Ozanimod (Zeposia) offers an oral, once-daily option for adults with moderate to severe ulcerative colitis in the USA, targeting inflammation for lasting remission.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers in the lining of the colon and rectum. For individuals in the USA living with moderately to severely active UC, the condition can significantly impact quality of life, leading to debilitating symptoms such as abdominal pain, frequent and urgent bowel movements, bloody diarrhea, and fatigue.

While various treatments have emerged over the years, the introduction of novel oral therapies like Ozanimod (marketed as Zeposia by Bristol Myers Squibb) represents a significant advancement, offering a new pathway to manage this challenging disease.  

Understanding Ozanimod: A Sphingosine 1-Phosphate (S1P) Receptor Modulator

Ozanimod is a type of medication known as a sphingosine 1-phosphate (S1P) receptor modulator. It is the first oral S1P receptor modulator approved in the USA for the treatment of moderately to severely active ulcerative colitis in adults. Unlike traditional immunosuppressants or biologic therapies that target specific cytokines or immune cells more broadly, Ozanimod works by specifically binding to S1P1 and S1P5 receptors on lymphocytes (a type of white blood cell).

Here's how it works in the context of UC: The inflammation in ulcerative colitis is driven by immune cells, particularly lymphocytes, migrating from the bloodstream into the lining of the gut. S1P receptors play a crucial role in controlling the egress (exit) of lymphocytes from lymph nodes into the general circulation. By modulating these S1P receptors, Ozanimod effectively traps a subset of lymphocytes within the lymph nodes. This action reduces the number of circulating lymphocytes available to travel to the inflamed colon, thereby decreasing inflammation in the intestinal lining and alleviating UC symptoms.

Indications and Administration in the USA

In the USA, Zeposia is specifically approved for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to prior treatments. It is also approved for relapsing forms of multiple sclerosis (MS).  

A key advantage of Ozanimod is its oral, once-daily administration. This offers a convenient alternative to injectable or infused biologic therapies, which can be a significant preference for many patients. Treatment begins with a 7-day starter pack, where the dose is gradually increased to minimize the risk of a temporary decrease in heart rate (bradycardia) that can occur when initiating S1P modulators. After the initial titration, a maintenance dose is taken once daily.

Efficacy of Ozanimod in Ulcerative Colitis

Clinical trials, most notably the TRUE NORTH study, have demonstrated the efficacy of Ozanimod in both inducing and maintaining remission in adults with moderately to severely active UC. Key findings include:

• Clinical Remission: A significant proportion of patients achieved clinical remission (defined by symptom reduction, such as decreased rectal bleeding and stool frequency, and endoscopic improvement) by Week 10 (induction phase) and sustained this remission through Week 52 (maintenance phase).
• Endoscopic Improvement: Patients treated with Ozanimod showed significant endoscopic improvement, indicating healing of the colon lining, which is a critical goal in UC management.
• Mucosal Healing: Beyond surface-level improvement, Ozanimod has also demonstrated the ability to promote mucosal healing, suggesting a deeper resolution of inflammation.
• Corticosteroid-Free Remission: For many patients, Ozanimod allowed them to achieve remission without the need for corticosteroids, which are often used for acute flares but carry significant long-term side effects.

Ozanimod has shown effectiveness in patients who were new to advanced therapies as well as those who had previously failed other advanced treatments, including biologics.

Important Considerations and Potential Side Effects in the USA

Like all powerful medications, Ozanimod has potential side effects and requires careful monitoring:

• Infections: Because Ozanimod reduces the number of circulating lymphocytes, it can increase the risk of serious infections. Before starting treatment, patients are typically screened for infections (including tuberculosis and hepatitis viruses) and should be up-to-date on vaccinations. Live vaccines should generally be avoided during and for a period after treatment.
• Bradycardia and Heart Effects: The initial dose titration is crucial because Ozanimod can cause a temporary slowing of the heart rate, particularly during the first few days of treatment. Patients typically undergo an electrocardiogram (ECG) before starting therapy, and those with certain pre-existing heart conditions (e.g., recent heart attack or stroke, certain types of heart block) may be contraindicated or require specific monitoring.
• Liver Enzyme Elevations: Elevated liver enzymes can occur, and liver function tests are typically monitored before and during treatment.
• Blood Pressure Increase: Some patients may experience an increase in blood pressure.
• Macular Edema: A rare but serious eye condition involving swelling in the retina can occur. Patients with a history of diabetes or uveitis may be at higher risk and require baseline and periodic eye exams.
• Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain infection that has been associated with S1P modulators, though extremely uncommon.
• Skin Cancer Risk: An increased risk of skin cancer (e.g., basal cell carcinoma, melanoma) has been noted with S1P modulators, emphasizing the importance of regular skin exams and sun protection.

Place in UC Treatment Strategy in the USA

Ozanimod offers a valuable oral treatment option for adults with moderately to severely active UC. It can be particularly attractive for patients who prefer oral medication over injections or infusions, or for those who have not responded adequately to conventional therapies or other advanced treatments. The decision to use Ozanimod is made by a gastroenterologist or IBD specialist, taking into account the patient's disease severity, prior treatment history, comorbidities, and individual risk factors. With its distinct mechanism of action and proven efficacy, Ozanimod has become an important part of the expanding therapeutic armamentarium for ulcerative colitis in the USA.

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