Achievement of clinical, endoscopic, and histologic outcomes in patients with ulcerative colitis treated with etrasimod, and association with fecal calprotectin and C-reactive protein: results from the Phase 2 OASIS trial

钙蛋白酶 胃肠病学 医学 内科学 溃疡性结肠炎 安慰剂 C反应蛋白 结肠镜检查 临床试验 混淆 炎症性肠病 病理 疾病 结直肠癌 炎症 替代医学 癌症
作者
Andrés Yarur,Michael Chiorean,Julián Panés,Vipul Jairath,Jinkun Zhang,Christopher J. Rabbat,William J. Sandborn,Séverine Vermeire,Laurent Peyrin‐Biroulet
出处
期刊:Journal of Crohn's and Colitis [Oxford University Press]
标识
DOI:10.1093/ecco-jcc/jjae007
摘要

Abstract Background and Aims Etrasimod is an oral, selective sphingosine 1-phosphate receptor 1,4,5 [S1P1,4,5] modulator in development for 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 fecal calprotectin [FCP] and C-reactive protein [CRP] levels with efficacy outcomes. Methods 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 μg/g achieved optimum sensitivity and specificity for efficacy, including EIHR [0.857 and 0.786, respectively; κ coefficient, 0.3584]. Higher proportions of patients with FCP ≤250 μg/g achieved efficacy outcomes at Week 12 versus patients with FCP >250 μg/g. Conclusions Etrasimod was effective for inducing EIHR in patients with UC. FCP and CRP may be useful, noninvasive biomarkers to monitor treatment response.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
科研通AI2S应助Ethanyoyo0917采纳,获得10
1秒前
Orange应助sss采纳,获得150
1秒前
99发布了新的文献求助10
2秒前
愉快的隶完成签到,获得积分10
3秒前
Anan完成签到,获得积分10
3秒前
124完成签到 ,获得积分10
5秒前
wsh完成签到 ,获得积分10
5秒前
DQ完成签到,获得积分10
7秒前
iNk应助Rgly采纳,获得20
7秒前
唐妮完成签到,获得积分10
8秒前
果蝇宝宝完成签到,获得积分10
9秒前
dai完成签到,获得积分10
9秒前
9秒前
寻寻觅觅冷冷清清完成签到,获得积分10
9秒前
小朱完成签到,获得积分10
10秒前
12秒前
魁梧的冰菱完成签到,获得积分10
13秒前
年轻火车完成签到,获得积分10
13秒前
ZH完成签到 ,获得积分10
14秒前
16秒前
古今奇观完成签到 ,获得积分10
17秒前
路冰完成签到,获得积分10
17秒前
酷波er应助儒雅的友瑶采纳,获得10
19秒前
小分队发布了新的文献求助10
20秒前
20秒前
20秒前
情怀应助细心蚂蚁采纳,获得10
21秒前
yaoyh_gc完成签到,获得积分10
25秒前
Zik完成签到 ,获得积分10
27秒前
科研通AI5应助feng采纳,获得10
27秒前
Ying完成签到,获得积分10
27秒前
28秒前
29秒前
licheng完成签到,获得积分10
29秒前
儒雅的友瑶完成签到,获得积分10
29秒前
29秒前
Ava应助英勇含烟采纳,获得10
32秒前
斯文败类应助小分队采纳,获得10
32秒前
32秒前
33秒前
高分求助中
Production Logging: Theoretical and Interpretive Elements 2700
Neuromuscular and Electrodiagnostic Medicine Board Review 1000
こんなに痛いのにどうして「なんでもない」と医者にいわれてしまうのでしょうか 510
The First Nuclear Era: The Life and Times of a Technological Fixer 500
Unusual formation of 4-diazo-3-nitriminopyrazoles upon acid nitration of pyrazolo[3,4-d][1,2,3]triazoles 500
岡本唐貴自伝的回想画集 500
Distinct Aggregation Behaviors and Rheological Responses of Two Terminally Functionalized Polyisoprenes with Different Quadruple Hydrogen Bonding Motifs 450
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 物理 生物化学 纳米技术 计算机科学 化学工程 内科学 复合材料 物理化学 电极 遗传学 量子力学 基因 冶金 催化作用
热门帖子
关注 科研通微信公众号,转发送积分 3671619
求助须知:如何正确求助?哪些是违规求助? 3228325
关于积分的说明 9779523
捐赠科研通 2938636
什么是DOI,文献DOI怎么找? 1610158
邀请新用户注册赠送积分活动 760547
科研通“疑难数据库(出版商)”最低求助积分说明 736093