The anti-inflammatory drug ibudilast helped slow the progression of brain atrophy, or shrinkage, in patients with progressive multiple sclerosis, better than a placebo, suggest results from an NIH-funded study.
“These findings provide a glimmer of hope for people with a form of multiple sclerosis that causes long-term disability but does not have many treatment options,” says Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke (NINDS).
The study, published in The New England Journal of Medicine, was supported by the NINDS, part of the National Institutes of Health (NIH).
Robert J. Fox, MD, a neurologist at Cleveland Clinic in Ohio, led a team of researchers across 28 clinical sites in the brain imaging study.
A total of 255 patients were randomized to take up to 10 capsules of ibudilast or placebo per day for 96 weeks. Every 6 months, the participants underwent MRI brain scans. Fox’s team applied a variety of analysis techniques on the MRI images to assess differences in brain changes between the two groups, according to a media release from NIH.
According to the study, the researchers suggest that ibudilast slowed down the rate of brain atrophy compared to placebo. Fox and his colleagues discovered that there was a difference in brain shrinkage of 0.0009 units of atrophy per year between the two groups, which translates to approximately 2.5 milliliters of brain tissue.
In other words, although both groups experienced atrophy, the brains of the patients in the placebo group shrank on average 2.5 milliliters more over 2 years compared to the ibudilast group. The whole adult human brain has a volume of approximately 1,350 milliliters. However, it is unknown whether that difference had an effect on symptoms or loss of function.
There was no significant difference between the groups in the number of patients who reported adverse effects. The most common side effects associated with ibudilast were gastrointestinal, including nausea and diarrhea, as well as headaches and depression, the release explains.
“The trial’s results are very encouraging and point towards a potential new therapy to help people with progressive MS,” Fox says. “It also increased our understanding of advanced imaging techniques, so that future studies may require a smaller number of patients followed over a shorter period of time. This leads to increased efficiency of clinical research. These imaging methods may also be relevant to a host of other neurological disorders.”
Future research will test whether reducing brain shrinkage affects thinking, walking, and other problems in people with MS. In addition, future studies will examine whether ibudilast slows the progression of disability in MS patients, per the release.
[Source: National Institutes of Health]
