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Ocrevus (ocrelizumab)

December 2020

What is Ocrevus used for in MS?

Ocrevus is a disease modifying drug for active relapsing remitting, very active relapsing remitting MS and early primary progressive MS. You have fewer relapses than you might have had without treatment, and disease progression is slowed.

Ocrevus is a highly effective (category 2.0) DMD; in clinical trials people taking Ocrevus had about 50% fewer relapses than people taking Rebif. Unlike other DMDs, Ocrevus has not been tested against placebo.

During the clinical trials, Ocrevus appeared to reduce disability progression and significantly reduce the number of lesions seen on MRI scans compared to beta interferon. Brain volume loss was reduced and more people with no evidence of disease progression (NEDA) were seen in those taking Ocrevus compared to those taking Rebif.

Who can take Ocrevus?

Ocrevus can be prescribed for adults with active relapsing remitting MS and very active relapsing remitting MS, if they are unwilling or unable to take Lemtrada.

Ocrevus has been approved for use on the NHS since 2018. It can only be prescribed by a neurologist.

Contraindications

Ocrevus may not be appropriate if you have existing medical conditions including cancer or serious infections such as HIV/AIDS or hepatitis B.

Conception and pregnancy

Pregnancy is not recommended during treatment with Ocrevus. If you plan to start a family discuss your specific circumstances with your MS team.

Women of child-bearing age must use an effective method of contraception during treatment and for 12 months after stopping Ocrevus.

How do I take Ocrevus?

You take Ocrevus as an intravenous infusion (drip).

The first dose is given as two separate infusions, two weeks apart. Further doses are given as one infusion every six months, usually in a hospital clinic. The infusions take around 3 to 4 hours to complete.

What side effects can I get with Ocrevus?

Common side effects include:

infusion related reactions such as headache, rashes, fever and nausea

Many people treated with Ocrevus experience these reactions, but they are generally mild to moderate and short-lived. To minimise infusion reactions, you may be given additional medications before infusions, and be monitored closely during the infusion.

infections including coughs, colds, chest infections and herpes virus infections (such as cold sores or shingles)

Ocrevus suppresses part of the immune system so that you will be more vulnerable to infections such as colds and viruses. Your MS team should give advice on ways to minimise the risk of infections.

Common side effects (affecting more than 1 person in 100)

infusion-related reactions
flu (influenza)
sinus infections
bronchitis (bronchial tube inflammation)
herpes infection (cold sore or shingles)
infection of the stomach and bowel (gastroenteritis)
viral infections
skin infection (cellulitis)

A full list of side effects is included in the manufacturer's Patient Information Leaflet.

Assessment before treatment

Before starting Ocrevus, you will have tests to check for HIV and hepatitis B. Your white blood cell levels will also be checked. If you take medicine for high blood pressure, you may be asked to stop taking it for 12 hours before each infusion, as Ocrevus can lower blood pressure.

Assessment during treatment

Before each infusion you will be given a corticosteroid and an anti-histamine and you may also be given medicine to reduce fever. This is to reduce any infusion reaction. You will be closely monitored for reactions such as a rash or itchy skin, fever, nausea or headache. The infusion may be slowed, temporarily stopped or permanently stopped if you have an infusion reaction, depending on how serious it is.

How does Ocrevus work?

Ocrevus is a monoclonal antibody, a type of drug developed to attack specific targets in the immune system.

Ocrevus has been designed to target a particular marker (CD20) on the surface of B cells, a type of white blood cell (lymphocyte) which is thought to be involved when the immune system attacks the myelin around nerve cells. The targeted B cells are destroyed.

Ocrevus research for relapsing remitting MS

What are the results so far?

In a phase II, 24 week, clinical trial, 218 people were split into groups receiving one of two doses of Ocrevus (600mg and 2000mg), interferon beta-1a (Avonex) or placebo. After 24 weeks, the number of active lesions as measured by MRI scans was 89% lower in the low dose group and 96% lower in the high dose group compared with the placebo group.

At 24 weeks the annual relapse rate was 0.13 in the low dose group and 0.17 in the high dose group compared to 0.36 for people on interferon beta and 0.64 in the placebo group.

Opera I and II - Ocrevus compared to interferon beta 1a (Rebif)

These phase III studies recruited 1656 participants with relapsing remitting MS who took either Ocrevus 600mg every 6 months or interferon beta 1a (Rebif) three times per week for approximately two years.

Over the two years of the clinical trials, Ocrevus reduced the number of relapses by 50% compared to interferon beta 1a, reduced disability progression sustained for 3 and 6 months, and significantly reduced the number of lesions seen on MRI scans compared to beta interferon. Brain volume loss was reduced and numbers of participants with no evidence of disease progression (NEDA) were increased in the Ocrevus treatment groups compared to interferon beta 1a.

What further research is planned?

Ocrevus for people who have had relapses despite taking another disease modifying drug

This phase III study is recruiting 600 people with relapsing remitting MS who have stopped taking a disease modifying drug because of lack of efficacy. All participants will take Ocrevus 600mg every 24 weeks by iv infusion for 96 weeks. The main measure of the study is the percentage of participants with no evidence of disease activity at the end of the study. An identical study is underway in the United States and Canada.
Estimated completion date December 2020. Further details of this study.

Ocrevus in early stage relapsing remitting MS

This phase III study is recruiting 600 participants who have a diagnosis of relapsing remitting MS and whose first symptoms of MS occurred less than three years ago. All participants will take Ocrevus 600mg every 24 weeks by iv infusion for 192 weeks with a follow-up period of at least 48 weeks. The study will monitor a number of measures of MS activity, including disability worsening or improvement, relapses and lesions seen on MRI.
Estimated completion date January 2022. Further details of this study.

Ocrevus for primary progressive MS

Licensing

The European Commission has granted marketing authorization for ocrelizumab (Ocrevus) for the treatment of both active relapsing MS and early active primary progressive multiple sclerosis. This follows a recommendation from the European Medicines Agency in November that a licence should be granted for:

Active relapsing MS, meaning people who are having relapses or showing new lesions on MRI scans
Early primary progressive MS,defined as people who have had symptoms of MS for 15 years or less, have an EDSS of 3.0 to 6.5 and evidence of MS activity on MRI scans

Appraisal

NICE and SMC have approved Ocrevus for people with primary progressive MS if they:

have had symptoms of primary progressive MS for 15 years or less and
are able to walk 20 metres or more, with or without walking aids (up to EDSS 6.5) and
have evidence of MS activity on MRI scans

This reverses an earlier decision by NICE to reject Ocrevus for PPMS. The final publication of this decision was paused to allow time for further discussions to take place between NICE, NHS England and drug manufacturer Roche.

This decision applies initially to England and Scotland only.

Roche is working with the NHS in Wales and Northern Ireland to make Ocrevus available throughout the UK.

Research on Ocrevus for primary progressive MS:

ORATORIO - Ocrevus compared to placebo

This phase III study recruited 732 participants with primary progressive MS and EDSS of 3 to 6.5 who took either Ocrevus or placebo by iv infusion every 6 months for more than 2 years.

The main measure of the study was the onset of disability progression. This was measured by the number of participants with an increased EDSS which was still evident 3 months later. The study also recorded the number of participants with an increased EDSS still evident after 6 months, walking speed over 25 feet and volume of brain and MS lesions.

Fewer people taking Ocrevus had an increase in disability, compared to placebo. An increase in disability which lasted 3 months was seen in 32.9% of those taking Ocrevus and 39.3% of those taking placebo. In addition, increased disability which lasted at least 6 months was seen in 29.6% taking Ocrevus and 35.7% taking placebo. Comparing the two groups, people taking Ocrevus were 24% less likely to have an increase in their disability than those taking placebo.

After 120 weeks of treatment, walking speed over 25 feet was 39% slower for Ocrevus compared to 55% slower for placebo. Brain lesion volume decreased by 3.4% with Ocrevus and increased by 7.4% with placebo. Loss of brain volume was 0.9% for Ocrevus and 1.09% for placebo.

Future research on Ocrevus for primary progressive MS:

ORATORIO-HAND (O'HAND)- Ocrevus compared to placebo

This phase III study is designed to evaluate the effect of Ocrevus on hand and arm function in people with more advanced disability, including those who use a wheelchair. The study will recruit approximately 1000 participants with EDSS between 3 and 8 and includes eleven study centres in the UK. The main measure of the study will be the nine-hole peg test, a measure of arm, wrist and hand function. A secondary measure will be onset of disability progression, measured by the number of participants with an increased EDSS which persists for 3 months or longer.
Estimated completion date April 2028.
Further details of this study.

Consonance - Ocrevus

This study is recruiting 600 people with either secondary or primary progressive MS. All participants will take Ocrevus every 24 weeks for four years. Progression of disability will be assessed using a combination of measures.
Estimated completion date January 2024.
Further details of this study.

Find out more

Ocrelizumab - European Medicines Agency report
Research update - Can ocrelizumab slow down disability in primary progressive MS - 30 January 2017
Patient Information Leaflet - Ocrevus (EMC website)
Full prescribing information - Ocrevus (EMC website)

References

National Institute For Health And Care Excellence (NICE) Ocrelizumab for treating relapsing multiple sclerosis: final appraisal determination Read online
Kappos L, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 2011;378(9805):1779-1787 Summary
Montalban X, et al. Ocrelizumab versus placebo in primary progressive multiple sclerosis. New England Journal of Medicine 2017;376(3):209-220. Summary
Hauser SL, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis New England Journal of Medicine 2017;376(3):221-234. Summary

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