Drug May Slow Brain Atrophy in People with Progressive MS
Clinical trials indicate ibudilast could be effective in slowing the advancement of brain atrophy in progressive multiple sclerosis patients.
Progress is being made in trying to halt the progression of multiple sclerosis in some people.
Researchers reported recently that a repurposed drug significantly slowed the advance of brain atrophy in progressive multiple sclerosis patients.
Brain atrophy, or brain shrinkage, is an important aspect of multiple sclerosis (MS). It’s one of the most destructive consequences of the disease.
Brain atrophy can be seen in the earliest stages of MS and may lead to irreversible neurological and cognitive impairments.
The definitive results of the SPRINT-MS, phase II trial were published in the New England Journal of Medicine.
The report showed that the drug, ibudilast, decreased progression of brain atrophy in progressive MS patients by 48 percent when compared to participants who were given a placebo.
“These findings are significant for patients with progressive MS,” Dr. Robert Fox, the study’s principal investigator and vice chair for research in the Cleveland Clinic’s Neurological Institute, told Healthline. “Our hope is that the benefit of ibudilast in slowing brain shrinkage will also translate to decreased progression of associated physical disabilities in a future phase III trial.”
Ibudilast is approved in Japan and is used mostly for asthma and stroke prevention.
In addition to MS, recent evidence shows the drug’s potential in treating amyotrophic lateral sclerosis (ALS) as well as substance abuse/addiction.
It’s not yet approved for use in the United States.
“Ibudilast is known to have anti-inflammatory capabilities. It is reported that it has abilities to protect the nervous system from damage. And, it may promote myelin repair,” Bruce Bebo, executive vice president of research at the National Multiple Sclerosis Society, told Healthline.
“This makes it an interesting candidate for treating MS,” Bebo added.
The drug was tested years ago for relapsing-remitting multiple sclerosis (RRMS) and didn’t show a significant difference in clinical results.
But after focusing in on some of these studies, Bebo said ibudilast did have an effect on slowing down the rate of brain atrophy.
There are few treatments for primary progressive MS (PPMS) or secondary progressive MS (SPMS). RRMS has 16 treatments available.
“We think that it can help people with progressive MS,” Bebo said
What the study revealed
The SPRINT-MS study took 2 years and was conducted at 28 sites with 255 patients.
The Cleveland Clinic study was funded in part by the National MS Society and the National Institute of Neurological Disorders and Stroke for the NeuroNEXT Clinical Coordinating Center, part of the National Institutes of Health.
“This was a well-done, rigorous clinical trial,” Bebo said, “It showed a profound reduction in the brain shrinkage and atrophy, close to 50 percent.”
“There is a significant need for new treatment options to effectively delay disability progression for patients with progressive MS,” added Fox. “We are hopeful these findings will help us develop more therapies for progressive MS and do so more rapidly and efficiently.”
There needs to be at least one more clinical trial, a phase III study, in order for the drug to be approved for use on MS patients in the United States.
The effect of brain atrophy
Brain atrophy is important and can say a lot about an MS patient.
Researchers are taking a closer look at how shrinkage can best be examined in a clinical situation, such as regular neurological appointments.
Research has shown that brain atrophy is a better measurement tool for disability and cognitive impairment than focal lesions found on an MRI. And, if present, brain atrophy can be used to measure disease progression in MS patients.
But detecting brain atrophy is expensive and complicated for routine, clinical use. Evidence suggests that new software can predict atrophy based on data from routine MRIs, using specific calculations.
Studies have shown that brains of MS patients deteriorate at a faster-than-usual rate compared to people without the disease.
Other factors that contribute to increased brain atrophy in people living with MS include heart disease, hypertension, and level of education. Those with higher education are at less risk of brain atrophy.
Brain atrophy can cause cognitive decline, a major disabling result of MS. About half of patients with multiple sclerosis exhibit cognitive impairment that negatively affects their quality of life.
There’s some evidence that patients can do intellectual enrichment exercises to help prevent brain atrophy.
If ibudilast pans out as expected, patients can be relieved by the relatively mild side effects.
Those reported during the study included gastrointestinal (nausea, diarrhea, abdominal pain, and vomiting), rash, depression, and fatigue.
Editor’s note: Caroline Craven is a patient expert living with MS. Her award-winning blog is GirlwithMS.com, and she can be found on Twitter.