Ocrelizumab

Ocrelizumab can slow progression of MS, according to the results of its phase 3 trials.

It is the first treatment that can slow the advancement of primary progressive MS. It can also treat relapsing MS.

>> Read about ocrelizumab's phase 3 trial

What is ocrelizumab?

Ocrelizumab is an intravenous infusion treatment that has been developed by Roche.

In March 2017 ocrelizumab was approved by the US Food and Drug Administration (FDA) as a treatment for both relapsing and primary progressive MS.

It is being reviewed the European Medicines Agency (EMA), and a decision is expected in autumn 2017.

Current phase of trial: Under review by EMA

Type of MS: primary progressive and relapsing MS

How does ocrelizumab work?

Ocrelizumab works by targeting a type of immune cell (called a B cell). This helps to reduce the immune response by stopping these cells from attacking and damaging myelin.

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How is ocrelizumab taken?

Ocrelizumab is taken as an intravenous infusion every 6 months.

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Latest research

Relapsing MS

Two phase 3 trials (OPERA I and OPERA II) have shown that ocrelizumab reduces annual relapse rates by around 46% compared with beta interferon after two years. The treatment also reduce the progression of clinical disability by 40%, as measured by the Expanded Disability Status Scale (EDSS).

The trials involved over 1,600 people with relapsing MS. The trial also found that around 50% of people taking ocrelizumab saw no evidence of disease activity (NEDA) in both OPERA I and OPERA II. This was compared with 25-30% of people taking beta interferon.

NEDA is defined as no relapses, no confirmed disability progression as measured by EDSS, and no new or enlarging lesions.

Results were published in December 2016.

Primary progressive MS

A phase 3 trial (ORATORIO) began in 2011 to test ocrelizumab against placebo in 732 people with primary progressive MS. This involved two infusions 14 days apart in each treatment cycle.

Results published in December showed that treatment with ocrelizumab reduced the risk of disability progression. The percentage of people with primary progressive MS that had disability progression (measured by EDSS) after 24 weeks fell from 36% without treatment to 30% with ocrelizumab.

Those taking the drug scored better on the time needed to walk 25 feet and ocrelizumab also reduced the rate of brain atrophy (shrinkage) shown on an MRI.

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Earlier research

A phase 2 clinical trial tested the benefits of two doses of ocrelizumab against beta interferon and placebo for 218 people with relapsing MS.

Ocrelizumab reduced the the number of relapses by around 75% and number of active lesions (as measured by MRI) by around 90 compared with placebo over 24 weeks. People taking ocrelizumab also had significantly fewer relapses than those taking beta interferon.

These benefits were maintained in the group that continued to take ocrelizumab for 96 weeks.

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What are the side effects of ocrelizumab?

None of the phase 3 trials reported any unexpected adverse side effects. In ORATORIO, the incidence of side effects was similar to the placebo and in OPERA I and II, they were similar to those seen in the people taking beta interferon.

In the phase 2 relapsing remitting trial, serious side effects were rare and were comparable for all groups. One patient died in the high dose ocrelizumab group but it was unclear as to whether this was connected to ocrelizumab.

However, longer term studies are needed to understand the full safety profile of ocrelizumab. Weakening the immune system increases the risk of infection and of cancer emerging, and doctors have been advised to “stay vigilant”.

Ocrelizumab has also been investigated as a treatment for rheumatoid arthritis and lupus erythematosus, but studies were discontinued due to the number of infections that participants experienced.

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How does ocrelizumab compare with current therapies?

The phase 3 trial for relapsing MS showed that ocrelizumab significantly reduced the annual relapse rate and the progression of clinical disability compared with beta interferon.

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When is ocrelizumab likely to become available?

In July 2016 Roche submitted a licensing application to the European Medicines Agency (EMA), the body responsible for licensing drugs in Europe. The EMA has accepted this application and is currently reviewing the data. 

We expect a decision to be announced in late 2017.

In March 2017 ocrelizumab was approved by the US Food and Drug Administration (FDA) as a treatment for both relapsing and primary progressive MS.

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