What Is Ocrevus, and Why Does It Matter?
Ocrevus (ocrelizumab) is a prescription medicine given via intravenous (IV) infusion to treat multiple sclerosis (MS). The FDA has extended its approval to include relapsing-remitting MS (RRMS) in children aged 10 years or older who weigh at least 55 pounds (25 kilograms).
MS is a long-term autoimmune disease in which the immune system mistakenly attacks the protective covering of nerve fibers (myelin sheath) in the brain and spinal cord, leading to inflammation, loss of myelin sheath (demyelination), and progressive damage to the nerves.
MS affects more than 2.9 million people worldwide, including an estimated 5,000 to 10,000 children and teenagers in the U.S.
Most patients (about 85%) are initially diagnosed with RRMS, a form of MS characterized by symptoms that come and go in attacks (relapses) and gradually worsening disability. About 15% of patients have primary progressive MS, in which symptoms steadily get worse without clear relapses or recovery periods (remissions). All types of MS gradually worsen over time, so a key goal of treatment is to slow or stop this progression as early as possible.
Ocrevus is a lab-made humanized monoclonal antibody that targets specific immune cells called B cells, which mistakenly attack the nervous system in MS. Although the exact way by which Ocrevus works isn’t fully understood, it’s believed to attach to the surface of B cells. This helps the immune system destroy these cells, reducing the harmful immune activity that causes nerve damage.
This approval matters because Ocrevus was previously only approved for use in adults with RRMS. With this expanded approval, it is now the only B cell-targeted therapy approved for children aged 10 years or older with this condition.
Why Was It Approved?
The FDA’s approval was based on data from a clinical study in children and adolescents with RRMS, which showed that Ocrevus was as safe and effective as fingolimod, the previous FDA-approved treatment for this age group.
In the clinical study, Ocrevus was found to be as effective as fingolimod in reducing annual relapses. It also performed better on brain scans, reducing new or growing brain lesions by 48% and gadolinium‑enhancing lesions by 87% compared with fingolimod.
The overall safety profile in children and teens looked similar to that observed in adults. Common side effects included infusion reactions and infections, including respiratory infections, skin infections, and herpes. In some cases, these infections can be serious or life-threatening.
In rare cases, Ocrevus can cause a brain infection called progressive multifocal leukoencephalopathy, which leads to worsening neurologic symptoms over days to weeks and requires urgent medical attention. Ocrevus may increase the risk for certain cancers, inflammation of the colon (colitis), and liver damage in some people.
What Do I Need to Know?
You or your child will receive Ocrevus via IV infusion in a health care setting under medical supervision. Health care providers will monitor you or your child during the infusion and for at least one hour after it ends. Before each dose, they will give a corticosteroid and an antihistamine to help lower the chance and severity of infusion reactions. Typically, the first full dose will be split into two separate infusions given two weeks apart, followed by one infusion every six months.
Inform your health care provider about all medicines, vitamins, and supplements that you or your child is taking to avoid possible interactions. The risk for infections may be higher if you are also taking other immune-suppressing medicines. Your health care provider may perform blood tests to monitor certain antibody levels during the treatment.
Before starting Ocrevus, tell your health care provider if you have any liver problems, a history of inflammatory bowel disease or colitis, or have had recent vaccinations or are scheduled to receive any vaccinations. It is important to inform your health care team if you’ve ever had hepatitis B as Ocrevus can reactivate it, leading to serious liver complications. Your health care provider may perform certain blood tests to check your liver function during therapy.
It is advisable to get all age-appropriate vaccines before starting treatment. You or your child should not receive live or live-attenuated vaccines during treatment or until your health care provider says that your immune system has recovered. If you are planning to get the seasonal flu shot while being treated with Ocrevus, discuss this with your health care provider first.
It is not known whether Ocrevus may harm a fetus or pass into breast milk. If you can become pregnant, use effective birth control during treatment and for six months after your last infusion.
Contact your health care provider at once if you or your child develops an infection, vision changes, severe headache, confusion, weakness on one side of the body, difficulty maintaining balance, trouble thinking, diarrhea, severe abdominal pain, black or bloody stools, dark urine, or yellowing of the skin or the white part of the eyes. These could be signs of serious side effects.