Etrasimod不含皮质类固醇的疗效、并用皮质类固醇对疗效和安全性的影响以及皮质类固醇在UC中的稀释效应:ELEVATE UC 临床项目分析》。

Bruce E Sands, Yvette Leung, David T Rubin, Krisztina B Gecse, Julian Panés, Martina Goetsch, Wenjin Wang, John C Woolcott, Christina C Smith, Karolina Wosik, Stefan Schreiber
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CS-free efficacy at Week 52 was assessed in patients with baseline CS use.</p><p><strong>Results: </strong>In ELEVATE UC 52 and ELEVATE UC 12, 93/289 (32.2%) and 65/238 (27.3%) patients receiving etrasimod and 42/144 (29.2%) and 34/116 (29.3%) patients receiving placebo, respectively, had concomitant CS use at baseline. In the CS and no-CS subgroups, higher proportions of patients who received etrasimod vs placebo achieved clinical remission (p < 0.05) in ELEVATE UC 52 at Weeks 12 (CS: 32.3% vs 16.7%; no-CS: 26.0% vs 4.9%) and 52 (CS: 31.2% vs 9.5%; no-CS: 33.2% vs 6.9%). In the CS subgroup, significantly more patients receiving etrasimod than placebo achieved CS-free clinical remission at Week 52 (31.2% vs 7.1%). No increases in infection rates were observed with baseline CS use. Safety was comparable between subgroups.</p><p><strong>Conclusions: </strong>Etrasimod demonstrated efficacy in inducing and maintaining remission in both subgroups. 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引用次数: 0

摘要

研究背景Etrasimod是一种口服、每日一次的选择性1-磷酸鞘磷脂(S1P)1,4,5受体调节剂,用于治疗中度至重度活动性溃疡性结肠炎(UC)。这项事后分析报告了ELEVATE UC临床项目中按皮质类固醇使用基线划分的疗效和安全性:UC患者接受2毫克依曲莫德或安慰剂治疗,疗程长达52周。允许使用皮质类固醇;建议从第12周开始减少使用。ELEVATE UC 52在第12周和第52周评估疗效,ELEVATE UC 12在第12周评估皮质类固醇(CS)亚组和无CS亚组患者的疗效。对基线使用CS的患者第52周无CS疗效进行了评估:在 ELEVATE UC 52 和 ELEVATE UC 12 中,分别有 93/289 (32.2%) 和 65/238 (27.3%) 名接受依曲莫德治疗的患者和 42/144 (29.2%) 和 34/116 (29.3%) 名接受安慰剂治疗的患者在基线时同时使用 CS。在CS亚组和无CS亚组中,接受依曲莫德与安慰剂治疗的患者在ELEVATE UC 52第12周(CS:32.3% vs 16.7%;无CS:26.0% vs 4.9%)和第52周(CS:31.2% vs 9.5%;无CS:33.2% vs 6.9%)达到临床缓解的比例更高(p < 0.05)。在CS亚组中,接受依曲莫德治疗的患者在第52周达到无CS临床缓解的比例明显高于安慰剂(31.2% vs 7.1%)。没有观察到基线CS使用会增加感染率。各亚组之间的安全性相当:结论:Etrasimod在诱导和维持两个亚组的缓解方面均有疗效。CS亚组实现了无CS缓解。安全性一致,感染率没有增加。
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Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in UC: Analyses of the ELEVATE UC Clinical Programme.

Background: 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 reports efficacy and safety by baseline corticosteroid use in the ELEVATE UC clinical programme.

Methods: Patients with UC received etrasimod 2 mg or placebo for up to 52 weeks. Corticosteroid use was permitted; tapering was recommended from Week 12. Efficacy was assessed at Weeks 12 and 52 in ELEVATE UC 52, and Week 12 in ELEVATE UC 12, in patients in the corticosteroid (CS) and no-CS subgroups. CS-free efficacy at Week 52 was assessed in patients with baseline CS use.

Results: In ELEVATE UC 52 and ELEVATE UC 12, 93/289 (32.2%) and 65/238 (27.3%) patients receiving etrasimod and 42/144 (29.2%) and 34/116 (29.3%) patients receiving placebo, respectively, had concomitant CS use at baseline. In the CS and no-CS subgroups, higher proportions of patients who received etrasimod vs placebo achieved clinical remission (p < 0.05) in ELEVATE UC 52 at Weeks 12 (CS: 32.3% vs 16.7%; no-CS: 26.0% vs 4.9%) and 52 (CS: 31.2% vs 9.5%; no-CS: 33.2% vs 6.9%). In the CS subgroup, significantly more patients receiving etrasimod than placebo achieved CS-free clinical remission at Week 52 (31.2% vs 7.1%). No increases in infection rates were observed with baseline CS use. Safety was comparable between subgroups.

Conclusions: Etrasimod demonstrated efficacy in inducing and maintaining remission in both subgroups. CSfree remission was achieved in the CS subgroup. Safety was consistent, with no increase in infections.

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