Ocrevus for Multiple Sclerosis Treatment

The first drug approved for relapsing and primary-progressive MS

Nurse injecting medicine into IV bag
Ocrelizumab: An MS Drug in the Pipeline. Echo/Getty Images

Ocrevus (ocrelizumab) is the first primary progressive MS (PPMS) drug to be approved by the U.S. Food and Drug Administration (FDA). It's also approved for relapsing types of MS (RMS). Ocrevus is a disease-modifying therapy, which means it's meant to slow the progression of the disease, not to treat the symptoms.

PPMS accounts for between 10 percent and 15 percent of MS cases. Ocrevus' 2017 approval was a major milestone for people with this form of the disease. For people with RMS, which is the vast majority of those living with a form of this disease, each new drug approval means new hope for disease management.

How It Works

As a type of immunosuppressant called a humanized monoclonal antibody, the drug selectively binds to a molecule called CD20, which lies on the surface of B cells (a type of immune system cell). In doing so, the drug reduces the number of B cells in your bloodstream.

B cells play a role in myelin sheath loss and damage in multiple sclerosis, which is caused by an autoimmune reaction (the immune system mistakenly attacks parts of the body). Lowering the number of these particular B cells has been shown to reduce MS disease activity.

Ocrevus only targets B cells, though, so other immune-system cells (such as T cells) remain intact, helping to maintain your immune function.

Effectiveness

Prior to its approval, Ocrevus was examined in three phase-III trials for treating both relapsing MS and primary progressive MS.

In two trials—one published in 2016 and the other in 2017—Ocrevus was compared to Rebif (interferon beta-1a) for treating people with relapsing-remitting MS. Since there is currently no FDA-approved medication for primary-progressive MS, Ocrevus was compared to placebo in that trial.

Ocrevus fared well. The RMS trials involved more than 1,600 participants who were followed for nearly two years. Compared to Rebif, Ocrevus demonstrated:

In the PPMS trial, more than 700 participants were treated with either Ocrevus or a placebo for at least 120 weeks (about 2.25 years). Researchers noted the Ocrevus group:

  • Had a reduction in confirmed disability progression of 24 percent at 12 weeks and 25 percent at 24 weeks
  • Decreased the time it took to walk 25 feet by nearly 30 percent
  • Had the total volume of T2-hyperintense brain lesions drop by 3.4 percent, as opposed to an increase of 7.4 percent in the control group

A 2018 review of B cell therapies for MS posed several questions for future research based on Ocrevus' high effectiveness, including:

  • Could secondary progression be prevented altogether if anti-CD20 therapy were given at disease onset?
  • Could more selective B cell therapies target only the undesirable CD20 cells as opposed to all of them?

These questions show just how promising this type of treatment appears.

Administration

Ocrevus is given via infusion, meaning you go to an infusion center or doctor's office, have a needle inserted, and receive the drug intravenously (into your veins).

The first dose of Ocrevus is given in two infusions 14 days apart. After that, you'll get a single infusion every six months. The dosage is 300 milligrams (mg) for each of the first two, and 600 mg thereafter.

The initial treatments generally take at least two and a half hours, and subsequent ones will be more than three hours. Doctors are advised to monitor you for at least an hour after the infusion as well, so they can watch for any infusion-related side effects.

Side Effects

It takes time to establish the full safety profile for any drug. However, a review of studies on Ocrevus published in 2018 concluded that the real-world safety profile appeared to be remaining consistent with what was observed in clinical trials, meaning there haven't been any unexpected problems cropping up.

Negative side effects seen in the two RMS trials included:

  • Infusion-related reactions such as rash, flushing, or itchiness
  • Serious infections in 1.3 percent of the Ocrevus group (compared to 2.9 percent in the Rebif group)
  • New, abnormal tissue growths (neoplasms) in 0.5 percent of Ocrevus user, which is slightly higher than the 0.2 percent seen in Rebif users

In the PPMS trial, side effects included:

  • Infusion-relation reactions (rash, itching, flushing, throat irritation), which were more common after the first infusion
  • Upper respiratory tract infections
  • Oral herpes infections
  • Serious infections in 6.2 percent of the Ocrevus group (only slightly higher than 5.9 percent in the placebo group)
  • Higher rate of neoplasms, such as breast and skin cancer, in the Ocrevus group, which warrants further investigation into why

Thus far, Ocrevus has not been linked to any cases of progressive multifocal leukoencephalopathy (PML), which is a risk of MS drugs in the same class. However, it's too early to say whether PML is or isn't a risk with this medication.

While side effects stemming from the infusion are common, they're rarely serious. Also, the risk of having a reaction gets lower with each treatment.

Considerations and Contraindications

If you've been infected with the hepatitis B virus, you shouldn't go on Ocrevus unless a liver specialist has approved it for you.

In trials in pregnant animals, Ocrevus was linked to serious side effects, including fetal death. The drug hasn't been tested in human pregnancies. Women of childbearing age are advised to use contraception while on this drug. If you want to become pregnant, your doctor may advise you to be off of the drug for several months before trying to conceive.

Ocrevus does pass into breast milk, according to data from animal studies. Talk to your doctor about the risks to your baby versus the benefits to you.

Cost

The cost of Ocrevus is $65,000 per year, or about $5,400 a month. Though expensive, that's about 20 percent below the average price for an MS drug.

If your insurance doesn't cover it, or you are left paying a substantial amount, there are resources that may help. To see if you qualify for an assistance program, contact the manufacturer, Genentech, at 1-866-422-2377 or visit their website.

A Word From Verywell

No matter how well a drug may work for some people, it's not guaranteed to work for everyone. Choosing the right MS treatment is a delicate and individualized process. Working closely with your doctor, doing your own research, and paying close attention to how new drugs affect you can help you find the best treatment regimen.

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