Over the past 15 years multiple sclerosis (MS) treatments have come a long way. MS is easier to diagnose now than it was in the past, and we have 12 different disease modifying drugs (DMDs) for people with relapsing-remitting MS. This is a huge step in the right direction, but we still have a long way to go. As of now there are no FDA approved treatment options for people with progressive MS, but one may be on the horizon.
What is Progressive MS?
There are two different types of progressive MS: progressive (PPMS) and secondary-progressive (SPMS).
Primary Progressive MS
Unlike relapsing forms of MS, where symptoms flare up and and then remit, Primary Progressive MS, or PPMS, is characterized by a continuous worsening of symptoms, with no obvious periods of exacerbation or remission. It is equally prevalent in both men and women, whereas relapsing-remitting MS (RRMS) is about three times more likely to occur in women. PPMS also has a later average age of onset and tends to cause more disability, especially with mobility. Unfortunately, there are currently no treatments or medications on the market that effectively slow PPMS down or prevent the accumulation of disability.
Secondary Progressive MS
People with RRMS can eventually transition into a more progressive form of MS called secondary progressive MS, or SPMS. Thankfully, now that we are treating RRMS more successfully, we are seeing fewer people go on to develop SPMS. If they do, the onset is often delayed compared to past statistics. People with SPMS may or may not still have relapses. It is usually characterized by a steady worsening of disease over a long period of time without any changes on MRI scans. If the person with SPMS is still having relapses, they will usually stay on their disease modifying drug until their physician determines that it is no longer providing any benefit. At that time a medication call Novantrone (mitoxantrone), which is a chemotherapeutic agent, can be used. Novantrone is the only FDA approved medication for SPMS.
It is an understatement to say that we need more options for people with progressive MS. It truly is a crises situation.
What is Being Done to Find Treatments for SPMS and PPMS?
Researchers have tried using many existing medications that work for RRMS in people with progressive MS, but they have found that traditional DMDs do not effectively slow the course of PPMS. Therefore, one of the main focuses of research is to identify what the underlying difference is between the relapsing-remitting and progressive forms of MS so that we can effectively treat it. Some especially exciting research is also being done on reversing damage (remyelination), something that was previously thought to be impossible.
Despite the best efforts of some of the brightest minds in MS research, an effective treatment for progressive MS remains largely a mystery. Now more than ever we need to be focusing all of our efforts on finding answers. Recognizing the urgent need for solutions, the International Progressive MS Alliance was formed in 2012 with the specific goal of finding those solutions for people with progressive MS and their families.
Thanks to the effort and determination of researchers, we are now closer then ever to having the first FDA approved treatment option for progressive MS, Ocrelizumab.
What is Ocrelizumab?
Ocrelizumab is an experimental monoclonal antibody, which is a man-made molecule that imitates your own antibodies. Antibodies are the security guards of the immune system, patrolling your body in search of foreign invaders. However, in autoimmune disease the immune system can go rogue and turn against you. Monoclonal antibodies work by altering your immune system’s response, with the goal of stopping it from inflicting damage. Other monoclonal antibodies, including Tysabri, Lemtrada, and Rituxan, are successfully used to treat relapsing-remitting MS. Ocrelizumab’s monoclonal antibodies target the CD20 protein on B cells, which are a type of white blood cell thought to contribute to myelin destruction in MS.
Genentech, a biotechnology company that’s part of the Roche group, has been running clinical trials testing ocrelizumab in SPMS and PPMS. The results from phase II of their first trials (OPERA I and OPERA II) showed that ocrelizumab was more effective than Interferon therapy. It significantly reduced the rate of relapses, disease progression, and number of brain lesions in people with RRMS and SPMS who still had relapses.
Encouraged by their findings, Genentech went on to launch the ORATORIO study, which explored the effectiveness of ocrelizumab in people with PPMS. In the ORATORIO study, 732 participants with primary progressive MS from all over the world were randomly picked to either receive ocrelizumab or a placebo via IV infusions. Researchers then compared the rate of disease progression, walking ability, lesions on MRI scans, and medication tolerance between the two groups. Preliminary results showed that the participants who received ocrelizumab had significantly less disease progression, and that the rate of side effects was similar to the placebo group. The most common side effects reported were mild to moderate infusion reactions. Ocrelizumab is an IV infusion that is given in two doses of 300mg each, administered two weeks apart.
Now that they have data from the OPERA I, OPERA II, and ORATORIO studies Genentech will present it to the U.S. Food and Drug Administration (FDA) for approval. Currently they plan to submit ocrelizumab to the FDA in early 2016, with the hopes of getting it to the MS population as soon as possible.
Article by: Stephanie Buxhoeveden MSCN, FNP-BC Stephanie is a nurse practitioner who was diagnosed with MS at age 25. Shortly after being diagnosed she realized she could use her experiences as a patient to make a difference in the lives of others, so she became a multiple sclerosis certified nurse. Stephanie completed her master’s in nursing at Rutgers University, and now specializes in the care of people with MS and other neurological diseases.
Her blog, www.justkeepsmyelin.com, offers a unique perspective on MS from both a healthcare provider’s point of view, and through the eyes of a person living with the disease every day. Her mission is to bring compassion, humor, and a deeper understanding of MS to anyone who reads it. She also writes for MultipleSclerosis.net, MSFocus Magazine, serves as a District Activist Leader for the National MS Society and is on the membership committee of iConquerMS.clinical trials, dmds, fda, international progressive ms alliance, ms treatments, ocrelizumab