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Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial
Silvio Danese, Remo Panaccione, Brian G. Feagan, Anita Afzali, David T. Rubin, Bruce E. Sands, Walter Reinisch, Julián Panés, Aparna Sahoo, Natalie A. Terry, Daphne Chan, Chenglong Han, Mary Ellen Frustaci, Zijiang Yang, William J. Sandborn, Tadakazu Hisamatsu, Jane M. Andrews, Geert D’Haens, Oleksandr Oliinyk, Leonid Bilіanskyi, Jadwiga Gniady-Jastrzebska, Robert Petryka, Tomasz Arłukowicz, Piotr Gietka, Marcin Zmudziński, Syed Mumtaz, Douglas C. Wolf, Katarzyna Wójcik‐Pszczoła, George Duvall, Monika Augustyn, Rafał Filip, Dino Tarabar, Tkachev Av, Ursula Seidler, Eran Zittan, Juris Pokrotnieks, О. Б. Щукина, Andro Machavariani, Laura Loy, Niazy Abu-farsakh, Pesegova Marina, Slobodan Srećković, Martin Laclav, Shu‐Chen Wei, Daniel R. Suiter, A Borsuk, Xavier Hébuterne, Carsten Büning, Adi Lahat-Zok, Wit Danilkiewicz, Bernadetta Frysna, Ivana Jovicic, Olena Datsenko, Maninder Guram, Animesh Jain, Zahid Rashid, Sonja Heeren, Natallia Shulga, Ivan Timkin, Srdjan Gornjakovic, Milan Lukáš, Romain Altwegg, Ariadne Desjeux, Jean‐Marie Reimund, Manana Giorgadze, Christoph Jochum, Hiroaki Ito, Katsuhiko Nakai, Tomohisa Takagi, Osamu Zaha, Chang‐Hwan Choi, Taeoh Kim, Jong Hun Lee, Ieva Stundienė, Ida Hilmi, Rosaida Hj Md Said, Jarosław Leszczyszyn, Д. И. Абдулганиева, Yu. A. Fominykh, Svetlana V Maksyashina, Jozef Baláž, Manuel Van Domselaar, Taylan Kav, Patrick Dennis, Patricia Henry, Robert Holmes, Christopher M. Johnson, Matthew J. McBride, H Sarles, Gregory Moore, R. E. Yakubtsevich, Vinciane Muls, Stevan Trbojević, Waqqas Afif, Çharles N. Bernstein, Ivo Klarin, Zuzana Šerclová, Miroslava Volfová, Pierre Desreumaux, Xavier Roblin, Lucine Vuitton, Kakhaber Chelidze, Tanja Kuehbacher, Ioannis E. Κoutroubakis, Michele Cicala, Walter Fries, Antonio Gasbarrini, Nobuo Aoyama, Yoshito Hayashi, Fumihito Hirai, Norkiyuki Horiki, Namiko Hoshi, Tomoki Inaba, Ishida Hiroyasu, Atsuo Maemoto, Takayuki Matsumoto, Kayoko Matsushima, Satoshi Motoya, Masaki Taruishi, Mohammed Rashid, Jaeyoung Chun, Young‐Ho Kim, Dong Il Park, Ala I. Sharara, Laimas Virginijus Jonaitis, Gjorgi Deriban, James Brooker, Beata Gawdis-Wojnarska, Barbara Woźniak−Stolarska, П. С. Андреев, В. И. Симаненков, В. И. Трофимов, Igor Jovanović, Nataša Zdravković, Xavier Aldeguer i Mante, Hale Akpınar, Gürkan Çelebi, Hülya Över Hamzaoğlu, J. C. Fernández, Jayaprakash Kamath, Nicole Palekar, Jatinder Pruthi, David Rausher, Timothy E. Ritter
Bibliographic record
VenueThe Lancet. Gastroenterology & hepatology · 2023
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicInflammatory Bowel Disease
Canadian institutionsWestern UniversityUniversity of Calgary
FundersJanssen Scientific AffairsGenentechCelgeneAmgenPfizerEli Lilly and CompanyBristol-Myers Squibb
KeywordsCrohn's diseaseMedicineDiseaseInternal medicinePhase (matter)Double blindMaintenance therapyPhysical therapySurgeryPediatricsAlternative medicinePlaceboPathologyChemotherapy
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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation 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 score0.211
Threshold uncertainty score0.809
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 head0.017
GPT teacher head0.268
Teacher spread0.251 · 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 teacher head, 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
Citations70
Published2023
Admission routes1
Has abstractno