Trial reportJournal of Crohn's & colitis2021
Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study.
Trial report in Journal of Crohn's & colitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02531126 (A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis), which is not on this map. Cited by 62 papers, 1 of them a synthesis 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, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Who cites it
62 citing papers in PubMed, 1 synthesis or guideline pooled it, 105 citations in OpenAlex.
- Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis.Inflammatory bowel diseases · 2026Pooled it
- The Effect of Etrasimod on Fecal Calprotectin and High-sensitivity C-reactive Protein: Results From the ELEVATE UC Clinical Program.Inflammatory bowel diseases · 2025Trial
- Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis.Inflammatory bowel diseases · 2025Trial
- Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension.Journal of Crohn's & colitis · 2024Trial
- Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program.Contemporary clinical trials · 2022Trial
- Efficacy and Safety of Ozanimod in Ulcerative Colitis: A Real-World Pan-Hellenic Study.Medicina (Kaunas, Lithuania) · 2026Article
- Label-free cell phenotypic profiling of sphingosine-1-phosphate receptor 1 and discovery of its agonist from natural products.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Efficacy and safety of dual biologics or combination therapy with JAK inhibitors in refractory inflammatory bowel disease: a retrospective single-center real-world study from China.BMC gastroenterology · 2026Article
- Advances in the Treatment of Ulcerative Colitis-From Conventional Therapies to Targeted Biologics and Small Molecules.International journal of molecular sciences · 2026Review
- Cost calculation model of introducing Upadacitinib and Risankizumab for adult ulcerative colitis and Crohn's disease in the Kingdom of Saudi Arabia.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026Article
- Inflammatory Bowel Disease: Understanding Therapeutic Effects of Distinct Molecular Inhibitors as the Key to Current and Future Advanced Therapeutic Strategies.Biomedicines · 2025Review
- Review
- Sphingosine-1-Phosphate Receptor Modulators for the Treatment of Ulcerative Colitis: A Narrative Review Focusing on Safety.United European gastroenterology journal · 2025Review
- Prescribing Inflammatory Bowel Disease Medications in Chronic Kidney Disease: A Practical Guide.Alimentary pharmacology & therapeutics · 2025Review
- The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis.Journal of clinical medicine · 2025Review
- Drug Development in Inflammatory Bowel Diseases: What Is Next?Pharmaceuticals (Basel, Switzerland) · 2025Review
- Gut bacteria Prevotellaceae related lithocholic acid metabolism promotes colonic inflammation.Journal of translational medicine · 2025Article
- Efficacy and safety of sphingosine-1-phosphate receptor modulators in the management of inflammatory bowel disease: a systematic review and meta-analysis.Gastroenterology and hepatology from bed to bench · 2025Review
- Sphingosine-1-phosphate receptor modulators in ulcerative colitis - a narrative review of current evidence and practical considerations.Drugs in context · 2025Review
- Antibiotic combination therapy for the induction and maintenance of remission in patients with ulcerative colitis.Bioscience of microbiota, food and health · 2025Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 4 countries.
Funding
Abstract
BACKGROUND AND
aimsThis analysis examined the long-term safety and efficacy of ozanimod in patients with moderately to severely active ulcerative colitis [UC] with ≥ 4 years of follow-up in the phase 2 TOUCHSTONE open-label extension [OLE].
methodsPatients receiving placebo or ozanimod HCl 0.5 mg or 1 mg during the double-blind period could enter the OLE [ozanimod HCl 1 mg daily]. Partial Mayo score [pMS] clinical response and remission were assessed through OLE week 200 and summarized descriptively using observed cases [OC] and non-responder imputation [NRI]. Endoscopy was required at OLE week 56 and the end of treatment. Parameters associated with endoscopy were summarized at weeks 56 and 104 [OC], and week 56 [NRI]. C-reactive protein and faecal calprotectin were assessed. Adverse events were monitored throughout the study.
resultsOf 197 patients receiving double-blind treatment, 170 entered the OLE. Discontinuation rates were 28% at year 1 and 15-18% annually through year 4. Partial Mayo measures indicated clinical response and remission rates at OLE week 200 of 93.3% and 82.7%, respectively, using OC and 41% and 37% with the more conservative NRI analysis. At weeks 56 and 104, respectively, histological remission rates were 46.3% and 38.5%, and endoscopic improvement rates were 46.4% and 46.5% [OC]. No new safety signals were identified during ≥ 4 years of follow-up.
conclusionsThere was a high rate of continued study participation and long-term benefit with ozanimod HCl 1 mg daily based on clinical, histological and biomarker measures in patients with moderately to severely active UC in the TOUCHSTONE OLE. [NCT02531126].
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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.