In 2017, the United States Food and Drug Administration approved the drug – Ocrevus (ocrelizumab) – as a treatment for both relapsing and progressive forms of multiple sclerosis.
In 2017, the United States Food and Drug Administration (USFDA) approved the drug – Ocrevus (ocrelizumab) – as a treatment for both relapsing and progressive forms of multiple sclerosis.
The severe form of MS, known as primary progressive MS (PPMS), accounts for 10-15% of all cases of MS. Patients with the neurological condition experience a gradual worsening of symptoms. Another common form of MS, known as relapsing-remitting MS (RRMS), triggers attacks when symptoms flare up. After 10-20 years, RRMS tends to shift towards a different form of MS, known as secondary progressive MS. The relapses do not occur as often, but the disease does gradually worsen.
Now, Ocrevus has been found to slow down the progression of both of these aggressive forms of MS.
Reinforcing a favorable benefit-risk profile
Ocrevus is a monoclonal antibody that works by targeting a specific type of B-cells, which appear to malfunction and cause damage to the central nervous system in individuals with MS. In a clinical trial that involved that participation of over 700 patients with PPMS, researchers found those taking Ocrevus had a 24% risk reduction in disability progression, as opposed to the patients taking a placebo.
In another clinical trial that involved the participation of patients with relapsing-remitting multiple sclerosis (RRMS), researchers found that those taking Ocrevus had a 47% reduced rate of relapses, as opposed to the patients taking Merck & Co’s Rebif – an older MS therapy. “I think that this is a very big deal. The magnitude of the benefits that we’ve seen with ocrelizumab in all forms of M.S. are really quite stunning” said Stephen Hauser, Professor of the Department of Neurology at the University of California, San Francisco.
In general, PPMS is more difficult to diagnose and treat than RRMS. “We have a huge number of patients that have sort of been waiting in the wings for some therapy for PPMS. But one year of progression is very difficult to judge, and to say before two years what’s going on is impossible” said Dr. Robert Lisak, neurologist. He went on to add that it can be rather difficult to determine if a therapy is working in an individual patient unless they were doing terribly and now they are doing very well or if they are now doing poorly. Still, the current improvement in parameters among both groups on Ocrevus is considered clinically meaningful.
Efficacy, safety, and tolerability in clinical practice
Dr. Lisak noted that access to Ocrevus costs $65,000 per year and varies according to a patient’s insurance company. “The only problem we’ve had occasionally is when a patient has such active disease and such poor indicators that you’d like to put them on Ocrevus or Tysabri right from the beginning. We have had a lot of resistance from insurance companies. But as a second- or third-line treatment, when a patient has failed or doesn’t tolerate another drug, we’ve done pretty well” he said.
In regards to the safety issues associated with Ocrevus, no tumors or opportunistic infections have been spotted. The biggest concern is a possibly heightened risk of breast cancer among women on Ocrevus. In clinical trials, 50% of patients with RRMS and 2.3% of patient with PPMS developed cancer. “It’s a concern until we see statistics one way or another” said Dr. Lisak. “We have a lot of patients who, when they hear that there’s a risk and they have a family history, they shy away from it. So, you’re sort of self-selecting out the patients who might be more likely to get breast cancer” he added.
Lori Mayer, director of medical research at Central Texas Neurology Consultants in Austin, stated that the drug gives patients with MS more stability, making a significant difference in their lives. “When patients don’t need to think about their MS on a daily basis, their whole life changes,” she said.
The side effects associated with the immunosuppressant drug, including upper respiratory infections and cold sores, appear to be tolerated “really well” in comparison with other currently available drugs for MS. However, health experts cautioned about the potential long-term safety of Ocrevus once it becomes widely prescribed, including breast cancer issues. “The drug looks to be incredibly safe for its efficacy. Now the problem, to qualify things, is that natalizumab looked that way when it was approved. Time will tell whether other things will emerge” said Jerry Wolinsky, Professor Emeritus in Neurology for McGovern Medical School at the University of Texas Health Science Center at Houston.
Mayer echoes Dr. Lisak’s concerns that long-term safety evaluations must be followed up over time. She recommends that women get their vaccines at least 6 weeks before undergoing treatment with Ocrevus.
Staying active – even with MS
Vickie Siculiano is an online marketing coach for small entities and entrepreneurs and the mother of a three-year-old son named Sean. Back in 2007, she was diagnosed with primary progressive MS. Her disease progressed somewhat after she gave birth to her son, making walking a little more challenging. Her mother, Debi Smith, claimed that she was in denial when she first learned about her daughter’s condition. “You start to think, what did I do? You know, is it me? Did I not take care when I was pregnant with her? Is it something genetic that I don’t know about” said Smith.
Dr. Florian Thomas, a neurologist, stated that up until last year, there wasn’t a treatment available to slow down the progression of the disease. Now, Ocrevus is showing great promise in helping patients with MS - like Siculiano. “There are different approaches in calming down this overactive immune system. Ocrevus does this by eliminating a certain type of white blood cell, a lymphocyte” he said.
Treatment with Ocrevus involves an infusion given every six months, which is compatible with Siculiano’s active lifestyle. “When we take him [Sean] to ‘The Little Gym,’ she used to have to sit on the chair. She doesn’t do that anymore. She stands, with the crutches, but she stands there” said Smith, her mother.
However, Ocrevus is a rather aggressive treatment. Seeing as how there are more than 15 medications for MS, each medication can be tailored to a person’s individual needs. “These needs are impacted by their perception of risk versus benefit,” said Dr. Thomas. He cautioned that there are many things about MS that are not yet fully understood, but medications, such as Ocrevus, represent a significant milestone. “I think any of the medications that have been introduced in the last 15 years have raised the bar further in terms of efficacy. And I think I’m much more comfortable that many of my patients will reach the goal of dancing at their grandchild’s wedding in 2018 than I was 20 years ago” she said.
For Siculiano, her son is her top priority and participating in activities with him is very important to her. “When you have a three-year-old, it is not his fault he was born into this, so I need to make his environment as positive as I can. Physically being able to lift him and walk with him is impossible for me, but I can lay on the floor with him all day. He can roll over me and we do pony rides” she said. For now, Ocrevus has helped her to maintain independence and quality of life.