When Cathy Bryant went to the emergency room in 2011, she thought she was having a stroke. Her health had been perfect, so something sudden and unexpected seemed like the only logical explanation. However, the doctor had another diagnosis—she had Multiple Sclerosis (MS).
“It rocks your world when you find out something like that,” Bryant said. “My health had been wonderful, and then suddenly my world was upside down.”
Five years after her diagnosis, Bryant has fought the progression of MS with Rituximab, a cancer treatment drug that has shown astonishing potential in treating MS.
Fighting MS head-on
After her ER diagnosis, Bryant sought treatment from the best doctors in the country. Her search eventually led her to Augusto Miravalle, MD, associate professor and vice chair of education in the Department of Neurology and member of the Rocky Mountain MS Center at University of Colorado.
“I told him that I wanted him to treat me like he would a family member,” Bryant said. “I wanted to do everything to stop the progression of the MS. I didn’t want to be in a wheelchair.”
Bryant was drawn to Miravalle by his patience in making sure she and her family understood available options. She also appreciated the idea of treating the MS head-on.
“What differentiates our MS Center here at CU Anschutz is that we tend to be very proactive in stopping the disease from progression early on,” Miravalle said. “That’s why our patients tend to have better outcomes. We don’t waste time in using ineffective therapies.”
Time is of the essence when treating MS. According to Miravalle, without treatment, 50 percent of individuals with MS will require a cane for ambulation within 10 years of onset, 30 percent will need to use a wheelchair and life span is decreased. The disease is thought to affect more than 2.3 million people worldwide according to the National Multiple Sclerosis Society, including more than half a million Americans.
How Rituximab works
While there are 13 approved medications to treat MS, Miravalle and his colleagues have seen great success with Rituximab, a drug typically used to treat lupus or lymphoma.
MS, which impacts the central nervous system, is a disease in which the immune system is triggered to attack the brain and spinal cord. As a result, myelin, which protects nerve fibers, is destroyed, causing the disruption of signals to and from the brain, which creates a variety of symptoms of differing severity. Originally, doctors and researchers tried to treat MS with treatments that eliminate T Cells, which attack myelin. However, drugs like Rituximab are showing greater success by focusing on B Cells.
“Killing T Cells can create a great deal of problems with infections and immune suppression,” Miravalle said. “B Cells activate T Cells, so without the B Cells, T Cells don’t activate and can’t cause the disease.”
Rituximab is an antibody that attaches to, and then kills, B Cells. As a result, the drug both improves function and prevents new attacks. In addition, infusions of Rituximab are only necessary every six months to destroy new B Cells. Other drugs commonly used to treat MS can require monthly infusions or daily shots and are also not as effective as Rituximab.
The University of Colorado Multiple Sclerosis Center currently has 400 patients with relapsing MS who are being treated with Rituximab. Miravalle and his colleagues have been pleased with results so far. Only 5 percent of patients saw occurrences of new lesions—essentially a 95 percent efficacy rate. In addition, patients who are not on other medications have not seen any negative side effects from Rituximab.
“Medications like this are educating us,” Miravalle said. “We never thought about B Cells in MS. Now by knocking them down, we have this amazing effect on the disease itself. It is telling us a lot about the immune cells.”
Using Rituximab off-label
Despite the effectiveness of Rituximab, not all patients have access to the drug, since its use for MS is still considered off-label. Miravalle and his colleagues have been offering Rituximab primarily to patients who cannot get other approved medications or who are not having success with other approved medications.
Bryant was one patient who did not have success with other drugs. Before Rituximab, she tried Copaxone and Tysabri, both of which are officially designated for use in treating MS. Health complications while on these drugs caused her to seek a new option. That is when Miravalle introduced her to Rituximab.
“Rituximab is considered experimental, but with my health conditions, I didn’t have any other options,” Bryant said. “Since I have been on Rituximab, I have had no problems with MS. The only bad part is that because it is not approved for MS, I have to pay out of pocket, and the drugs are not cheap.”
Miravalle said that some of the MS Center’s patients are able to get Rituximab at no charge through a patient assistant program, but some patients have to pay out-of-pocket since they do not qualify for the program and many insurance providers will not pay for a drug that is being used off-label.
This may change if Ocrelizumab, a modified version of Rituximab that is currently in clinical trials, is approved. The company responsible for Ocrelizumab frames the new drug as one that will cause fewer allergic reactions in patients.
“It could become a game changer for MS,” Miravalle said. “It is too early to say for sure since Ocrelizumab has not been released yet. I do not expect a difference between Rituximab and Ocrelizumab, but it has the potential to change the way we treat MS patients.”