Ozanimod Dosing Regimen for Moderate to Severe Active Ulcerative Colitis
Ozanimod requires a 7-day dose titration regimen followed by maintenance dosing at 0.92 mg once daily, regardless of whether it is being used for induction or maintenance therapy. 1
Dosing Schedule
Initial Titration (Days 1-7)
- A mandatory 7-day dose titration is required when initiating ozanimod, whether starting as induction therapy or transitioning for maintenance after another advanced therapy 1
- This titration regimen is critical for minimizing cardiac effects, particularly bradycardia and atrioventricular conduction delays 2
Maintenance Dosing
- After completing the 7-day titration, continue with ozanimod 0.92 mg once daily for both induction and maintenance phases 1, 2
- The same 0.92 mg daily dose is used throughout treatment without dose adjustments based on disease phase 1, 2
Treatment Duration and Response Timeline
Induction Phase
- Clinical efficacy is assessed at Week 10 following initiation 2, 3
- Clinical remission rates at Week 10 were 18% with ozanimod versus 6% with placebo in the True North trial 2
- Biologic-naive patients demonstrate superior response rates (23% clinical remission) compared to those with prior biologic exposure (17.2% with 1 prior biologic, 3.7% with 2+ prior biologics) 4
Maintenance Phase
- Patients who respond to induction continue the same 0.92 mg daily dose through Week 52 2, 4
- Maintenance therapy shows more consistent response rates across biologic exposure groups (61% biologic-naive, 60% with 1 prior biologic, 55% with 2+ prior biologics) 4
Clinical Positioning
Optimal Patient Selection
- Ozanimod is best positioned before biologics given the greater effect size in biologic-naive versus biologic-exposed patients during induction 1
- Typical candidates include patients requiring more than one course of steroids per year after starting aminosalicylates or thiopurines 1
- Can be used in any patient who fails or loses response to aminosalicylates, regardless of steroid requirement 1
Alternative Positioning Scenarios
- After biologic failure or loss of response in patients who have failed biologics 1
- For maintenance after induction with other advanced therapies including ciclosporin, biologics, or JAK inhibitors 1
- In patients achieving remission with biologics but concerned about injection inconvenience or safety 1
Critical Monitoring Requirements
Baseline Assessments (Before Initiation)
- Complete blood count 1
- Electrocardiogram to screen for cardiac conduction abnormalities 1
- Liver enzymes 1
- Ophthalmic examination of fundus and macula if history of diabetes, uveitis, or macular edema exists 1
- VZV antibody testing in patients without chickenpox history or confirmed vaccination 1
During Treatment Monitoring
- Blood pressure: Monitor for 3 months after initiation, then every 6 months 1
- Lymphocyte count: Assess every 3 months (expect 49% reduction from baseline with 0.92 mg dose) 1, 3
- Liver function: Assess at 1 month, then every 3 months 1
- Infection surveillance: Monitor during treatment and up to 3 months after discontinuation 1
- Respiratory function: Assess if clinically indicated 1
Important Safety Considerations
Contraindications and Precautions
- Discontinue other immunosuppressive therapies before starting ozanimod 1
- Avoid drugs that slow heart rate or AV conduction 1
- Do not use during active infection 1
- Avoid in pregnancy 1, 5
- Contraindicated in clinically significant cardiovascular disease, type II second-degree or third-degree AV blocks 5
Comparative Safety Profile
- Ozanimod discontinuation due to adverse events was only 1-4% in the True North trial, compared to up to one-third with thiopurines 1
- No black-box warnings unlike some TNF inhibitors and JAK inhibitors 1
- No evidence of immunogenicity observed in clinical trials 1
- Risk of serious infections and malignancies was low in UC clinical trials 1
Real-World Effectiveness Considerations
- Patients with prior biologic exposure may require additional time to respond to ozanimod therapy 4
- Real-world data shows week 10 clinical response rates of 58% and remission rates of 53% in treatment-refractory patients, though long-term maintenance effectiveness was more modest (25% at week 52) 6
- Greater lymphocyte count reduction (>75%) correlates with numerically higher response rates (80% vs 54% clinical response) 6