall, Matthias Ebert, Ana Echarri Piudo, Robert Ehehalt, Magdy Elkhashab, Craig Ennis, Jason Etzel, Jan Fallingborg, Brian Feagan, Roland Fejes, Daniel Ferraz de Campos Mazo, Valéria Ferreira de Almeida Borges, Andreas Fischer, Alan Fixelle, Mark Fleisher, Sharyle Fowler, Bradley Freilich, Keith Friedenberg, Walter Fries, Csaba Fulop, Mathurin Fumery, Sergio Fuster, Gyula G Kiss, Santiago Garcia Lopez, Sonja Gassner, Kanwar Gill, Cyrielle Gilletta de Saint Joseph, Philip Ginsburg, Paolo Gionchetti, Eran Goldin, Adrian-Eugen Goldis, Hector Alejandro Gomez Jaramillo, Maciej Gonciarz, Glenn Gordon, Daniel Green, Jean-Charles Grimaud, Rogelio Guajardo Rodriguez, Zoltan Gurzo, Alexandra Gutierrez, Tibor Gyökeres, Ki Baik Hahm, Stephen Hanauer, John Hanson, William Harlan III, Peter Hasselblatt, Buhussain Hayee, Xavier Hebuterne, Peter Hendy, Melvin Heyman, Peter Higgins, Raouf Hilal, Pieter Hindryckx, Frank Hoentjen, Peter Hoffmann, Frank Holtkamp-Endemann, Gerald Holtmann, Gyula Horvat, Stefanie Howaldt, Samuel Huber, Ikechukwu Ibegbu, Maria Isabel Iborra Colomino, Peter Irving, Kim Isaacs, Kiran Jagarlamudi, Rajesh Jain, Sender Jankiel Miszputen, Jeroen Jansen, Jennifer Jones, John Karagiannis, Nicholas Karyotakis, Arthur Kaser, Lior Katz, Seymour Katz, Leo Katz, Nirmal Kaur, Edita Kazenaite, Reena Khanna, Sunil Khurana, Joo Sung Kim, Young-Ho Kim, Sung Kook Kim, Dongwoo Kim, Jochen Klaus, Dariusz Kleczkowski, Pavel Kohout, Bartosz Korczowski, Georgios Kouklakis, Ioannis Koutroubakis, Richard Krause, Tunde Kristof, Ian Kronborg, Annette Krummenerl, Limas Kupcinskas, Jorge Laborda Molteni, David Laharie, Adi Lahat-zok, Jonghun Lee, Kang-Moon Lee, Rupert Leong, Henry Levine, Jimmy Limdi, James Lindsay, Nilesh Lodhia, Edward Loftus, Randy Longman, Pilar Lopez Serrano, Edouard Louis, Maria Helena Louzada Pereira, John Lowe, Stefan Lueth, Milan Lukas, Giovanni Maconi, Finlay Macrae, Laszlo Madi-Szabo, Uma Mahadevan-Velayos, Everson Fernando Malluta, Fazia Mana, Peter Mannon, Gerasimos Mantzaris, Ignacio Marin Jimenez, Maria Dolores Martin Arranz, Radu-Bogdan Mateescu, Felipe Mazzoleni, Agnieszka Meder, Ehud Melzer, Jessica Mertens, Konstantinos Mimidis, Brent Mitchell, Tamas Molnar, Gregory Moore, Luis Alonso Morales Garza, Reme Mountifield, Vinciane Muls, Charles Murray, Bela Nagy, Markus Neurath, Augustin Nguyen, Remo Panaccione, William Pandak, Julian Panes Diaz, Jihye Park, Luca Pastorelli, Bhaktasharan Patel, Markus Peck-Radosavljevic, Gyula Pecsi, Farhad Peerani, Javier Perez Gisbert, Martin Pesta, Robert Petryka, Raymond Phillips, Marieke Pierik, Vijayalakshmi Pratha, Vlastimil Prochazka, Istvan Racz, Graham Radford-Smith, Daniel Ramos Castañeda, Odery Ramos Júnior, Jaroslaw Regula, Jean-Marie Reimund, Bryan Robbins, Xavier Roblin, Francesca Rogai, Gerhard Rogler, Jerzy Rozciecha, David Rubin, Azalia Yuriria Ruiz Flores, Maciej Rupinski, Grazyna Rydzewska, Sumona Saha, Simone Saibeni, Agnes Salamon, Zoltan Sallo, Bruce Salzberg, Douglas Samuel, Sunil Samuel, William Sandborn, Edoardo Vincenzo Savarino, Anja Schirbel, Robert Schnabel, Stefan Schreiber, John Scott, Shahriar Sedghi, Frank Seibold, Jakob Seidelin, Ursula Seidler, Ahmad Shaban, Ira Shafran, Aasim Sheikh, Alex Sherman, Haim Shirin, Patryk Smolinski, Geun Am Song, Konstantinos Soufleris, Alexander Speight, Dirk Staessen, Andreas Stallmach, Michael Staun, Daniel Stein, Hillary Steinhart, Jonathas Stifft, David Stokesberry, Andreas Sturm, Keith Sultan, Gyorgy Szekely, Kuldeep Tagore, Hugo Tanno, Lena Thin, Syed Thiwan, Carlton Thomas, Michal Tichy, Gabor Tamas Toth, Zsolt Tulassay, Jan Ulbrych, John Valentine, Marta Varga, Eduardo Vasconcellos, Byron Vaughn, Brenda Velasco, Francisco Velazquez, Severine Vermeire, Erica Villa, Aron Vincze, Harald Vogelsang, Miroslava Volfova, Lucine Vuitton, Petr Vyhnalek, Peter Wahab, Jens Walldorf, Mattitiahu Waterman, John Weber, L. Michael Weiss, Anna Wiechowska-Kozlowska, Elise Wiesner, Thomas Witthoeft, Robert Wohlman, Barbara Wozniak-Stolarska, Bruce Yacyshyn, Byong-Duk Ye, Ziad Younes, Lígia Yukie Sassaki, Cyrla Zaltman, Stefan Zeuzem, Neurosurgery, ANS - Neurovascular Disorders, Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Peyrin-Biroulet L., Hart A., Bossuyt P., Long M., Allez M., Juillerat P., Armuzzi A., Loftus E.V., Ostad-Saffari E., Scalori A., Oh Y.S., Tole S., Chai A., Pulley J., Lacey S., Sandborn W.J., Aguilar H., Ahmad T., Akriviadis E., Aldeguer Mante X., Altorjay I., Ananthakrishnan A., Andersen V., Andreu Garcia M., Aumais G., Avni-Biron I., Axler J., Ayub K., Baert F., Bafutto M., Bamias G., Bassan I., Baum C., Beaugerie L., Behm B., Bekal P., Bennett M., Bermejo San Jose F., Bernstein C., Bettenworth D., Bhaskar S., Biancone L., Bilir B., Blaeker M., Bloom S., Bohman V., Bosques Padilla F.J., Bouhnik Y., Bouma G., Bourdages R., Brand S., Bressler B., Bruckner M., Buening C., Carbonnel F., Caves T., Chapman J., Cheon J.H., Chiba N., Chioncel C., Christodoulou D., Clodi M., Cohen A., Corazza G.R., Corlin R., Cosintino R., Cummings F., Dalal R., Danese S., De Maeyer M., De Magalhaes Francesconi C.F., De Silva A., Debinski H., Desreumaux P., Dewit O., D'Haens G., Di Felice Boratto S., Ding J.N., Dixon T., Dryden G., Du Vall G.A., Ebert M., Echarri Piudo A., Ehehalt R., Elkhashab M., Ennis C., Etzel J., Fallingborg J., Feagan B., Fejes R., Ferraz de Campos Mazo D., Ferreira de Almeida Borges V., Fischer A., Fixelle A., Fleisher M., Fowler S., Freilich B., Friedenberg K., Fries W., Fulop C., Fumery M., Fuster S., G Kiss G., Garcia Lopez S., Gassner S., Gill K., Gilletta de Saint Joseph C., Ginsburg P., Gionchetti P., Goldin E., Goldis A.-E., Gomez Jaramillo H.A., Gonciarz M., Gordon G., Green D., Grimaud J.-C., Guajardo Rodriguez R., Gurzo Z., Gutierrez A., Gyokeres T., Hahm K.B., Hanauer S., Hanson J., Harlan III W., Hasselblatt P., Hayee B., Hebuterne X., Hendy P., Heyman M., Higgins P., Hilal R., Hindryckx P., Hoentjen F., Hoffmann P., Holtkamp-Endemann F., Holtmann G., Horvat G., Howaldt S., Huber S., Ibegbu I., Iborra Colomino M.I., Irving P., Isaacs K., Jagarlamudi K., Jain R., Jankiel Miszputen S., Jansen J., Jones J., Karagiannis J., Karyotakis N., Kaser A., Katz L., Katz S., Kaur N., Kazenaite E., Khanna R., Khurana S., Kim J.S., Kim Y.-H., Kim S.K., Kim D., Klaus J., Kleczkowski D., Kohout P., Korczowski B., Kouklakis G., Koutroubakis I., Krause R., Kristof T., Kronborg I., Krummenerl A., Kupcinskas L., Laborda Molteni J., Laharie D., Lahat-zok A., Lee J., Lee K.-M., Leong R., Levine H., Limdi J., Lindsay J., Lodhia N., Loftus E., Longman R., Lopez Serrano P., Louis E., Louzada Pereira M.H., Lowe J., Lueth S., Lukas M., Maconi G., Macrae F., Madi-Szabo L., Mahadevan-Velayos U., Malluta E.F., Mana F., Mannon P., Mantzaris G., Marin Jimenez I., Martin Arranz M.D., Mateescu R.-B., Mazzoleni F., Meder A., Melzer E., Mertens J., Mimidis K., Mitchell B., Molnar T., Moore G., Morales Garza L.A., Mountifield R., Muls V., Murray C., Nagy B., Neurath M., Nguyen A., Panaccione R., Pandak W., Panes Diaz J., Park J., Pastorelli L., Patel B., Peck-Radosavljevic M., Pecsi G., Peerani F., Perez Gisbert J., Pesta M., Petryka R., Phillips R., Pierik M., Pratha V., Prochazka V., Racz I., Radford-Smith G., Ramos Castaneda D., Ramos Junior O., Regula J., Reimund J.-M., Robbins B., Roblin X., Rogai F., Rogler G., Rozciecha J., Rubin D., Ruiz Flores A.Y., Rupinski M., Rydzewska G., Saha S., Saibeni S., Salamon A., Sallo Z., Salzberg B., Samuel D., Samuel S., Sandborn W., Savarino E.V., Schirbel A., Schnabel R., Schreiber S., Scott J., Sedghi S., Seibold F., Seidelin J., Seidler U., Shaban A., Shafran I., Sheikh A., Sherman A., Shirin H., Smolinski P., Song G.A., Soufleris K., Speight A., Staessen D., Stallmach A., Staun M., Stein D., Steinhart H., Stifft J., Stokesberry D., Sturm A., Sultan K., Szekely G., Tagore K., Tanno H., Thin L., Thiwan S., Thomas C., Tichy M., Toth G.T., Tulassay Z., Ulbrych J., Valentine J., Varga M., Vasconcellos E., Vaughn B., Velasco B., Velazquez F., Vermeire S., Villa E., Vincze A., Vogelsang H., Volfova M., Vuitton L., Vyhnalek P., Wahab P., Walldorf J., Waterman M., Weber J., Weiss L.M., Wiechowska-Kozlowska A., Wiesner E., Witthoeft T., Wohlman R., Wozniak-Stolarska B., Yacyshyn B., Ye B.-D., Younes Z., Yukie Sassaki L., Zaltman C., and Zeuzem S.

Subjects
Adult, Male, Ulcerative Colitis Flare, medicine.medical_specialty, Asia, Adolescent, Oceania, Population, Antibodies, Monoclonal, Humanized, Injections, Subcutaneou, Placebo, Severity of Illness Index, law.invention, Middle East, Young Adult, Maintenance therapy, Randomized controlled trial, law, Internal medicine, Gastrointestinal Agent, medicine, Adverse effect, education, Aged, Aged, 80 and over, Tumor Necrosis Factor Inhibitor, education.field_of_study, Hepatology, business.industry, Remission Induction, Gastroenterology, Middle Aged, South America, medicine.disease, Ulcerative colitis, Europe, Treatment Outcome, Etrolizumab, North America, Colitis, Ulcerative, Female, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Human
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 compared with placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who had been previously treated with anti-tumour necrosis factor (TNF) agents. Methods HICKORY was a multicentre, phase 3, double-blind, placebo-controlled study 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) previously treated with TNF inhibitors. Patients were recruited from 184 treatment centres across 24 countries in North America, South America, Europe, Asia, Oceania, and the Middle East. Patients needed to have 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 cohort 1, patients received open-label etrolizumab 105 mg every 4 weeks for a 14-week induction period. In cohort 2, patients were randomly assigned (4:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks for the 14-week induction phase. Patients in either cohort achieving clinical response to etrolizumab induction were eligible for the maintenance phase, in which they were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks through to week 66. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants (induction randomisation only), baseline disease activity, week 14 MCS remission status (maintenance randomisation only), and induction cohort (maintenance randomisation only). All patients and study site personnel were masked to treatment assignment. Primary endpoints were remission (Mayo Clinic total score [MCS] ≤2, with individual subscores of ≤1 and a rectal bleeding subscore of 0) at week 14, and remission at week 66 among patients with a clinical response (MCS with ≥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) at week 14. Efficacy was analysed using a modified intent-to-treat population. Safety analyses included all patients who received at least one dose of study drug during the induction phase. This study is registered at ClinicalTrials.gov , NCT02100696 . Findings HICKORY was conducted from May 21, 2014, to April 16, 2020, during which time 1081 patients were screened, and 609 deemed eligible for inclusion. 130 patients were included in cohort 1. In cohort 2,479 patients were randomly assigned to the induction phase (etrolizumab n=384, placebo n=95). 232 patients were randomly assigned to the maintenance phase (etrolizumab to etrolizumab n=117, etrolizumab to placebo n=115). At week 14, 71 (18·5%) of 384 patients in the etrolizumab group and six (6·3%) of 95 patients in the placebo group achieved the primary induction endpoint of remission (p=0·0033). No significant difference between etrolizumab and placebo was observed for the primary maintenance endpoint of remission at week 66 among patients with a clinical response at week 14 (27 [24·1%] of 112 vs 23 [20·2%] of 114; p=0·50). Four patients in the etrolizumab group reported treatment-related adverse events leading to treatment discontinuation. The proportion of patients reporting at least adverse event was similar between treatment groups for induction (etrolizumab 253 [66%] of 384; placebo 63 [66%] of 95) and maintenance (etrolizumab to etrolizumab 98 [88%] of 112; etrolizumab to placebo 97 [85%] of 114). The most common adverse event in both groups was ulcerative colitis flare. Most adverse events were mild or moderate. During induction, the most common serious adverse event was ulcerative colitis flare (etrolizumab ten [3%] of 384; placebo: two [2%] of 95). During maintenance, the most common serious adverse event in the etrolizumab to etrolizumab group was appendicitis (two [2%] of 112) and the most common serious adverse events in the etrolizumab to placebo group were ulcerative colitis flare (two [2%] of 114) and anaemia (two [2%] of 114). Interpretation HICKORY demonstrated that a significantly higher proportion of patients with moderately to severely active ulcerative colitis who had been previously treated with anti-TNF agent were able to achieve remission at week 14 when treated with etrolizumab compared with placebo; however, there was no significant difference between groups in remission at week 66 among patients with a clinical response at week 14. Funding F Hoffmann-La Roche.

Published
2022

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
Full Text
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13. 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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14. CHAPTER 22. Selenium and Cancer

Author

Jaworska-Bieniek, Katarzyna, primary, Lener, Marcin, additional, Muszynska, Magdalena, additional, Serrano-Fernández, Pablo, additional, Sukiennicki, Grzegorz, additional, Durda, Katarzyna, additional, Gromowski, Tomasz, additional, Gupta, Satish, additional, Kladny, Józef, additional, Wiechowska-Kozlowska, Anna, additional, Grodzki, Tomasz, additional, Jaworowska, Ewa, additional, Lubinski, Jakub, additional, Górecka-Szyld, Barbara, additional, Wilk, Grazyna, additional, Huzarski, Tomasz, additional, Byrski, Tomasz, additional, Cybulski, Cezary, additional, Gronwald, Jacek, additional, Debniak, Tadeusz, additional, Ashuryk, Olgierd, additional, Toloczko-Grabarek, Aleksandra, additional, Morawski, Antoni, additional, Scott, Rodney J., additional, Jakubowska, Anna, additional, and Lubinski, Jan, additional

Published
2015
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15. 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

16. Dysregulation of Mucosal Membrane Transporters and Drug-Metabolizing Enzymes in Ulcerative Colitis

Author

Diana Busch, Pascal Erdmann, Ingolf Cascorbi, Stefan Oswald, Sierk Haenisch, Anna Wiechowska-Kozlowska, Lars Ivo Partecke, Marek Drozdzik, Henrike Bruckmueller, Claus-Dieter Heidecke, Paul Martin, and Janett Müller

Subjects
Adult, Male, Organic Cation Transport Proteins, Abcg2, Pharmaceutical Science, Inflammation, 02 engineering and technology, ABCC4, Pharmacology, 030226 pharmacology & pharmacy, Inflammatory bowel disease, Intestinal absorption, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Cytochrome P-450 Enzyme System, Intestinal mucosa, Gene expression, medicine, Humans, Glucuronosyltransferase, Intestinal Mucosa, biology, Chemistry, Membrane Transport Proteins, Middle Aged, 021001 nanoscience & nanotechnology, medicine.disease, Intestines, Monocarboxylate transporter 1, Gene Expression Regulation, Pharmaceutical Preparations, biology.protein, ATP-Binding Cassette Transporters, Colitis, Ulcerative, Female, medicine.symptom, 0210 nano-technology
Abstract

Intestinal transporters and metabolizing enzymes are the important factors of the intestinal absorption barrier. Because there is evidence that their expression and function may be affected during inflammatory conditions, we investigated gene expression, protein abundance, and regulation of relevant intestinal transporters and metabolizing enzymes in the intestinal mucosa of patients with ulcerative colitis (UC). Specimens from inflamed and noninflamed tissues of 10 patients with UC as well as colonic control tissues of 10 patients without inflammation were subjected to gene (9 enzymes, 15 transporters, 9 cytokines) and microRNA (N = 54) expression analysis. Protein abundance was quantified by liquid chromatography-tandem mass spectrometry–based targeted proteomics. Gene expression of several metabolizing enzymes (e.g., CYP2C9, UGT1A1) and transporters such as ABCB1 (ABCB1), ABCG2 (ABCG2), and monocarboxylate transporter 1 (MCT1, SLC16A1) were significantly decreased during inflammation and negatively correlated to microRNAs. On contrary, multidrug resistance-protein 4 (MRP4, ABCC4), organic anion–transporting polypeptide 2B1 (OATP2B1, SLCO2B1), and organic cation transporter-like 2 (ORCTL2, SLC22A18) were significantly elevated in inflamed tissue. However, at protein level, these findings could only be confirmed for MCT1. UC is associated with complex changes in the intestinal expression of enzymes, transporters, cytokines, and microRNAs, which may affect efficacy of anti-inflammatory drug therapy or the disease state itself.

Published
2019

19. 477a A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PRA023 AS INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: ARTEMISUC, COHORT 1

Author

Sands, Bruce E., Peyrin-Biroulet, Laurent, Danese, Silvio, Rubin, David T., Vermeire, Severine, Ma, Christopher, Ritter, Timothy, Panaccione, Remo, Feagan, Brian G., Mcgovern, Dermot P.B., Laurent, Olivier, Luo, Allison, Nguyen, Deanna D., Lu, JD, Wiechowska-Kozlowska, Anna, Leszczyszyn, Jaroslaw, Kempinski, Radoslaw, Kierkus, Jaroslaw, and Targan, Stephan

Published
2023
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21. A randomized, double‐blind, placebo‐controlled trial to evaluate the efficacy, safety, and tolerability of long‐term treatment with prucalopride

Author

Enrico Corazziari, Marina Cools, Anna Wiechowska-Kozlowska, Rene Kerstens, Enrique Rey, Amy Levine, Karen Barrett, Magnus Simren, and Hubert Piessevaux

Subjects
Adult, Male, medicine.medical_specialty, Constipation, Physiology, Placebo-controlled study, Placebo, law.invention, Serotonin 5-HT4 Receptor Agonists, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Humans, Longitudinal Studies, Aged, Benzofurans, Prucalopride, Endocrine and Autonomic Systems, business.industry, Gastroenterology, Middle Aged, Clinical trial, Treatment Outcome, Tolerability, Chronic Disease, Physical therapy, Female, medicine.symptom, business, medicine.drug
Abstract

Background Randomized trials have confirmed the efficacy of prucalopride for the treatment of chronic constipation up to 12 weeks. This study aimed to assess the efficacy of prucalopride over a 24-week period (ClinicalTrials.gov: NCT01424228). Methods Adults with chronic constipation and ≤2 spontaneous complete bowel movements (SCBMs)/week were randomized to receive prucalopride 2 mg or placebo daily for 24 weeks. The primary endpoint was the proportion of patients achieving a mean of ≥3 SCBMs/week over the treatment period, assessed using daily e-diaries. Secondary outcomes and safety parameters were assessed throughout the study. Key Results Overall, 361 patients were randomized and received prucalopride or placebo. Baseline characteristics were similar in the prucalopride (N = 181) and placebo (N = 180) groups. Mean age was 48.9 years (standard deviation, 16.0) and most patients were women. The proportion of participants achieving the primary endpoint was not statistically different between the prucalopride and placebo groups (25.1% vs 20.7%; p = 0.367). There was also no statistically significant difference between groups over the first 12-week period (prucalopride, 25.1%; placebo, 20.1%; p = 0.341). There were no statistically significant differences between groups for most secondary endpoints. No new safety concerns were identified. Conclusions & Inferences This trial did not show statistically significant improvements in primary or secondary outcomes with prucalopride compared with placebo over 24 or 12 weeks. This is in contrast to the results of four previous 12-week trials, which demonstrated prucalopride to be significantly more effective than placebo. An extensive evaluation did not provide an explanation for the null efficacy results of this study.

Published
2015

24. Expression of transporter proteins and metabolic enzymes in ulcerative colitis

Author

Pascal Erdmann, Marek Drozdzik, Stefan Oswald, Diana Busch, Claus-Dieter Heidecke, Janette Müller, Lars-Ivo Partecke, and A. Wiechowska-Kozlowska

Subjects
Pharmacology, Biochemistry, Metabolic enzymes, medicine, Pharmaceutical Science, Pharmacology (medical), Transporter, Biology, medicine.disease, Ulcerative colitis
Published
2017

25. Vedolizumab as induction and maintenance therapy for ulcerative colitis

Author

Feagan, Bg, Rutgeerts, P, Sands, Be, Hanauer, S, Colombel, Jf, Sandborn, Wj, Van Assche, G, Axler, J, Kim, Hj, Danese, S, Fox, I, Milch, C, Sankoh, S, Wyant, T, Xu, J, Parikh, A, Bampton P, GEMINI 1 Study G. r. o. u. p., Chung, A, Debinski, H, Florin, T, Hetzel, D, Kronborg, I, Lawrance, I, Leong, R, Macrae, F, Moore, G, Pavli, P, Radford Smith, G, Weltman, M, Haas, T, Reinisch, W, Stockenhuber, F, Vogel, W, De Maeyer, M, De Vos, M, D'Haens, G, Louis, E, Muls, V, Petrov, P, Aumais, G, Bitton, A, Bourdages, R, Bressler, B, Cohen, A, Fedorak, R, Greenberg, G, Jones, J, Kutcher, W, Macintosh, D, Ponich, T, Singh, R, Steinhart, H, Sy, R, Douda, L, Lukas, M, Samek, M, Vyhnalek, P, Woznica, V, Zadorova, Z, Andersen, V, Rannem, T, Staun, M, Maelt, A, Margus, B, Bonaz, B, Coffin, B, Desreumaux, P, Laharie, D, Reimund, Jm, Karaus, M, Pace, A, Ross, M, Schmidt, W, Witthoeft, T, Zeitz, M, Karamanolis, D, Mantzaris, G, Maris, T, Ng, C, Gall, J, Hunyady, B, Szepes, A, Toth, T, Vincze, A, Oddsson, E, Jósefsspktali, Kö, Ahuja, V, Amarapurkar, D, Goenka, M, Habeeb, Ma, Jalihal, U, Kalambe, B, Koshy, A, Kumar, R, Prasad, V, Reddy, N, Sekar, T, Shankar, R, Tantry, V, Ryan, B, Avni, Y, Ben Horin, S, Ardizzone, S, Armuzzi, A, Corazziari, E, Fries, Walter, Kohn, A, Lisova, D, George, Am, Hilmi, In, Bhaskaran, Sk, Soon, Sy, Engels, L, Ponsioen, C, Wallace, I, Wyeth, J, Florholmen, J, Jahnsen, J, Lygren, I, Röseth, A, Ciecko Michalska, I, Gonciarz, M, Huk, J, Jamrozik Kruk, Z, Kondusz Szklarz, M, Paradowski, L, Wiechowska Kozlowska, A, Han, Ds, Hong, Sp, Kim, Js, Kim, Ko, Kim, Yh, Yang, Sk, Alexeeva, O, Bunkova, E, Burnevich, E, Dolgikh, O, Kasherininova, I, Khovaeva, Y, Lakhin, A, Ling, Kl, Bester, F, Coetzer, T, Grundling Hde, K, Jackson, Ld, Spies, P, Wright, Jp, Ziady, C, Garcia Planella, E, Perez Gisbert, J, Rogler, G, Seibold, F, Kao, Aw, Wu, Dc, Atug, O, Kurdas, Oo, Hawthorne, Ab, Lindsay, J, Abreu, M, Aggarwal, A, Bala, N, Becker, S, Behm, B, Braun, R, Cohn, W, Cross, R, Dar, S, Dassopoulos, T, De Villiers, W, Desta, T, Dryden, G, Duvall, A, Farraye, F, Fein, S, Liu, Bf, Gatof, D, Geenen, D, Ginsburg, P, Glover, S, Gopal, V, Hanson, J, Hardi, R, Isaacs, K, Jain, R, Karyotakis, N, Korzenik, J, Koshy, G, Koval, G, Lawitz, E, Lee, S, Loftus, E, Luther, R, Mahadevan, U, Mannon, P, Matsuyama, R, Mcintosh, A, Melmed, G, Mirkin, K, Nichols, M, Oubre, B, Pandak, W, Quadri, A, Quallich, L, Randall, C, Rausher, D, Regueiro, M, Safdi, A, Sands, B, Scherl, E, Schneier, J, Schwartz, D, Sedghi, S, Shafran, I, Siegel, C, Stein, L, Tatum, H, Weinberg, D, Winston, B, Wolf, D, Younes, Z, Jewell, D, Mahon, J, Rothstein, R, Snydman, D, Massaro, J, Clifford, D, Berger, J, Major, E, Provenzale, J, Abstract, Lev M., Feagan, Bg, Rutgeerts, P, Sands, Be, Hanauer, S, Colombel, Jf, Sandborn, Wj, Van Assche, G, Axler, J, Kim, Hj, Danese, S, Fox, I, Milch, C, Sankoh, S, Wyant, T, Xu, J, and Parikh, A

Subjects
Adult, Male, medicine.medical_specialty, Integrins, Placebo, Antibodies, Monoclonal, Humanized, Drug Administration Schedule, law.invention, Vedolizumab, Maintenance Chemotherapy, Maintenance therapy, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Glucocorticoids, Aged, business.industry, General Medicine, Induction Chemotherapy, Middle Aged, medicine.disease, Ulcerative colitis, Infliximab, Surgery, Clinical trial, Cohort, Colitis, Ulcerative, Drug Therapy, Combination, Female, business, Immunosuppressive Agents, medicine.drug
Abstract

Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis.We conducted two integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease. In the trial of induction therapy, 374 patients (cohort 1) received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score (range, 0 to 12, with higher scores indicating more active disease) of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.Response rates at week 6 were 47.1% and 25.5% among patients in the vedolizumab group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95% confidence interval [CI], 11.6 to 31.7; P0.001). At week 52, 41.8% of patients who continued to receive vedolizumab every 8 weeks and 44.8% of patients who continued to receive vedolizumab every 4 weeks were in clinical remission (Mayo Clinic score ≤2 and no subscore1), as compared with 15.9% of patients who switched to placebo (adjusted difference, 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [95% CI, 14.9 to 37.2; P0.001] and 29.1 percentage points for vedolizumab every 4 weeks vs. placebo [95% CI, 17.9 to 40.4; P0.001]). The frequency of adverse events was similar in the vedolizumab and placebo groups.Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis. (Funded by Millennium Pharmaceuticals; GEMINI 1 ClinicalTrials.gov number, NCT00783718.).

Published
2013

26. 'Odd-looking' oesophageal varices

Author

Wiechowska-Kozlowska, A., Bialek, A., Wojcicki, M., and Milkiewicz, P.

Subjects
Esophageal varices -- Diagnosis, Esophageal varices -- Care and treatment, Esophageal varices -- Development and progression, Esophageal varices -- Case studies, Health
Published
2009

27. Aggressive Surgical Management of Recurrent Lymph Node and Pancreatic Head Metastases of Resected Fibrolamellar Hepatocellular Carcinoma: A Case Report

Author

Maciej, Wojcicki, Jerzy, Lubikowski, Mariola, Post, Tomasz, Chmurowicz, Anna, Wiechowska-Kozlowska, and Marek, Krawczyk

Subjects
Adult, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Treatment Outcome, Lymphatic Metastasis, Liver Neoplasms, Fibrolamellar hepatocellular carcinoma, Neoplasm Metastasis, Pancreas, Hepatectomy, Humans, Female, Lymph Nodes, Neoplasm Recurrence, Local, Pancreaticoduodenectomy
Abstract

Context Fibrolamellar hepatocellular carcinoma is a rare liver tumor with the propensity to metastasize to the lymph nodes months or years after initial surgery. However, its metastatic spread to the pancreas was previously reported only in a child. Case report We present an unusual case of a young female patient who was repeatedly treated by surgical excision of abdominal and mediastinal lymph node recurrences between 2 and 6 years after left hepatic lobectomy for fibrolamellar hepatocellular carcinoma. At 8 years following her initial surgery, the patient was diagnosed with pancreatic head metastasis and a pancreaticoduodenectomy was performed. Postoperative course was uneventful and the patient did not experience recurrence within the last 18 months. Conclusion The metastasis of fibrolamellar hepatocellular carcinoma to the pancreas is highly exceptional but possible and its excision appears warranted as well., JOP. Journal of the Pancreas, Vol 13, N° 5 (2012): September - p. 470-547

Published
2012
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28. Serum concentrations of Cu, Se, Fe and Zn in patients diagnosed with pancreatic cancer

Author

Lener, Marcin, primary, Wiechowska-Kozlowska, Anna, additional, Scott, Rodney J, additional, Muszynska, Magdalena, additional, Kladny, Jozef, additional, Waloszczyk, Piotr, additional, Rutkowska, Anna, additional, Sukiennicki, Grzegorz, additional, Gromowski, Tomasz, additional, Jaworska-Bieniek, Katarzyna, additional, van de Wetering, Thierry, additional, Kaczmarek, Katarzyna, additional, Jakubowska, Anna, additional, and Lubinski, Jan, additional

Published
2015
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37. Isolated right posterior bile duct injury following cholecystectomy: report of two cases.

Author

Wojcicki M, Patkowski W, Chmurowicz T, Bialek A, Wiechowska-Kozlowska A, Stankiewicz R, Milkiewicz P, and Krawczyk M

Subjects
Adolescent, Anastomosis, Roux-en-Y, Bile Ducts abnormalities, Bile Ducts surgery, Cholangiopancreatography, Endoscopic Retrograde, Cholangiopancreatography, Magnetic Resonance, Female, Hepatectomy, Humans, Jejunostomy, Reoperation, Risk Factors, Treatment Outcome, Young Adult, Bile Ducts injuries, Cholecystectomy, Laparoscopic adverse effects, Cholecystitis surgery, Gallstones surgery
Abstract

Anatomic variations of the right biliary system are one of the most common risk factors for sectoral bile duct injury (BDI) during cholecystectomy. Isolated right posterior BDI may in particular be a challenge for both diagnosis and management. Herein we describe two cases of isolated right posterior sectoral BDI that took place during laparoscopic cholecystectomy. Despite effective external biliary drainage from the liver hilum in both cases, there was a persistent biliary leak observed which was not visible on endoscopic retrograde cholangiogram. Careful evaluation of images from both endoscopic and magnetic resonance cholangiograms revealed the diagnosis of an isolated right posterior sectoral BDI. These were treated with a delayed bisegmental (segments 6 and 7) liver resection and a Roux-en-Y hepaticojejunostomy respectively with good outcomes at 24 and 4 mo of follow-up. This paper discusses strategies for prevention of such injuries along with the diagnostic and therapeutic challenges it offers.

Published
2013
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38. Aggressive surgical management of recurrent lymph node and pancreatic head metastases of resected fibrolamellar hepatocellular carcinoma: a case report.

Author

Wojcicki M, Lubikowski J, Post M, Chmurowicz T, Wiechowska-Kozlowska A, and Krawczyk M

Subjects
Adult, Carcinoma, Hepatocellular surgery, Female, Hepatectomy, Humans, Liver Neoplasms surgery, Lymphatic Metastasis, Neoplasm Recurrence, Local, Pancreatic Neoplasms surgery, Pancreaticoduodenectomy, Treatment Outcome, Carcinoma, Hepatocellular pathology, Liver Neoplasms pathology, Lymph Nodes pathology, Pancreatic Neoplasms secondary
Abstract

Context: Fibrolamellar hepatocellular carcinoma is a rare liver tumor with the propensity to metastasize to the lymph nodes months or years after initial surgery. However, its metastatic spread to the pancreas was previously reported only in a child., Case Report: We present an unusual case of a young female patient who was repeatedly treated by surgical excision of abdominal and mediastinal lymph node recurrences between 2 and 6 years after left hepatic lobectomy for fibrolamellar hepatocellular carcinoma. At 8 years following her initial surgery, the patient was diagnosed with pancreatic head metastasis and a pancreaticoduodenectomy was performed. Postoperative course was uneventful and the patient did not experience recurrence within the last 18 months., Conclusion: The metastasis of fibrolamellar hepatocellular carcinoma to the pancreas is highly exceptional but possible and its excision appears warranted as well.

Published
2012
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39. Pancreatoduodenectomy with a modified duct-to-mucosa pancreaticojejunostomy: an analysis of 101 consecutive patients.

Author

Wojcicki M, Post M, Jarosz K, Bialek A, Wiechowska-Kozlowska A, Milkiewicz P, and Lubikowski J

Subjects
Adult, Aged, Anastomotic Leak etiology, Female, Hospital Mortality, Humans, Intestinal Mucosa surgery, Male, Middle Aged, Pancreatic Ducts surgery, Postoperative Hemorrhage etiology, Retrospective Studies, Sepsis etiology, Stents, Surgical Wound Infection etiology, Young Adult, Bile Duct Neoplasms surgery, Pancreatic Neoplasms surgery, Pancreaticoduodenectomy adverse effects, Pancreaticoduodenectomy methods, Pancreaticojejunostomy adverse effects, Pancreaticojejunostomy methods
Abstract

Background/aims: The aim of the study was to analyze in-hospital morbidity and mortality after pancreatoduodenectomy (PD) with a modified duct-to-mucosa pancreaticojejunostomy., Methodology: We retrospectively analyzed 101 consecutive patients who underwent PD at our center between January 2002 and December 2010. Two-layered duct-to-mucosa pancreaticojejunostomy was performed over an internal transanastomotic stent in all patients., Results: The overall in-hospital morbidity and mortality rate was 48% and 6%, respectively. Three patients died as a consequence of local complications including mesenteric ischemia in two and acute necrotizing pancreatitis in one case. Pancreatic fistula occurred in one (1%) patient and was treated conservatively with good outcome. The wound infection was the most common surgical complication (20/101; 20%) and occurred more often in patients who had a biliary stent inserted endoscopically prior to surgery (15/38; 39%), as compared to those without the stent (5/63; 8%; p=0.0003)., Conclusions: The results of the present study suggest that a two-layered duct-to-mucosa pancreaticojejunostomy with internal transanastomotic stent is a safe anastomosis, associated with a very low risk of pancreatic fistula. The presence of a biliary stent at the time of surgery represents a risk factor for the development of postoperative wound infection.

Published
2012
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