Sands Bruce E, Leung Yvette, Rubin David T, Gecse Krisztina B, Panés Julian, Goetsch Martina, Wang Wenjin, Woolcott John C, Smith Christina C, Wosik Karolina, Schreiber Stefan
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
J Crohns Colitis. 2025 Mar 5;19(3). doi: 10.1093/ecco-jcc/jjae150.
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 the efficacy and safety of etrasimod based on baseline corticosteroid (CS) use in the ELEVATE UC clinical program.
Patients with UC received etrasimod 2 mg or placebo for up to 52 weeks. CS 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, for patients in the CS and no-CS subgroups. CS-free efficacy at Week 52 was assessed in patients with baseline CS use.
In ELEVATE UC 52 and ELEVATE UC 12, 93 of 289 (32.2%) and 65 of 238 (27.3%) patients receiving etrasimod and 42 of 144 (29.2%) and 34 of 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 Week 12 (CS: 32.3% vs 16.7%; no-CS: 26.0% vs 4.9%) and Week 52 (CS: 31.2% vs 9.5%; no-CS: 33.2% vs 6.9%). In the CS subgroup, significantly more patients receiving etrasimod achieved CS-free clinical remission at Week 52 (31.2% vs 7.1%) compared with those receiving placebo. No increases in infection rates were observed with baseline CS use. Safety was comparable between subgroups.
Etrasimod demonstrated efficacy in inducing and maintaining remission in both subgroups. CS-free remission was achieved in the CS subgroup. Safety was consistent, with no increase in infections.
NCT03945188; NCT03996369.
艾曲莫德是一种口服的、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）。这项事后分析报告了在ELEVATE UC临床项目中，基于基线皮质类固醇（CS）使用情况的艾曲莫德的疗效和安全性。
UC患者接受2毫克艾曲莫德或安慰剂治疗，最长52周。允许使用CS；建议从第12周开始逐渐减量。在ELEVATE UC 52研究的第12周和第52周，以及ELEVATE UC 12研究的第12周，对CS和非CS亚组的患者进行疗效评估。对基线使用CS的患者评估第52周时无CS情况下的疗效。
在ELEVATE UC 52和ELEVATE UC 12研究中，接受艾曲莫德治疗的289例患者中有93例（32.2%）、238例患者中有65例（27.3%），接受安慰剂治疗的144例患者中有42例（29.2%）、116例患者中有34例（29.3%）在基线时同时使用CS。在CS和非CS亚组中，在ELEVATE UC 52研究的第12周（CS组：32.3%对16.7%；非CS组：26.0%对4.9%）和第52周（CS组：31.2%对9.5%；非CS组：33.2%对6.9%），接受艾曲莫德治疗的患者实现临床缓解的比例高于接受安慰剂治疗的患者（p<0.05）。在CS亚组中，与接受安慰剂治疗的患者相比，接受艾曲莫德治疗的患者在第52周实现无CS临床缓解的比例显著更高（31.2%对7.1%）。未观察到基线使用CS会增加感染率。亚组间安全性相当。
艾曲莫德在两个亚组中均显示出诱导和维持缓解的疗效。CS亚组实现了无CS缓解。安全性一致，感染率未增加。
NCT03945188；NCT03996369。
