Ocrevus (ocrelizumab)

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Ocrevus (ocrelizumab)

How to buy Ocrevus: You can order Ocrevus (ocrelizumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Roche
Disease Multiple Sclerosis
Indication Relapsing or primary progressive forms of multiple sclerosis
Mode of Action Monoclonal antibody (immunotherapy)
Approval Status FDA approved (USA); TGA approved (AUS)
Strength 30 mg/mL

Who is ocrelizumab for?

Ocrevus (ocrelizumab) is indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis [1][4].

Recommended dose

Complete information about Ocrevus (ocrelizumab) dosage and administration can be found here: [1][4].
The standard dosage is:
  • Start dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
  • Subsequent doses: 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.
Consult your treating doctor for personalised dosing.

What is ocrelizumab and how does it work?

Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis (MS) [1][4]. It is the first approved treatment for the primary progressive form of MS [2].

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 body [2]. The patient’s own immune system is supposed to be the cause of the damage to neurons [3]. In its relapsing form, MS is characterized by episodes of worsening function (relapses) which are initially followed by recovery periods (remissions). In its primary progressive form, MS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions [2].

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 death [2]. In this way, it is supposed to prevent these antibodies from damaging neurons.

What is ocrelizumab's approval status?

Ocrevus (ocrelizumab) was approved by:
  • FDA (USA) on March 28, 2017
  • TGA (AUS) on July 13, 2017
for the treatment of adults with relapsing or primary progressive forms of multiple sclerosis [2][4].

The approval of Ocrevus (ocrelizumab) for relapsing forms of multiple sclerosis (RMS) was based on two randomized, double-blind clinical trials of identical design in patients with RMS who were treated for 96 weeks. In both studies, ocrelizumab was compared to another medicine for RMS named interferon beta-1a. In study 1, 410 patients received ocrelizumab and 411 received the interferon beta-1a, while in study 2 the distrubution of patients in the two groups was 417 and 418, respectively [1][4].

In both studies, the patients receiving ocrelizumab had reduced relapse rates and reduced worsening of disability compared to interferon beta-1a. Patients treated with ocrelizumab had a reduction in the annualized relapse rate of 46 % in study 1 and 47 % in study 2, with a proportion of relapse-free of 83 % (vs. 71% in the group treated with interferon beta-1a) in study 1, and 82 % (vs. 72 %) in study 2. The risk of disability progression was reduced by 40 % in the ocrelizumab arm. Disability progression was defined as an increase of 1.0 point or more from the baseline Expanded Disability Status Scale (EDSS) score for patients with baseline score of 5.5 or less, or 0.5 or more when the baseline score is greater than 5.5 at week 96. Moreover, the number of enlarged or new lesions was substantially less in the ocrelizumab group: the relative reduction of the mean number of new and/or enlarging lesions was around 95 % with one type of measure (T1 Gd-enhancing lesions) and about 80 % with another type of measure (new and/or enlarging T2 hyperintense lesions) [1][4].

The most common adverse reactions were upper respiratory tract infections and infusion reactions [1].

The approval of Ocrevus (ocrelizumab) for primary progressive multiple sclerosis (PPMS) was based on one randomized, double-blind clinical trial in which ocrelizumab (488 patients) was compared to placebo (244 patients).

The percentage of patients on ocrelizumab who had confirmed disability progression was 32.9 % versus 39.3 % of those on placebo, which accounts for a risk reduction of 24 %. Disability progression was defined as an increase of 1.0 point or more from the baseline Expanded Disability Status Scale (EDSS) score for patients with baseline score of 5.5 or less, or 0.5 or more when the baseline score is greater than 5.5. The mean change in the volume of lesions at week 120 was -0.39 with ocrelizumab and 0.79 with placebo [1][4].

The most common adverse reactions were upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections [1].
References
[1] Summary of Product Characteristics [FDA]: Ocrevus (ocrelizumab), Genentech, Mar. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf
[2] FDA News Release: FDA approves new drug to treat multiple sclerosis, 29/09/2017.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm
[3] Wikipedia. Multiple sclerosis, (last update: 31/03/2017), cited on 19/05/21017.
https://en.wikipedia.org/wiki/Multiple_sclerosis
[4] Summary of Product Characteristics [TGA]: Ocrevus (ocrelizumab), Roche, July 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-02089-1









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