From the Guidelines
Zeposia (ozanimod) is an oral medication approved for treating relapsing forms of multiple sclerosis and moderate to severe ulcerative colitis, with a recommended titration schedule starting with 0.23 mg once daily for days 1-4, increasing to 0.46 mg for days 5-7, and then maintaining at 0.92 mg once daily thereafter, as demonstrated in the True North study 1.
Key Points
- Zeposia belongs to a class of drugs called sphingosine 1-phosphate (S1P) receptor modulators, which work by preventing certain immune cells from leaving lymph nodes, thereby reducing inflammation in the central nervous system and intestines.
- The medication has been shown to be efficacious in both biologic-naive and biologic-exposed patients with ulcerative colitis, with significant improvements in clinical remission, response, and mucosal healing compared to placebo 1.
- Patients should be aware that Zeposia requires several pre-treatment assessments, including blood tests, ECG, and eye examination, due to potential side effects such as upper respiratory infections, elevated liver enzymes, low blood pressure, and back pain.
- Common side effects include upper respiratory infections, elevated liver enzymes, low blood pressure, and back pain, and the medication should not be used during pregnancy and is contraindicated in patients with certain cardiac conditions, untreated severe sleep apnea, or those taking MAO inhibitors.
- The medication works differently from traditional immunosuppressants by selectively targeting specific immune pathways rather than broadly suppressing immune function.
Monitoring and Safety
- Monitoring during ozanimod treatment may include blood pressure, infections, lymphocyte count, changes in vision or symptoms of macular edema, liver function, and respiratory function 1.
- Ozanimod treatment should be interrupted or discontinued with certain infections, such as serious infection, progressive multifocal leukoencephalopathy, cryptococcal meningitis, and posterior reversible encephalopathy 1.
- Post hoc analyses of clinical trial data have shown that most ozanimod-treated patients with UC or MS who contracted COVID-19 had non-serious infections, recovered, and did not discontinue ozanimod treatment 1.
Placement in Treatment Armamentarium
- Ozanimod could be positioned before biologics, given the greater effect size of ozanimod in biologic-naive than biologic-exposed patients during induction therapy, and may be used as a first-line therapy after aminosalicylate, steroid, and/or thiopurine failure 1.
- Ozanimod could also be positioned after biologics in patients who fail or lose response to biologics, or in patients in remission with biologic therapy but who are inconvenienced by injections or worried about safety.
From the FDA Drug Label
What is ZEPOSIA? ZEPOSIA is a prescription medicine used to treat: • adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. • adults with moderately to severely active ulcerative colitis
Zeposia (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis in adults. 2
From the Research
What is Zeposia (Ozanimod)
- Zeposia, also known as ozanimod, is a novel, orally administered sphingosine 1-phosphate (S1P) receptor modulator 3.
- It is approved for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults 3, 4.
- Ozanimod is also approved for the treatment of adults with moderately to severely active ulcerative colitis 5.
Mechanism of Action
- Ozanimod works by selectively modulating the S1P1 and S1P5 receptor subtypes, which helps to reduce disease activity in multiple sclerosis and ulcerative colitis 4, 5.
Efficacy and Safety
- Clinical trials have demonstrated the efficacy and safety of ozanimod in reducing annualized relapse rates, MRI lesion activity, and disability progression in multiple sclerosis 3, 4, 6.
- Ozanimod has also been shown to be effective in inducing and maintaining clinical remission in ulcerative colitis, with a favorable safety profile 5, 7.
- Common adverse reactions associated with ozanimod include upper respiratory tract infection, hepatic transaminase elevation, and nasopharyngitis 4, 6.