In a new study published on April 11, investigators in Italy found that, in patients with relapsing-remitting multiple sclerosis (RRMS), the immune response to the Epstein-Barr virus (EBV) appeared to cycle simultaneously with their disease activity, meaning that when the virus was active, so was their MS.
The study, conducted by investigators at the Santa Lucia Foundation in Rome, Italy examined cytotoxic (CD8+) T-cells, which are cells that kill infected or abnormal cells in the body. They found an increased response to the antigens produced by active EBV in the blood of MS patients during relapses, as compared with samples taken during periods of remission. Antigens are substances that the body sees as foreign or harmful—including toxins from viruses like Epstein-Barr—and deploys an immune response to find and kill.
An international team has reported results of a small, early clinical trial involving 10 people with relapsing or secondary-progressive MS that tested the feasibility and preliminary safety of using a patient’s own altered blood cells to reduce immune responses against specific components of myelin, the nerve covering that is a key target of immune attacks in MS. They report that the treatment appeared safe and showed signs of reducing immune responses to myelin. Larger, longer trials of this approach would be needed to evaluate its safety and potential to treat multiple sclerosis. The study, by Roland Martin, MD (Institute of Neuroimmunology and Clinical MS Research, Hamburg and University Hospital Zürick) and colleagues including Stephen D. Miller, PhD (Northwestern University, Chicago), was published in the June 5, 2013 issue of Science Translational Medicine (5,188ra75 (2013). The trial was largely funded by the German Federal Ministry of Education and Research.
In proclaiming May as National Mental Health Awareness Month, President Barack Obama sought to “shine a light” on the mental health problems experienced by tens of millions of Americans. Emotional changes may be a major concern for people with MS. Clinical psychologist David Rintell, EdD (Brigham & Women’s Hospital, Boston) addresses these issues with people with MS in his practice, and has been funded by the National MS Society’s Health Care Delivery and Policy Research (HCDPR)program to study ways to help enhance mental health to people with MS.
Summary: Investigators nationwide are recruiting 60 people with all types of MS for a phase I study to determine the safety and tolerability of rHIgM22, an experimental antibody. The study is funded by Acorda Therapeutics, Inc.
Rationale: Although the body repairs some damage to nerve-insulating myelin that occurs in MS, this repair is insufficient. One strategy under study encourages internal “repair” capabilities of immune-system proteins called antibodies. With funding from the National MS Society, Moses Rodriguez, MD, and colleagues (Mayo Clinic Foundation, Rochester, MN) identified a human antibody -- rHIgM22 – that targets and attaches to oligodendrocytes (myelin-making cells). When given to mice with an MS-like disease, the antibodies promote myelin repair. This is the first study of rHIgM22 in humans.
Updated May 21, 2013: Based on the results reported below, Biogen Idec announced in a May 21 press release that it has submitted an application to the FDA for approval of peginterferon beta-1a for the treatment of relapsing forms of MS.
Biogen Idec announced that a phase III study of peginterferon beta-1a, injected under the skin either every two or four weeks, reduced the relapse rate significantly more than placebo in a study of 1500 people with relapsing MS, reaching the primary goal of the study. Peginterferon is a new formulation of the interferon beta-1a molecule which enables it to maintain effects in the body for longer periods of time. More data from this ongoing study, also called the ADVANCE study, will be presented at the American Academy of Neurology Annual Meeting in March. According to a press release, the company is planning to file for regulatory approval in the United States and European Union in 2013.