Trial reportJournal of Crohn's & colitis2024
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.
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. Cited by 29 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines on the Use of Small Molecules and IL-23 p19 Inhibitors in Ulcerative Colitis and Crohn's Disease.Journal of gastroenterology and hepatology · 2026Guideline
- 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
- Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid.Inflammatory bowel diseases · 2026Trial
- Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 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 Ozanimod in Ulcerative Colitis: A Real-World Pan-Hellenic Study.Medicina (Kaunas, Lithuania) · 2026Article
- Review
- Review
- Potential for anti‑angiogenic therapy targeting the receptor for advanced glycation end products/VEGF axis in ulcerative colitis (Review).Molecular medicine reports · 2026Review
- Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study.Intestinal research · 2026Article
- Once-Daily Oral Ozanimod for Japanese Patients With Ulcerative Colitis: Results From the Phase 2/3 J-True North Study.Gastro hep advances · 2026Article
- EPS deficiency aggravates intestinal mucosal inflammation and dysbiosis through disrupting macrophage polarization balance in ulcerative colitis.Frontiers in immunology · 2026Article
- Review
- Safety Outcomes in Patients With Ulcerative Colitis Using a Healthcare Administrative Database in the United States.Inflammatory bowel diseases · 2025Article
- Sphingosine-1-Phosphate Receptor Modulators for the Treatment of Ulcerative Colitis: A Narrative Review Focusing on Safety.United European gastroenterology journal · 2025Review
- Understanding the therapeutic toolkit for inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2025Review
- The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis.Journal of clinical medicine · 2025Review
- Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program.Journal of Crohn's & colitis · 2025Article
- Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies.Journal of clinical medicine · 2025Review
- Drug Development in Inflammatory Bowel Diseases: What Is Next?Pharmaceuticals (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 12 institutions in 5 countries.
Funding
Abstract
BACKGROUNDS AND
aimsThis interim analysis from the True North open-label extension [OLE] study examines efficacy and safety of approximately 3 years of continuous ozanimod treatment in patients with moderately to severely active ulcerative colitis.
methodsClinical responders after 52 weeks of ozanimod during the phase 3 True North study, who continued treatment in the OLE, were evaluated. Efficacy, including endoscopic and histological endpoints, was assessed during the OLE for approximately 2 additional years through OLE Week 94, using observed case [OC] and nonresponder imputation [NRI] analyses. Adverse events were monitored from True North baseline through OLE data cutoff and expressed as exposure-adjusted incidence rates.
resultsThis analysis included 131 patients; 54% had achieved corticosteroid-free remission at True North Week 52. In OC analyses, clinical response, clinical remission, and corticosteroid-free remission were achieved by 91.4%, 69.1%, and 67.9% of patients, respectively, at OLE Week 94 [146 weeks of total treatment]. Similarly, endoscopic improvement, histological remission, and mucosal healing were achieved by 73.3%, 67.3%, and 56.3% of patients, respectively, at OLE Week 94. Efficacy rates were lower using NRI analyses, but maintenance of efficacy was demonstrated through OLE Week 94. No new safety signals emerged from this analysis. Serious infections, malignancy, cardiovascular events, and hepatic events occurred infrequently.
conclusionsAmong patients who achieved clinical response after 1 year of ozanimod treatment during True North, a high percentage sustained clinical and mucosal efficacy over 2 additional years in the OLE. No new safety signals were observed with long-term ozanimod use.
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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.