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.
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