Κoutroubakis, Ioannis E.
Mayo Clinic
for the INSPIRE and COMMAND Study Group
Citations 2
Risankizumab for Ulcerative Colitis
Louis, Edouard, Panaccione, Remo, Biedermann, Luc , Colombel, Jean–Frédéric, D’Haens, Geert , Hisamatsu, Tadakazu , Siegmund, Britta , Boland, Brigid S. , Melmed, Gil , Armuzzi, Alessandro , Levine, Phillip, Kalabic, Jasmina , Cheng, Ling, Shu, Lei , Duan, W. Rachel, Pivorunas, Valerie , González, Yuri Sánchez , D’Cunha, Ronilda , Neimark, Ezequiel, Wallace, Kori, Ferrante, Marc , Group, INSPIRE and COMMAND Study, Balderramo, Domingo , Goncalves, Silvina A., Lasa, Juan, Novillo, Abel, Ruffinengo, Orlando, Heeren, Sonja, Reinisch, Walter , Baert, Filip , Colard, A, Ferrante, Marc, Franchimont, Denis , Rahier, Jean‐François , Francesconi, Carlos Fernando de Magalhães , Stanchev, Desislav , Atkinson, Kenneth, Beaton, Melanie, Greenbloom, Susan, Lachance, Jean-Rene, Lim, Allen, Samson, Jean-Michel, Shulman, Scott, Siffledeen, Jesse, Alfaro, Ignacio , Valenzuela, Carlos , Walsen, Gustavo, An, Ping , Cao, Qian , Chen, Yan , Gao, Xiang , Hou, Xiaohua , Hu, Naizhong, Liu, Mei , Lungen, LU, Ran, Zhihua, Tang, Tongyu , Yang, Shaoqi , Zhan, Qiang , Zhang, Guoxin , Zhang, Xiaolan , Zhong, Jie , Zou, Xiaoping, Álvarez, Eligio, Ricaurte, Juan, Borzan, Vladimir , Puljiz, Željko , Svoboda, Pavel , Ulbrych, Jan, Vaňásek, Tomáš , Ali, Ezzat, Salem, Osama , Sawah, Hisham, Altwegg, Romain , Flamant, Mathurin, Hébuterne, Xavier , Deppe, Herbert, Klaus, Jochen , Kucharzik, Torsten , Mertens, Jessica, Mroß, Michael, Reindl, Wolfgang , Schiefke, Ingolf, Schreiber, Stefan, Sturm, Andreas , Bamias, Georgios, Manolakopoulos, Spilios , Mantzaris, Gerassimos J. , Tzouvala, Maria , Viazis, N. , Avni‐Biron, Irit , Goldin, Eran , Katz, Lior H. , Lahat-Zok, Adi, Segal, Arik, Colecchia, Antonio , Cosintino, R. , Geccherle, Andrea, Monteleone, Giovanni , Privitera, Antonino Carlo , Vangeli, Marcello, Abe, Yasuhiko , Aoyama, Nobuo , Endo, Yutaka , Esaki, Motohiro, Fujii, Toshimitsu , Fukuda, Katsuyuki , Hirai, Fumihito , Hisanaga, Yasuhiro, Horiki, Noriyuki , Iguchi, Mikitaka , Ishiguro, Yoh , Ito, Hiroaki , Kamikozuru, Koji , Kato, Jun , Kawanishi, Teruki, Kobayashi, Taku , Kuge, Hiroyuki , Masuda, Tomoyuki, Matsuoka, Katsuyoshi , Matsushima, Kayoko , Matsushima, Masashi, Motoya, Satoshi , Nakai, Katsuhiko, Nakajima, Koichi, Nakamura, Masanao, Nishida, Atsushi , Nishikawa, Takahiro , Nishimata, Nobuaki, Ochiai, Toshiaki, Ohmiya, Naoki , Ohnishi, Yoshifumi , Oka, Shiro , Ozeki, Keiji , Saito, Daisuke, Saruta, Masayuki, Sasaki, Makoto, Shimizu, Masahito , Sujino, Tomohisa , Takatori, Hajime , Takatsu, Noritaka , Tokito, Satoki, Endo, Toshiyuki, Toyokawa, Tatsuya , Uenoyama, Yoshito , Yamamoto, Takatsugu, Yasuda, Hiroshi , Yokoyama, Kaoru , Jonaitis, Laimas, Kazėnaitė, Edita, Te, Lourdes Lol-be Pinzon, Lutgens, Maurice, Brooker, James, Griffiths, Ben, Inns, Stephen , Schultz, Michael, Eszyk, Jerzy, Kleczkowski, D, Kopoń, Adam, Petryka, Robert, Romańczyk, Tomasz , Rydzewska-Wyszkowska, Grażyna , Sikorski, Piotr, Talarek, Michał, Ministro, Paula , Tavares, Helena, Diculescu, Mihai-Mircea, Goldiș, Adrian , Agafina, Alina, Edin, Anton, Gerasimova, Evgenia, Gettueva, Maryana, Кашников, В. Н. , Pirmagomedov, Albert , Rafalskiy, Vladimir , Шарапова, К. М., Varganova, Daria L , Grgov, Saša, Svorcan, Petar , Tarabar, Dino, Ling, Khoon Lin , Baláž, Jozef, Ďurina, J, Greguš, Miloš, Laclav, Martin , Deetlefs, Eduan, Peter, Jonny , Rajabally, Muhammad, Rosa, Jennifer, Zyl, JI van, Wright, John , Jang, Byung Ik , Kang, Sang-Bum, Kim, Duk-Hwan , Kim, Tae Oh , Kim, Young-Ho , Song, Geun Am , Laria, Luisa Castro, Piudo, Ana Echarri, Ramirez, Vincent Hernandez, Martín‐Arranz, María Dolores , Trastoy, Pilar Varela, Mendoza, M Vera, Lördal, Mikael, Chang, Chung-Hsin, Kuo, Chia-Jung , Lin, Ching‐Pin , Tu, Chia–Hung, Erzın, Yusuf , Soykan, İrfan , Kravchenko, Tetiana , Tsarynna, Nataliia, Vyshyvanyuk, Vira , Cummings, Fraser , Kapur, Kapil , Kaser, Arthur , Kent, Alexandra , Parkes, Gareth, Patel, Kamal , Steel, Alan , Aberra, Faten , Aguilar, Humberto , Al‐Bawardy, Badr , Barnes, Matthew D., Beck, Kendall , Berkelhammer, Charles , Bullock, Jeff, Chiplunker, Adeeti , Dalal, Robin, Dalal, Sushila , Delgado, Belkis, DiGiovanna, Michael P., Duvall, George, Freedland, Curtis, Friedenberg, Keith, Gaidos, Jill , Ginsburg, Philip, Hassanein, Tarek , Higgins, Peter , Hou, Jason K. , Huilgol, Vivek, Inamdar, Nikhil, Kapur, Saurabh, Kerman, David H., Levine, Henry, Lodhia, Nilesh, Mayoral, Jaime L., McNeil, Donald, Mushahwar, Andria M., Ojeas, Harry, Patel, Bhaktasharan, Phillips, Raymond E. , Pouzar, Joe, Sarles, H, Schock, Joel, Sedghi, Shahriar , Shah, Nirav V. , Stokesberry, David, Su, Le‐Chu, Verma, Dharmendra, Weber, John T. , Younes, Ziad , Zisman, Timothy L. , Melmed, Gil Y , Kobayashi, Taku , Siegmund, Britta , Schreiber, Stefan , Bossuyt, Peter , Parkes, Gareth, Peyrin‐Biroulet, Laurent , Wu, Kaichun , Chen, Su , Atreya, Raja Narayana , Loftus, Edward V. , Group, INSPIRE and COMMAND Study, Reinisch, Walter , Dewit, Olivier , Franchimont, Denis , Kaiser, Roberto Luiz , Parra, Rogério Serafim , Sassaki, Lígia Yukie , Пенчев, Пламен , Bessissow, Talat , Lachance, Jean-René, Panaccione, Remo , Walsen, Gustavo, Chen, Youxiang , Li, Yan , Liu, Fei , Wang, Xin , Zhan, Qiang, Zhang, Hu , Zhang, Jie , Ricaurte, Juan, Krznarić, Željko , Bortlík, Martin , Svoboda, Pavel, Kjeldsen, Jens , Munck, Lars Kristian , Poulsen, Anja, Waked, Imam A. , Fumery, Mathurin , Laharie, David , Roblin, Xavier , Tréton, Xavier , Deppe, Herbert, Hasselblatt, Peter , Kandulski, Arne , Krause, Thomas , Naumann, Axel, Schreiber, Stefan , Schubert, Stefan, Κoutroubakis, Ioannis E. , Ardizzone, Sandro , Cicala, Michele , Gasbarrini, Antonio , Giannini, Edoardo Giovanni , Gionchetti, Paolo , Luzza, Francesco , Saibeni, Simone , Abe, Yasuhiko, Asonuma, Kunio , Hisanaga, Yasuhiro, Ishigami, Keisuke, Kakuta, Yoichi , Maemoto, Atsuo , Nakajima, Koichi, Nishida, Atsushi, Sasaki, Makoto, Sugimoto, Ken , Suzuki, Takayoshi , Takedatsu, Hidetoshi , Takeuchi, Ken, Tanaka, Hiroki , Tokito, Satoki, Yamamoto, Takayuki , Derovs, Aleksejs , Puķītis, Aldis , Jonaitis, Laimas Virginijus , Gearry, Richard B. , Griffiths, Ben, Kierkuś, Jarosław , Reguła, Jarosław , Cerqueira, Rute Maria , Goncalves, Tiago, Lopes, Susana , Portela, Francisco , Seicean, Andrada , Gerasimova, Evgenia, Sharapova, Ksenia, Smolyarchuk, Е. А. , Jovanović, Igor , Balaz, Jozef, Drobne, David , Wright, John, Cheon, Jae Hee , Kim, Jee Hyun , Lee, Jong Hun , Lee, Kang‐Moon , Park, Dong Il , Argüelles‐Arias, Federico , Piudo, Ana Echarri, García‐López, Santiago , Ramirez, V Hernández, Misselwitz, Benjamin , Chou, Jen‐Wei , Tu, Chia‐Hung , Alkım, Hüseyin , Kravchenko, Tetiana, Ahmad, Tariq, Parkes, Gareth, Speight, Richard, Ananthakrishnan, Ashwin N. , Barnes, Matthew, Bullock, Jeff, DiGiovanna, Michael, Hong, John D. , Huilgol, V.R., Phillips, Raymond, Siddiqui, Junaid, Swaminath, Arun C. , Weber, John, Matsuoka, K
JAMA | July 22, 2024 | Volume: 332 | Issue: 11 | Pages: 881
Importance The clinical effects of risankizumab (a monoclonal antibody that selectively targets the p19 subunit of IL-23) for the treatment of ulcerative colitis are unknown. Objective To evaluate the efficacy and safety of risankizumab when administered as an induction and a maintenance therapy for patients with ulcerative colitis. Design, Setting, and Participants Two phase 3 randomized clinical trials were conducted. The induction trial was conducted at 261 clinical centers (in 41 countries) and enrolled 977 patients from November 5, 2020, to August 4, 2022 (final follow-up on May 16, 2023). The maintenance trial was conducted at 238 clinical centers (in 37 countries) and enrolled 754 patients from August 28, 2018, to March 30, 2022 (final follow-up on April 11, 2023). Eligible patients had moderately to severely active ulcerative colitis; a history of intolerance or inadequate response to 1 or more conventional therapies, advanced therapies, or both types of therapies; and no prior exposure to risankizumab. Interventions For the induction trial, patients were randomized 2:1 to receive 1200 mg of risankizumab or placebo administered intravenously at weeks 0, 4, and 8. For the maintenance trial, patients with a clinical response (determined using the adapted Mayo score) after intravenous treatment with risankizumab were randomized 1:1:1 to receive subcutaneous treatment with 180 mg or 360 mg of risankizumab or placebo (no longer receiving risankizumab) every 8 weeks for 52 weeks. Main Outcomes and Measures The primary outcome was clinical remission (stool frequency score ≤1 and not greater than baseline, rectal bleeding score of 0, and endoscopic subscore ≤1 without friability) at week 12 for the induction trial and at week 52 for the maintenance trial. Results Among the 975 patients analyzed in the induction trial (aged 42.1 [SD, 13.8] years; 586/973 [60.1%] were male; and 677 [69.6%] were White), the clinical remission rates at week 12 were 132/650 (20.3%) for 1200 mg of risankizumab and 20/325 (6.2%) for placebo (adjusted between-group difference, 14.0% [95% CI, 10.0%-18.0%], P < .001). Among the 548 patients analyzed in the maintenance trial (aged 40.9 [SD, 14.0] years; 313 [57.1%] were male; and 407 [74.3%] were White), the clinical remission rates at week 52 were 72/179 (40.2%) for 180 mg of risankizumab, 70/186 (37.6%) for 360 mg of risankizumab, and 46/183 (25.1%) for placebo (adjusted between-group difference for 180 mg of risankizumab vs placebo, 16.3% [97.5% CI, 6.1%-26.6%], P < .001; adjusted between-group difference for 360 mg of risankizumab vs placebo, 14.2% [97.5% CI, 4.0%-24.5%], P = .002). No new safety risks were detected in the treatment groups. Conclusion and Relevance Compared with placebo, risankizumab improved clinical remission rates in an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis. Further study is needed to identify benefits beyond the 52-week follow-up. Trial Registration ClinicalTrials.gov Identifiers: NCT03398148 and NCT03398135
Development of an index to define overall disease severity in IBD
Whitman, Cynthia B. , Spiegel, Brennan , Feagan, Brian G. , Loftus, Edward V. , D’Haens, Geert , Bernstein, Çharles N. , Gearry, Richard B. , Mantzaris, Gerassimos J. , Sartor, Balfour R., Silverberg, Mark S. , Riddell, Robert H. , O’Morain, Colm, Lakatos, Péter L. , Halfvarson, Jonas , Reinisch, Walter, Rogler, Gerhard , Kruis, Wolfgang , Tysk, Curt , Danese, Silvio , Sandborn, William J. , Gasché, Christoph , Pallone, Francesco, Travis, Simon , Peyrin‐Biroulet, Laurent , Siegel, Corey A , Sands, Bruce E , Panaccione, Remo , Bernstein, Charles Noah , Ng, Siew C. , Κoutroubakis, Ioannis E. , McGovern, Dermot , Halfvarson, Jonas , Schreiber, Stefan , Griffiths, Anne Marie , Moum, Bjørn Allan , Panés, Julián , Colombel, Jean‐Frédéric , Hanauer, Stephen B. , Loftus, Edward V , Danese, Silvio , Peyrin-Biroulet, Laurent , Spiegel, Brennan , Lakatos, Peter L
Gut | October 25, 2016 | Volume: 67 | Issue: 2 | Pages: 244-254
Background and aim Disease activity for Crohn's disease (CD) and UC is typically defined based on symptoms at a moment in time, and ignores the long-term burden of disease. The aims of this study were to select the attributes determining overall disease severity, to rank the importance of and to score these individual attributes for both CD and UC. Methods Using a modified Delphi panel, 14 members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) selected the most important attributes related to IBD. Eighteen IOIBD members then completed a statistical exercise (conjoint analysis) to create a relative ranking of these attributes. Adjusted utilities were developed by creating proportions for each level within an attribute. Results For CD, 15.8% of overall disease severity was attributed to the presence of mucosal lesions, 10.9% to history of a fistula, 9.7% to history of abscess and 7.4% to history of intestinal resection. For UC, 18.1% of overall disease severity was attributed to mucosal lesions, followed by 14.0% for impact on daily activities, 11.2% C reactive protein and 10.1% for prior experience with biologics. Overall disease severity indices were created on a 100-point scale by applying each attribute's average importance to the adjusted utilities. Conclusions Based on specialist opinion, overall CD severity was associated more with intestinal damage, in contrast to overall UC disease severity, which was more dependent on symptoms and impact on daily life. Once validated, disease severity indices may provide a useful tool for consistent assessment of overall disease severity in patients with IBD.