Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies
Bruce E Sands1, Geert D'Haens2, Remo Panaccione3
1Icahn School of Medicine at Mount Sinai, New York, New York.
Background & Aims:
The pivotal phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod in patients with moderately to severely active ulcerative colitis. This analysis assessed ozanimod during TN and the ongoing open-label extension (OLE) in patients with active disease who were naive to advanced therapies (ATs).
Methods:
TN was a randomized, double-blind, placebo-controlled trial consisting of 10-week induction period and 42-week maintenance period. Eligible patients could enter the OLE. Symptomatic efficacy was evaluated from induction through the OLE. Clinical, endoscopic, and mucosal outcomes were evaluated at the end of induction (Week [W] 10) and maintenance (W52) and at predefined OLE timepoints (OLE W46 and W94). Safety during TN was reported.
Results:
This analysis included 616 AT-naive patients. Numerically greater proportions of patients receiving ozanimod than placebo achieved symptomatic response (39% vs 29%, 95% confidence interval, -0.1 to 18.8) by W2, with significant differences (56% vs 39%, 95% confidence interval, 6.3-26.3) achieved by W4. Patients receiving ozanimod showed significant improvements across efficacy outcomes versus placebo at W10 and W52 (P < .05, all endpoints). In patients on continuous ozanimod who entered the OLE in clinical response at W52, 91% maintained clinical response through OLE W94, and 74% achieved endoscopic improvement and 57% achieved mucosal healing at OLE W94. In ozanimod-treated patients without clinical response by W10 who received extended induction in the OLE, 62% achieved symptomatic response by OLE W10. Safety outcomes in AT-naive patients were consistent with the total TN population.
Conclusions:
Ozanimod is an effective, durable, and well-tolerated oral therapy for AT-naive ulcerative colitis patients.
Clinicaltrials:
gov, numbers NCT02435992 and NCT02531126.
Insights
Ozanimod offers an effective and well-tolerated oral treatment for ulcerative colitis patients naive to advanced therapies. This study in the True North trial showed durable efficacy and safety through maintenance and extension periods.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
- Advanced therapies (ATs) are used for moderate to severe UC.
- Ozanimod is an oral sphingosine 1-phosphate receptor modulator.
Purpose of the Study:
- To assess the efficacy and safety of ozanimod in AT-naive patients with moderately to severely active UC.
- To evaluate ozanimod's long-term effects during the True North (TN) study and its open-label extension (OLE).
Main Methods:
- The TN study was a randomized, double-blind, placebo-controlled trial with induction and maintenance periods.
- Patients received ozanimod or placebo, with eligible patients entering an OLE.
- Efficacy outcomes included symptomatic, clinical, endoscopic, and mucosal healing assessments.
Main Results:
- Ozanimod showed significantly greater symptomatic response by Week 4 compared to placebo (56% vs 39%).
- Patients on continuous ozanimod maintained clinical response (91%) and showed endoscopic improvement (74%) and mucosal healing (57%) through OLE Week 94.
- Safety profiles were consistent with the overall TN population.
Conclusions:
- Ozanimod demonstrates durable efficacy and a well-tolerated safety profile in AT-naive UC patients.
- Ozanimod provides an effective oral treatment option for this patient population.
More Related Videos
09:01Non-invasive Assessment of the Efficacy of New Therapeutics for Intestinal Pathologies Using Serial Endoscopic Imaging of Live Mice
Published on: March 10, 2015
07:05Fluorescence-mediated Tomography for the Detection and Quantification of Macrophage-related Murine Intestinal Inflammation
Published on: December 15, 2017
Related Concept Videos
01:29Drugs for Treatment of Ulcerative Colitis in IBD
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:29Inflammatory Bowel Disease IV: Pharmacological Management
Pharmacologic...
01:21Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
01:27Inflammatory Bowel Disease I: Ulcerative Colitis
Inflammatory bowel disease, or IBD, encompasses a group of disorders characterized by chronic inflammation or ulceration of the gastrointestinal tract.
Risk Factors
The exact cause of IBD remains unclear, although it is believed to be due to a mix of genetic, environmental, microbial, and immune factors. Genetic factors are significant in determining susceptibility to IBD, with family history being a critical risk factor. Individuals with a first-degree relative who has IBD are at...