ELEVATE UC 52 和 ELEVATE UC 12 试验中,既往生物制剂或 Janus 激酶抑制剂疗法对 Etrasimod 疗效和安全性的影响。

Séverine Vermeire, Bruce E Sands, Laurent Peyrin-Biroulet, Geert R D'Haens, Julian Panés, Andres J Yarur, Douglas C Wolf, Timothy Ritter, Stefan Schreiber, John C Woolcott, Irene Modesto, Michael Keating, Kevin Shan, Joseph Wu, Michael V Chiorean, Filip Baert, Marla C Dubinsky, Martina Goetsch, Silvio Danese, Brian G Feagan
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In both bio/JAKi-naïve and -experienced patients, a significantly greater proportion receiving etrasimod vs placebo achieved clinical remission [p < 0.05] in ELEVATE UC 52 at Weeks 12 [naïve: 30.9% vs 9.7%; experienced: 17.5% vs 2.4%] and 52 [naïve: 36.6% vs 7.5%; experienced: 21.3% vs 4.8%]; in ELEVATE UC 12, this was observed only for bio/JAKi-naïve patients [naïve: 27.7% vs 16.2%, p = 0.033; experienced: 18.9% vs 13.2%, p = 0.349]. Similar patterns were observed for most efficacy endpoints. 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引用次数: 0

摘要

背景和目的依曲莫德是一种口服、每日一次的选择性1-磷酸鞘氨醇[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]。本亚组分析评估了 ELEVATE UC 52 和 ELEVATE UC 12 中,按照生物制剂/Janus 激酶抑制剂[bio/JAKi]的既往暴露情况,每日一次 2 毫克依曲莫德与安慰剂相比的疗效和安全性:在 ELEVATE UC 52 第 12 周和第 52 周以及 ELEVATE UC 12 第 12 周,对生物/JAKi 无经验和有经验的患者进行了预先定义的疗效终点评估,并在第 12 周[汇总]根据之前的晚期治疗暴露机制进行了评估:在ELEVATE UC 52和ELEVATE UC 12分析人群中,接受依曲莫德治疗的患者中分别有80/274[29.2%]和74/222[33.3%]人有生物/JAKi经验,接受安慰剂治疗的患者中分别有42/135[31.1%]和38/112[33.9%]人有生物/JAKi经验。在生物/JAKi-naïve和-experi-experi患者中,接受依曲莫德治疗的患者获得临床缓解的比例明显高于安慰剂(p结论:与安慰剂相比,生物/JAKi无效和有经验的患者接受依曲莫德的诱导和维持治疗具有临床意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials.

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 subgroup analysis evaluated the efficacy and safety of etrasimod 2 mg once daily vs placebo by prior biologic/Janus kinase inhibitor [bio/JAKi] exposure in ELEVATE UC 52 and ELEVATE UC 12.

Methods: Pre-defined efficacy endpoints were assessed at Weeks 12 and 52 in ELEVATE UC 52 and Week 12 in ELEVATE UC 12 in bio/JAKi-naïve and -experienced patients, and at Week 12 [pooled] based on prior advanced therapy exposure mechanism.

Results: In the ELEVATE UC 52 and ELEVATE UC 12 analysis populations, 80/274 [29.2%] and 74/222 [33.3%] patients receiving etrasimod and 42/135 [31.1%] and 38/112 [33.9%] patients receiving placebo, respectively, were bio/JAKi-experienced. In both bio/JAKi-naïve and -experienced patients, a significantly greater proportion receiving etrasimod vs placebo achieved clinical remission [p < 0.05] in ELEVATE UC 52 at Weeks 12 [naïve: 30.9% vs 9.7%; experienced: 17.5% vs 2.4%] and 52 [naïve: 36.6% vs 7.5%; experienced: 21.3% vs 4.8%]; in ELEVATE UC 12, this was observed only for bio/JAKi-naïve patients [naïve: 27.7% vs 16.2%, p = 0.033; experienced: 18.9% vs 13.2%, p = 0.349]. Similar patterns were observed for most efficacy endpoints. Among patients with prior anti-integrin exposure [N = 90], a significantly greater proportion achieved clinical response [54.1% vs 27.6%, p = 0.030], but not clinical remission [9.8% vs 3.4%, p = 0.248], with etrasimod vs placebo.

Conclusions: Bio/JAKi-naïve and -experienced patients had clinically meaningful induction and maintenance treatment benefits with etrasimod vs placebo.

Clinicaltrials.gov: NCT03945188; NCT03996369.

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