Evidence map›Paper›PMID 38877972›Full record

Trial reportJournal of Crohn's & colitis2024

Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials.

Séverine Vermeire, Bruce E Sands, Laurent Peyrin-Biroulet, Geert R D'Haens, Julian Panés, Andres J Yarur, Douglas C Wolf, Timothy Ritter, Stefan Schreiber, John C Woolcott and 10 more

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

Trial report in Journal of Crohn's & colitis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
  2. Practical guidelines on medical management of adults with moderate-to-severe inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
    Article
  3. Review
  4. Article
  5. Article
  6. Etrasimod in Treatment of Ulcerative Colitis: A Comprehensive Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2025
    Review
  7. Review
  8. Review
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-9942-3019
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Laurent Peyrin-BirouletDepartment of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France.
Geert R D'HaensDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Julian PanésFormerly Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.ORCID 0000-0002-4971-6902
Andres J YarurDivision of Gastroenterology and Hepatology, Inflammatory Bowel Disease Center, Cedars Sinai Medical Center, Los Angeles, CA, USA.
Douglas C WolfAtlanta Gastroenterology Associates, Atlanta, GA, USA.
Timothy RitterDepartment of Research, GI Alliance, Southlake, TX, USA.
Stefan SchreiberDepartment of Internal Medicine, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
John C WoolcottPfizer Inc, Collegeville, PA, USA.
Irene ModestoPfizer Inc, New York, NY, USA.
Michael KeatingPfizer Inc, New York, NY, USA.
Kevin ShanPfizer Inc, New York, NY, USA.
Joseph WuPfizer Inc, Cambridge, MA, USA.
Michael V ChioreanInflammatory Bowel Disease Center, Swedish Medical Center, Seattle, WA, USA.
Filip BaertDepartment of Gastroenterology, AZ Delta, Roeselare, Belgium.
Marla C DubinskySusan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Martina GoetschPfizer AG, Zürich, Switzerland.
Silvio DaneseDivision of Gastroenterology and Digestive Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0001-7341-1351
Brian G FeaganDivision of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.

Funding

Pfizer
6 · The paper itself

Abstract

BACKGROUND AND

aimsEtrasimod 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 subgroup analysis evaluated the efficacy and safety of etrasimod 2 mg once daily vs placebo by prior biologic/Janus kinase inhibitor [bio/JAKi] exposure in ELEVATE UC 52 and ELEVATE UC 12.

methodsPre-defined efficacy endpoints were assessed at Weeks 12 and 52 in ELEVATE UC 52 and Week 12 in ELEVATE UC 12 in bio/JAKi-naïve and -experienced patients, and at Week 12 [pooled] based on prior advanced therapy exposure mechanism.

resultsIn the ELEVATE UC 52 and ELEVATE UC 12 analysis populations, 80/274 [29.2%] and 74/222 [33.3%] patients receiving etrasimod and 42/135 [31.1%] and 38/112 [33.9%] patients receiving placebo, respectively, were bio/JAKi-experienced. In both bio/JAKi-naïve and -experienced patients, a significantly greater proportion receiving etrasimod vs placebo achieved clinical remission [p < 0.05] in ELEVATE UC 52 at Weeks 12 [naïve: 30.9% vs 9.7%; experienced: 17.5% vs 2.4%] and 52 [naïve: 36.6% vs 7.5%; experienced: 21.3% vs 4.8%]; in ELEVATE UC 12, this was observed only for bio/JAKi-naïve patients [naïve: 27.7% vs 16.2%, p = 0.033; experienced: 18.9% vs 13.2%, p = 0.349]. Similar patterns were observed for most efficacy endpoints. Among patients with prior anti-integrin exposure [N = 90], a significantly greater proportion achieved clinical response [54.1% vs 27.6%, p = 0.030], but not clinical remission [9.8% vs 3.4%, p = 0.248], with etrasimod vs placebo.

conclusionsBio/JAKi-naïve and -experienced patients had clinically meaningful induction and maintenance treatment benefits with etrasimod vs placebo. CLINICALTRIALS.GOV: NCT03945188; NCT03996369.

Indexed as

Colitis, UlcerativeJanus Kinase InhibitorsAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedSphingosine 1 Phosphate Receptor ModulatorsTreatment OutcomeJanus Kinase InhibitorsSphingosine 1 Phosphate Receptor Modulatorsadvanced therapiesetrasimodUlcerative colitis

Identifiers

PMID38877972
PMCPMC11532610

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.