Evidence map›Paper›PMID 39671695›Full record

Trial reportInflammatory bowel diseases2025

Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and/or Aminosalicylates: Results From the ELEVATE UC Clinical Program.

Andres J Yarur, Michael V Chiorean, Jessica R Allegretti, Raymond K Cross, Christina Ha, Martina Goetsch, Aoibhinn McDonnell, Alexis B Dalam, Joseph Wu, David A Blanco and 2 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Inflammatory bowel diseases, 2025. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Etrasimod in Treatment of Ulcerative Colitis: A Comprehensive Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2025
    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

12 authors.

Andres J YarurInflammatory Bowel Disease Institute and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Michael V ChioreanInflammatory Bowel Disease Center, Swedish Medical Center, Seattle, WA, USA.
Jessica R AllegrettiDivision of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-3585-2425
Raymond K CrossDivision of Gastroenterology and Hepatology, Melissa L. Posner Institute for Digestive Health and Liver Diseases at Mercy Medical Center, Baltimore, MD, USA.
Christina HaDivision of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA.ORCID 0000-0003-3897-7370
Martina GoetschPfizer AG, Zürich, Switzerland.
Aoibhinn McDonnellPfizer Ltd, Sandwich, Kent, UK.
Alexis B DalamPfizer Inc, Manila, Philippines.
Joseph WuPfizer Inc, Cambridge, MA, USA.
David A BlancoPfizer Inc, Collegeville, PA, USA.
Arcangelo M AbbatemarcoPfizer Inc, New York, NY, USA.ORCID 0009-0006-7998-1770
Julian PanésFormerly Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

Funding

Pfizer
6 · The paper itself

Abstract

backgroundEtrasimod is an oral, once daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). We assessed the benefit of etrasimod monotherapy and the impact of concomitant corticosteroids (CS) and/or 5-aminosalicylates (5-ASA) therapy.

methodsIn ELEVATE UC 52 and ELEVATE UC 12, patients with moderately to severely active UC were randomized 2:1 to etrasimod 2 mg QD or placebo for 52 and 12 weeks, respectively. Oral CS or 5-ASA were allowed at baseline. Patients in the monotherapy subgroup received etrasimod or placebo without concomitant CS and/or 5-ASA at baseline. Predefined primary (clinical remission) and key secondary efficacy endpoints aligned with those from both trials and were assessed at Week 12 and Week 52. Safety was assessed up to Week 52.

resultsClinical remission rates at Weeks 12 and 52 were significantly higher for etrasimod compared with placebo in patients receiving monotherapy (Week 12: 26.2% vs 4.8%; Week 52: 35.7% vs 4.0%). Differences vs placebo were statistically significant for all predefined endpoints at both time points in patients receiving monotherapy or etrasimod with concomitant 5-ASA only (all P < .05); numerical differences, due to small sample sizes, vs placebo were observed for all endpoints in the CS only and CS + 5-ASA subgroups. Safety was consistent with the overall population.

conclusionsEtrasimod monotherapy showed consistent efficacy and safety vs placebo; no apparent benefit was observed with concomitant CS and/or 5-ASA in patients receiving etrasimod. CLINICAL

trial registrationNCT03945188; NCT03996369.

Indexed as

Adrenal Cortex HormonesAnti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeMesalamineAdultAgedDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisRemission InductionTreatment OutcomeAdrenal Cortex HormonesAnti-Inflammatory Agents, Non-SteroidalMesalamine45-ASA5 receptor modulatorcorticosteroidetrasimodsphingosine 1-phosphate1ulcerative colitis

Identifiers

PMID39671695
PMCPMC12342761

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.