Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022
Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Up to 5 years of follow-up in the DAYBREAK open-label extension trial.
Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
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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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- 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
- Metabolic dysfunction-associated steatohepatitis (MASH): intersections with type 2 diabetes and insulin resistance.Frontiers in endocrinology · 2026Pooled it
- Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Trial
- Safety and tolerability of conversion to siponimod from other disease-modifying therapies in patients with advancing forms of relapsing MS: Results from the EXCHANGE study.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Trial
- Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis.Inflammatory bowel diseases · 2025Trial
- Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease.Digestive diseases and sciences · 2024Trial
- 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
- Siponimod vs placebo in active secondary progressive multiple sclerosis: a post hoc analysis from the phase 3 EXPAND study.Journal of neurology · 2022Trial
- The Art of Sequencing Disease-Modifying Therapies in Multiple Sclerosis.Neurology(R) neuroimmunology & neuroinflammation · 2026Review
- Therapeutic reactivation of hippocampal progenitors reverse cognition decline in mice with progressive brain demyelination.Stem cell reports · 2026Article
- Elucidating the binding specificity of interactive compounds targeting ATP-binding cassette subfamily G member 2 (ABCG2).Molecular diversity · 2025Article
- Sphingosine-1-Phosphate Receptor Modulators for the Treatment of Ulcerative Colitis: A Narrative Review Focusing on Safety.United European gastroenterology journal · 2025Review
- Choosing initial MS therapy; personal, disease, and medication factors.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Review
- The Relationship Between Autoimmune Disorders and Multiple Sclerosis: Clinical Insights and Therapeutic Approaches.Brain sciences · 2025Article
- Case Report: Asymptomatic macular edema in ozanimod.Frontiers in ophthalmology · 2025Article
- Switch from fingolimod to ozanimod for safety or intolerance reasons.Therapeutic advances in neurological disorders · 2025Article
- Immunity in digestive diseases: new drugs for inflammatory bowel disease treatment-insights from Phase II and III trials.Journal of gastroenterology · 2024Review
- Sphingosine 1-phosphate receptor modulators in multiple sclerosis treatment: A practical review.Annals of clinical and translational neurology · 2024Review
- [Comorbidities in multiple sclerosis and their influence on the choice of treatment].Revista de neurologia · 2024Review
- Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOzanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS.
objectiveTo characterize long-term safety and efficacy of ozanimod.
methodsPatients with relapsing MS who completed a phase 1‒3 ozanimod trial were eligible for an open-label extension study (DAYBREAK) of ozanimod 0.92 mg/d. DAYBREAK began 16 October 2015; cutoff for this interim analysis was 2 February 2021.
resultsThis analysis included 2494 participants with mean 46.8 (SD 11.9; range 0.033‒62.7) months of ozanimod exposure in DAYBREAK. During DAYBREAK, 2143 patients (85.9%) had treatment-emergent adverse events (TEAEs; similar in nature to those in the parent trials), 298 (11.9%) had a serious TEAE, and 75 (3.0%) discontinued treatment due to TEAEs. Serious infections (2.8%), herpes zoster infections (1.7%), confirmed macular edema cases (0.2%), and cardiac TEAEs (2.8%) were infrequent. Adjusted annualized relapse rate was 0.103 (95% confidence interval, 0.086‒0.123). Over 48 months, 71% of patients remained relapse free. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and similar across parent trial treatment subgroups.
conclusionsThis long-term extension of ozanimod trials confirmed a favorable safety/tolerability profile and sustained benefit on clinical and magnetic resonance imaging measures of disease activity.
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