OCREVUS® (ocrelizumab) is a therapeutic monoclonal antibody that represents a different scientific approach to treating MS. It targets a type of immune cell called a CD20-positive B cell that plays a key role in the disease. OCREVUS is approved by the FDA to treat relapsing or primary progressive forms of multiple sclerosis (MS). OCREVUS is given once every six months by an intravenous (IV) infusion.1
MS is a chronic neurological disease for which there is no cure, and over time will lead to some level of disability in most people.3,4 The cause of MS is unknown. In people with MS, the immune system attacks the insulation around nerve cells in the brain, spinal cord and/or optic nerves, causing inflammation and potentially debilitating symptoms.4 The majority of people living with MS either have a relapsing form or PPMS at the time of diagnosis. 5 Relapsing forms of MS are characterized by episodes of new or worsening symptoms (relapses) followed by periods of recovery.6 PPMS is a highly disabling form of MS characterized by steadily worsening symptoms, usually without periods of improvement/remission.6
People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain, spinal cord or optic nerves – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse.8
Disease activity causes lesions in the brain, which can be measured with magnetic resonance imaging (MRI).8
Most people with MS continue to experience disease activity and worsening disability. An important goal of treating MS is to slow the progression of disability.6
T cells have long been believed to be the culprit in MS. Pioneering science has shown B cells may also play a key role in MS in several ways:
Activate other immune cells to attack the insulation and support around nerve cells (myelin)9,10
Release chemicals that stimulate inflammatory activity in the brain and spinal cord11,12
Produce antibodies that attack myelin and recruit other immune cells to attack myelin13,14
May form structures with other immune cells in the brain that sustain the immune system attack on nerve cells in certain types of MS15,16
OCREVUS is a humanized monoclonal antibody that is designed to target CD20-positive B cells.
Although the exact way OCREVUS works is not known, it is thought to work in MS by decreasing certain B cells which have the CD20 protein on its surface. Since the CD20 protein is not found on all B cells, other B cells may still be available to help your body fight infection and other illnesses.
The FDA approval of OCREVUS is based on positive results from three Phase III studies (OPERA I and OPERA II in RMS; ORATORIO in PPMS).
In the OPERA I and OPERA II studies, OCREVUS adverse reactions in at least 5% of RMS patients and higher than Rebif were:
In the ORATORIO study, OCREVUS adverse reactions in at least 5% of PPMS patients and higher than placebo were:
What is OCREVUS?
OCREVUS is a prescription medicine used to treat:
It is not known if OCREVUS is safe or effective in children.
Who should not receive OCREVUS?
Do not rif you have an active hepatitis B virus (HBV) infection.
Do not if you have had a life-threatening allergic reaction to OCREVUS. Tell your healthcare provider if you have had an allergic reaction to OCREVUS or any of its ingredients in the past.
What is the most important information I should know about OCREVUS?
OCREVUS can cause serious side effects, including:
These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
Before receiving OCREVUS, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of OCREVUS?
OCREVUS may cause serious side effects, including:
Most common side effects include infusion reactions and infections.
These are not all the possible side effects of OCREVUS.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information, go to www.OCREVUS.com or call 1-844-627-3887.
1 OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.
2 National Multiple Sclerosis Society. Treating PPMS. Available at
3 MS International Federation. What is MS? Available at http://www.msif.org/about-ms/what-is-ms/.
4 National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research.
5 Multiple Sclerosis International Federation. Types of MS. Available at https://www.msif.org/about-ms/types-of-ms/.
6 National Multiple Sclerosis Society. Types of MS. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS.
7 Tullman MJ. Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis. Am J Manag Care. 2013;19(suppl 2):S15-S20.
8 Erbayat A, et al. (2013). Reliability of classifying multiple sclerosis disease activity using magnetic resonance imaging in a multiple sclerosis clinic. JAMA Neurol, 70(3):338-44.
9 Constant SL. (1999). B lymphocytes as antigen-presenting cells for CD4+ T cell priming in vivo. J Immunol, 162(10):5695-5703.
10 Crawford A, et al. (2006). Primary T cell expansion and differentiation in vivo requires antigen presentation by B cells. J Immunol, 176(6):3498-3506.
11 Bar-Or A, et al. (2010). Abnormal B-cell cytokine responses a trigger of T-cell-mediated disease in MS? Ann Neurol, 67(4):452-461.
12 Duddy M, et al. (2007). Distinct effector cytokine profiles of memory and naive human B cell subsets and implication in multiple sclerosis. J Immunol, 178(10):6092-6099.
13 Genain CP, et al. (1999). Identification of autoantibodies associated with myelin damage in multiple sclerosis. Nat Med, 5(2):170-175.
14 Storch MK, et al. (1998). Multiple sclerosis: in situ evidence for antibody- and complement-mediated demyelination. Ann Neurol, 43(4):465-471.
15 Serafini B, et al. (2004). Detection of ectopic B-cell follicles with germinal centers in the meninges of patients with secondary progressive multiple sclerosis. Brain Pathol, 14(2):164-174.
16 Magliozzi R, et al. (2010). A Gradient of neuronal loss and meningeal inflammation in multiple sclerosis. Ann Neurol, 68(4):477-493.