Ocrelizumab (Ocrevus®) (NEW)

What is Ocrelizumab

OCREVUS is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

Data sheet.pdf


How is Ocrelizumab Administered?

OCREVUS is administered by intravenous infusion.

First & second infusions (day 1 and day 15):

  • Pre-medications 30-60 mins before infusion
  • Infusion 2.5 – 3.5 hours or the shorter 2 hour option as per the data sheet above
  • Observe for at least one hour after infusion

Subsequent infusions (every 6 months)

  • Pre-medications 30-60 mins before infusion
  • Infusion 3.5 hours
  • Observe for at least one hour after infusion


What trials have there been for Ocrevus?


Relapsing Remitting MS

Two identical trials involving 1656 people with RRMS, 821 of which received the proposed treatment, showed clear demonstrable evidence that relapses were reduced, the volume of brain lesions were significantly decreased and the reduction in disability progression. Trials OPERA 1 and OPERA 2 clearly showed in comparison to its Rebif (interferon beta-1a) trial comparator:

  • 46% and 47% lower rate of relapses
  • 40% lowered the risk of disability progression
  • 33% higher disability improvement
  • between 47.9% and 47.5% of the Ocrelizumab recipients had no evidence of disease activity over the trial period compared to 29.2% and 25.1% of those on the interferon
  • 94% and 95% lower number of T1 gadolinium enhancing lesions in those patients MRIs who were being administered Ocrelizumab than the interferon recipients
  • 77% and 83% lower number of new or growing T2 hyperintense lesion
  • the longer the patients underwent treatment the number of new lesions decreased

Read more on the OPERA 1 and OPERA 2 trials:
Hauser, S. L., et al, Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N ENGL J MED (2016).
Calabresi, P. A., B-Cell Depletion — A Frontier in Monoclonal Antibodies for Multiple Sclerosis. N ENGL J MED (2016)


Primary Progressive MS

A Phase III study (ORATORIO) involving 732 participants with PPMS was undertaken which showed evidence of reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. The results showed that at 120-weeks:

  • on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo
  • the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo
  • the percentage of brain-volume loss was 0.90% with ocrelizumab versus 1.09% with placebo

Read more on the ORATORIO trial: Montalban, X, et al, Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N ENGL J MED (2016).


Will I be eligible for treatment with Ocrevus?


Relapsing Remitting MS

The eligibility criteria for Ocrevus RRMS is the same as other RRMS treatments. We recommend reading the Special Authority Criteria here: Disease Modifying Treatment Special Authority Criteria | Multiple Sclerosis Society of NZMultiple Sclerosis Society of NZ (msnz.org.nz)


Primary Progressive MS

To access PHARMAC funded Ocrevus for the treatment of PPMS, you must meet the following criteria:

  1. Have a neurologist confirmed diagnosis of PPMS meeting McDonald 2017.
  2. Have an Expanded Disability Status Scale (EDSS) score between 2.0 and 6.5 (inclusive). An EDSS score of 6.5 means you can walk around 20 metres with one or two aids (crutches, sticks or walkers) without stopping for rests.
  3. Have no history of relapsing remitting multiple sclerosis (RRMS).

Ocrevus is the only treatment available for primary progressive MS. As this is new we appreciate there are a lot of questions. Check out our handy FAQ document that we hope answers all your questions: PPMS Ocrevus FAQ – 13 September 2023


Side Effects

The most common side effects of OCREVUS are infusion-related reactions (IRR). Infusion reactions can be serious, so you’ll be carefully monitored throughout your infusion and for at least one hour afterwards.

However, because IRRs can happen for up to 24 hours after a dose of Ocrevus, it’s important that you tell your doctor or go to the Accident and Emergency at your nearest hospital if you notice any unusual symptoms.

Ocrevus increases your risk of getting upper respiratory and lower respiratory tract infections, skin infections, and herpes infections. Tell your healthcare provider if you have an infection or have any of signs of infection.

There have been reports of a rare, serious brain infection called PML (progressive multifocal leukoencephalopathy) in patients receiving medicines for MS. PML can cause severe disability or even death- it is mostly associated with risk factors, such as age and use of other medicines that affect your immune system.

We recommend having a robust conversation with your neurology team to ensure you are aware of all the benefits and potential risks/side effects. Together, you should make an informed decision about whether Ocrevus is right for you. Before commencing treatment ensure you are alert of potential side effects you may experience and when and how to report these.


Who can prescribe Ocrevus?

Under Pharmac’s criteria ‘any relevant prescriber’ can make a Special Authority Application for MS DMTs if they feel this is within their scope of practice. As it is a complex decision making process, in most cases a neurologist will make the Special Authority Application.

A neurologist needs to confirm an MS diagnosis which meets the 2017 McDonald MS diagnostic criteria. Confirmation may not necessarily require a re-visit to a neurologist but could be confirmed via previous clinic letters from a neurologist.

If your GP or other relevant prescriber is making an initial or renewal application but has any concerns, it is recommended they reach out to their local Neurology team.

Once established on treatment ‘any relevant prescriber’ could do a renewal application providing they know and understand the treatment and monitor patients for potential complications.

Please contact your MS Nurse Specialist or your local GP who will be able to discuss further with you and refer to a neurology service if required.


Where can I find out more information about Ocrevus?

You can find more information about Ocrevus in the Consumer Medicine Information https://www.medsafe.govt.nz/consumers/cmi/o/Ocrevus.pdf

Visit www.getonwithlife.co.nz to learn more about Ocrevus

Watch more about Ocrevus: https://www.youtube.com/watch?v=SX7kHhmrelI

If you still have further questions or want to understand if Ocrevus is right for you, speak to your MS Nurse specialist or doctor.


More information for Prescribers

For more information about Ocrelizumab contact the Roche NZ Medical Information Line:

Phone: 0800 276 243 (8.30am-4.30pm)
Email: auckland.medinfonz@roche.com


What to do about a bad reaction to medication

Reports from health professionals are preferred as doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction. However anyone may report a suspected adverse event or reaction to medication taken to the Centre for Adverse Reactions Monitoring (CARM).

For instructions and further information https://nzphvc.otago.ac.nz/reporting/