Ibudilast is better than placebo in slowing down brain shrinkage in the patients with progressive multiple sclerosis (MS), according to a Phase 2 Trial involving more than 250 participants with the disease. The study, published in the New England Journal of Medicine also showed that ibudilast was associated with higher rates of gastrointestinal side effects, depression and headache.
Robert J. Fox, a neurologist at Cleveland Clinic in Ohio, and colleagues conducted the study to investigate whether ibudilast was better than placebo in reducing the progression of brain atrophy, or shrinkage, in patients with progressive multiple sclerosis.
MS occurs when there is a breakdown of myelin, a fatty white substance wrapped around axons, which are long strands that carry messages from and between brain cells. When myelin starts to break down, communication between brain cells slows down, leading to muscle weakness and problems with movement, balance, sensation, and vision. MS can be relapsing-remitting, in which symptoms occur then disappear for weeks or months and then may reappear, or progressive, which is marked by a gradual decline in function.
In the study, 255 patients underwent randomization, 129 were assigned to ibudilast and 126 to placebo Every six months, the participants underwent MRI brain scans. The research team applied a variety of analysis techniques on the MRI images to assess differences in brain changes between the two groups.
- ibudilast slowed down the rate of brain atrophy compared to placebo.
- 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.
- , although both groups experienced atrophy, the brains of the patients in the placebo group shrank on average 2.5 milliliters more over two 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 trial’s results are very encouraging and point towards a potential new therapy to help people with progressive MS,” said Dr. Fox. “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,” concluded the authors.
For further information log on to 10.1056/NEJMoa1803583