干旱区生态环境知识资源中心(Arid): Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial

Arid

DOI	10.1093/ecco-jcc/jjae007
	Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial
	Yarur, Andres J.; Chiorean, Michael, V; Panes, Julian; Jairath, Vipul; Zhang, Jinkun; Rabbat, Christopher J.; Sandborn, William J.; Vermeire, Severine; Peyrin-Biroulet, Laurent
通讯作者	Yarur, AJ
来源期刊	JOURNAL OF CROHNS & COLITIS
ISSN	1873-9946
EISSN	1876-4479
出版年	2024
卷号	18 期号:6 页码:885-894
英文摘要	Background and Aims Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis [UC]. This post-hoc analysis of the phase 2 OASIS trial [NCT02447302] evaluated its efficacy for endoscopic improvement-histologic remission [EIHR] and assessed correlation between faecal calprotectin [FCP] and C-reactive protein [CRP] levels with efficacy outcomes. Methods In total, 156 adults with moderately to severely active UC received once-daily etrasimod (1 mg [n = 52]; 2 mg [n = 50]) or placebo [n = 54] for 12 weeks. Clinical, endoscopic, and histologic variables were evaluated at baseline and Week 12. EIHR was defined as achievement of endoscopic improvement [endoscopic subscore <= 1, without friability] and histologic remission [Geboes score < 2.0]. Outcomes included the relationships between FCP and CRP concentration and clinical, endoscopic, and histologic variables. Results Achievement of EIHR was significantly higher in patients who received etrasimod 2 mg versus placebo [19.5% vs 4.1%; Mantel-Haenszel estimated difference, 15.4%; p = 0.010]. In the etrasimod 2 mg group, median FCP and CRP levels at Week 12 were significantly lower in patients who achieved clinical remission, endoscopic improvement, histologic remission, and EIHR versus patients who did not [all p < 0.05]. An FCP concentration cutoff of 250 mu g/g achieved optimum sensitivity and specificity for efficacy, including EIHR [0.857 and 0.786, respectively; kappa coefficient, 0.3584]. Higher proportions of patients with FCP <= 250 mu g/g achieved efficacy outcomes at Week 12 versus patients with FCP > 250 mu g/g. Conclusions Etrasimod was effective for inducing EIHR in patients with UC. FCP and CRP may be useful, noninvasive biomarkers to monitor treatment response. ClinicalTrials.gov number NCT02447302.
英文关键词	Etrasimod ulcerative colitis S1P receptor modulator mucosal healing endoscopic improvement-histologic remission
类型	Article
语种	英语
开放获取类型	Green Accepted, hybrid
收录类别	SCI-E
WOS记录号	WOS:001158290000001
WOS关键词	MAINTENANCE THERAPY ; DISEASE-ACTIVITY ; INDUCTION ; INFLAMMATION ; OZANIMOD ; EFFICACY
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/2XILL650/404424
推荐引用方式 GB/T 7714	Yarur, Andres J.,Chiorean, Michael, V,Panes, Julian,et al. Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial[J],2024,18(6):885-894.
APA	Yarur, Andres J..,Chiorean, Michael, V.,Panes, Julian.,Jairath, Vipul.,Zhang, Jinkun.,...&Peyrin-Biroulet, Laurent.(2024).Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial.JOURNAL OF CROHNS & COLITIS,18(6),885-894.
MLA	Yarur, Andres J.,et al."Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial".JOURNAL OF CROHNS & COLITIS 18.6(2024):885-894.