Ocrevus (ocrelizumab)

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Ocrevus (ocrelizumab)

Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis (MS). It is the first approved treatment for the primary progressive form of MS.

Neurology Multiple Sclerosis
Marketing Authorisation Holder Roche Registration Limited
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 30 milligram / millilitre
Package 1 vial of 10 ml - Vials

What is Ocrevus (ocrelizumab) for?

Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of people with relapsing or primary progressive forms of multiple sclerosis (MS)1,4. It is the first approved treatment for the primary progressive form of MS2.

Relapsing MS (RMS) is characterized by episodes of worsening function (relapses) which are initially followed by recovery periods (remissions). In its primary progressive form (PPMS), MS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions2.

How does Ocrevus (ocrelizumab) work?

MS is a chronic, inflammatory, autoimmune disease that affects the central nervous system, and in particular the communication between the brain and other parts of the body2. The patient’s own immune system is supposed to be the cause of the damage to neurons3.

The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to bind to a type of antigen, named CD20, found on the surface of some antibodies (pre-B and mature B lymphocytes) and induce their death2. In this way, it is supposed to prevent these antibodies from damaging neurons.

Where has Ocrevus (ocrelizumab) been approved?

Ocrevus (ocrelizumab) was approved for relapsing or primary progressive forms of multiple sclerosis (MS) by:

  • Food and Drug Administration (FDA), USA, March 28, 20171
  • European Medical Agency (EMA), European Union, January 11, 20175
  • Therapeutic Goods Administration (TGA), Australia, July 13, 20174

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Ocrevus (ocrelizumab) taken?

The standard dosage is1,4,5:

  • Starting dose of 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
  • Subsequent doses of 600 mg intravenous infusion every 6 months.

Patients should be monitored closely during and for at least one hour after infusion as infusion reactions may be possible.

Complete information about Ocrevus (ocrelizumab) dosage and administration can be found in the official prescribing information listed in our resources section1,4,5.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Ocrevus (ocrelizumab)?

Common adverse reactions

Relapsing MS

The most common adverse reactions listed in the prescribing information include1,4,5:

  • upper respiratory tract infections
  • infusion reactions.

Primary progressive MS

The most common adverse reactions listed in the prescribing information include1,4,5:

  • upper respiratory tract infections
  • infusion reactions
  • skin infections
  • lower respiratory tract infections.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,4,5:

  • serious infusion reactions requiring hospitalisation
  • infections: administration should be delayed in patients with an active infection until the infection is resolved.
  • an increased risk of malignancy, including breast cancer, may exist.

Use in a specific population

Ocrevus (ocrelizumab) can cause fetal harm, it is advised to avoid pregnancies1 unless the potential benefit to the mother outweighs the potential risk to the foetus4,5. It is unknown whether ocrelizumab/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Women should be advised to discontinue breastfeeding during Ocrevus (ocrelizumab) therapy1,4,5.

Patients in a severely immunocompromised state must not be treated until the condition resolves1,4,5.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,4,5.

More Information
Working ingredient ocrelizumab
Shipping method Cold chain (temperature controlled)
Package 1 vial of 10 ml -
Therapeutic Area Neurology
Neurology Multiple Sclerosis
Indication Relapsing and primary progressive MS
Administration Intravenous
Mode of Action Monoclonal antibody (immunotherapy)
Strength 30
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Roche Registration Limited
HS Code N/A
CAS Number N/A

Relapsing MS

The Food and Drug Administration (FDA), European Medical Agency (EMA), and Therapeutic Goods Administration (TGA),  approvals of Ocrevus (ocrelizumab) for relapsing MS were based on two randomized, double-blind clinical trials of identical design (OPERA I and OPERA II). These studies involved a total of 1656 patients with relapsing forms of MS who had experienced at least two relapses within the prior two years or one relapse within the prior year. The studies lasted 2 years and compared Ocrevus (ocrelizumab) to interferon beta-1a1,4,5.

Results

The major efficacy outcome measures were annualized relapse rate (ARR), proportion of patients with confirmed disability progression, the mean number of lesions in the brain (MRI T1 gadolinium (Gd)-enhancing lesions, and new or enlarging MRI T2 hyperintense lesions).

In both studies, Ocrevus (ocrelizumab) significantly lowered the annualized relapse rate and the proportion of patients with disability progression confirmed at 12 weeks after onset compared to interferon beta-1a.

The annualised relapse rate (ARR) was:

  • 0.156 with ocrevus vs. 0.292 with interferon beta-1a in OPERA I
    • Relative reduction: 46%
  • 0.155 with ocrevus vs. 0.290 with interferon beta-1a in OPERA II
    • Relative reduction: 47%

The proportion of patients with 12-week confirmed disability progression was:

  • 9.8% with ocrevus vs. 15.2% with interferon beta-1a in both studies
    • Relative reduction: 40%

The relative reduction in the mean number of brain lesions was:

  • T1 Gd-enhancing lesions:
    • 94% in OPERA I
    • 95% in OPERA II
  • T2 hyperintense lesions
    • 77% in OPERA I
    • 83% in OPERA II

Primary Progressive MS

The Food and Drug Administration (FDA), European Medical Agency (EMA), and Therapeutic Goods Administration (TGA), approvals of Ocrevus (ocrelizumab) for primary progressive MS were based on one randomized, double-blind clinical trial (ORATORIO). This study involved a total of 732 patients with PPMS. The study lasted a minimum of 2 years and compared Ocrevus (ocrelizumab) to placebo1,4,5.

Results

The major efficacy outcome measures were the proportion of patients with 12 and 24 weeks-confirmed disability progression, the change in time to walk 25-feet from baseline to week 120, the percentage change in volume of T2 hyperintense lesions, and the percentage change in brain volume1,4,5.

The results of this study show that Ocrevus (ocrelizumab) significantly delays disease progression and reduces deterioration in walking speed compared with placebo1,4,5.

The proportion of patients with 12 weeks - Confirmed Disability Progression was1,4,5:

  • 30.2% with ocrevus vs. 34% with placebo
    • relative reduction: 24%.

The proportion of patients with 24 weeks - Confirmed Disability Progression was1,4,5:

  • 28.3% with Ocrevus vs. 32.7% with placebo
    • relative reduction: 25%.

The percentage change in Timed 25-Foot Walk from baseline to Week 120 was1,4,5:

  • 38.9% with ocrevus vs. 55.1% with placebo
    • relative reduction in progression rate of walking time: 29.4%.

The percentage change in the mean volume of T2 hyperintense lesions brain lesions was1,4,5:

  • -3.4% with Ocrevus vs. 7.4% with placebo

The percentage change in brain volume from week 24 to week 120 was1,4,5:

  • -0.902% with Ocrevus vs. -1.093% with placebo
    • relative reduction in rate of brain volume loss: 17.5%.
Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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