- Multiple sclerosis (MS) affects 2.8 million people globally and currently has no cure.
- The most common form of MS, relapsing-remitting MS (RRMS), causes patients to experience inflammatory attacks resulting in new or increased symptoms.
- A phase 3 clinical trial conducted by researchers from the Karolinska Institutet and Danderyd Hospital in Sweden found that RRMS patients treated with the lymphoma drug rituximab were five times less likely to experience relapses compared with those treated with a drug currently used to treat MS patients.
About 2.8 million people globally live with the neurodegenerative disease multiple sclerosis (MS). Although there is currently no cure for the condition, there are medications available to help slow its progression.
A team of researchers from the Karolinska Institutet and Danderyd Hospital in Sweden is looking to add to the list of currently available therapies through a phase 3 clinical trial for the drug rituximab.
According to trial results, rituximab helped lower relapse risk in MS patients compared with patients receiving the standard treatment drug dimethyl fumarate.
The study recently appeared in the journal The Lancet.
What are MS relapses?
MS impacts a person’s central nervous system, including the brain and spinal cord. The condition damages a substance called myelin, which protects the body’s nerves.
There are four main types of MS. Relapsing-remitting MS (RRMS) is the most common type, affecting about 85% of those diagnosed with MS.
Patients with RRMS experience inflammatory attacks — also called relapses — on the myelin around their nerves. These relapses cause new or increased symptoms. Each relapse is followed by a time period of partial or complete recovery, known as remission.
In addition to new or increased MS symptoms, research shows that RRMS can cause other issues including brain atrophy, increased stress, and lowered self-esteem.
According to Prof. Anders Svenningsson, adjunct professor in the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, chief physician at the neurology clinic at Danderyd Hospital, and first author of this study, MS relapses represent “the top of the iceberg” in MS inflammatory activity and place considerable stress on patients who experience relapses.
“By preventing relapses to a high degree, we will help patients with MS live as normal a life as possible, and with high likelihood minimize the risk for long-term progression of the disease,” he told Medical News Today.
Comparing MS relapse treatment options
There are currently a number of medications available to treat MS. According to Prof. Svenningsson, rituximab — a drug originally developed to treat lymphoma — is increasingly being used as an off-label treatment for MS in Sweden.
“We saw the potential of rituximab as both an effective and inexpensive therapy and wanted to collect the best possible evidence for its efficacy,” he explained. “We then wanted to compare it with one of the most effective first-line therapies in order to position rituximab as an effective first-line therapy in MS.”
For this phase 3 clinical trial, Prof. Svenningsson and his team compared the use of rituximab (MabThera) to dimethyl fumarate (Tecfidera) as a treatment in 195 patients newly diagnosed with RRMS. Dimethyl fumarate is a drug developed for the treatment of the relapsing forms of MS.
Through the clinical trial, the researchers found that patients treated with rituximab were five times less likely to have a relapse compared to patients treated with dimethyl fumarate.
Additionally, magnetic resonance imaging (MRI) showed that patients receiving rituximab had fewer new MS plaques — or areas of scarring on the central nervous system — than those receiving dimethyl fumarate.
Prof. Svenningsson said rituximab is an effective therapy for lowering relapse risk in patients with MS because it helps eliminate B-lymphocytes in the blood. That interferes with the activation of the immune system in a way that it will not attack its own tissue.
“By doing that, the immune cells will not invade the central nervous system and thus not create the focal inflammations that lead to relapses,” he added.
Prof. Svenningsson said another benefit of rituximab is that the treatment is administered in long intervals. During the phase 3 clinical trial, patients received rituximab infusions every 6 months.
“In-between, the patients do not need to think about their treatment and hopefully not so much about their disease, either,” he added. “After some years, it appears it is possible to extend those infusion intervals to one year or even longer. That way patients do not have to worry or think about their disease more than a couple of days every year.”
New information for clinicians
MNT also spoke with Dr. Barbara Giesser, neurologist and MS specialist at the Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, CA, about this clinical trial.
She said that although clinicians were aware rituximab is a higher efficacy therapy than dimethyl fumarate for treating MS, this study provides a needed head-to-head comparison.
Additionally, Dr. Giesser said this study supports the case for clinicians to provide high-efficacy, disease-modifying therapy earlier for MS patients:
“In the most common form of multiple sclerosis, which is the relapsing-remitting form, the relapses are due to a lot of inflammatory activity. And we know that once you have inflammation and nerve damage early on, what’s lost is lost. So we want to try to prevent inflammation and nerve damage as soon as we can.”
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