Risankizumab for Ulcerative Colitis

作者：Edouard Louis, Stefan Schreiber, Remo Panaccione, Peter Bossuyt, Luc Biedermann, Jean–Frédéric Colombel, Gareth M. B. Parkes, Laurent Peyrin‐Biroulet, Geert D’Haens, Tadakazu Hisamatsu, Britta Siegmund, Kaichun Wu, Brigid S. Boland, Gil Melmed, Alessandro Armuzzi, Phillip Levine, Jasmina Kalabic, Su Chen, Ling Cheng, Lei Shu, W. Rachel Duan, Valerie Pivorunas, Yuri Sánchez González, Ronilda D’Cunha, Ezequiel Neimark, Kori Wallace, Raja Atreya, Marc Ferrante, Edward V. Loftus, INSPIRE and COMMAND Study Group, Domingo Balderramo, Silvina A. Goncalves, Juan Lasa, Abel Novillo, Orlando Ruffinengo, Sonja Heeren, Walter Reinisch, Filip Baert, Peter Bossuyt, A Colard, Olivier Dewit, Marc Ferrante, Denis Franchimont, Edouard Louis, Jean‐François Rahier, Carlos Fernando de Magalhães Francesconi, Roberto Luiz Kaiser, Rogério Serafim Parra, Lígia Yukie Sassaki, Пламен Пенчев, Desislav Stanchev, Kenneth Atkinson, Melanie Beaton, Talat Bessissow, Susan Greenbloom, Jean-Rene Lachance, Allen Lim, Remo Panaccione, Jean-Michel Samson, Scott Shulman, Jesse Siffledeen, Ignacio Alfaro, Carlos Valenzuela, Gustavo Walsen, Ping An, Qian Cao, Yan Chen, Youxiang Chen, Xiang Gao, Xiaohua Hou, Naizhong Hu, Yan Li, Fei Liu, Mei Liu, LU Lungen, Zhihua Ran, Tongyu Tang, Xin Wang, Shaoqi Yang, Qiang Zhan, Guoxin Zhang, Hu Zhang, Jie Zhang, Xiaolan Zhang, Jie Zhong, Xiaoping Zou, Eligio Álvarez, Juan Ricaurte, Vladimir Borzan, Željko Krznarić, Željko Puljiz, Martin Bortlík, Pavel Svoboda, Jan Ulbrych, Tomáš Vaňásek, Jens Kjeldsen, Lars Kristian Munck, Anja Poulsen, Ezzat Ali, Osama Salem, Hisham Sawah, Imam Waked, Romain Altwegg, Mathurin Flamant, Mathurin Fuméry, Xavier Hébuterne, David Laharie, Laurent Peyrin‐Biroulet, Xavier Roblin, Xavier Tréton, Raja Atreya, Herbert Deppe, Peter Hasselblatt, Arne Kandulski, Jochen Klaus, Thomas Krause, Torsten Kucharzik, Jessica Mertens, Michael Mroß, N. A. Naumann, Wolfgang Reindl, Ingolf Schiefke, Stefan Schreiber, Stefan Schubert, Britta Siegmund, Andreas Sturm, Georgios Bamias, Ioannis E. Κoutroubakis, Spilios Manolakopoulos, Gerassimos J. Mantzaris, Maria Tzouvala, N. Viazis, Irit Avni‐Biron, Eran Goldin, Lior H. Katz, Adi Lahat-Zok, Arik Segal, Sandro Ardizzone, Alessandro Armuzzi, Michele Cicala, Antonio Colecchia, R. Cosintino, Antonio Gasbarrini, Andrea Geccherle, Edoardo G. Giannini, Paolo Gionchetti, Francesco Luzza, Giovanni Monteleone, Antonino Carlo Privitera, Simone Saibeni, Marcello Vangeli, Yasuhiko Abe, Nobuo Aoyama, Kunio Asonuma, Yutaka Endo, Motohiro Esaki, Toshimitsu Fujii, Katsuyuki Fukuda, Fumihito Hirai, Yasuhiro Hisanaga, Noriyuki Horiki, Mikitaka Iguchi, Keisuke Ishigami, Yoh Ishiguro, Hiroaki Ito, Yoichi Kakuta, Koji Kamikozuru, Jun Kato, Teruki Kawanishi, Taku Kobayashi, Hiroyuki Kuge, Atsuo Maemoto, Tomoyuki Masuda, Katsuyoshi Matsuoka, Kayoko Matsushima, Masashi Matsushima, Satoshi Motoya, Katsuhiko Nakai, Koichi Nakajima, Masanao Nakamura, Atsushi Nishida, Takahiro Nishikawa, Nobuaki Nishimata, Toshiaki Ochiai, Naoki Ohmiya, Yoshifumi Ohnishi, Shiro Oka, Keiji Ozeki, Daisuke Saito, Masayuki Saruta, Makoto Sasaki, Masahito Shimizu, Ken Sugimoto, Tomohisa Sujino, Takayoshi Suzuki, Hajime Takatori, Noritaka Takatsu, Hidetoshi Takedatsu, Ken Takeuchi, Hiroki Tanaka, Satoki Tokito, Toshiyuki Endo, Tatsuya Toyokawa, Yoshito Uenoyama, Takatsugu Yamamoto, Takayuki Yamamoto, Hiroshi Yasuda, Kaoru Yokoyama, Aleksejs Derovs, Aldis Puķītis, Laimas Jonaitis, Edita Kazėnaitė, Lourdes Lol-be Pinzon Te, Geert D’Haens, Maurice Lutgens, James Brooker, Richard B. Gearry, Ben Griffiths, Stephen Inns, Michael Schultz, Jerzy Eszyk, Jarosław Kierkuś, D Kleczkowski, Adam Kopoń, Robert Petryka, Jarosław Reguła, Tomasz Romańczyk, Grażyna Rydzewska-Wyszkowska, Piotr Sikorski, Michał Talarek, Rute Cerqueira, Tiago Gonçalves, Susana Lopes, Paula Ministro, Francisco Portela, Helena Tavares, Mihai-Mircea Diculescu, Adrian Goldiș, Andrada Seicean, Alina Agafina, Anton Edin, Evgenia Gerasimova, Maryana Gettueva, В. Н. Кашников, Albert Pirmagomedov, Vladimir Rafalskiy, К. М. Шарапова, Е. А. Smolyarchuk, Daria L Varganova, Saša Grgov, Igor Jovanović, Petar Svorcan, Dino Tarabar, Khoon Lin Ling, Jozef Baláž, J Ďurina, Miloš Greguš, Martin Laclav, David Drobne, Eduan Deetlefs, Jonny Peter, Muhammad Rajabally, Jennifer Rosa, JI van Zyl, John Wright, Jae Hee Cheon, Byung Ik Jang, Jee Hyun Kim, Sang-Bum Kang, Duk-Hwan Kim, Tae Oh Kim, Young-Ho Kim, Jong Hun Lee, Kang‐Moon Lee, Dong Il Park, Geun Am Song, Federico Argüelles‐Arias, Luisa Castro Laria, Ana Echarri Piudo, Santiago García‐López, Vincent Hernandez Ramirez, María Dolores Martín‐Arranz, Pilar Varela Trastoy, M Vera Mendoza, Mikael Lördal, Luc Biedermann, Benjamin Misselwitz, Chung-Hsin Chang, Jen‐Wei Chou, Chia-Jung Kuo, Ching‐Pin Lin, Chia–Hung Tu, Hüseyin Alkım, Yusuf Erzın, İrfan Soykan, Tetiana Kravchenko, Nataliia Tsarynna, Vira Vyshyvanyuk, Tariq Ali Ahmad, Fraser Cummings, Kapil Kapur, Arthur Kaser, Alexandra Kent, Gareth Parkes, Kamal Patel, R. Speight, Alan Steel, Faten Aberra, Humberto Aguilar, Badr Al‐Bawardy, Ashwin N. Ananthakrishnan, Matthew D. Barnes, Kendall Beck, Charles Berkelhammer, Brigid S. Boland, Jeff Bullock, Adeeti Chiplunker, Robin Dalal, Sushila Dalal, Belkis Delgado, Michael P. DiGiovanna, George Duvall, Curtis Freedland, Keith Friedenberg, Jill Gaidos, Philip Ginsburg, Tarek Hassanein, Peter Higgins, John D. Hong, Jason K. Hou, Vivek Huilgol, Nikhil Inamdar, Saurabh Kapur, David H. Kerman, Henry Levine, Nilesh Lodhia, Edward V. Loftus, Jaime L. Mayoral, Donald McNeil, Gil Melmed, Andria M. Mushahwar, Harry Ojeas, Bhaktasharan Patel, Raymond E. Phillips, Joe Pouzar, H Sarles, Joel Schock, Shahriar Sedghi, Nirav V. Shah, Junaid Siddiqui, David Stokesberry, Le‐Chu Su, Arun Swaminath, Dharmendra Verma, John T. Weber, Ziad Younes, Timothy L. Zisman · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.12414 · 被引用次数：120 · 研究领域：Inflammatory Bowel Disease、Psoriasis: Treatment and Pathogenesis、Spondyloarthritis Studies and Treatments

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...