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Ocrelizumab – Uses, Mechanism & MS Treatment
Ocrelizumab is a monoclonal antibody used to treat multiple sclerosis. It targets CD20-positive B cells, reducing inflammation and nerve damage in the central nervous system.
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Ocrelizumab is a monoclonal antibody used to treat multiple sclerosis. It targets CD20-positive B cells, reducing inflammation and nerve damage in the central nervous system.
What is Ocrelizumab?
Ocrelizumab is a humanized monoclonal antibody used in the treatment of multiple sclerosis (MS). It was approved by the European Medicines Agency (EMA) in 2018 and by the U.S. Food and Drug Administration (FDA) in 2017. It belongs to the group of disease-modifying therapies (DMTs) and is the first approved treatment specifically for primary progressive MS (PPMS). It is also used for relapsing-remitting MS (RRMS).
Indication
Ocrelizumab is approved for the treatment of:
- Relapsing-remitting multiple sclerosis (RRMS): in adults with active disease defined by clinical or imaging findings
- Primary progressive multiple sclerosis (PPMS): in adults with early disease and evidence of inflammatory activity
Mechanism of Action
Ocrelizumab selectively binds to the cell surface protein CD20, which is expressed on certain B lymphocytes (B cells). Upon binding, it destroys CD20-positive B cells through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Since B cells play an important role in the inflammatory processes that damage myelin and nerve fibers in MS, their depletion leads to a reduction in disease activity.
Compared to earlier anti-CD20 therapies such as rituximab, ocrelizumab is a fully humanized antibody, which lowers the risk of immunogenic reactions in the patient.
Dosage and Administration
Ocrelizumab is administered as an intravenous (IV) infusion:
- Initial dose: two infusions of 300 mg each, given 14 days apart
- Maintenance dose: 600 mg as a single infusion every 6 months
Infusions are administered under medical supervision in an appropriate clinical setting. Pre-medication with corticosteroids, antihistamines, and antipyretics is recommended before each infusion to reduce the risk of infusion-related reactions.
Side Effects
Like all medications, ocrelizumab may cause side effects. The most common include:
- Infusion-related reactions: skin rash, itching, nausea, dizziness, flushing (very common)
- Upper respiratory tract infections: cold-like symptoms, bronchitis
- Urinary tract infections
- Decreased immunoglobulin levels: long-term reduction of antibody levels in the blood
- Increased risk of infections: particularly respiratory and herpes infections
Less commonly but more seriously, opportunistic infections may occur. A potentially increased risk of certain cancers (particularly breast cancer) has also been observed during clinical monitoring, although causality has not been fully established.
Contraindications and Precautions
Ocrelizumab should not be used in patients with:
- Active severe infections
- Known hypersensitivity to the active substance or excipients
- Severely compromised immune function
Before starting treatment, vaccinations should be brought up to date, as live vaccines are contraindicated during therapy. Ocrelizumab is not recommended during pregnancy or breastfeeding, and reliable contraception is advised for women of childbearing potential.
Clinical Efficacy
The efficacy of ocrelizumab has been demonstrated in several large clinical trials:
- OPERA I and OPERA II: In RRMS patients, ocrelizumab reduced the annualized relapse rate by approximately 46–47 % compared to interferon beta-1a.
- ORATORIO: In PPMS patients, ocrelizumab significantly reduced the risk of confirmed disability progression compared to placebo.
These pivotal trials have established ocrelizumab as one of the most effective available therapies for multiple sclerosis.
References
- European Medicines Agency (EMA): Ocrevus (ocrelizumab) – Summary of Product Characteristics, 2018. Available at: https://www.ema.europa.eu
- Hauser S.L. et al.: Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. New England Journal of Medicine, 2017; 376(3):221–234.
- Montalban X. et al.: Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. New England Journal of Medicine, 2017; 376(3):209–220.
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