干旱区生态环境知识资源中心(Arid): Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study

Arid

DOI	10.1093/ecco-jcc/jjab016
	Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study
	Vermeire, Severine; Chiorean, Michael; Panes, Julian; Peyrin-Biroulet, Laurent; Zhang, Jinkun; Sands, Bruce E.; Lazin, Krisztina; Klassen, Preston; Naik, Snehal U.; Cabell, Christopher H.; Sandborn, William J.
通讯作者	Vermeire, S (corresponding author), Univ Hosp Leuven, Dept Gastroenterol & Hepatol, Herestr 49, B-3000 Leuven, Belgium.
来源期刊	JOURNAL OF CROHNS & COLITIS
ISSN	1873-9946
EISSN	1876-4479
出版年	2021
卷号	15 期号:6 页码:950-959
英文摘要	Background and Aims: Etrasimod is an oral, selective, sphingosine 1-phosphate receptor modulator. In a phase 2, randomised, double-blind, placebo-controlled trial in adults with moderately-to-severely active ulcerative colitis [OASIS], etrasimod 2 mg provided significant benefit versus placebo and was generally well tolerated. This open-label extension [OLE] evaluated safety and efficacy of etrasimod for up to 52 weeks. Methods: In OASIS, 156 patients received etrasimod 1 mg, etrasimod 2 mg, or placebo, once daily for 12 weeks. After completing OASIS, patients could enrol in the OLE and receive etrasimod 2 mg for an additional 34-40 weeks. Results: In all, 118 patients enrolled in the OLE; 112 patients received etrasimod 2 mg at any point and were evaluated for safety and efficacy. A total of 92 [82%] patients who received etrasimod 2 mg in the OLE completed the study.Treatment-emergent adverse events occurred in 60% [67/112] of patients receiving etrasimod 2 mg at any time, most commonly worsening ulcerative colitis and anaemia; 94% of adverse events were mild/moderate. At end of treatment, 64% of patients met the criteria for clinical response, 33% for clinical remission, and 43% for endoscopic improvement. Week 12 clinical response, clinical remission, or endoscopic improvement was maintained to end of treatment in 85%, 60%, or 69% of patients, respectively. Steroid-free clinical remission occurred in 22% of overall patients. Conclusions: In this long-term extension study, etrasimod 2 mg demonstrated a favourable safety profile. Most patients with clinical response, clinical remission, or endoscopic improvement at Week 12 maintained that status to end of treatment.
英文关键词	Ulcerative colitis etrasimod long-term extension study
类型	Article
语种	英语
开放获取类型	Green Published, hybrid
收录类别	SCI-E
WOS记录号	WOS:000670981200006
WOS关键词	MANAGEMENT ; MODERATE ; 1ST
WOS类目	Gastroenterology & Hepatology
WOS研究方向	Gastroenterology & Hepatology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/350775
作者单位	[Vermeire, Severine] Univ Hosp Leuven, Dept Gastroenterol & Hepatol, Herestr 49, B-3000 Leuven, Belgium; [Chiorean, Michael] Virginia Mason Med Ctr, Div Gastroenterol, Seattle, WA 98101 USA; [Panes, Julian] CIBERehd, Dept Gastroenterol, Hosp Clin Barcelona, IDIBAPS, Barcelona, Spain; [Peyrin-Biroulet, Laurent] Nancy Univ Hosp, Dept Gastroenterol, Nancy, France; [Zhang, Jinkun; Klassen, Preston; Naik, Snehal U.; Cabell, Christopher H.] Lorraine Univ, INSERM U1256 NGERE, Nancy, France; [Zhang, Jinkun; Klassen, Preston; Naik, Snehal U.; Cabell, Christopher H.] Arena Pharmaceut, San Diego, CA USA; [Sands, Bruce E.] Icahn Sch Med Mt Sinai, Dr Henry D Janowitz Div Gastroenterol, New York, NY 10029 USA; [Lazin, Krisztina] Arena Pharmaceut, Zug, Switzerland; [Sandborn, William J.] Univ Calif San Diego, Div Gastroenterol, La Jolla, CA 92093 USA
推荐引用方式 GB/T 7714	Vermeire, Severine,Chiorean, Michael,Panes, Julian,et al. Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study[J],2021,15(6):950-959.
APA	Vermeire, Severine.,Chiorean, Michael.,Panes, Julian.,Peyrin-Biroulet, Laurent.,Zhang, Jinkun.,...&Sandborn, William J..(2021).Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study.JOURNAL OF CROHNS & COLITIS,15(6),950-959.
MLA	Vermeire, Severine,et al."Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study".JOURNAL OF CROHNS & COLITIS 15.6(2021):950-959.