Get the latest news on MS research, the FDA approval of Ocrevus (ocrelizumab) for both relapsing and progressive forms of MS, insights and resources.
With MS research moving at a rapid pace, and the latest FDA approval of Ocrevus (ocrelizumab) for the treatment of both relapsing and progressive forms of MS, here’s what you need to know:
- What is multiple sclerosis MS?
- Latest research
- FDA approval of Ocrevus (ocrelizumab)
1. What is multiple sclerosis MS?
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.1
MS symptoms include changes in sensation, mobility, physical coordination, vision, and cognition.2 The disease is mainly classified as either relapsing-remitting, or primary progressive (PPMS) based on the initial disease course.
In its relapsing form which affects 85 - 90 % of patients, MS is characterised by episodes of worsening function (relapses or attacks) which are initially followed by recovery periods (remissions). In its primary progressive form (10 - 15 % of patients) , MS is characterised by steadily worsening function from the onset of symptoms, often without early relapses or remissions.2
Most people experience their first symptoms of MS between the ages of 20 and 40. The patient’s own immune system, along with environmental factors appears to be the cause of the damage to neurons, but the why and how are answers that researchers are still searching for.3
While MS can be a hugely challenging condition, many people with the disease lead healthy and active lives.
Jack Osbourne, son of British rock star Ozzy Osbourne was diagnosed with MS in 2012, and created the website You Don’t Know Jack About MS in partnership with Teva Neuroscience. The site provides insights and resources for those who are newly diagnosed or living with relapsing forms of MS. Jack abides by the motto “Adapt and Overcome” and uses the hashtag #JackMSchat on twitter to voice his experiences with MS.
Similarly, when filmmaker Jason DaSilva was 25 years old, he was diagnosed with primary progressive MS. He documented his struggles with the degenerative neurological disease in his film “When I Walk”, which went on to win him an Emmy Award in 2015 for Outstanding Informational Programming.
2. Latest research
MS research is moving at a rapid pace, and significant progress is being made in our understanding of the disease. The classification of MS phenotypes (physical and psychological characteristics), with the separation of the two major phenotypes (the relapsing and the progressive course) and further sub-categorisation has made a valid contribution to a better definition of MS treatment.4
Latest MS research shows that life expectancy for people with MS has increased considerably over time, indicating that people with MS may live an average of about seven years less than the general population due to disease complications or other medical conditions.5 However, new evidence suggests that the incidence of relapsing-remitting multiple sclerosis might be increasing, particularly in women.6
While there is no single test used to diagnose MS, it is often diagnosed through an MRI scan of the head and spine to look for characteristic lesions of MS. Advances in MRI, serological and genetic testing have improved the diagnosis of other disorders that can often be mistaken for MS.2
More than 20 years after the approval of the first drug to treat relapsing-remitting MS, the treatment of MS has radically changed.
Although great progress has been made in the treatment of relapsing-remitting multiple sclerosis with 14 drugs having regulatory approval, development of therapies that prevent or reverse progression has been slower.7
Similarly, effective therapies for progressive MS that prevent worsening, reverse damage, and restore function are a major need. The International Progressive MS Alliance are increasing the focus on progressive MS treatments and identifying specific research areas to target.
There is no cure for MS, but treatments are available for both relapsing and primary progressive symptoms.
Earlier this year, the FDA approved Ocrevus, known generically as ocrelizumab, for the treatment of both relapsing MS and primary progressive MS, making it the first therapy for the treatment of primary progressive MS (PPMS).1 Ocrelizumab will be available as a first-line treatment, which means that there are no recommendations in the approved labeling for people to try other MS therapies before taking it.
This is a crucial first step in the treatment of primary progressive MS, and it is expected to have huge impact in finding more effective treatments for everyone with progressive MS.
4. FDA approval of Ocrevus (ocrelizumab)
The FDA granted the approval of Ocrevus (ocrelizumab) to Genetech, Inc.
The efficacy of ocrelizumab for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared ocrelizumab to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving ocrelizumab had reduced relapse rates and reduced worsening of disability compared to Rebif.1
In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving ocrelizumab treatment showed a decrease in disability progression compared to placebo.1
Ocrelizumab treatment is administered by a healthcare provider using a needle in a vein known as intravenous infusion. The first two infusions are given 2 weeks apart followed by an infusion every 6 months.8
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.1 In this way, it is supposed to prevent these antibodies from damaging neurons.
The possible side effects of ocrelizumab are those frequently caused by infusion reactions, such as a rash, itching, trouble breathing, or fall in blood pressure. Before each infusion, patients should receive medicines to reduce the risk of infusion related allergic reactions. Serious side effects are increased risk of infections or cancer. The most common side effects of ocrelizumabare upper and lower respiratory infections and skin infections.8
Recent analysisshows that ocrelizumab will prove a challenge for other disease-modifying treatments for relapsing MS, and is now favoured by many, with neurologists predicting that ocrelizumab would become the next drug for approximately 20 % of their relapsing MS patients.
For primary progressive MS patients, ocrelizumab is currently the only approved treatment, and is therefore the main drug of choice for many.
Here are a list of MS support groups and resources dedicated to providing further information on MS and treatments: