Trial reportJournal of Crohn's & colitis2024
Efficacy and Safety of Etrasimod in Patients with Moderately to Severely Active Isolated Proctitis: Results From the Phase 3 ELEVATE UC Clinical Programme.
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 27 papers, 2 of them syntheses that pooled 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.
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.
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
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
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis.Alimentary pharmacology & therapeutics · 2023Pooled it
- Bowel urgency in inflammatory bowel disease: A concept analysis.Inflammatory bowel diseases · 2026Review
- Long-Term Comparative Outcomes of TNF-α Antagonists vs. Vedolizumab as First-Line Biologic Therapy for Refractory Ulcerative Proctitis: A Propensity-Matched Study.Biomedicines · 2026Article
- Combined bowel urgency, clinical outcomes, and quality of life improvement in mirikizumab-treated ulcerative colitis: a step toward comprehensive disease management.Crohn's & colitis 360 · 2026Article
- Management of Patients with Ulcerative Proctitis: A Global Survey.Digestive diseases and sciences · 2026Article
- Cost-Effectiveness Analysis of Etrasimod Compared With Biologic Therapies for the Treatment of Patients with Moderately-to-Severely Active Ulcerative Colitis in Spain.PharmacoEconomics - open · 2026Article
- Clinical characteristics and treatment pathways of ulcerative colitis patients with isolated proctitis in Europe and the United States.Therapeutic advances in gastroenterology · 2026Article
- Sphingosine-1-Phosphate (S1P) Receptor Modulators for the Treatment of Inflammatory Bowel Disease (IBD): Mechanisms, Clinical Evidence, and Practical Insights.Biomedicines · 2025Review
- Safety evaluation of etrasimod for ulcerative colitis based on the FAERS database.Scientific reports · 2025Article
- Review
- Sphingosine-1-Phosphate Receptor Modulators for the Treatment of Ulcerative Colitis: A Narrative Review Focusing on Safety.United European gastroenterology journal · 2025Review
- Etrasimod in Treatment of Ulcerative Colitis: A Comprehensive Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2025Review
- The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis.Journal of clinical medicine · 2025Review
- Evolution of Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials: A Clinical Trial Databank Analysis.United European gastroenterology journal · 2025Article
- New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review.Healthcare (Basel, Switzerland) · 2025Review
- Management of Patients With Refractory Ulcerative Proctitis.Gastroenterology & hepatology · 2025Article
- Progression of Disease When Mesalamine Fails.Gastroenterology & hepatology · 2025Article
- [Position paper of the Society for Paediatric Gastroenterology and Nutrition (GPGE) on the off-label use of biologics and signal inhibitors in children and adolescents with IBD that have already been approved for adults].Zeitschrift fur Gastroenterologie · 2025Article
- Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies.Journal of clinical medicine · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
19 authors at 14 institutions in 11 countries.
Funding
Abstract
BACKGROUND AND
aimsPivotal trials in ulcerative colitis have historically excluded patients with isolated proctitis. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis. This post hoc analysis assessed efficacy and safety of etrasimod 2 mg once daily in patients with isolated proctitis (centrally read) from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.
methodsPatients, including those with isolated proctitis (<10 cm rectal involvement) who met all other inclusion criteria in ELEVATE UC 52 and ELEVATE UC 12, were randomised 2:1 to receive etrasimod or placebo. Primary, secondary and other identified efficacy endpoints and safety were assessed.
resultsWe analysed data from 64 and 723 patients at Week 12 (both trials pooled), and 36 and 397 patients at Week 52 (ELEVATE UC 52 only) with isolated proctitis and more extensive colitis (≥10 cm rectal involvement), respectively. Patients with isolated proctitis receiving etrasimod demonstrated significant improvements versus placebo, including clinical remission rates at Weeks 12 (42.9% vs 13.6%) and 52 (44.4% vs 11.1%), endoscopic improvement (52.4% vs 22.7%) at Week 12 and bowel urgency numerical rating scale score at Week 12 (all p < 0.01). Generally similar trends were observed in patients with more extensive colitis. Safety was consistent across subgroups, with no new findings.
conclusionsEtrasimod demonstrated significant improvements versus placebo in patients with isolated proctitis, and those with more extensive disease, in most efficacy endpoints at Week 12 and 52. Clinicaltrials.gov: NCT03945188; NCT03996369.
Indexed as
Identifiers
What OpenQuestion holds
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.