Multiple sclerosis (MS) can be a devastating disease. It confuses the immune system and attacks the brain and spinal cord, causing numbness, weakness, and visual and cognitive problems.
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Later on, in the stage of disease called progressive MS, symptoms gradually worsen over time. A Cleveland Clinic-led NIH study suggests a new drug, ibudilast, has the potential to help the many patients who face gradually worsening disability during this stage.
“More than a dozen therapies work quite well in the early stages of MS. But we’ve had very few treatment options for patients with progressive MS,” says the study’s lead investigator, Robert Fox, MD, of the Mellen Center for Multiple Sclerosis. “These results point to a potential new therapy for progressive MS.”
They will likely pave the way for the larger studies required for FDA approval.
Ibudilast, an oral medication approved in Japan for treating asthma and symptoms that develop after a stroke, works through novel pathways that may protect nerve cells from damage.
Intermittent vs. progressive MS
In the early stages of MS, neurological symptoms come and go. About half of those with MS maintain this relapsing-remitting symptom pattern over time.
The other half with MS go on to develop progressive disease that gradually worsens over time and causes severe disability. (A small group of patients skip the relapsing-remitting stage and go straight to progressive MS.)
“One of the things we see in progressive MS is shrinkage of the brain. It is much faster than what we see in the normal, healthy adult brain,” notes Dr. Fox.
Impressive results with ibudilast
In this two-year study, ibudilast slowed progressive brain shrinkage by 48 percent when compared with placebo. That far exceeds the 18 percent reduction achieved with the first and only treatment approved for progressive MS: a chemotherapy drug called ocrelizumab.
The 28-center study involved 255 patients with progressive MS. Their mean age was 56. Half the patients received up to 100 milligrams of ibudilast, and half received a placebo. Participants were allowed to continue taking MS drugs, such as glatiramer acetate or interferon beta-1, throughout the study.
Every six months, five different types of imaging were performed to measure changes in brain volume and brain health. Researchers also looked at drug safety, disability and quality of life.
The ibudilast group had more gastrointestinal side effects, rash, depression and fatigue, but generally tolerated the drug well. “There was no increase in serious adverse events in those treated with ibudilast. It appears to be quite safe,” observes Dr. Fox.
MS research: What lies ahead
Additional study insights detailing ibudilast’s impact on the retinal nerves, the brain cortex and physical disability progression will be analyzed and published in the future.
“We hope to see that substantial slowing of brain shrinkage translates to a slowing of disability progression too,” says Dr. Fox.
It will probably take about five years before larger studies on ibudilast can confirm the drug’s promise. But researchers hope the innovative imaging studies used in this study will help shape future trials going forward.
“With this study, it looks like we’ve not only caught a nice fish, but we’ve also learned how to fish better,” Dr. Fox says. “This should help us develop more therapies for progressive MS — and to do so more quickly and efficiently.”
Ibudilast is also being studied as a potential treatment for amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease) and drug addiction.