SynthesisInflammatory bowel diseases2026
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.
Synthesis in Inflammatory bowel diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
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.
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Who cites it
1 citing paper in PubMed.
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Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
backgroundOzanimod is a once-daily oral selective sphingosine 1-phosphate receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC) or relapsing multiple sclerosis (RMS). Previous analyses in both indications demonstrated favorable long-term safety profiles of ozanimod. Here we report an integrated analysis of the long-term safety of ozanimod in patients with UC or RMS.
methodsData were pooled in patients with UC who received ozanimod in phase 2, phase 3, and open-label extension (OLE) trials and in patients with RMS who received ozanimod in an OLE trial after completing any phase 1-3 parent trial. Safety assessments included treatment-emergent adverse events (TEAEs) and laboratory abnormalities.
resultsOverall, 3652 patients with UC or RMS had 16 144 patient-years (PY) of ozanimod exposure over 10 years of follow-up. The most common TEAEs were nasopharyngitis, headache, and coronavirus disease 2019. Rates of TEAEs leading to treatment discontinuation (1.4/100 PY) and TEAEs of special interest, including serious infections (1.0/100 PY), herpes zoster (0.5/100 PY), malignancies (0.4/100 PY), bradycardia (0.1/100 PY), sinus bradycardia (0.04/100 PY), complete atrioventricular block (0.01/100 PY), and macular edema (0.1/100 PY), were low. No serious hepatic events or Hy's law cases occurred. Absolute lymphocyte count of < 200 cells/µL was not temporally associated with serious or opportunistic infections.
conclusionsLong-term exposure to ozanimod is well tolerated in patients with moderate to severe UC or RMS, confirming the previously established safety profile of ozanimod. CLINICAL TRIAL REGISTRY: NCT01647516; NCT02435992; NCT02576717.
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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.