Evidence map›Paper›PMID 41655066›Full record

Trial reportInflammatory bowel diseases2026

Rapid symptomatic improvement with etrasimod in ulcerative colitis: a post-hoc analysis of the ELEVATE UC program.

Marla C Dubinsky, María Chaparro, Peter M Irving, Peter Hur, Sarah Sidhu, John C Woolcott, Wenjin Wang, Martina Goetsch, Joana Torres, Remo Panaccione

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Inflammatory bowel diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03945188 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorArena PharmaceuticalsRan2019 to 2022Enrolled433ConditionsUlcerative ColitisArmsEtrasimod, Placebo
NCT03996369 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorArena PharmaceuticalsRan2020 to 2021Enrolled354ConditionsUlcerative ColitisArmsEtrasimod, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Marla C DubinskyDepartment of Medicine and Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, United States.ORCID 0000-0003-4968-5795
María ChaparroGastroenterology Unit, 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, Spain.ORCID 0000-0002-9275-4242
Peter M IrvingIBD Unit, Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom.ORCID 0000-0003-0972-8148
Peter HurHTA, Value & Evidence, Pfizer Inc, New York, NY, United States.
Sarah SidhuGlobal Medical Affairs, Pfizer Inc, New York, NY, United States.
John C WoolcottGlobal Medical Affairs, Pfizer Inc, Collegeville, PA, United States.
Wenjin WangPfizer Inc, Collegeville, PA, United States.
Martina GoetschI&I Research and Development, Pfizer AG, Zurich, Switzerland.
Joana TorresDivision of Gastroenterology, Hospital Beatriz Ângelo, Loures, Lisbon, Portugal.ORCID 0000-0003-2895-5821
Remo PanaccioneInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-5247-940X

Funding

Pfizer Inc.
6 · The paper itself

Abstract

introductionRapid symptom relief is an important consideration for patients with ulcerative colitis (UC) experiencing a flare. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active UC. We evaluated patient-reported symptomatic improvement from patients in the ELEVATE UC program.

methodsThis study was a post-hoc analysis of pooled daily e-diary data from patients with moderately to severely active UC receiving etrasimod or placebo in the phase III ELEVATE UC 52 and ELEVATE UC 12 trials. During the 12-week induction periods, patients self-reported stool frequency and rectal bleeding on days 1-28. Daily symptomatic response and symptomatic remission were calculated (partial modified Mayo Score).

resultsOverall, 787 patients (527 receiving etrasimod, 260 placebo) were included in the analysis. Etrasimod-treated patients had statistically significantly higher rates of symptomatic response and symptomatic remission during the first 28 days of therapy, with adjusted differences (95% CIs) reaching statistical significance from day 2 (5.6% [0.8-10.3], P = .022) to day 11 (4.7% [0.4-9.0], P = .034), respectively. In patients naïve to biologic/Janus kinase inhibitor therapy, symptomatic response was statistically significantly improved with etrasimod vs placebo from day 3 (8.9% [2.3-15.5], P = .008). Symptomatic improvement rates were similar with and without concomitant corticosteroid use.

conclusionsIn this post-hoc analysis, improvements in UC symptoms occurred in patients receiving etrasimod vs placebo from as early as day 2. These findings indicate a rapid onset of symptomatic effect with etrasimod treatment for moderately to severely active UC. CLINICALTRIALS.GOV NUMBERS: NCT03945188, NCT03996369.

Indexed as

Colitis, UlcerativeSphingosine 1 Phosphate Receptor ModulatorsAcetatesAdultDouble-Blind MethodFemaleHumansIndolesMaleMiddle AgedRemission InductionSeverity of Illness IndexTreatment OutcomeAcetatesetrasimodIndolesSphingosine 1 Phosphate Receptor Modulatorsetrasimodrapid symptom improvementsphingosine 1-phosphate receptor modulatorulcerative colitis

Identifiers

PMID41655066
PMCPMC13233136

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.