Histologic remission, a potentially important treatment target in ulcerative colitis (UC), is associated with favorable long-term outcomes. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately to severely active UC. This post-hoc analysis of the ELEVATE UC program evaluated the efficacy of etrasimod according to histologic and composite (histologic/endoscopic/symptomatic) endpoints and examined their prognostic value. Patients with moderately to severely active UC were randomized 2:1 to once-daily oral etrasimod 2 mg or placebo. Histologic and composite endpoints, including disease clearance (endoscopic/histologic/symptomatic remission), were assessed at Weeks 12 (ELEVATE UC 52; ELEVATE UC 12) and 52 (ELEVATE UC 52). Logistic regressions examined associations between baseline and Week 12 histologic/composite endpoints and Week 52 outcomes. At Weeks 12 and 52, significant improvements with etrasimod vs placebo were observed in histologic/composite outcomes, including endoscopic improvement-histologic remission and disease clearance. The proportion of patients treated with etrasimod achieving clinical remission at Week 52 was higher among those with disease clearance at Week 12 vs those without disease clearance (73.9% [17/23] vs 28.3% [71/251]). Histologic improvement and endoscopic improvement at Week 12 were moderately and strongly associated with clinical remission at Week 52 (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.27–4.41; and OR, 6.36; 95% CI, 3.47–11.64, respectively). Histologic remission and endoscopic improvement at Week 12 were strongly associated with endoscopic improvement-histologic remission at Week 52 (OR, 3.21; 95% CI, 1.70–6.06 and OR, 5.47; 95% CI, 2.89–10.36, respectively). Etrasimod was superior to placebo for achievement of stringent histologic and composite endpoints.

中文翻译：

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接受艾曲莫德治疗的溃疡性结肠炎患者的内镜、组织学和综合终点


组织学缓解是溃疡性结肠炎 (UC) 的一个潜在重要治疗目标，与良好的长期结果相关。 Etrasimod 是一种口服、每日一次的选择性 1-磷酸鞘氨醇 (S1P) 受体调节剂，用于治疗中度至重度活动性 UC。 ELEVATE UC 项目的事后分析根据组织学和复合（组织学/内窥镜/症状）终点评估了 etrasimod 的疗效，并检查了其预后价值。中度至重度活动性 UC 患者以 2:1 的比例随机分配至每日一次口服依曲莫德 2 mg 组或安慰剂组。在第12周（ELEVATE UC 52；ELEVATE UC 12）和第52周（ELEVATE UC 52）评估组织学和复合终点，包括疾病清除（内镜/组织学/症状缓解）。 Logistic 回归检查了基线和第 12 周组织学/复合终点与第 52 周结果之间的关联。在第 12 周和第 52 周，与安慰剂相比，在组织学/综合结果方面观察到 etrasimod 显着改善，包括内镜改善、组织学缓解和疾病清除。在第12周疾病清除的患者中，接受艾曲莫德治疗的患者在第52周实现临床缓解的比例高于未疾病清除的患者（73.9% [17/23] vs 28.3% [71/251]）。第 12 周时的组织学改善和内镜改善与第 52 周时的临床缓解存在中度和强相关性（优势比 [OR]，2.37；95% 置信区间 [CI]，1.27–4.41；OR，6.36；95% CI，3.47） –11.64，分别）。第 12 周的组织学缓解和内镜改善与第 52 周的内镜改善-组织学缓解密切相关（OR，3.21；95% CI，1.70-6.06；OR，5.47；95% CI，2.89-10。分别为 36)。在达到严格的组织学和复合终点方面，Etrasimod 优于安慰剂。