LOS ANGELES — A novel agent in development for treating relapsing-remitting multiple sclerosis (MS) significantly decreased the number of gadolinium-enhancing lesions that investigators saw on MRI at 1 year compared with baseline.
In 374 participants with available MRI data, the number of gadolinium-enhancing lesions decreased 80% compared with baseline, from a mean 1.5 to 0.3 (P < .0001), results show.
The study is the first to report clinical efficacy results in patients with relapsing-remitting MS treated with ALKS 8700.
This open-label, single-arm, phase 3 study assessing imaging results of gadolinium-enhancing lesion reduction after treatment “lends credence to ALKS 8700 as an oral treatment for relapsing-remitting multiple sclerosis,” Robert T Naismith, MD, associate professor of neurology at Washington University School of Medicine in St. Louis, Missouri, said during an emerging science session here at the American Academy of Neurology (AAN) 2018 Annual Meeting.
EVOLVE-MS-1 is an ongoing, 2-year study assessing the long-term safety and efficacy of ALKS 8700, a prodrug of monomethyl fumarate (the active metabolite of dimethyl fumarate). The US Food and Drug Administration approved oral dimethyl fumarate for treating relapsing-remitting MS. Previous studies of dimethyl fumarate in this population revealed that gastrointestinal (GI) effects were the most common adverse events. “The hypothesis is this has enhanced tolerability on the GI system,” Naismith said.
Researchers enrolled 528 adults with relapsing-remitting MS up until January 2018 in EVOLVE-MS-1. Mean age of the participants was 41 years, 72% were female, and the mean time since onset of MS was 9.7 years at baseline. About 93% of patients were white, and three quarters were previously treated for MS.
According to 1-year interim results of the phase 3 study, the proportion of the 374 patients who had no gadolinium lesions increased from 66% at baseline to 89% at 1 year. At the same time, the proportion with one to four gadolinium-enhancing lesions decreased from 26% to 10%, those with five to eight lesions dropped from 5% to 0.3%, and those with nine or more lesions decreased from 3.2% to 0.8%.
At 1 year, investigators observed new or enlarging T2 lesions in 8.6% of the 374 patients. They also found new T1 hypointense lesions in 5.6% of the imaging cohort
Lack of a control group and use of study endpoints considered exploratory are potential limitations of the study.
When asked to comment on the study, Paul George, MD, PhD, assistant professor of neurology at Stanford University School of Medicine in California, told Medscape Medical News that the findings demonstrate potential for this agent. “I think a lot of these MS-altering drugs are very exciting. This [study] shows a very positive reduction.”
“These are interim results, and I think the final analysis will also be interesting,” he added.
Alkermes Inc and Biogen are developing ALKS 8700 as an oral disease-modifying treatment for relapsing forms of MS.
Alkermes Inc funded the study. Naismith has received personal compensation for consulting/speaking with Acorda, Alkermes, Bayer, Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Teva. He also has received personal compensation in an editorial capacity for NEJM Journal Watch and research support from the National Institutes of Health and the National Multiple Sclerosis Society. George has disclosed no relevant financial relationships.
American Academy of Neurology (AAN) 2018 Annual Meeting. Emerging Science Abstract 006. Presented April 24, 2018.
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