PCORI has identified multiple sclerosis (MS) as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies, aimed at changing specific symptoms or the overall course of MS, affect patients’ symptoms and quality of life. To address this issue, PCORI launched a funding initiative in 2015, Treatment of Multiple Sclerosis. This research project is one of the studies PCORI awarded as part this program.
COVID-19-Related Project Enhancement
Given the immunomodulatory nature of disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS) and the infection risk associated with some of these agents, patients with MS and the clinicians who treat them have many questions about the relative safety of various DMTs in the time of COVID-19 and the effects of these drugs on individuals who do become infected with SARS-CoV2.
The enhancements to this study aim assess the risk of adverse outcomes associated with COVID-19 in MS patients treated with different DMTs and assess the serological response to SARS-CoV2 infection, severity of infection, and clinical outcomes pre- and post-COVID-19.
Enhancement Award Amount: $475,400
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.
What is the research about?
About 400,000 Americans have MS. This health problem affects the brain and spinal cord. MS can cause fatigue, numbness, vision changes, bladder problems, and mobility issues. Relapsing-remitting MS is the most common form of MS. Patients with this type of MS have attacks, with new or worse symptoms, followed by periods when symptoms get better.
Although there is no cure for MS, medicines can reduce the number and seriousness of MS attacks for people with the most common type of MS. Previous studies have shown that rituximab, a drug approved to treat some cancers and other diseases, can also treat relapsing-remitting MS. However, the US Food and Drug Administration hasn’t approved this medicine for MS. Also, doctors don’t know how well this medicine or other commonly used MS medicines work over many years, or whether they are safe when patients take them for a long time.
Researchers want to know how rituximab and other medicines compare over many years at improving patients’ quality of life. They want to know if the medicines work differently for patients who were just diagnosed with MS than they do for patients whose illness is more advanced. They also want to know how safe or effective rituximab is compared with other treatments for patients who have already tried another MS medicine.
Who can this research help?
This research can help doctors and patients decide what medicine to try first to treat relapsing-remitting MS. This research can also help doctors and patients choose a new medicine if another medicine doesn’t work as hoped.
What is the research team doing?
The research team is studying information from a Swedish database of patients with MS. The team also is collecting information from patients in Southern California who have MS. Every year for at least three years, researchers collect information about patients’ overall health, their MS, and quality of life. Using the national database helps researchers understand how medicines affect MS symptoms for a large number of patients. Using the information from patients in Southern California helps researchers find out how safe the medicines are over time. The research team expects to include information from about 6,000 patients by the end of the study. Because some patients started taking MS medicines several years before joining the study, researchers have information about how MS medicines affect these patients’ symptoms for up to nine years.
Researchers are looking at how well the medicines prevent MS symptoms and maintain quality of life. Researchers are also looking at whether safety issues like dangerous side effects cause patients to stop taking MS medicines.
The research team is working with patients with MS, families, caregivers, patient organizations, neurologists, scientists, and neurology organizations in the United States and Sweden. The group provides advice about how to carry out the study and what to measure. For example, the group suggested that the researchers measure both patient disability and quality of life.
Research methods at a glance
|Design||Observational: cohort study|
|Population||Adults aged 18 years and older with relapsing-remitting MS in Sweden and Southern California|
Primary: disease progression, disease-related impact on quality of life
Secondary: safety, including serious adverse reactions, relapse rate, number of contrast-enhancing lesions; time on drug, treatment satisfaction, quality of life, fatigue, employment
|3- to 9-year follow-up for primary outcomes|
Treatment of Multiple Sclerosis