Drug Identification Number (DIN): 02467224
Hoffmann-La Roche Limited
Ocrevus is a monoclonal antibody that specifically targets CD20, a protein that is found on the surface of white blood cells called B lymphocytes or B cells. Ocrevus is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.
NOTE: On February 15, Hoffmann-La Roche Limited (Roche Canada) announced Health Canada’s approval of ocrelizumab (Ocrevus) the first disease modifying therapy approved, with conditions, for the management of adult patients with early primary progressive multiple sclerosis (PPMS). Updates to come.
Indications and use
Ocrevus is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical and imaging features.
Ocrevus was approved, with conditions, by Health Canada as monotherapy for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity.
Ocrevus is contraindicated in patients with active hepatitis B virus infection and/or a in patients with a history of life threatening infusion reaction to Ocrevus.
Administration and dose
The first dose is administered in two separate intravenous infusions, 300mg each, two weeks apart. Subsequent doses are given as one 600 mg intravenous infusion every six months.
Mechanism of action (MOA)
Ocrevus is a monoclonal antibody that specifically targets CD20, a protein that is found on the surface of white blood cells called B lymphocytes or B cells. Because of this property, ocrelizumab acts as an immunomodulatory drug by targeting and removing potentially harmful B cells in people living with multiple sclerosis (MS).
The most common adverse effects reported for Ocrevus include infusion reactions (itchy skin, rash, hives, redness of the skin, flushing, low blood pressure, fever, tiredness, dizziness, headache, throat irritation or pain, shortness of breath, swelling of the throat, feeling sick or nausea, fast heart beat) and increased risk of infections such as upper and lower respiratory tract infections, common cold, gastroenteritis, viral infections, herpes infections and conjunctivitis.
Ocrevus may have the potential to cause more serious side effects including hepatitis B virus (HBV) reactivation, depression and feelings of self harm or suicide; Progressive Multifocal Leukoencephalopathy(PML), severe allergy, serious skin reactions (wide-spread redness or blistering of the skin and the inside of the mouth) and increased risk of certain malignancies.
This is not a comprehensive list of all possible side effects of Ocrevus. Please see the Ocrevus product monograph for a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Ocrevus.)
A phase II trial conducted by Dr. Ludwig Kappos and team was conducted in people with RRMS spanning 24 weeks. Participants received either placebo, low dose (600mg) ocrelizumab, high dose (2000mg) ocrelizumab, or interferon beta-1a treatment (an approved treatment for MS). At the end of the 24 weeks participants in both ocrelizumab groups had lower numbers of active brain lesions compared to the placebo group (89% lower in low dose ocrelizumab group and 96% lower in high dose ocrelizumab group). Both ocrelizumab groups were also better than the interferon beta-1a group for reducing active lesions. Annualized relapse rates over the 24 weeks were 80% lower in the low dose ocrelizumab group and 73% lower in the high dose ocrelizumab group compared to the placebo group. Findings also showed that both doses of ocrelizumab were effective in reducing MRI and clinical disease activity.
Two phase III clinical trials were conducted by Dr. Stephen Hauser and team, OPERA I and OPERA II, to compare the effects of ocrelizumab (600mg every 24 weeks) with already approved disease modifying therapy, interferon beta-1b (44 µg three times a week) for 96 weeks. Clinical outcomes from 1,656 participants enrolled in both trials show significantly reduced annualized relapse rates with ocrelizumab compared to interferon beta-1a at 2 years, thus meeting its primary endpoint. Secondary outcomes showed ocrelizumab had lower rate of disability progression at 24 weeks and fewer lesions.
Ocrevus is currently being evaluated by the Canadian Agency of Drugs and Technologies in Health (Common Drug Review) who will provide a recommendation for provincial public plan coverage for all Canadian provinces except Quebec. The Institut national d’excellence en sante et en services sociaux (INESSS) in Quebec conducts an independent review.
Drug support program
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Kappos L et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011; 378 1779-87.
Hauser S et al. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017; 376 221-34.
Ocrevus™ and COMPASS™ are trademarks of Hoffmann-La Roche Limited.