Munck, Lars Kristian
https://orcid.org/0000-0002-5014-8260
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
European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations
Miehlke, Stephan , Guagnozzi, Danila , Fiehn, Anne‐Marie Kanstrup , Wildt, Signe , Bohr, Johan, Bonderup, Ole K. , Bouma, Gerd , D’Amato, Mauro , Engel, Peter J. , Macaigne, Gilles , Hjortswang, Henrik , Koulaouzidis, Anastasios , Kupcinskas, Jouzas, Landolfi, Stefania , Lyutakov, Ivan , Madisch, Ahmed , Magro, Fernando , Mihály, Emese , Munck, Lars Kristian , Ostvik, Ann‐Elisabeth, Patai, Árpád V. , Penchev, P , Skonieczna‐Żydecka, Karolina , Verhaegh, Bas , Kupčinskas, Juozas , Landolfi, Stefania , Lucendo, Alfredo , Lyutakov, Ivan , Marlicz, Wojciech , Patai, Árpád V , D'Amato, Mauro , Magro, F , Kupcinskas, Juozas , Zabana, Yamile , Tontini, Gian Eugenio , Engel, Peter J. Heiberg, Fernández-Bañares, Fernando , Hörnquist, Elisabeth Hultgren , Latella, Giovanni , Münch, Andreas
United European Gastroenterology Journal | August 21, 2020 | Volume: 9 | Issue: 1 | Pages: 13-37
AbstractIntroductionMicroscopic colitis is a chronic inflammatory bowel disease characterised by normal or almost normal endoscopic appearance of the colon, chronic watery, nonbloody diarrhoea and distinct histological abnormalities, which identify three histological subtypes, the collagenous colitis, the lymphocytic colitis and the incomplete microscopic colitis. With ongoing uncertainties and new developments in the clinical management of microscopic colitis, there is a need for evidence‐based guidelines to improve the medical care of patients suffering from this disorder.MethodsGuidelines were developed by members from the European Microscopic Colitis Group and United European Gastroenterology in accordance with the Appraisal of Guidelines for Research and Evaluation II instrument. Following a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the certainty of the evidence. Statements and recommendations were developed by working groups consisting of gastroenterologists, pathologists and basic scientists, and voted upon using the Delphi method.ResultsThese guidelines provide information on epidemiology and risk factors of microscopic colitis, as well as evidence‐based statements and recommendations on diagnostic criteria and treatment options, including oral budesonide, bile acid binders, immunomodulators and biologics. Recommendations on the clinical management of microscopic colitis are provided based on evidence, expert opinion and best clinical practice.ConclusionThese guidelines may support clinicians worldwide to improve the clinical management of patients with microscopic colitis.