Sands Bruce E, Dubinsky Marla C, Kotze Paulo G, Vermeire Séverine, Panaccione Remo, Long Millie D, Woolcott John C, Wu Joseph, McDonnell Aoibhinn, Goetsch Martina, Bananis Eustratios, Yarur Andres J
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Inflamm Bowel Dis. 2025 Feb 28. doi: 10.1093/ibd/izaf036.
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 of the ELEVATE UC clinical program describes etrasimod efficacy and safety by patients' baseline disease activity.
Predefined efficacy endpoints were assessed at week 12 in patients with moderately (modified Mayo score [MMS] 5-7) or severely (MMS 8-9) active UC using pooled data from ELEVATE UC 52 and ELEVATE UC 12. Descriptive statistics with 95% CI were calculated.
Of 743 patients analyzed, 525 (70.7%) had moderately active and 218 (29.3%) had severely active disease at baseline. At week 12, patients treated with etrasimod showed larger mean percentage reductions (95% CI) in MMS vs placebo, regardless of baseline disease activity (-48.4% [-52.3, -44.4] vs -27.0% [-32.2, -21.7] for moderately active disease and -46.4% [-51.2, -41.5] vs -29.8% [-37.2, -22.3] for severely active disease). Similar proportions of patients with moderately or severely active disease treated with etrasimod vs placebo achieved clinical response at week 12 (61.3% vs 39.8% for moderately active disease and 64.5% vs 30.3% for severely active disease). Incidence of treatment-emergent adverse events were similar between disease activity subgroups.
At week 12, etrasimod showed greater reductions in disease activity and higher rates of clinical response vs placebo in patients with either moderately or severely active disease at baseline. The safety profile of etrasimod was consistent with the overall trial population and was unimpacted by baseline disease activity.
CLINICALTRIALS.GOV: NCT03945188; NCT03996369.
艾曲莫德是一种口服的、每日一次的选择性1,4,5-鞘氨醇-1-磷酸（S1P）受体调节剂，用于治疗中度至重度活动性溃疡性结肠炎（UC）。这项对ELEVATE UC临床项目的事后分析按患者基线疾病活动度描述了艾曲莫德的疗效和安全性。
使用来自ELEVATE UC 52和ELEVATE UC 12的汇总数据，在第12周对中度（改良梅奥评分[MMS]5-7）或重度（MMS 8-9）活动性UC患者评估预定义的疗效终点。计算了95%置信区间的描述性统计量。
在分析的743例患者中，525例（70.7%）基线时为中度活动性疾病，218例（29.3%）为重度活动性疾病。在第12周时，无论基线疾病活动度如何，接受艾曲莫德治疗的患者MMS平均降低百分比（95%置信区间）均高于安慰剂组（中度活动性疾病组为-48.4%[-52.3，-44.4]对-27.0%[-32.2，-21.7]，重度活动性疾病组为-46.4%[-51.2，-41.5]对-29.8%[-37.2，-22.3]）。在第12周时，接受艾曲莫德治疗与接受安慰剂治疗的中度或重度活动性疾病患者达到临床缓解的比例相似（中度活动性疾病组为61.3%对39.8%，重度活动性疾病组为64.5%对30.3%）。治疗中出现的不良事件发生率在疾病活动亚组之间相似。
在第12周时，对于基线时为中度或重度活动性疾病的患者，艾曲莫德与安慰剂相比，疾病活动度降低幅度更大，临床缓解率更高。艾曲莫德的安全性概况与总体试验人群一致，且不受基线疾病活动度的影响。
NCT03945188；NCT03996369。
