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Record W4404581096 · doi:10.1016/s0140-6736(24)01762-8

Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study

2024· article· en· W4404581096 on OpenAlexaff
Marc Ferrante, Geert D’Haens, Vipul Jairath, Silvio Danese, Minhu Chen, Subrata Ghosh, Tadakazu Hisamatsu, Jarosław Kierkuś, Britta Siegmund, Sonja M. Bragg, Wallace Crandall, Frédérick Durand, Emily Hon, Zhantao Lin, Michelle Ugolini Lopes, Nathan Morris, Marijana Protić, Hilde Carlier, Bruce E Sands, Emiliano Tron, Fernanda Dorado, Lena Thin, Rupert W. Leong, Hansjoerg Seltenreich, Britt Christensen, Anthony Croft, Simon Ghaly, Robert Koch, Walter Reinisch, Sonja Heeren, Peter Bossuyt, Fabio Luiz Maximiano, Lígia Yukie Sassaki, Carolina Baía, D. Poli, A D S Carlos, Carlos Fernando de Magalhães Francesconi, Alexander De Sa Rolim, J. Razera, Joaquim Simões Neto, Rodrigo Rocco, Jonathas Stifft, Jonathan Soldera, C. Clemente, Sandra Di Felice Boratto, Luciana Teixeira de Campos, Marcelo Rodrigues Borba, Gregory Rosenfeld, Terry Ponich, Allen Lim, Chadwick Williams, Bruce Musgrave, Wenjia Liu, Chengdang Wang, Hong Guo, Chunxiao Chen, Yan Chen, Qian Cao, Jie Zhong, Min Xu, Yufang Wang, Changqing Zheng, Xiang Gao, Youxiang Chen, Yinglei Miao, Lin Wang, Deliang Liu, Bangmao Wang, Zhengji Song, Xiaowei Liu, Baili Chen, Wen Jiang, Qiang Zhan, Kaiguang Zhang, Hong Shen, Zhaotao Li, Xiaoyan Wang, Dean Tian, Leilei Chen, Wen Tang, Vladimir Borzan, Željko Krznarić, Miroslava Volfová, Jiri Pumprla, Lucie Veberova, Michal Tichý, Jan Gregar, David Stepek, Jan Ulbrych, Pavel Drastich, Zdenek Papik, Jan Matouš, Martin Lukáš, Radka Koskova, Jan Fallingborg, Romain Altwegg, Ginette Fotsing, David Laharie, Stéphane Nancey, Laurent Peyrin, Stefan Schreiber, Jörg Hoffmann, Ursula Seidler, Lars Fechner, Katrin Arélin, Christel Contzen, Guido Trenn, Thomas Schaum, Katrin Schoettker, Oliver Bachmann, Jens Encke, Michael Ibe, Christian Jakobeit, Márta Varga, Á Salamon, András Káfony, Gyula Horvat, Zsanett Heringh, Katalin Bezzegh, F Izbéki, L Szalai, Robert Schnabel, Jayanta Samanta, Rupa Banerjee, Ganesh Subramanian, Shrikant Mukewar, Naresh Bansal, Ajit Sood, Ravi Shankar Bagepally, P. Shravan Kumar, Pankaj Shrimal, Saumin Shah, Nitin Pai, Vineet Ahuja, Ehud Melzer, Nimer Assy, Eran Goldin, Haim Shirin, Arik Segal, Adi Lahat, Simone Saibeni, Francesco Luzza, Flavio Caprioli, Maria Laura Annunziata, Massimo Claudio Fantini, Koichiro Matsuda, Sho Takagi, Shuji Kanmura, Mitsuhide Goto, Toshifumi Ashida, Nobuaki Nishimata, Kazuhiko Kawakami, Atsuo Maemoto, Hideaki Naoe, Hiroshi Nakase, Tomohiro Iida, Junichi Akiyama, Masao Yoshioka, Yasuhiko Abe, Ken Takeuchi, Mikio Kawai, Fumihito Hirai, Noriyuki Horiki, Sang Hyoung Park, Dong II Park, Min Kyu Jung, Byung Ik Jang, Yoo Jin Lee, Sung Jae Shin, Hyun‐Soo Kim, Bo‐In Lee, Jong Hun Lee, Hyo Jong Kim, Chang Hwan Choi, Dong‐Woo Kim, Chang Soo Eun, Juris Pokrotnieks, Gediminas Kiudelis, Karina Ramirez, Robert J.F. Laheij, Maria Kłopocka, Zbigniew Wylegala, Beata Mroziak, Katarzyna Wójcik‐Pszczoła, Bartosz Korczowski, Beata Gawdis, Wit Danilkiewicz, Magdalena Olszanecka, Jolanta Krzykowska, Malgorzata Duszynska, Agnieszka Ciesiolkiewicz, Malgorzata Baluta, M. Horyński, Jarosław Leszczyszyn, Grzegorz Rozumek, Lukasz Firkowski, Marzena Konopko, Jakub Orleanski, Rafał Filip, Anna Wiechowska, Krzysztof Niezgoda, Radu Mateescu, E Crăciun, Camelia Chioncel, Theodor Voiosu, В. И. Трофимов, О. Б. Щукина, Anatoly Pershko, Olga Fedorishina, Galina Chumakova, И. Г. Бакулин, М. Ф. Осипенко, D Nikolin, О Б Барышева, Olga Alexeeva, К. А. Захаров, Irina Khodareva, Tkachev Av, А. О. Головенко, Veronika Popova, В. Н. Кашников, Maria Vershinina, P. A. Makarchuk, Ekaterina Valuyskikh, Slobodanka Crevar, Petar Svorcan, Tatjana Latinovic Radakovic, Tibor Hlavatý, Ivan Bunganič, Miroslav Fedurco, Iveta Kalisova, Jozef Baláž, Lubomír Mihalkanin, María Dolores Martín‐Arranz, L. de Teresa Parreño, Miquel Sans Cuffi, Alejandro Hernández-Camba, Stephan Brand, Pascal Juillerat, Frank Seibold, Hakan Demirci, Ahmet Tezel, Murat Kıyıcı, Can Gönen, Sadettin Hülagü, Tarkan Karakan, Ayhan Hilmi Çekın, Engin Altıntaşž, Kadri Güven, Hale Akpınar, Yasemin Özın, Yusuf Erzın, Mehmet Cihat Demir, Tuncer Temel, Tetiana Lohdanidi, V. Y. Ivanov, Olha Ivanishyn, Oleksandr Golovchenko, О.M. Gerasymenko, S.V. Danyliuk, Vira Vyshyvanyuk, Olena Datsenko, Mykola Stanislavchuk, Yaroslava Rishko, Dmytro Donets, Yu A Shapovalova, Andriy Yurkiv, Oleksandr Oliinyk, Nataliia Tsarynna, О. І. Федів, Yevgen Poplyonkin, Arthur Kaser, S Hoque, Hawys Thomas, Shalini Iyengar, Frederic Newman, Ronald Fogel, P.C. Pedersen, Chad Gonzales, Gregory S. McCord, Michael Galambos, Paul Lamb, Jeffrey A. Schneider, Bal Raj Bhandari, Michael D. Weiss, Christine Thai, Michael D. Shapiro, Ziad Younes, Narayanachar Murali, Jason Hou, Todd Williams, Omer Khalid, Connie Hsu, Christopher R. Bartalos, Calin Arimie, Syed Mumtaz, Israel Crespo, Renée M. Marchioni Beery, Anne Tuskey, Ryan Gaible, Alan F. Cutler, Anita Afzali, Kevin Stuart, Eric Ibegbu, Moises Irizarry-Roman, Kimberly A. Harris, Kwadwo Agyei, Frances Jones, Aasim Sheikh, Liam Zakko, Erica Cohen, George Duvall, Houssam Al Kharrat, Robert Wohlman, William Holderman, Alan Schulman, Sheldon Lidofsky, Peter M. Wayne, Luis Victores, Christian D. Stone, Kenolisa Onwueme, Monika Fischer, Shabana Shahid, Keith Moore, Jeffry Katz, Julien Fahed, James S. Bullock

Bibliographic record

VenueThe Lancet · 2024
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicInflammatory Bowel Disease
Canadian institutionsWestern University
FundersDaiichi Sankyo EuropeGenentechSun PharmaMitsubishi Tanabe Pharma CorporationCelltrionBoston PharmaceuticalsKisseiBoston Scientific CorporationTeva Pharmaceutical IndustriesJanssen PharmaceuticalsEA Pharma Co., Ltd.Gilead SciencesGlaxoSmithKlineAmgenKyorin PharmaceuticalPfizerCelgeneAstraZenecaEli Lilly and CompanyBristol-Myers Squibb
KeywordsMedicineUstekinumabPlaceboInternal medicineCrohn's diseaseClinical trialClinical endpointUlcerative colitisAdverse effectPhases of clinical researchRandomized controlled trialColonoscopyGastroenterologyInflammatory bowel diseaseSurgeryDiseaseAdalimumabColorectal cancer

Abstract

fetched live from OpenAlex
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 imitation

Not 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)0.002
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 score0.004
Threshold uncertainty score0.011

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.002
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0040.002
Bibliometrics0.0000.000
Science and technology studies0.0010.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0020.003
Insufficient payload (model declined to judge)0.0030.001

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 head0.014
GPT teacher head0.286
Teacher spread0.271 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine 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

Citations102
Published2024
Admission routes1
Has abstractno

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Same venueThe LancetSame topicInflammatory Bowel DiseaseFrench-language works237,207