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Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
- Peyrin-Biroulet, Laurent;
- Allegretti, Jessica R.;
- Rubin, David T.;
- Bressler, Brian;
- Germinaro, Matthew;
- ... Choi, Chang Hwan;
- 외 157명
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86초록
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
키워드
- 제목
- Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
- 저자
- Peyrin-Biroulet, Laurent; Allegretti, Jessica R.; Rubin, David T.; Bressler, Brian; Germinaro, Matthew; Huang, Kuan-Hsiang; Shipitofsky, Nicole; Zhang, Hongyan; Wilson, Rebbecca; Han, Chenglong; Feagan, Brian G.; Sandborn, William J.; Panés, Julian; Hisamatsu, Tadakazu; Lichtenstein, Gary R.; Sands, Bruce E.; Dignass, Axel; Abrahamovych, Orest; Afanasieva, Halyna; Aitova, Lilia; Altintas, Engin; Altwegg, Romain; Andreev, Pavel; Aomatsu, Kazuki; Augustyn, Monika; Balestrieri, Paola; Begun, Jakob; Brunatto, Luciana; Bulgheroni, Diego; Bunkova, Elena; Cabello, Mercedes; Cao, Qian; Caprioli, Flavio; Cerqueira, Rute; Chen, Baili; Chen, Chou-Chen; Chen, Chou-Pin; Chiu, Cheng-Tang; Choi, Chang Hwan; Cicala, Michele; Datsenko, Olena; Dewint, Pieter; Domenech, Eugeni; Dutré, Joris; Duvall, George; Fernandez, Juan; Filip, Rafal; Fogel, Ronald; Fowler, Sharyle; Fujii, Toshimitsu; Fukata, Masayuki; Furumoto, Yohei; Gasbarrini, Antonio; Gawdis-Wojnarska, Beata; Gilletta, Cyrielle; Gionchetti, Paolo; Goldin, Eran; Golovchenko, Oleksandr; Gonciarz, Maciej; Gonen, Can; Segura, Gaston Gonzalez; Gridnyev, Oleksii; Gyokeres, Tibor; Hébuterne, Xavier; Hedin, Charlotte; Hellström, Per; Hilmi, Ida Normiha; Horný, Ivo; Horvat, Gyula; Hoshi, Namiko; Hrdlicka, Ludek; Ishihara, Shunji; Ivanishyn, Olha; Jang, Byung Ik; Junior, Odery; Kagaya, Takashi; Kanmura, Shuji; Karakina, Marina; Katsuhiko, Nakai; Kierkus, Jaroslaw; Kim, Hyo Jong; Kim, Tae-Oh; Kim, Young-Ho; Kiss, Gyula G.; Klaus, Jochen; Kleczkowski, Dariusz; Klopocka, Maria; Kobayashi, Taku; Kobielusz-Gembala, Iwona; Koo, Ja Seol; Kopon, Adam; Kravchenko, Tetiana; Kudo, Masatoshi; Kwon, Kwang An; Lago, Paula; Laharie, David; Lawrance, Ian; Leszczyszyn, Jaroslaw; Li, Yan; Lukas, Milan; Maaser, Christian; Maemoto, Atsuo; Marusawa, Hiroyuki; McBride, Matthew; Mendu, Shoba; Miheller, Pal; Miyabayashi, Hideharu; Mohl, Wolfgang; Moore, Gregory; Motoya, Satoshi; Murali, Narayanachar; Naem, Mohammed; Nakajima, Koichi; Nakamoto, Yasunari; Nancey, Stéphane; Neto, Joaquim; Onizawa, Michio; Ono, Yohei; Osada, Taro; Osipenko, Marina; Owczarek, Danuta; Patel, Bhaktasharan; Patel, Kamal; Petrova, Elina; Poroshina, Elena; Portela, Francisco; Prystupa, Lyudmyla; Rivero, Monserrat; Roblin, Xavier; Romatowski, Jacek; Rydzewska, Grazyna; Saibeni, Simone; Sakuraba, Hirotake; Samaan, Mark; Schultz, Michael; Schulze, Joerg; Sedghi, Shahriar; Seidler, Ursula; Shin, Sung Jae; Stanislavchuk, Mykola; Stokesberry, David; Suzuki, Takayoshi; Taguchi, Hiroki; Tankova, Lyudmila; Thin, Lena; Tkachev, Alexander; Torrealba, Leyanira; Tsarynna, Nataliia; Tulassay, Zsolt; Ueo, Tetsuya; Valuyskikh, Ekaterina; Vasilevskaya, Olga; Viamonte, Manuel; Wei, Shu-Chen; Weisshof, Roni; Wojcik, Katarzyna; Ye, Byong Duk; Yen, Hsu-Heng; Yoon, Hyuk; Yoshida, Kosuke; Yurkiv, Andriy; Zaha, Osamu; Zhan, Qiang
- 발행일
- 2023-12
- 유형
- Article in press
- 저널명
- Gastroenterology
- 권
- 165
- 호
- 6
- 페이지
- 1443 ~ 1457