Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
DC Field | Value | Language |
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dc.contributor.author | Peyrin-Biroulet, Laurent | - |
dc.contributor.author | Allegretti, Jessica R. | - |
dc.contributor.author | Rubin, David T. | - |
dc.contributor.author | Bressler, Brian | - |
dc.contributor.author | Germinaro, Matthew | - |
dc.contributor.author | Huang, Kuan-Hsiang | - |
dc.contributor.author | Shipitofsky, Nicole | - |
dc.contributor.author | Zhang, Hongyan | - |
dc.contributor.author | Wilson, Rebbecca | - |
dc.contributor.author | Han, Chenglong | - |
dc.contributor.author | Feagan, Brian G. | - |
dc.contributor.author | Sandborn, William J. | - |
dc.contributor.author | Panés, Julian | - |
dc.contributor.author | Hisamatsu, Tadakazu | - |
dc.contributor.author | Lichtenstein, Gary R. | - |
dc.contributor.author | Sands, Bruce E. | - |
dc.contributor.author | Dignass, Axel | - |
dc.contributor.author | Abrahamovych, Orest | - |
dc.contributor.author | Afanasieva, Halyna | - |
dc.contributor.author | Aitova, Lilia | - |
dc.contributor.author | Altintas, Engin | - |
dc.contributor.author | Altwegg, Romain | - |
dc.contributor.author | Andreev, Pavel | - |
dc.contributor.author | Aomatsu, Kazuki | - |
dc.contributor.author | Augustyn, Monika | - |
dc.contributor.author | Balestrieri, Paola | - |
dc.contributor.author | Begun, Jakob | - |
dc.contributor.author | Brunatto, Luciana | - |
dc.contributor.author | Bulgheroni, Diego | - |
dc.contributor.author | Bunkova, Elena | - |
dc.contributor.author | Cabello, Mercedes | - |
dc.contributor.author | Cao, Qian | - |
dc.contributor.author | Caprioli, Flavio | - |
dc.contributor.author | Cerqueira, Rute | - |
dc.contributor.author | Chen, Baili | - |
dc.contributor.author | Chen, Chou-Chen | - |
dc.contributor.author | Chen, Chou-Pin | - |
dc.contributor.author | Chiu, Cheng-Tang | - |
dc.contributor.author | Choi, Chang Hwan | - |
dc.contributor.author | Cicala, Michele | - |
dc.contributor.author | Datsenko, Olena | - |
dc.contributor.author | Dewint, Pieter | - |
dc.contributor.author | Domenech, Eugeni | - |
dc.contributor.author | Dutré, Joris | - |
dc.contributor.author | Duvall, George | - |
dc.contributor.author | Fernandez, Juan | - |
dc.contributor.author | Filip, Rafal | - |
dc.contributor.author | Fogel, Ronald | - |
dc.contributor.author | Fowler, Sharyle | - |
dc.contributor.author | Fujii, Toshimitsu | - |
dc.contributor.author | Fukata, Masayuki | - |
dc.contributor.author | Furumoto, Yohei | - |
dc.contributor.author | Gasbarrini, Antonio | - |
dc.contributor.author | Gawdis-Wojnarska, Beata | - |
dc.contributor.author | Gilletta, Cyrielle | - |
dc.contributor.author | Gionchetti, Paolo | - |
dc.contributor.author | Goldin, Eran | - |
dc.contributor.author | Golovchenko, Oleksandr | - |
dc.contributor.author | Gonciarz, Maciej | - |
dc.contributor.author | Gonen, Can | - |
dc.contributor.author | Segura, Gaston Gonzalez | - |
dc.contributor.author | Gridnyev, Oleksii | - |
dc.contributor.author | Gyokeres, Tibor | - |
dc.contributor.author | Hébuterne, Xavier | - |
dc.contributor.author | Hedin, Charlotte | - |
dc.contributor.author | Hellström, Per | - |
dc.contributor.author | Hilmi, Ida Normiha | - |
dc.contributor.author | Horný, Ivo | - |
dc.contributor.author | Horvat, Gyula | - |
dc.contributor.author | Hoshi, Namiko | - |
dc.contributor.author | Hrdlicka, Ludek | - |
dc.contributor.author | Ishihara, Shunji | - |
dc.contributor.author | Ivanishyn, Olha | - |
dc.contributor.author | Jang, Byung Ik | - |
dc.contributor.author | Junior, Odery | - |
dc.contributor.author | Kagaya, Takashi | - |
dc.contributor.author | Kanmura, Shuji | - |
dc.contributor.author | Karakina, Marina | - |
dc.contributor.author | Katsuhiko, Nakai | - |
dc.contributor.author | Kierkus, Jaroslaw | - |
dc.contributor.author | Kim, Hyo Jong | - |
dc.contributor.author | Kim, Tae-Oh | - |
dc.contributor.author | Kim, Young-Ho | - |
dc.contributor.author | Kiss, Gyula G. | - |
dc.contributor.author | Klaus, Jochen | - |
dc.contributor.author | Kleczkowski, Dariusz | - |
dc.contributor.author | Klopocka, Maria | - |
dc.contributor.author | Kobayashi, Taku | - |
dc.contributor.author | Kobielusz-Gembala, Iwona | - |
dc.contributor.author | Koo, Ja Seol | - |
dc.contributor.author | Kopon, Adam | - |
dc.contributor.author | Kravchenko, Tetiana | - |
dc.contributor.author | Kudo, Masatoshi | - |
dc.contributor.author | Kwon, Kwang An | - |
dc.contributor.author | Lago, Paula | - |
dc.contributor.author | Laharie, David | - |
dc.contributor.author | Lawrance, Ian | - |
dc.contributor.author | Leszczyszyn, Jaroslaw | - |
dc.contributor.author | Li, Yan | - |
dc.contributor.author | Lukas, Milan | - |
dc.contributor.author | Maaser, Christian | - |
dc.contributor.author | Maemoto, Atsuo | - |
dc.contributor.author | Marusawa, Hiroyuki | - |
dc.contributor.author | McBride, Matthew | - |
dc.contributor.author | Mendu, Shoba | - |
dc.contributor.author | Miheller, Pal | - |
dc.contributor.author | Miyabayashi, Hideharu | - |
dc.contributor.author | Mohl, Wolfgang | - |
dc.contributor.author | Moore, Gregory | - |
dc.contributor.author | Motoya, Satoshi | - |
dc.contributor.author | Murali, Narayanachar | - |
dc.contributor.author | Naem, Mohammed | - |
dc.contributor.author | Nakajima, Koichi | - |
dc.contributor.author | Nakamoto, Yasunari | - |
dc.contributor.author | Nancey, Stéphane | - |
dc.contributor.author | Neto, Joaquim | - |
dc.contributor.author | Onizawa, Michio | - |
dc.contributor.author | Ono, Yohei | - |
dc.contributor.author | Osada, Taro | - |
dc.contributor.author | Osipenko, Marina | - |
dc.contributor.author | Owczarek, Danuta | - |
dc.contributor.author | Patel, Bhaktasharan | - |
dc.contributor.author | Patel, Kamal | - |
dc.contributor.author | Petrova, Elina | - |
dc.contributor.author | Poroshina, Elena | - |
dc.contributor.author | Portela, Francisco | - |
dc.contributor.author | Prystupa, Lyudmyla | - |
dc.contributor.author | Rivero, Monserrat | - |
dc.contributor.author | Roblin, Xavier | - |
dc.contributor.author | Romatowski, Jacek | - |
dc.contributor.author | Rydzewska, Grazyna | - |
dc.contributor.author | Saibeni, Simone | - |
dc.contributor.author | Sakuraba, Hirotake | - |
dc.contributor.author | Samaan, Mark | - |
dc.contributor.author | Schultz, Michael | - |
dc.contributor.author | Schulze, Joerg | - |
dc.contributor.author | Sedghi, Shahriar | - |
dc.contributor.author | Seidler, Ursula | - |
dc.contributor.author | Shin, Sung Jae | - |
dc.contributor.author | Stanislavchuk, Mykola | - |
dc.contributor.author | Stokesberry, David | - |
dc.contributor.author | Suzuki, Takayoshi | - |
dc.contributor.author | Taguchi, Hiroki | - |
dc.contributor.author | Tankova, Lyudmila | - |
dc.contributor.author | Thin, Lena | - |
dc.contributor.author | Tkachev, Alexander | - |
dc.contributor.author | Torrealba, Leyanira | - |
dc.contributor.author | Tsarynna, Nataliia | - |
dc.contributor.author | Tulassay, Zsolt | - |
dc.contributor.author | Ueo, Tetsuya | - |
dc.contributor.author | Valuyskikh, Ekaterina | - |
dc.contributor.author | Vasilevskaya, Olga | - |
dc.contributor.author | Viamonte, Manuel | - |
dc.contributor.author | Wei, Shu-Chen | - |
dc.contributor.author | Weisshof, Roni | - |
dc.contributor.author | Wojcik, Katarzyna | - |
dc.contributor.author | Ye, Byong Duk | - |
dc.contributor.author | Yen, Hsu-Heng | - |
dc.contributor.author | Yoon, Hyuk | - |
dc.contributor.author | Yoshida, Kosuke | - |
dc.contributor.author | Yurkiv, Andriy | - |
dc.contributor.author | Zaha, Osamu | - |
dc.contributor.author | Zhan, Qiang | - |
dc.date.accessioned | 2024-04-13T09:30:17Z | - |
dc.date.available | 2024-04-13T09:30:17Z | - |
dc.date.issued | 2023-12 | - |
dc.identifier.issn | 0016-5085 | - |
dc.identifier.issn | 1528-0012 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/90970 | - |
dc.description.abstract | 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. © 2023 The Authors | - |
dc.format.extent | 15 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | W.B. Saunders | - |
dc.title | Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study | - |
dc.type | Article | - |
dc.identifier.wosid | 001124438000001 | - |
dc.identifier.doi | 10.1053/j.gastro.2023.08.038 | - |
dc.identifier.bibliographicCitation | Gastroenterology, v.165, no.6, pp 1443 - 1457 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85174843526 | - |
dc.citation.endPage | 1457 | - |
dc.citation.startPage | 1443 | - |
dc.citation.title | Gastroenterology | - |
dc.citation.volume | 165 | - |
dc.citation.number | 6 | - |
dc.type.docType | Article | - |
dc.publisher.location | 미국 | - |
dc.subject.keywordAuthor | Advanced Therapy | - |
dc.subject.keywordAuthor | Interleukin-23p19 Subunit Antagonist | - |
dc.subject.keywordAuthor | QUASAR | - |
dc.subject.keywordAuthor | Ulcerative Colitis | - |
dc.subject.keywordPlus | MAINTENANCE THERAPY | - |
dc.subject.keywordPlus | DIFFERENTIATION | - |
dc.subject.keywordPlus | ANTIBODY | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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