艾曲莫德用于溃疡性结肠炎症状缓解的事后分析：来自ELEVATE UC临床项目的分析

Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme.

作者信息

Chaparro María, Panaccione Remo, Sands Bruce E, Irving Peter M, Goetsch Martina, Kunina Eugenia, Wang Wenjin, Wu Joseph, Woolcott John C, Bartolome Lauren, Cognata Christina, Wosik Karolina, Dubinsky Marla C

机构信息

Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Community of Madrid, Spain.

Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.

出版信息

BMJ Open Gastroenterol. 2025 Aug 31;12(1):e001838. doi: 10.1136/bmjgast-2025-001838.

DOI:10.1136/bmjgast-2025-001838

PMID:40889900

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12406896/

Abstract

OBJECTIVE

Bothersome ulcerative colitis (UC) symptoms include stool frequency (SF), rectal bleeding (RB), abdominal pain and bowel urgency; symptomatic relief is a key treatment goal. Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate receptor modulator for the treatment of moderately to severely active UC. We assessed outcomes related to symptomatic relief among patients with moderately to severely active UC in the phase III ELEVATE UC clinical programme.

METHODS

In both ELEVATE UC 52 and ELEVATE UC 12, adults were randomly assigned (2:1) to etrasimod 2 mg QD or placebo. Symptomatic remission, symptomatic response, complete symptomatic remission, SF and RB were evaluated at each trial visit. Bowel urgency and abdominal pain were also assessed (weeks 12 and 52).

RESULTS

Significantly more patients receiving etrasimod were in symptomatic remission and symptomatic response at weeks 12 and 52 versus placebo (all p<0.001). Improvements from baseline in RB and SF subscores were significantly greater in those receiving etrasimod versus placebo from weeks 2 (ELEVATE UC 12) and 4 (ELEVATE UC 52). Similarly, a significantly greater number of patients in the etrasimod versus placebo group were in complete symptomatic remission. At weeks 12 and 52, the number of patients achieving clinically meaningful improvements in bowel urgency, bowel urgency remission and abdominal pain remission was significantly greater for etrasimod versus placebo (all p<0.05).

CONCLUSION

Etrasimod was efficacious in improving symptoms of UC from week 2; improvements were maintained through week 52.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov: NCT03945188; NCT03996369.

摘要

目的

溃疡性结肠炎（UC）的困扰症状包括排便频率（SF）、直肠出血（RB）、腹痛和排便急迫感；症状缓解是关键的治疗目标。艾曲莫德是一种口服、每日一次（QD）的选择性1-磷酸鞘氨醇受体调节剂，用于治疗中度至重度活动性UC。我们在III期ELEVATE UC临床项目中评估了中度至重度活动性UC患者症状缓解的相关结果。

方法

在ELEVATE UC 52和ELEVATE UC 12试验中，成人被随机分配（2:1）接受2mg QD的艾曲莫德或安慰剂。在每次试验访视时评估症状缓解、症状反应、完全症状缓解、SF和RB。还评估了排便急迫感和腹痛（第12周和第52周）。

结果

与安慰剂相比，接受艾曲莫德治疗的患者在第12周和第52周出现症状缓解和症状反应的比例显著更高（所有p<0.001）。从第2周（ELEVATE UC 12）和第4周（ELEVATE UC 52）起，接受艾曲莫德治疗的患者RB和SF子评分较基线的改善显著大于安慰剂组。同样，艾曲莫德组完全症状缓解的患者数量显著多于安慰剂组。在第12周和第52周，艾曲莫德组在排便急迫感、排便急迫感缓解和腹痛缓解方面实现临床意义改善的患者数量显著多于安慰剂组（所有p<0.05）。