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Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies
David T. Rubin, Jessica R. Allegretti, Julián Panés, Nicole Shipitofsky, Shadi Yarandi, Kuan‐Hsiang Gary Huang, Matthew Germinaro, Rebbecca Wilson, Hongyan Zhang, Jewel Johanns, Brian G. Feagan, Tadakazu Hisamatsu, Gary R. Lichtenstein, Brian Bressler, Laurent Peyrin‐Biroulet, Bruce E Sands, Axel Dignaß, О. Аbrahamovych, Niazy Abu-farsakh, Halyna Afanasieva, Hale Akpınar, Houssam Al Kharrat, Engin Altıntaş, Romain Altwegg, П. С. Андреев, Kazuki Aomatsu, Marjorie Argollo, Federico Ariel, Alessandro Armuzzi, Toshifumi Ashida, Monika Augustyn, Guy Aumais, Martín Azum, Filip Baert, Jozef Baláž, Domingo Balderramo, Jakob Begun, Temenuzhka Berova, Lore Billiauws, Antonio Blanco, Martin Bortlík, Fabrizio Bossa, Elena Bunkova, Mercedes Cabello, Qian Cao, Flavio Caprioli, Rute Cerqueira, Karen A. Chachu, Patrick Chamouard, Chunxiao Chen, Yan Chen, Baili Chen, Dongfeng Chen, Hong Chen, Youxiang Chen, Chou‐Chen Chen, Minhu Chen, Cheng-Tang Chiu, Chang‐Hwan Choi, Elizabeth Chow, Michele Cicala, Wit Danilkiewicz, Olena Datsenko, Gert De Hertogh, Julio De María, L Medina, Deliang Liu, Pierre Desreumaux, Pieter Dewint, Shigang Ding, Glen Doherty, Joris Dutré, George Duvall, Laurence J. Egan, Julien Fahed, Lars Fechner, Miroslav Fedurco, Aykut Ferhat Celik, J. C. Fernández, Rafał Filip, Sigal Fishman, Cristina Flores, Ronald Fogel, Sharyle Fowler, Carlos Fernando de Magalhães Francesconi, Toshimitsu Fujii, Mikihiro Fujiya, Masayuki Fukata, Seiichiro Fukuhara, Yohei Furumoto, G Kiss, Waldemar Gachowski, Xiang Gao, Antonio Gasbarrini, Beata Gawdis-Wojnarska, Daniel R. Gaya, Andrea Geccherle, Edgardo I. Gimenez, Paolo Gionchetti, Eran Goldin, Oleksandr Golovchenko, Maciej Gonciarz, Can Gönen, Chad Gonzales, Raquel Luengo González, Oleksiy Gridnyev, Fang Gu, Nitin Gupta, T Gyökeres, Melissa Haines, Xavier Hébuterne, Charlotte Hedin, Per M. Hellström, Ida Hilmi, Fumihito Hirai, Takashi Hisabe, Tibor Hlavatý, Frank Hoentjen, Gerald Holtmann, Noriyuki Horiki, Ivo Horný, Gyula Horvat, F Horváth, Namiko Hoshi, Shuhei Hosomi, Ihor Hospodarskyy, Xiaohua Hou, Luděk Hrdlička, Naizhong Hu, Vivian Huang, Caibin Huang, Tomoki Inaba, Yoh Ishiguro, Shunji Ishihara, Takeshi Ishikawa, Heba Iskandar, Eran Israeli, Soichi Itaba, Olha Ivanishyn, F Izbéki, Animesh Jain, Vipul Jairath, Byung Ik Jang, Chunmeng Jiang, Michael Jones, Takashi Kagaya, Dilara Kalimullina, Marina Karakina, Ali Karataş, Hiroshi Kashimura, Dan Keret, Yaroslava Khovaeva, Jarosław Kierkuś, Taeoh Kim, Young‐Ho Kim, Hyo Jong Kim, Jochen Klaus, D Kleczkowski, Maria Kłopocka, Taku Kobayashi, Iwona Kobielusz‐Gembala, Yuichiro Kojima, Ja Seol Koo, Adam Kopoń, James Kopp, Fumikazu Koyama, V. Koynarski, Tetiana Kravchenko, Masatoshi Kudo, Ryusaku Kusunoki, Kwang-An Kwon, Martin Laclav, Paula Lago, David Laharie, Juan S. Lasa, Syed Salman Lateef, Tatjana Latinovic Radakovic, Kang‐Moon Lee, Jarosław Leszczyszyn, Yan Li, Mei Liu, Eashen Liu, Triana Lobatón, Susana Lopes, M. Jovanović, Márcio Lubini, Milan Lukáš, Christian Maaser, Evžen Machytka, Atsuo Maemoto, Fernando Magro, Jorge Marcet, Hiroyuki Marusawa, Jan Matouš, Takayuki Matsumoto, Shoba Mendu, Yinglei Miao, Emese Mihály, Pál Miheller, Paula Ministro, Hideharu Miyabayashi, Wolfgang Mohl, Martin Molnar, Gregory Moore, Gabriela Moran Faienzo, Eugeni Domènech Morral, Satoshi Motoya, Narayanachar Murali, Nazri Mustaffa, Mohamed Naem, Katsuhiko Nakai, Koichi Nakajima, Yasunari Nakamoto, Masanao Nakamura, Stéphane Nancey, Udayakumar Navaneethan, Khairul Najmi Muhammad Nawawi, Tomoyuki Ninomiya, János Novák, Motoji Oki, Genoile Oliveira Santana, Michio Onizawa, Yohei Ono, Taro Osada, М. Ф. Осипенко, Danuta Owczarek, José Miguel Luz Parente, Kamal Patel, Bhaktasharan Patel, P.C. Pedersen, Rima Petronienė, Asen Petrov, Elina Petrova, Marie‐Astrid Piquet, Juris Pokrotnieks, Е Г Порошина, Francisco Portela, Jatinder Pruthi, L Prystupa, Aldis Puķītis, Yun Qiu, V. V. Rafalsky, Tova Rainis, Odery Ramos, Mohammed Rashid, O. V. Reshetko, Tarsila Campanha da Rocha Ribeiro, Montserrat Rivero, Xavier Roblin, Jacek Romatowski, David J. Rowbotham, Orlando Ruffinengo, Grażyna Rydzewska-Wyszkowska, О. И. Саблин, Souken Sai, Simone Saibeni, Rosaida Hj Md Said, Hirotake Sakuraba, Mark Samaan, William J. Sandborn, Masayuki Saruta, Jenny Sauk, Edoardo Savarino, Michael Schultz, J Schulze, Shahriar Sedghi, Ursula Seidler, Philippe Seksik, Ömer Şentürk, Edward Shelton, Masahito Shimizu, Sung Jae Shin, Michael Sigal, Roberto Silva, Joaquim Simões Neto, Milan Široký, Vít Šmajstrla, V. Šmíd, Sarah Smiley, Luciana Soledad Brunatto, Mykola Stanislavchuk, David Stokesberry, Christian D. Stone, Daniel R. 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Bibliographic record
VenueThe Lancet · 2024
Typearticle
Languageen
FieldImmunology and Microbiology
TopicPsoriasis: Treatment and Pathogenesis
Canadian institutionsSt. Paul's HospitalUniversity of British ColumbiaWestern University
FundersJanssen Research and Development
KeywordsMedicineUlcerative colitisPlaceboInternal medicinePopulationMaintenance therapyGastroenterologyIntention-to-treat analysisSurgeryClinical trialChemotherapyPathology
Abstract
No abstract in any covered source. Its absence is recorded, not treated as a negative.
No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.017
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
Opus teacher head0.043
GPT teacher head0.299
Teacher spread0.256 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".
Quick stats
Citations83
Published2024
Admission routes1
Has abstractno