Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS). It is hypothesized that CNS auto-reactive T cells are stimulated in the peripheral circulation to become active and proliferate, with subsequent migration into the CNS compartment. These cells, upon interacting with CNS myelin antigens, again proliferate and initiate a pro-inflammatory cascade within the brain that results in damage.
Magnetic resonance imaging (MRI) of the brain of MS patients allows clinicians to identify and monitor the development of the T1, T2, and gadolinium-enhancing lesions typical of MS. Advances in MRI technology have allowed a “deeper” look into the brain tissue, and have facilitated measurement of common MS processes such as demyelination and remyelination, lesion and brain volume changes, and CNS iron deposition.
PROMETRIKA biostatisticians and medical writers provided analyses and report writing for a pharmaceutical sponsor’s cutting edge research using advanced MRI techniques to assess the effects of an MS treatment on the brain tissue of patients. The normal-appearing brain tissue (NABT) of people affected by MS was compared to that of healthy controls. An increasing volume of NABT, as measured with a technique known as voxel-wise magnetization transfer ratio (VW-MTR), is believed to indicate remyelination of nerve cells. Of course, there should be little activity of remyelination in healthy controls because they are not losing myelin. Biostatisticians showed that VW-MTR was increasing in MS patients who had been treated for approximately 3 months compared to healthy controls. However, after 6 months of treatment, the VW-MTR increase in MS patients was not meaningfully different from the healthy controls. Additionally, decreasing VW-MTR in treated MS patients compared to healthy controls after 6 months was meaningfully greater, suggesting that the demyelination process was overcoming the remyelination process in MS patients, despite treatment.
These and other findings from this study have confirmed the astonishing reality that, in the brains of persons affected by MS, damage and destruction are occurring before there are visible lesions. This information directs continued research that may diagnose MS at early stages and predict the clinical course and treatment effects. PROMETRIKA plans to continue our associations with sponsors doing this important research.