A new treatment for Multiple Sclerosis (MS) took a big step forward as the promising results of Phase III clinical trials for the drug Ocrelizumab revealed a significant decline in disease progression in human subjects.
The new study, published in The New England Journal of Medicine, shares the results of a nearly three-year trial for Ocrelizumab. The drug, manufactured by Genentech (brand name Ocrevus), specifically targets primary progressive MS, a form of the disease that accounts for roughly 15 percent of all cases of MS.
Currently, there is no available treatment for people with primary progressive MS, which is more likely to affect the spinal cord than other types of MS and often leads to difficulty walking and maintaining a job, according to the National MS Society.
But the new study offers hope. The study participants with primary progressive MS who took Ocrelizumab saw a 25 percent risk reduction in disease progression over six months and an 18 percent reduction in the rate of brain volume loss over more than two years.
Study participants taking Ocrelizumab also saw a slower decline in their functional walking ability and a reduction in the rate of developing brain lesions.
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“Ocrevus is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” said study author Dr. Xavier Montalban, a professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat in Barcelona, Spain.
Estimates show that some 400,000 people in the U.S. have MS, which means that approximately 60,000 people are afflicted with the primary progressive form of the disease. The new study means that a potential treatment may be on the horizon for thousands of people.
“Over the last decade, other molecules have tried and failed to demonstrate efficacy for [primary progressive MS], so the positive results for Ocrevus mark an important step in our understanding of this highly disabling form of the disease,” said Montalban.
Signs of Potential Treatment Prowess
The Phase III clinical trials for Ocrelizumab also showed positive results for other forms of MS, including relapsing forms which make up the majority of disease incidence.
“Ocrevus consistently and significantly reduced disease activity and disability progression compared with a standard-of-care high-dose interferon while demonstrating a favorable safety profile,” said fellow study author Dr. Stephen Hauser, Chair of the Scientific Steering Committee of the OPERA studies.
“The consistency of these pioneering data, the effect seen in these clinical studies and the favorable safety profile may support treating MS earlier with a high-efficacy disease-modifying medicine,” added Hauser.
Specifically, patients taking the drug saw up to a 47% reduction in relapse rate for these forms of MS over a two-year period, as well as a significant reduction of certain forms of lesions that are characteristic of MS.
Currently, there are more than a dozen medications on the market to treat MS. With the latest clinical trial results, the medical community is one step closer to adding another treatment to their arsenal and filling the large void facing those with the primary progressive form of the disease.
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Richard Scott is a health care reporter focusing on health policy and public health. Richard keeps tabs on national health trends from his Philadelphia location and is an active member of the Association of Health Care Journalists.