Ibudilast Reduces Brain Shrinkage in Progressive MS in Phase 2 Trial

Treatment with ibudilast reduced the progression of brain atrophy in patients with progressive multiple sclerosis compared with a placebo.

An investigational multiple sclerosis (MS) therapy, ibudilast, reduced the progression of brain atrophy in patients with progressive MS, according to recent data from a phase 2 clinical trial.

The trial included 255 patients with primary or secondary progressive MS. Patients were randomized to take up to 10 capsules of ibudilast or a placebo per day for 96 weeks. Of the 255 patients enrolled, 129 were assigned to the ibudilast group and 126 to the placebo group. Fifty-three percent of patients who received ibudilast and 52% of patients in the placebo group had primary progressive disease.

All patients underwent MRI brain scans every 6 months and the researchers analyzed MRI images to assess the differences in brain changes between the 2 groups.

According to the findings, treatment with ibudilast slowed down the rate of brain shrinkage compared with the placebo group. The researchers found a difference of 0.0009 units of brain atrophy per year between both groups, which translates to approximately 2.5 milliliters of brain tissue, they noted.

Common adverse events reported by patients who received ibudilast included gastrointestinal symptoms, headache, and depression.

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“The trial’s results are very encouraging and point towards a potential new therapy to help people with progressive MS,” lead study investigator Robert J Fox, MD, neurologist at Cleveland Clinic, said in a press release. “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.”

The researchers noted that further research will test whether reducing brain shrinkage affects symptoms and loss of function associated with MS.

“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,” Walter J Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, said in a statement.

The study results were published in the New England Journal of Medicine.

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References

Fox RJ, Coffey CS, Conwit R, et al. Phase 2 trial of ibduilast in progressive multiple sclerosis. NEJM. 2018. Doi: 10.1056/NEJMoa1803583.

Study finds multiple sclerosis drug slows brain shrinkage [news release]. NIH’s website. https://www.ninds.nih.gov/News-Events/News-and-Press-Releases/Press-Releases/Study-finds-multiple-sclerosis-drug-slows-brain. Accessed August 30, 2018.