Accès ouvert déclaré
2023
article
Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
Laurent Peyrin‐Biroulet, Jessica R. Allegretti, David T. Rubin, Brian Bressler, Matthew Germinaro, Kuan‐Hsiang Gary Huang, Nicole Shipitofsky, Hongyan Zhang, Rebbecca Wilson, Chenglong Han, Brian G. Feagan, William J. Sandborn, Julián Panés, Tadakazu Hisamatsu, Gary R. Lichtenstein, Bruce E. Sands, Axel Dignaß, О. Аbrahamovych, Halyna Afanasieva, Lilia Aitova, Engin Altıntaş, Romain Altwegg, П. С. Андреев, Kazuki Aomatsu, Monika Augustyn, Paola Balestrieri, Jakob Begun, Luciana Soledad Brunatto, Diego Bulgheroni, Elena Bunkova, Mercedes Cabello, Qian Cao, Flavio Caprioli, Rute Cerqueira, Baili Chen, Chou‐Chen Chen, Chou-Pin Chen, Cheng‐Tang Chiu, Chang Hwan Choi, Michele Cicala, Olena Datsenko, Pieter Dewint, Eugeni Domènech, Joris Dutré, George Duvall, J. C. Fernández, Rafał Filip, Ronald Fogel, Sharyle Fowler, Toshimitsu Fujii, Masayuki Fukata, Yohei Furumoto, Antonio Gasbarrini, Beata Gawdis-Wojnarska, Cyrielle Gilletta, Paolo Gionchetti, Eran Goldin, Oleksandr Golovchenko, Maciej Gonciarz, Can Gönen, Gaston Gonzalez Segura, Oleksii Gridnyev, T Gyökeres, Xavier Hébuterne, Charlotte Hedin, Per M. Hellström, Ida Hilmi, Ivo Horný, Gyula Horvat, Namiko Hoshi, Luděk Hrdlička, Shunji Ishihara, Olha Ivanishyn, Byung Ik Jang, Takashi Kagaya, Shuji Kanmura, Marina Karakina, Nakai Katsuhiko, Jarosław Kierkuś, Hyo Jong Kim, Young‐Ho Kim, G Kiss, Jochen Klaus, D Kleczkowski, Maria Kłopocka, Taku Kobayashi, Iwona Kobielusz‐Gembala, Ja Seol Koo, Adam Kopoń, Tetiana Kravchenko, Masatoshi Kudo, Kwang An Kwon, Paula Lago, David Laharie, Ian C. Lawrance, Jarosław Leszczyszyn, Yan Li, Milan Lukáš, Christian Maaser, Atsuo Maemoto, Hiroyuki Marusawa, Matthew J. McBride, Shoba Mendu, Pál Miheller, Hideharu Miyabayashi, Wolfgang Mohl, Gregory Moore, Satoshi Motoya, Narayanachar Murali, Mohammed Al Naem, Koichi Nakajima, Yasunari Nakamoto, Stéphane Nancey, Joaquim Isquierdo Quadrado Neto, Michio Onizawa, Yohei Ono, Taro Osada, М. Ф. Осипенко, Danuta Owczarek, Bhaktasharan Patel, Kamal Patel, Elina Petrova, Е Г Порошина, Francisco Portela, Lyudmyla Prystupa, Xavier Roblin, Jacek Romatowski, Grażyna Rydzewska, Simone Saibeni, Hirotake Sakuraba, Mark Samaan, Michael Schultz, J Schulze, Shahriar Sedghi, Ursula Seidler, Sung Jae Shin, Mykola Stanislavchuk, David Stokesberry, Takayoshi Suzuki, Hiroki Taguchi, Lyudmila Tankova, Lena Thin, Tkachev Av, Leyanira Torrealba, Nataliia Tsarynna, Zsolt Tulassay, Tetsuya Ueo, Ekaterina Valuyskikh, Olga Vasilevskaya, Manuel Viamonte, Shu‐Chen Wei, Roni Weisshof, Katarzyna Wójcik‐Pszczoła, Byong Duk Ye, Hsu‐Heng Yen, Hyuk Yoon, Kosuke Yoshida, Andriy Yurkiv, Osamu Zaha, Qiang Zhan
99Citations signalées, ce qui n’est pas une note de qualité
21Institutions déclarées
6Pays d’affiliation déclarés
Rattachement africain : fr, ca, us, es, jp, de.
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Le résumé fourni par la source
BACKGROUND & AIMS: The QUASAR Phase 2b Induction Study evaluated the efficacy and safety of guselkumab, an interleukin-23p19 subunit antagonist, in patients with moderately to severely active ulcerative colitis (UC) with prior inadequate response and/or intolerance to corticosteroids, immunosuppressants, and/or advanced therapy. METHODS: In this double-blind, placebo-controlled, dose-ranging, induction study, patients were randomized (1:1:1) to receive intravenous guselkumab 200 or 400 mg or placebo at weeks 0/4/8. The primary endpoint was clinical response (compared with baseline, modified Mayo score decrease ≥30% and ≥2 points, rectal bleeding subscore ≥1-point decrease or subscore of 0/1) at week 12. Guselkumab and placebo week-12 clinical nonresponders received subcutaneous or intravenous guselkumab 200 mg, respectively, at weeks 12/16/20 (uncontrolled study period). RESULTS: The primary analysis population included patients with baseline modified Mayo scores ≥5 and ≤9 (intravenous guselkumab 200 mg, n = 101; 400 mg, n = 107; placebo, n = 105). Week-12 clinical response percentage was greater with guselkumab 200 mg (61.4%) and 400 mg (60.7%) vs placebo (27.6%; both P < .001). Greater proportions of guselkumab-treated vs placebo-treated patients achieved all major secondary endpoints (clinical remission, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, and endoscopic normalization) at week 12. Among guselkumab week-12 clinical nonresponders, 54.3% and 50.0% of patients in the 200- and 400-mg groups, respectively, achieved clinical response at week 24. Safety was similar among guselkumab and placebo groups. CONCLUSIONS: Guselkumab intravenous induction was effective vs placebo in patients with moderately to severely active UC. Guselkumab was safe, and efficacy and safety were similar between guselkumab dose groups. CLINICALTRIALS: gov number: NCT04033445.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
- Date Crossref
- 01/12/2023
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Les institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Les sujets associés
Inflammatory Bowel DiseaseInflammasome and immune disordersPsoriasis: Treatment and Pathogenesis