Neurologist DeRen Huang M.D., Ph.D., of Licking Memorial Neurology served as the principal investigator during a therapeutic trial for an investigational medication for the treatment of Multiple Sclerosis.  The research from the trial was published in August in the prestigious New England Journal of Medicine.
 
The trial, Ublituximab versus Terflunomide in Relapsing Multiple Sclerosis, combined two phase 3 studies to include a patient enrollment of 1,089 patients diagnosed with relapsing-remitting Multiple Sclerosis (MS).  Phase 3 trials are the next to last stage of a multi-phase process to assess the safety and monitor side effects of new medications, and compare the new treatment to currently available options. 
 
MS is a progressive central nervous system disorder, which aside from trauma, is the most frequent cause of permanent disability in young adults.  Relapsing-remitting MS is characterized by a patient experiencing relapses and periods of stability in between relapses.  Relapses are episodes of new or worsening symptoms not caused by fever or infection lasting more than 48 hours.  Of the various types of MS, relapsing-remitting MS comprises 85 percent of those with the disease.
 
The cause of MS is not definitively known; however, it is believed to start as an immune-mediated disorder in which the body’s immune system attacks the central nervous system.  B-lymphocytes or B cells – a type of white blood cell that produces antibodies against viruses and bacteria – enter the brain and attack the myelin sheath that protects the nerves.
 
The investigational medication in the study is a monoclonal antibody – an engineered molecule that acts as a substitute antibody to restore, enhance, or mimic the immune system's attack on cells.  The antibody is directed to deplete the B cells to ease inflammation and slow nerve damage.
 
During Dr. Huang’s investigation, randomly assigned patients were divided into two groups – those treated with an established therapy, and those taking the investigational medication, Ubituximab.  Dr. Huang assessed patients to determine if the relapse rate throughout the year decreased, the number of MS type lesions evident on a magnetic resonance imaging (MRI) test by week 96 of the study, and evidence of clinical worsening of the disease at week 24 of the study.
 
The study demonstrated that the new medication, ublituximab, resulted in a lower annualized relapse rate and fewer brain lesions compared to the existing treatment.  The percentage of patients that experienced worsening of the disease was not statistically different in either group.  The researchers concluded that larger and longer trials are required to determine the efficacy and safety of ublituximab in patients with relapsing multiple sclerosis, including comparison with other disease-modifying treatments.