PCORI Awards $20M to 4 Studies Comparing Current Drug and Rehab Therapies for MS

The National Multiple Sclerosis Society reported that the Patient-Centered Outcomes Research Institute (PCORI) has granted nearly $20 million in funding to four research projects assessing various multiple sclerosis (MS) therapies for their clinical effectiveness.

Two of the grants will cover studies comparing disease-modifying treatments, looking to identify differences in how effective the drugs are, as well as assessing their downsides. A third funded project will evaluate drugs to alleviate fatigue, and the fourth will assess whether MS patients living in rural or low-income areas benefit equally well from rehabilitation provided through phone or the internet as those with access to clinic-based rehabilitation.

All the projects are noteworthy for their patient engagement, a key focus of PCORI-funded research. MS patients, family caregivers and MS healthcare providers, such as nurses and physicians, will contribute to both the design and performance of the studies.

“These PCORI awards are a welcome and much-needed infusion of new MS research funding for important real-world questions about treatment strategies and their effectiveness,” Bruce Bebo, PhD, executive vice president of Research at the National MS Society, said in a news release.

“PCORI is delighted to make these new awards addressing crucial evidence gaps and questions of vital interest to the more than 400,000 people in the U.S. living with multiple sclerosis,” added Joe Selby, MD, MPH and executive director at PCORI. “These studies will provide significant new evidence to help patients, their families, and their clinicians decide more confidently which of the therapies available to them will work best given their needs and preferences.”

The design and selection of the four studies came from priorities identified at a 2015 workshop.  There, people with MS, their healthcare providers, scientists, government agencies, pharmaceutical industry representatives, and health insurers gathered to refine the questions that PCORI later used for their funding announcements. The session identified a number of evidence gaps and other issues put forward as top priorities by workshop participants — now addressed by these four research projects.

The first grant of $8.5 million went to a study that will explore if the biological drug Rituxan (rituximab) is more effective than other commonly used disease-modifying drugs for people with relapsing-remitting MS, also also compare side effects between drugs. The study will be based at Karolinska Institutet in Sweden and performed in partnership with healthcare insurance provider Kaiser Permanente Southern California.

Another $5.8 million goes to a project run by a research team from the University of Alabama at Birmingham, assessing whether patients in Alabama and Mississippi rural and low-income areas benefit as much from an exercise-based rehabilitation program delivered via internet or telephone, as when the therapy is provided in a clinic. Clinics providing such services in these areas are scarce, putting emphasis on alternative options.

Three drugs often used to relieve fatigue in people with MS will be evaluated in a study at the University of California at San Francisco that received $1.9 million. The drugs – Symmetrel (amantadine), Provigil (modafinil), and methylphenidate (known under several brand names, including Ritalin) – have rarely been compared side-by-side.

Finally, $3.3 million was awarded to a trial comparing benefits and side effects of the two oral disease-modifying treatments Gilenya (fingolimod) and Tecfidera (dimethyl fumarate). Again, the drugs have never been directly compared, and although the general view is that they are similarly effective, their side effects might differ. The trial will be led by a research team based at the Foundation of the Carlo Besta Neurological Institute in Italy, and will include study sites in the U.S., Europe, and Israel.

The MS grants were among 35 grants totaling $153 million to support research in various disease areas that were approved by PCORI’s Board of Governors last week.