体重指数不影响etrasimod的疗效和安全性：ELEVATE溃疡性结肠炎临床项目的事后分析
Body Mass Index Did Not Affect Efficacy and Safety of Etrasimod: A Post Hoc Analysis of the ELEVATE Ulcerative Colitis Clinical Program.
作者信息
Yarur Andres J, Long Millie D, Torres Joana, Nandi Neilanjan, Cross Raymond K, Abbatemarco Arcangelo M, Blanco David, Niezychowski Wojciech, Crosby Catherine, Wu Joseph, Pradeep Gokul, Goetsch Martina, Panaccione Remo
机构信息
Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina, USA.
出版信息
Am J Gastroenterol. 2025 Jan 29. doi: 10.14309/ajg.0000000000003330.
INTRODUCTION
High body mass index (BMI) may reduce ulcerative colitis (UC) treatment efficacy. Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate 1,4,5 receptor modulator for the treatment of moderately to severely active UC. This post hoc analysis assessed treatment outcomes according to BMI in ELEVATE UC 52 and ELEVATE UC 12.
METHODS
Patients receiving etrasimod 2 mg QD or placebo were stratified by BMI: <25, 25-30, and >30 kg/m 2 . Efficacy and safety were assessed at weeks 12 (pooled data) and 52 (ELEVATE UC 52 only) in addition to biomarkers assessments from week 0-12.
RESULTS
For BMI <25 (N = 443) and 25-30 kg/m 2 (N = 217) subgroups, more patients receiving etrasimod vs placebo achieved clinical remission at weeks 12 (BMI <25 kg/m 2 : 27.9% vs 13.3%; 25-30 kg/m 2 : 28.5% vs 10.0%; all P < 0.001) and 52 (BMI <25 kg/m 2 : 30.8% vs 10.0%; 25-30 kg/m 2 : 33.3% vs 6.3%; all P < 0.0001), and also for all other efficacy end points ( P < 0.05). In the BMI >30 kg/m 2 subgroup (N = 127), more patients receiving etrasimod vs placebo achieved clinical remission at week 52 (36.5% vs 3.9%; P < 0.0001) and most other efficacy end points at weeks 12 and 52 (all P < 0.05). Overall, regardless of baseline BMI, numerically lower fecal calprotectin levels were observed with etrasimod vs placebo in treatment responders. The safety profile of etrasimod was consistent between BMI subgroups.
DISCUSSION
A high BMI did not significantly affect efficacy and safety outcomes of etrasimod (NCT03945188; NCT03996369).
引言
高体重指数（BMI）可能会降低溃疡性结肠炎（UC）的治疗效果。埃曲莫德是一种口服的每日一次（QD）的选择性1,4,5-鞘氨醇-1-磷酸受体调节剂，用于治疗中度至重度活动性UC。这项事后分析根据BMI评估了ELEVATE UC 52和ELEVATE UC 12试验中的治疗结果。
方法
接受2mg QD埃曲莫德或安慰剂治疗的患者按BMI分层：<25、25-30和>30kg/m²。除了在第0至12周进行生物标志物评估外，还在第12周（汇总数据）和第52周（仅ELEVATE UC 52试验）评估疗效和安全性。
结果
对于BMI<25（n = 443）和25-30kg/m²（n = 217）亚组，在第12周（BMI<25kg/m²：27.9%对13.3%；25-30kg/m²：28.5%对10.0%；所有P<0.001）和第52周（BMI<25kg/m²：30.8%对10.0%；25-30kg/m²：33.3%对6.3%；所有P<0.0001），接受埃曲莫德治疗的患者比接受安慰剂治疗的患者有更多达到临床缓解，并且在所有其他疗效终点也是如此（P<0.05）。在BMI>30kg/m²亚组（n = 127）中，接受埃曲莫德治疗的患者比接受安慰剂治疗的患者在第52周有更多达到临床缓解（36.5%对3.9%；P<0.0001），并且在第12周和第52周的大多数其他疗效终点也是如此（所有P<0.05）。总体而言，无论基线BMI如何，在治疗反应者中，与安慰剂相比，埃曲莫德治疗后粪便钙卫蛋白水平在数值上更低。埃曲莫德在各BMI亚组中的安全性概况是一致的。
讨论
高BMI并未显著影响埃曲莫德的疗效和安全性结果（NCT03945188；NCT03996369）。
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